2016 shareholder meeting presentation final
TRANSCRIPT
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2016 ANNUAL MEETING OF STOCKHOLDERS
July 14, 2016
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FORWARD LOOKING STATEMENT
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future expectations, plans and prospects for the development and commercialization of the Company's product candidates, including patient enrollment in our clinical trials, present or future licensing, collaborative or financing arrangements, expected outcomes with regulatory agencies, and projected market opportunities for product candidates are subject to a number of risks, uncertainties and assumptions, including those identified under Risk Factors in the Companys most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings the Company periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. The Company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.
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DEVELOPMENT PIPELINE
Product Therapeutic Area Phase 1 Phase 2 Phase 3 BLA / NDA
Immunotherapy: Breast Cancer
NeuVax (nelipepimut-S) Node-positiveHER2 IHC 1+/2+
NeuVax + Herceptin Node-positive or node negative/triple negative HER2 IHC 1+/2+
NeuVax + Herceptin High risk, node-positive or negative, HER2 IHC 3+
NeuVax Ductal Carcinoma in Situ (DCIS)
Immunotherapy: Gastric Cancer
NeuVax Gastric, HER2 IHC 1+/2+/3+
Immunotherapy: Gynecological Cancer
GALE-301 Ovarian & Endometrial
GALE-301 + GALE-302 Ovarian & Breast
Hematology
GALE-401 (Anagrelide CR) MPN-related thrombocytosis
*NeuVax is an investigational product. Efficacy has not been established. Herceptin is a registered trademark of Genentech.
Ongoing Planned
VADIS
3
2b
StoppedPRESENT
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PRESENT CURRENT STATUS
IDMC recommend the trial stop for futility Study drug and all procedures have stopped
Investigation ongoing Compiled team with addition of outside experts and the Company
remains blinded to the data Operational elements under review include: Database and data analysis (programming) Randomization Manufacturing and packaging elements such as filling, labeling and
kit assembly Biology and immunology Anticipated timeline: up to 3 months or longer
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T-Cell
Activating Receptors Inhibitory Receptors
CD28
OX40
GITR
CD122
CD27
CD360
HVEM
CD137
CTLA-4
PD-1
TIM-3
BTLA
VISTA
LAG-3
IMMUNO-ONCOLOGY:UNLOCKING THE POWER OF THE T-CELL
5
Checkpoint inhibitors
Indirect Immune Modulators
Co-stimulators
Immune Inhibitory Enzymes
CAR TTechnology
TCRTechnology
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T-Cell
Activating Receptors Inhibitory Receptors
CD28
OX40
GITR
CD122
CD27
CD360
HVEM
CD137
CTLA-4
PD-1
TIM-3
BTLA
VISTA
LAG-3
LACK OF REACTIVE T-CELLS MAY RENDER SOME TOOLS INEFFECTIVE IN MANY CANCERS
6
Checkpoint inhibitors
Indirect Immune Modulators
Co-stimulators
Immune Inhibitory Enzymes
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T-Cell
CD28OX40
GITR
CD122
CD27
CD360
HVEM
CD137
CTLA-4
PD-1
TIM-3
BTLA
VISTA
LAG-3
Activating Receptors Inhibitory Receptors
OUR VACCINES STIMULATE T-CELL PROLIFERATION AND EXPANSION
7
T cells
Checkpoint inhibitors
Indirect Immune Modulators
Co-stimulators
Immune Inhibitory Enzymes
T cells
T cells
T cells
T cells
T cells
T cells
T cells
T cells
T cells
GALE-301
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NOVEL DEVELOPMENT STRATEGY: SECONDARY PREVENTION IN CANCER SURVIVORS
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RECEIVES PRIMARY TREATMENT
Surgery Chemotherapy and/or Radiation
Disease freesurvivor
Breast: HER2, 1+/2+25% recurrence rate in 3 yrs
No FDA Approved targeted therapies
Breast: HER2, 3+ High Risk20% recurrence rate
DECLAREDTO PREVENT RECURRENCE / METASTATIC DISEASE
Breast: Ductal Carcinoma in Situ8-10% progression to invasive
Ovarian Cancer~50% recurrence rate in 1 yr
No FDA Approved targeted therapies
Watch & Wait, or
Repetitive therapies
TOLD
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NEUVAX: DEVELOPMENT COLLABORATIONS
Phase Treatment HER2 Status Indication Trial StatusProtocol Defined
# of PatientsCollaborations
3Single agent
PRESENTStudy
1+, 2+BREAST
Node PositiveHLA A2+, A3+
STOPPED 700(enrolled 758)
2bCombination
with trastuzumab
1+, 2+
BREAST Node Positive or High Risk Node Negative
HLA A2+, A3+, A24+, A26+
EnrollingU.S. only
33 centers300
2Combination
with trastuzumab
3+ high risk
BREASTNode PositiveHLA A2+, A3+
EnrollingU.S. only
28 centers100
2 Single agentVADIS Study1+,
2+,3+
BREASTDuctal Carcinoma in
Situ (DCIS)HLA A2+
RecruitingU.S. only4 centers
48
2 Single agent 1+, 2+,3+GASTRIC
HLA A2+, A3+Planned
India Only 50
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Targeting Folate Binding Protein
GALE-301 & GALE-302
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GALE-301 & GALE-302:CURRENT CLINICAL DEVELOPMENT
11
Phase Treatment Cancer Type TargetIndicationCurrent Status
# of Enrolled Patients
1/2a GALE-301Ovarian,
EndometrialHLA A2+
Ovarian Enrolled 51
1b GALE-301 & GALE-302Ovarian, Breast
HLA A2+Ovarian /
Breast Enrolled 39
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GALE-301: OPTIMAL DOSE GROUP SHOWS PRELIMINARY EFFICACY
Source: Peoples, et. al, Poster Presentation, American Society of Clinical Oncology 2015 12
Phase 1/2a trial ongoing Phase 1: Determined optimal dose and
demonstrated safety and potent immune response
Phase 2a Preliminary data:
At 16 months median follow-up:
Overall recurrence rate was 44.8% in the VG versus 54.5% in the CG (p=0.58),
Recurrence rate of 23.5% in patients who received booster inoculations.
Two year DFS estimate in 1000 mcg dose group is 73.5% vaccine vs. 38.1% control (p=.03)
GALE-301 plus GM-CSF is well tolerated and elicits a strong in vivo immune response with primarily Grade 1 and Grade 2 toxicities
Estimated 24 months Disease Free Survival by Dosing Cohort
Chart1
0.3103448276
0.5
*p=0.17
% of Subjects
Recurrence
Demographics
Enroll DateDOBAge at EnrollCohortDosageBooster CohortBooster DoseTumor Size (cm)GradeCytology# pos nodedStatusStatus CommentDate offRecurrence TypeLast VaxVax Date
NV005V15/24/127/10/6250Group 1100mcg E39 + 250mcg GM-CSF13poorlypositivenaCompletePt recurred with primary cancer11/7/13TreatedV612/4/12
NV033V23/29/126/19/5161Group 1100mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF8poorlypositive1
NV015V39/21/126/22/5656Group 1100mcg E39 + 250mcg GM-CSF3poorlypositive0CompletePt recurred with primary cancer12/18/13TreatedV62/4/13
NV009V411/27/123/13/4271Group 2500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF5.5poorlyunknownnaCompletePt recurred with primary cancer3/18/14Treated
NV025V511/29/127/18/5656Group 2500mcg E39 + 250mcg GM-CSF6.5poorlypositive0CompletePt recurred with primary cancer2/7/13EarlyV32/5/13
NV032V612/3/121/11/5360Group 2500mcg E39 + 250mcg GM-CSFArm 1500mcg E39 + 250mcg GM-CSF6poorlypositive1
NV030V71/24/132/20/4073Group 3500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF15moderatenegative0
NV016V82/11/139/28/5557Group 31000mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF3.5well-differentiatedpositive
NV054V93/4/138/2/3875Group 31000mcg E39 + 250mcg GM-CSFArm 1500mcg E39 + 125mcg GM-CSFcannot be determinedpoorlyunknown
NV060V105/2/132/23/5261OBD500mcg E39 + 250mcg GM-CSF1.7moderateunknown0Off TreatmentIntercurrent Illness8/16/13(patient hospitalized for NSTEMI and subsequent CABG)
NV061V115/23/137/23/5261OBD500mcg E39 + 250mcg GM-CSF7.3poorlypositive0CompletePt recurred with primary cancer7/10/13EarlyV27/9/13
NV062V125/30/139/23/6449OBD500mcg E39 + 250mcg GM-CSF3poorlyunknown1CompletePt recurred with primary cancer3/7/14Treated
NV070V137/11/137/21/4568OBD500mcg E39 + 250mcg GM-CSF4.5poorlynegative0CompletePt recurred with primary cancer12/23/13TreatedV611/18/13
NV064V146/3/136/14/3974OBD500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF3poorlyunknown4
NV065V156/4/135/11/4271OBD500mcg E39 + 250mcg GM-CSF8moderatepositive3CompletePt recurred with primary cancer11/14/13TreatedV610/1/13
NV100V1612/30/134/6/5163OBD500mcg E39 + 250mcg GM-CSF7poorlypositivena
NV101V172/3/147/16/5955OBD500mcg E39 + 250mcg GM-CSF11.5moderatenegative3
NV102V182/24/1410/12/7340OBD1000mcg E39 + 250mcg GM-CSFperitoneal carcinomatosispoorlyunknown13
NV103V192/27/148/29/4766OBD1000mcg E39 + 250mcg GM-CSF9well-differentiatednegative0
NV104V203/24/145/28/7539OBD1000mcg E39 + 250mcg GM-CSF10poorlyunknown0
NV105V215/5/144/29/5361OBD1000mcg E39 + 250mcg GM-CSF8poorlypositive19Off StudyWithdrawn5/8/14
NV106V224/25/142/26/6252OBD1000mcg E39 + 250mcg GM-CSF6poorlyatypical cells0
NV107V235/19/1410/5/4767OBD1000mcg E39 + 250mcg GM-CSF10poorlypositivena
NV108V246/3/149/29/5955OBD1000mcg E39 + 250mcg GM-CSF8.5poorlypositivena
NV109V256/16/146/25/3876OBD1000mcg E39 + 250mcg GM-CSF3.5poorlyunknown0
NV0279/13/121/11/5063controlNApoorlyatypical cells3CompletePt recurred with primary cancer8/22/13
NV0315/5/124/10/5656control4poorlypositive4CompletePt recurred with primary cancer11/28/12
WR02312/5/117/22/6942control9poorly0CompletePt has completed 18 months on trial12/19/13
NV0083/23/126/10/7042control10poorlypositiveNACompletePt recurred with primary cancer11/1/12
NV0189/19/1210/25/5359control14poorlypositivenaCompletePt recurred with primary cancer6/4/14
NV0363/23/128/10/4666control15poorlypositiveNACompletePt recurred with primary cancer10/26/12
NV0201/8/132/23/7439control10well-differentiatedunknownNAOff StudyWithdrawn: Pt refuses participation in control group1/9/13
NV0291/24/135/3/4271control11poorlyunknownnaOff StudyWithdrawn: screen failure1/25/13
NV0012/12/1311/4/5854control7.5poorlyatypical cellsnaCompletePt recurred with primary cancer6/13/14
NV0232/14/1310/11/5062controlnot measurablepoorlypositive1CompletePt recurred with primary cancer8/16/13
NV0131/23/133/15/6647control8well-differentiatedunknown0
NV0112/28/132/17/5063control5poorlyunknownnaCompletePt recurred with primary cancer10/14/13
NV0636/25/139/8/3776control5.2poorlypositivena
NV0666/26/136/13/6152control9.5poorlypositivenaCompletePt recurred with primary cancer11/14/13
NV0676/25/139/27/5162control8poorlypositivena
NV0687/3/135/9/5954control8poorlypositive0
NV0982/10/145/8/5163control10poorlynegative0
NV0992/6/147/4/5361control12poorlypositive0
NV0973/27/144/4/6153control1.5poorlypositive0
NV0964/8/142/1/4866control3.5poorlypositive0CompletePt recurred with primary cancer6/13/14
NV0955/8/143/8/4965control5moderateunknown1
NV0946/4/143/4/2886control5moderateunknown2
AgeSizePoorly graded, mod, wellCytologyNodesStage IIIStage IIStage IStage IV
Vac6119,4,212 pos2.515334
Cont5918,2,212 pos0.916666666711335
pvalue10.33672648630.73,0.67, 10.770.2308385170.56110.714
Demographics
VaccinatedControl
n2522
Age (mean)6159p=1
Nodes30.92p=0.23
Poor Grade1918p=0.73
Mod Grade42p=0.67
Well Differentiated22p=1
Stage I33p=1
Stage II33p=1
Stage III1511p=0.56
Stage IV45p=0.714
Laura:diffuse cannot be determined
Path_Stage
Study IDSyncronous 1* Malignancies1* SiteFIGOTNMMetastasis LocationHistologyEpithelial1Epithelial2Epithelial3Endometrial1
NV005V1NoOvarianIIIC3cNxM1transverse 2nd sigmoid colonOvarianAdenocarcinoma
NV0033V2NoOvarianIIIC3bN1MxOvarianPapillary Serous Carcinoma
NV015V3NoOvarianIIIC3cNxMxOvarianEndometrioid CystoadenocarcinomaMixed Epithelial TumorPapillary Serous Carcinoma
NV009V4NoOvarianIIIC3cNxM0OvarianSerous Cystoadenocarcinoma
NV025V5NoOvarianIC1cN0MxOvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor
NV032V6NoOvarianIIIC3cN1M0OvarianSerous Cystoadenocarcinoma
NV030V7NoOvarianIIA1aN0M0OvarianEndometrioid Cystoadenocarcinoma
NV016V8NoOvarianIIIA3aNxM1Gall BladderOvarianSerous Cystoadenocarcinoma
NV054V9NoOvarianIIB2bNxMxOvarianMixed Epithelial Tumor
NV060V10NoEndometrialIV4N0M1PulmonaryEndometrialEndometriod Adenocarcinoma
NV061V11NoOvarianIIIC3CNxMxOvarianSerous Cystoadenocarcinoma
NV062V12NoPeritonealIIIC3cN1MxPrimary PeritonealSerous CystoadenocarcinomaClear Cell Cystoadenocarcinoma
NV070V13NoEndometrialIIIC11aN1M0EndometrialCarcinosarcoma
NV064V14NoFallopian TubeIIIC1aN1MxFallopian tubeSerous Cystoadenocarcinoma
NV065V15NoOvarianIIIC3CN1MxOvarianSerous Cystoadenocarcinoma
NV100V16NoOvarianIIIC3cNxMxOvarianSerous Cystoadenocarcinoma
NV101V17NoEndometrialIVB4N2M1PulmonaryEndometrialEndometrioid Adenocarcinoma
NV102V18NoPeritonealIV4N2(13)M1LO, RO, liver parenchyma, splenic serosa, peripancreatic LN, pericecal adispose tissue, anterior abdominal wall fascia & subcutaneous tissue, uterine serosa, omentumPrimary PeritonealSerous Cystoadenocarcinoma
NV103V19NoOvarianIC1cN0MxOvarianEndometrioid Cystoadenocarcinoma
NV104V20NoOvarianIIIC3cN0M0OvarianSerous Cystoadenocarcinoma
NV105V21NoOvarianIV4N2M1SpleenOvarianSerous Cystoadenocarcinoma
NV106V22NoOvarianIICTxNxMxOvarianClear cell cystoadenocarcinoma
NV107V23NoOvarianIIIC3cNxMxOvarianSerous Cystoadenocarcinoma
NV108V24NoOvarianIIIC3cNxMxOvarian
NV109V25NoEndometrialIA1aN0MxEndometrialEndometrioid Adenocarcinoma
NV008NoOvarianIIIC3bNxMxOvarianCarcinosarcoma
NV018NoOvarianIIIB3bN0MxOvarianSerous Cystoadenocarcinoma
NV020NoOvarianIA1aNxMxOvarianMucinous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor
NV027NoEndometrialIVB3bN2M1IntraperitonealEndometrialEndometrioid Adenocarcinoma
NV031NoOvarianIV4NxM1skin implants in abdominal wall where intraperitoneal port would be placedOvarianSerous Cystoadenocarcinoma
NV036NoOvarianIIIC3cNxMxOvarianCarcinosarcoma
WR023NoOvarianIC1cNxMxOvarianSerous CystoadenocarcinomaEndometrioid Cystoadenocarcinoma
NV029NoOvarianIIIC3cNxM0OvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor
NV023NoOvarianIV3cN1M1Cardiophrenic LNOvarianSerous Cystoadenocarcinoma
NV013NoOvarianIIC2cN0M0OvarianSexcord Stromal
NV001NoOvarianIA1aNxMxOvarianClear cell cystoadenocarcinoma
NV011NoOvarianIV4NxM1lungsOvarianSerous Cystoadenocarcinoma
NV063NoOvarianIIIC2cNxMxOvarianSerous Cystoadenocarcinoma
NV066NoOvarianIIIB3bNxM0OvarianClear cell cystoadenocarcinoma
NV067NoOvarianIIIC3cNxMxovarianSerous Cystoadenocarcinoma
NV068NoOvarianIIC2cN0MxOvarianSerous Cystoadenocarcinoma
NV098NoOvarianIIIB3bNxMxOvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor
NV099NoOvarianIIIC3cN0MxOvarianSerous Cystoadenocarcinoma
NV097NoOvarianIIIB3bNxMxOvarianSerous Cystoadenocarcinoma
NV096NoOvarianIIB2bN0MxOvarianSerous Cystoadenocarcinoma
NV095NoEndometrialIV4N1M1Hernia and omentumEndometrialEndometrioid Adenocarcinoma
NV094NoEndometrialIIIC3bN2MxEndometrialEndometrioid Adenocarcinoma
DTH
R0 E39RO NSSR6 E39R6 NSSR0 E39RO NSSR6 E39R6 NSSR0R6
NV005V113.50480n242414147.145833333315.8214285714
NV033V24000median20130
NV015V37.509.50mean7.14583333332.1915.82142857145.5357142857
NV009V440230Stdev8.363324654415.7182000619
NV025V500Count2414
NV032V6162.52622.5Sqrt4.89897948563.7416573868
NV030V718.50250SEM1.70715649644.2008656692
NV016V8210390
NV054V91701100.0723360654
NV060V1000
NV061V1117.50
NV062V1215000
NV070V13020015
NV064V1418301520
NV065V1519.5000
NV100V160000
NV101V17002520
NV102V1800
NV103V1900
NV104V2000
NV105V2100
NV106V2200
NV107V2300
NV108V2400
joyceog wendynew wendy
NV030V72523.518.5
NV016V822.52621
NV054V923.52717
Laura:off study
Laura:off study
Laura:off treatment
DTH
1.7071564964
4.20086566924.2008656692
Orthogonal Mean (mm)
E39 DTH Response (mm)
Local Reaction
R0R1R2R3R4R5B1
NV015V33884.515077.550105Vax 1Vax 2Vax 3Vax 4Vax 5Vax 6B1
NV005V152.5101.5106171200210.5n1515141212125
NV033V228143.5137154.514165median42.56982.59495100.7597.5
NV009V41483.5120.512861127.5103.5mean45.565217391371.904761904893.3947368421105.470588235395.4666666667102.357142857197.25
NV25V50087
NV032V6759103134.510011491.5
NV030V749113190136102126135
NV016V842.578.579147.51219875.5Vax 1Vax 2Vax 3Vax 4Vax 5Vax 6Booster 1
NV054V951.592.5112.58897.5112103.5median42.56982.59495100.7597.25
NV060V1073.59846.5
NV061V117062.5
NV062V127059.581.594111.510374.5
NV070V13456963.564.576.545
NV064V146845.572.57274.574
NV065V15113.584.582.5105.56258.5
NV100V163547.570.58675.598.5
NV101V173864.593.586.59596
NV102V184085.55869
NV103V1954505672.564.5
NV104V20264265106
NV105V21did not present
NV106V2233.545.5
NV107V2382
NV108V2417
0.00388804070.05145904570.30687968230.44061529060.63902523620.72097308930
Mean45.565217391371.904761904893.3947368421105.470588235395.4666666667102.357142857197.25
Stdev26.169163127930.399267691736.368705620933.46755452538.274603042939.816129593722.4805471464
Count2321191715146
Sqrt4.79583152334.5825756954.35889894354.12310562563.87298334623.74165738682.4494897428
SEM5.4566477166.63366406048.34355328998.11707425529.882460011210.64130824349.1776449412
0.02345634050.5131632142
0.04717082220.7605079717
Laura:recurrence/off study
Laura:no dose reduction
Laura:off study
Laura:OFF TX
Local Reaction
5.4566477165.456647716
6.63366406046.6336640604
8.34355328998.3435532899
8.11707425528.1170742552
9.88246001129.8824600112
10.641308243410.6413082434
9.17764494129.1776449412
*
Orthogonal Mean (mm)
E39 Local Reaction
Max Toxicity
Max ToxicityLocal GradeSystemic Grade
NV015V3VAX#11Induration0No adverse eventLocalSystemic0123401234
NV015V3VAX#21Erythema0No adverse eventNV015V3110%96%4%0%0%9%56.5%26.1%4.30%4.30%
NV015V3VAX#21PruritusNV005V112red numbers are for graph purposes only
NV015V3VAX#21IndurationNV033V211
NV015V3VAX#31Erythema0No adverse eventNV009V411
NV015V3VAX#31PruritusNV025V511
NV015V3VAX#31IndurationNV032V611
NV015V3VAX#41Induration1FatigueNV030V712
NV015V3VAX#41Pruritus1MalaiseNV016V811
NV015V3VAX#41ErythemaNV054V912
NV015V3VAX#51Erythema0No adverse eventNV060V1013possibly related
NV015V3VAX#51PruritusNV061V1110
NV015V3VAX#51IndurationNV062V1211
NV015V3VAX#61Erythema0No adverse eventNV070V1312
NV015V3VAX#61PruritusNV064V1412
NV015V3VAX#61IndurationNV065V1522
NV005V1VAX#11Induration1HeadacheNV100V1611
NV005V1VAX#11FlushingNV101V1711
NV005V1VAX#21Erythema1FlushingNV102V1814possibly related
NV005V1VAX#21PruritusNV103V1911
NV005V1VAX#21IndurationNV104V2011
NV005V1VAX#31Erythema1NauseaNV16V8 had a grade 3 SAE for low WBC, but the attribution is unlikely related, so it isn't includedNV106V2211
NV005V1VAX#31Pruritus1FlushingNV107V2310
NV005V1VAX#31IndurationNV108V2411
NV005V1VAX#41Erythema1Arthralgias
NV005V1VAX#41Pruritus2Joint Effusion
NV005V1VAX#41Induration
NV005V1VAX#51Erythema1Arthralgias
NV005V1VAX#51Pruritus1Joint Effusion
NV005V1VAX#51IndurationGradeLocalSystemic
NV005V1VAX#61Erythema1Arthralgias000.00%28.7%
NV005V1VAX#61Pruritus12296%1356.5%
NV005V1VAX#61Induration214%626.1%
NV033V2VAX#11Induration1Fatigue300%14.3%
NV033V2VAX#11Erythema400%14.3%
NV033V2VAX#11Pruritus2323
NV033V2VAX#21Erythema1Flushing
NV033V2VAX#21Pruritus
NV033V2VAX#21Induration
NV033V2VAX#31Erythema1Headache
NV033V2VAX#31Pruritus1Dizziness
NV033V2VAX#31Induration
NV033V2VAX#41Erythema0No adverse event
NV033V2VAX#41Pruritus
NV033V2VAX#41Induration
NV033V2VAX#51Erythema0No adverse event
NV033V2VAX#51Pruritus
NV033V2VAX#51Induration
NV033V2VAX#61Erythema0No adverse event
NV033V2VAX#61Pruritus
NV033V2VAX#61Induration
NV009V4VAX#11Pruritus0No adverse event
NV009V4VAX#11Induration
NV009V4VAX#21Erythema1Arthralgias
NV009V4VAX#21Pruritus
NV009V4VAX#21Induration
NV009V4VAX#31Erythema1Bone Pain
NV009V4VAX#31Induration1Fatigue
NV009V4VAX#31Pruritus1Headache
NV009V4VAX#41Erythema0No adverse event
NV009V4VAX#41Pruritus
NV009V4VAX#41Induration
NV009V4VAX#51Erythema1Bone Pain
NV009V4VAX#51Induration1Headache
NV009V4VAX#61Erythema1Headache
NV009V4VAX#61Pruritus
NV009V4VAX#61Induration
NV009V4Booster#11Erythema1Arthralgias
NV009V4Booster#11Pruritus1Back Pain
NV009V4Booster#11Induration1Fatigue
NV025V5VAX#11Erythema1Diarrhea
NV025V5VAX#11GI pain
NV025V5VAX#21Erythema0No adverse event
NV025V5VAX#21Pruritus
NV025V5VAX#2
NV025V5VAX#31Erythema0No adverse event
NV025V5VAX#31Pruritus
NV025V5VAX#31Induration
NV032V6VAX#11Erythema1Back Pain
NV032V6VAX#11Pruritus1Diarrhea
NV032V6VAX#11Induration
NV032V6VAX#21Erythema1Back Pain
NV032V6VAX#21Pruritus
NV032V6VAX#21Induration
NV032V6VAX#31Erythema0No adverse event
NV032V6VAX#31Pruritus
NV032V6VAX#31Induration
NV032V6VAX#41Erythema1Fatigue
NV032V6VAX#41Induration1Headache
NV032V6VAX#41Nausea
NV032V6VAX#51Erythema0No adverse event
NV032V6VAX#51Induration
NV032V6VAX#51Bruising
NV032V6VAX#61Erythema0No adverse event
NV032V6VAX#61Induration
NV032V6Booster#11Erythema1Bone Pain
NV032V6Booster#11Pruritus
NV032V6Booster#11Induration
NV030V7VAX#11Erythema0No adverse event
NV030V7VAX#11Induration
NV030V7VAX#11Bruising
NV030V7VAX#21Erythema0No adverse event
NV030V7VAX#21Pruritus
NV030V7VAX#21Induration
NV030V7VAX#21Burning
NV030V7VAX#31Erythema0No adverse event
NV030V7VAX#31Pruritus
NV030V7VAX#31Induration
NV030V7VAX#41Erythema0No adverse event
NV030V7VAX#41Pruritus
NV030V7VAX#41Induration
NV030V7VAX#51Erythema0No adverse event
NV030V7VAX#51Pruritus
NV030V7VAX#51Induration
NV030V7VAX#61Erythema0No adverse event
NV030V7VAX#61Pruritus
NV030V7VAX#61Induration
NV030V7Booster#11Erythema1Neuropathy
NV030V7Booster#11Pruritus1Arthralgias
NV030V7Booster#11Induration1Headache
NV030V7Booster#11Malaise
NV030V7Booster#12Maculo-papular rash
NV016V8VAX#11Induration1Headache
NV016V8VAX#21Induration1Headache
NV016V8VAX#21Pruritus
NV016V8VAX#31Induration1Headache
NV016V8VAX#31Pruritus
NV016V8VAX#31Induration
NV016V8VAX#41Erythema1Headache
NV016V8VAX#41Pruritus1Nausea
NV016V8VAX#41Induration1Neuropathy
NV016V8VAX#41Dizziness
NV016V8VAX#41Insomnia
NV016V8VAX#51Erythema0No adverse event
NV016V8VAX#51Pruritus
NV016V8VAX#51Induration
NV016V8VAX#61Erythema0No adverse event
NV016V8VAX#61Pruritus
NV016V8VAX#61Induration
NV016V8Booster#11Erythema1Neuropathy
NV016V8Booster#11Pruritus
NV016V8Booster#11Induration
NV054V9VAX#11Erythema0No adverse event
NV054V9VAX#11Induration
NV054V9VAX#11Bruising
NV054V9VAX#21Erythema0No adverse event
NV054V9VAX#21Pruritus
NV054V9VAX#21Induration
NV054V9VAX#31Erythema2Neuropathy
NV054V9VAX#31Pruritus
NV054V9VAX#31Induration
NV054V9VAX#41Erythema2Neuropathy
NV054V9VAX#41Pruritus
NV054V9VAX#41Induration
NV054V9VAX#51Erythema2Neuropathy
NV054V9VAX#51Pruritus
NV054V9VAX#51Induration
NV054V9VAX#61Erythema0No adverse event
NV054V9VAX#61Pruritus
NV054V9VAX#61Induration
NV054V9Booster#11Erythema0No adverse event
NV054V9Booster#11Pruritus
NV054V9Booster#11Induration
NV060V10VAX#11Erythema1Arthralgias
NV060V10VAX#11Induration2Fatigue
NV060V10VAX#11Pruritus2Headache
NV060V10VAX#11Malaise
NV060V10VAX#11Dizziness
NV060V10VAX#21Induration1Arthralgias
NV060V10VAX#21Pruritus1Fatigue
NV060V10VAX#21Erythema2Headache
NV060V10VAX#21Nausea
NV060V10VAX#31Erythema1Arthralgias
NV060V10VAX#31Pruritus1Fatigue
NV060V10VAX#31Induration1Headache
NV060V10VAX#31Myalgias
NV060V103Cardiac disorder
NV061V11VAX#11Pruritus0No adverse event
NV061V11VAX#11Induration
NV061V11VAX#21Erythema0No adverse event
NV061V11VAX#21Induration
NV061V11VAX#21Pruritus
NV062V12VAX#11Induration1Bone Pain
NV062V12VAX#11Fatigue
NV062V12VAX#11Malaise
NV062V12VAX#11Myalgias
NV062V12VAX#11Nausea
NV062V12VAX#21Erythema0No adverse event
NV062V12VAX#21Induration
NV062V12VAX#21Pruritus
NV062V12VAX#31Erythema0No adverse event
NV062V12VAX#31Induration
NV062V12VAX#31Pruritus
NV062V12VAX#41Erythema1Headache
NV062V12VAX#41Induration1Malaise
NV062V12VAX#41Pruritus
NV062V12VAX#51Erythema1Headache
NV062V12VAX#51Pruritus1Malaise
NV062V12VAX#51Induration
NV062V12VAX#61Erythema1Fatigue
NV062V12VAX#61Pruritus
NV062V12VAX#61Induration
NV070V13VAX#11Erythema1Fatigue
NV070V13VAX#11Induration1Headache
NV070V13VAX#11Nausea
NV070V13VAX#21Erythema1Fatigue
NV070V13VAX#21Pruritus
NV070V13VAX#21Induration
NV070V13VAX#21Pain
NV070V13VAX#31Erythema1Arthralgias
NV070V13VAX#31Pruritus2Fatigue
NV070V13VAX#31Induration1Headache
NV070V13VAX#31Pain at site
NV070V13VAX#41Erythema1Arthralgias
NV070V13VAX#41Pruritus1Fatigue
NV070V13VAX#41Induration1Headache
NV070V13VAX#41Pain at site
NV070V13VAX#51Erythema1Arthralgias
NV070V13VAX#51Pruritus2Fatigue
NV070V13VAX#51Induration1Headache
NV070V13VAX#51Pain at site
NV070V13VAX#61Erythema1Arthralgias
NV070V13VAX#61Pruritus2Fatigue
NV070V13VAX#61Induration1Headache
NV070V13VAX#61Pain at site
NV064V14VAX#11Erythema0No adverse event
NV064V14VAX#11Induration
NV064V14VAX#11Pruritus
NV064V14Delayed2DUR: Urticarial lesion (Left buttock)
NV064V14VAX#21Erythema0No adverse event
NV064V14VAX#21Induration
NV064V14VAX#21Pruritus
NV064V14VAX#21Bruising
NV064V14VAX#31Erythema0No adverse event
NV064V14VAX#31Induration
NV064V14VAX#31Pruritus
NV064V14VAX#41Erythema0No adverse event
NV064V14VAX#41Pruritus
NV064V14VAX#41Induration
NV064V14VAX#51Erythema0No adverse event
NV064V14VAX#51Pruritus
NV064V14VAX#51Induration
NV064V14VAX#61Erythema0No adverse event
NV064V14VAX#61Pruritus
NV064V14VAX#61Induration
NV064V14Delayed2DUR: Urticarial lesion (Left buttock)
NV064V14Booster#11Erythema1Headache
NV064V14Booster#11Induration
NV065V15VAX#11Erythema1Fatigue
NV065V15VAX#11Pruritus
NV065V15VAX#11Induration
NV065V15VAX#21Erythema1Fatigue
NV065V15VAX#21Pruritus
NV065V15VAX#21Induration
NV065V15VAX#31Erythema1Fatigue
NV065V15VAX#31Pruritus
NV065V15VAX#31Induration
NV065V15VAX#42Erythema2Fatigue
NV065V15VAX#42Pruritus2Headache
NV065V15VAX#51Erythema1Arthralgias
NV065V15VAX#51Pruritus1Chills
NV065V15VAX#51Induration1Fatigue
NV065V15VAX#51Headache
NV065V15VAX#61Erythema1Arthralgias
NV065V15VAX#61Pruritus1Fatigue
NV065V15VAX#61Induration1Headache
NV0100V16VAX#11Erythema1Back Pain
NV0100V16VAX#11Pruritus1Malaise
NV0100V16VAX#11Induration
NV0100V16VAX#21Induration1Fatigue
NV100V16VAX#31Erythema1Malaise
NV100V16VAX#31Pruritus
NV100V16VAX#31Induration
NV100V16VAX#41Erythema1Abdominal pain
NV100V16VAX#41Pruritus
NV100V16VAX#41Induration
NV100V16VAX#51Erythema0No adverse event
NV100V16VAX#51Induration
NV100V16VAX#61Erythema0No adverse event
NV100V16VAX#61Induration
NV0101V17VAX#11Pruritus0No adverse event
NV0101V17VAX#11Induration
NV0101V17VAX#21Pruritus0No adverse event
NV0101V17VAX#21Induration
NV0101V17VAX#31Erythema1Neuropathy
NV0101V17VAX#31Pruritus
NV0101V17VAX#31Induration
NV0101V17VAX#31Pain at site
NV0101V17VAX#41Erythema0No adverse event
NV0101V17VAX#41Pruritus
NV0101V17VAX#41Induration
NV0101V17VAX#51Erythema0No adverse event
NV0101V17VAX#51Induration
NV0101V17VAX#61Erythema0No adverse event
NV0101V17VAX#61Pruritus
NV0101V17VAX#61Erythema
NV102V18VAX#11Induration2Fatigue
NV102V18VAX#12Fever
NV102V18VAX#12Headache
NV102V18VAX#12Malaise
NV102V18VAX#21Erythema1Fatigue
NV102V18VAX#21Pruritus1Fever
NV102V18VAX#21Induration1Malaise
NV102V18VAX#24Sepsispossiblydelayed
NV102V18VAX#31Erythema1Fatigue
NV102V18VAX#31Induration
NV102V18VAX#24Cellulitispossiblydelayed
NV102V18VAX#41Erythema0No adverse event
NV102V18VAX#41Pruritus
NV102V18VAX#41Induration
NV103V19VAX#11Erythema0No adverse event
NV103V19VAX#11Induration
NV103V19VAX#21Erythema0No adverse event
NV103V19VAX#21Induration
NV103V19VAX#21Discomfort
NV103V19VAX#31Erythema0No adverse event
NV103V19VAX#31Induration
NV103V19VAX#41Erythema1Chills
NV103V19VAX#41Induration
NV103V19VAX#51Erythema0No adverse event
NV103V19VAX#51Pruritus
NV103V19VAX#51Induration
NV104V20VAX#11Induration1Chills
NV104V20VAX#11Neuropathy
NV104V20VAX#11Nausea
NV104V20VAX#21Erythema0No adverse event
NV104V20VAX#21Pruritus
NV104V20VAX#21Induration
NV104V20VAX#31Erythema0No adverse event
NV104V20VAX#31Induration
NV104V20VAX#41Erythema1Chills
NV104V20VAX#41Pruritus1Headache
NV104V20VAX#41Induration
NV106V22VAX#11Induration0No adverse event
NV106V22VAX#21Induration1Bone Pain
NV106V22VAX#21Fatigue
NV107V23VAX#11Erythema0No adverse event
NV107V23VAX#11Induration
NV108V24VAX#11Induration1Headache
NV108V24VAX#11Bruising
Laura:delayed
Laura:possibly related
Laura:possibly related
Max Toxicity
% of Subjects
E39 Maximum Toxicity
Recurrence
VaccineControl
Number of Recurrences911
Total patient2922
% recurred31.0%50.0%
Recurrence
% of Subjects
Recurrence
Chart1
0.3103448276
0.5
*p=0.17
% of Subjects
Recurrence
Demographics
Enroll DateDOBAge at EnrollCohortDosageBooster CohortBooster DoseTumor Size (cm)GradeCytology# pos nodedStatusStatus CommentDate offRecurrence TypeLast VaxVax Date
NV005V15/24/127/10/6250Group 1100mcg E39 + 250mcg GM-CSF13poorlypositivenaCompletePt recurred with primary cancer11/7/13TreatedV612/4/12
NV033V23/29/126/19/5161Group 1100mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF8poorlypositive1
NV015V39/21/126/22/5656Group 1100mcg E39 + 250mcg GM-CSF3poorlypositive0CompletePt recurred with primary cancer12/18/13TreatedV62/4/13
NV009V411/27/123/13/4271Group 2500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF5.5poorlyunknownnaCompletePt recurred with primary cancer3/18/14Treated
NV025V511/29/127/18/5656Group 2500mcg E39 + 250mcg GM-CSF6.5poorlypositive0CompletePt recurred with primary cancer2/7/13EarlyV32/5/13
NV032V612/3/121/11/5360Group 2500mcg E39 + 250mcg GM-CSFArm 1500mcg E39 + 250mcg GM-CSF6poorlypositive1
NV030V71/24/132/20/4073Group 3500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF15moderatenegative0
NV016V82/11/139/28/5557Group 31000mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF3.5well-differentiatedpositive
NV054V93/4/138/2/3875Group 31000mcg E39 + 250mcg GM-CSFArm 1500mcg E39 + 125mcg GM-CSFcannot be determinedpoorlyunknown
NV060V105/2/132/23/5261OBD500mcg E39 + 250mcg GM-CSF1.7moderateunknown0Off TreatmentIntercurrent Illness8/16/13(patient hospitalized for NSTEMI and subsequent CABG)
NV061V115/23/137/23/5261OBD500mcg E39 + 250mcg GM-CSF7.3poorlypositive0CompletePt recurred with primary cancer7/10/13EarlyV27/9/13
NV062V125/30/139/23/6449OBD500mcg E39 + 250mcg GM-CSF3poorlyunknown1CompletePt recurred with primary cancer3/7/14Treated
NV070V137/11/137/21/4568OBD500mcg E39 + 250mcg GM-CSF4.5poorlynegative0CompletePt recurred with primary cancer12/23/13TreatedV611/18/13
NV064V146/3/136/14/3974OBD500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF3poorlyunknown4
NV065V156/4/135/11/4271OBD500mcg E39 + 250mcg GM-CSF8moderatepositive3CompletePt recurred with primary cancer11/14/13TreatedV610/1/13
NV100V1612/30/134/6/5163OBD500mcg E39 + 250mcg GM-CSF7poorlypositivena
NV101V172/3/147/16/5955OBD500mcg E39 + 250mcg GM-CSF11.5moderatenegative3
NV102V182/24/1410/12/7340OBD1000mcg E39 + 250mcg GM-CSFperitoneal carcinomatosispoorlyunknown13
NV103V192/27/148/29/4766OBD1000mcg E39 + 250mcg GM-CSF9well-differentiatednegative0
NV104V203/24/145/28/7539OBD1000mcg E39 + 250mcg GM-CSF10poorlyunknown0
NV105V215/5/144/29/5361OBD1000mcg E39 + 250mcg GM-CSF8poorlypositive19Off StudyWithdrawn5/8/14
NV106V224/25/142/26/6252OBD1000mcg E39 + 250mcg GM-CSF6poorlyatypical cells0
NV107V235/19/1410/5/4767OBD1000mcg E39 + 250mcg GM-CSF10poorlypositivena
NV108V246/3/149/29/5955OBD1000mcg E39 + 250mcg GM-CSF8.5poorlypositivena
NV109V256/16/146/25/3876OBD1000mcg E39 + 250mcg GM-CSF3.5poorlyunknown0
NV0279/13/121/11/5063controlNApoorlyatypical cells3CompletePt recurred with primary cancer8/22/13
NV0315/5/124/10/5656control4poorlypositive4CompletePt recurred with primary cancer11/28/12
WR02312/5/117/22/6942control9poorly0CompletePt has completed 18 months on trial12/19/13
NV0083/23/126/10/7042control10poorlypositiveNACompletePt recurred with primary cancer11/1/12
NV0189/19/1210/25/5359control14poorlypositivenaCompletePt recurred with primary cancer6/4/14
NV0363/23/128/10/4666control15poorlypositiveNACompletePt recurred with primary cancer10/26/12
NV0201/8/132/23/7439control10well-differentiatedunknownNAOff StudyWithdrawn: Pt refuses participation in control group1/9/13
NV0291/24/135/3/4271control11poorlyunknownnaOff StudyWithdrawn: screen failure1/25/13
NV0012/12/1311/4/5854control7.5poorlyatypical cellsnaCompletePt recurred with primary cancer6/13/14
NV0232/14/1310/11/5062controlnot measurablepoorlypositive1CompletePt recurred with primary cancer8/16/13
NV0131/23/133/15/6647control8well-differentiatedunknown0
NV0112/28/132/17/5063control5poorlyunknownnaCompletePt recurred with primary cancer10/14/13
NV0636/25/139/8/3776control5.2poorlypositivena
NV0666/26/136/13/6152control9.5poorlypositivenaCompletePt recurred with primary cancer11/14/13
NV0676/25/139/27/5162control8poorlypositivena
NV0687/3/135/9/5954control8poorlypositive0
NV0982/10/145/8/5163control10poorlynegative0
NV0992/6/147/4/5361control12poorlypositive0
NV0973/27/144/4/6153control1.5poorlypositive0
NV0964/8/142/1/4866control3.5poorlypositive0CompletePt recurred with primary cancer6/13/14
NV0955/8/143/8/4965control5moderateunknown1
NV0946/4/143/4/2886control5moderateunknown2
AgeSizePoorly graded, mod, wellCytologyNodesStage IIIStage IIStage IStage IV
Vac6119,4,212 pos2.515334
Cont5918,2,212 pos0.916666666711335
pvalue10.33672648630.73,0.67, 10.770.2308385170.56110.714
Demographics
VaccinatedControl
n2522
Age (mean)6159p=1
Nodes30.92p=0.23
Poor Grade1918p=0.73
Mod Grade42p=0.67
Well Differentiated22p=1
Stage I33p=1
Stage II33p=1
Stage III1511p=0.56
Stage IV45p=0.714
Laura:diffuse cannot be determined
Path_Stage
Study IDSyncronous 1* Malignancies1* SiteFIGOTNMMetastasis LocationHistologyEpithelial1Epithelial2Epithelial3Endometrial1
NV005V1NoOvarianIIIC3cNxM1transverse 2nd sigmoid colonOvarianAdenocarcinoma
NV0033V2NoOvarianIIIC3bN1MxOvarianPapillary Serous Carcinoma
NV015V3NoOvarianIIIC3cNxMxOvarianEndometrioid CystoadenocarcinomaMixed Epithelial TumorPapillary Serous Carcinoma
NV009V4NoOvarianIIIC3cNxM0OvarianSerous Cystoadenocarcinoma
NV025V5NoOvarianIC1cN0MxOvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor
NV032V6NoOvarianIIIC3cN1M0OvarianSerous Cystoadenocarcinoma
NV030V7NoOvarianIIA1aN0M0OvarianEndometrioid Cystoadenocarcinoma
NV016V8NoOvarianIIIA3aNxM1Gall BladderOvarianSerous Cystoadenocarcinoma
NV054V9NoOvarianIIB2bNxMxOvarianMixed Epithelial Tumor
NV060V10NoEndometrialIV4N0M1PulmonaryEndometrialEndometriod Adenocarcinoma
NV061V11NoOvarianIIIC3CNxMxOvarianSerous Cystoadenocarcinoma
NV062V12NoPeritonealIIIC3cN1MxPrimary PeritonealSerous CystoadenocarcinomaClear Cell Cystoadenocarcinoma
NV070V13NoEndometrialIIIC11aN1M0EndometrialCarcinosarcoma
NV064V14NoFallopian TubeIIIC1aN1MxFallopian tubeSerous Cystoadenocarcinoma
NV065V15NoOvarianIIIC3CN1MxOvarianSerous Cystoadenocarcinoma
NV100V16NoOvarianIIIC3cNxMxOvarianSerous Cystoadenocarcinoma
NV101V17NoEndometrialIVB4N2M1PulmonaryEndometrialEndometrioid Adenocarcinoma
NV102V18NoPeritonealIV4N2(13)M1LO, RO, liver parenchyma, splenic serosa, peripancreatic LN, pericecal adispose tissue, anterior abdominal wall fascia & subcutaneous tissue, uterine serosa, omentumPrimary PeritonealSerous Cystoadenocarcinoma
NV103V19NoOvarianIC1cN0MxOvarianEndometrioid Cystoadenocarcinoma
NV104V20NoOvarianIIIC3cN0M0OvarianSerous Cystoadenocarcinoma
NV105V21NoOvarianIV4N2M1SpleenOvarianSerous Cystoadenocarcinoma
NV106V22NoOvarianIICTxNxMxOvarianClear cell cystoadenocarcinoma
NV107V23NoOvarianIIIC3cNxMxOvarianSerous Cystoadenocarcinoma
NV108V24NoOvarianIIIC3cNxMxOvarian
NV109V25NoEndometrialIA1aN0MxEndometrialEndometrioid Adenocarcinoma
NV008NoOvarianIIIC3bNxMxOvarianCarcinosarcoma
NV018NoOvarianIIIB3bN0MxOvarianSerous Cystoadenocarcinoma
NV020NoOvarianIA1aNxMxOvarianMucinous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor
NV027NoEndometrialIVB3bN2M1IntraperitonealEndometrialEndometrioid Adenocarcinoma
NV031NoOvarianIV4NxM1skin implants in abdominal wall where intraperitoneal port would be placedOvarianSerous Cystoadenocarcinoma
NV036NoOvarianIIIC3cNxMxOvarianCarcinosarcoma
WR023NoOvarianIC1cNxMxOvarianSerous CystoadenocarcinomaEndometrioid Cystoadenocarcinoma
NV029NoOvarianIIIC3cNxM0OvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor
NV023NoOvarianIV3cN1M1Cardiophrenic LNOvarianSerous Cystoadenocarcinoma
NV013NoOvarianIIC2cN0M0OvarianSexcord Stromal
NV001NoOvarianIA1aNxMxOvarianClear cell cystoadenocarcinoma
NV011NoOvarianIV4NxM1lungsOvarianSerous Cystoadenocarcinoma
NV063NoOvarianIIIC2cNxMxOvarianSerous Cystoadenocarcinoma
NV066NoOvarianIIIB3bNxM0OvarianClear cell cystoadenocarcinoma
NV067NoOvarianIIIC3cNxMxovarianSerous Cystoadenocarcinoma
NV068NoOvarianIIC2cN0MxOvarianSerous Cystoadenocarcinoma
NV098NoOvarianIIIB3bNxMxOvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor
NV099NoOvarianIIIC3cN0MxOvarianSerous Cystoadenocarcinoma
NV097NoOvarianIIIB3bNxMxOvarianSerous Cystoadenocarcinoma
NV096NoOvarianIIB2bN0MxOvarianSerous Cystoadenocarcinoma
NV095NoEndometrialIV4N1M1Hernia and omentumEndometrialEndometrioid Adenocarcinoma
NV094NoEndometrialIIIC3bN2MxEndometrialEndometrioid Adenocarcinoma
DTH
R0 E39RO NSSR6 E39R6 NSSR0 E39RO NSSR6 E39R6 NSSR0R6
NV005V113.50480n242414147.145833333315.8214285714
NV033V24000median20130
NV015V37.509.50mean7.14583333332.1915.82142857145.5357142857
NV009V440230Stdev8.363324654415.7182000619
NV025V500Count2414
NV032V6162.52622.5Sqrt4.89897948563.7416573868
NV030V718.50250SEM1.70715649644.2008656692
NV016V8210390
NV054V91701100.0723360654
NV060V1000
NV061V1117.50
NV062V1215000
NV070V13020015
NV064V1418301520
NV065V1519.5000
NV100V160000
NV101V17002520
NV102V1800
NV103V1900
NV104V2000
NV105V2100
NV106V2200
NV107V2300
NV108V2400
joyceog wendynew wendy
NV030V72523.518.5
NV016V822.52621
NV054V923.52717
Laura:off study
Laura:off study
Laura:off treatment
DTH
1.7071564964
4.20086566924.2008656692
Orthogonal Mean (mm)
E39 DTH Response (mm)
Local Reaction
R0R1R2R3R4R5B1
NV015V33884.515077.550105Vax 1Vax 2Vax 3Vax 4Vax 5Vax 6B1
NV005V152.5101.5106171200210.5n1515141212125
NV033V228143.5137154.514165median42.56982.59495100.7597.5
NV009V41483.5120.512861127.5103.5mean45.565217391371.904761904893.3947368421105.470588235395.4666666667102.357142857197.25
NV25V50087
NV032V6759103134.510011491.5
NV030V749113190136102126135
NV016V842.578.579147.51219875.5Vax 1Vax 2Vax 3Vax 4Vax 5Vax 6Booster 1
NV054V951.592.5112.58897.5112103.5median42.56982.59495100.7597.25
NV060V1073.59846.5
NV061V117062.5
NV062V127059.581.594111.510374.5
NV070V13456963.564.576.545
NV064V146845.572.57274.574
NV065V15113.584.582.5105.56258.5
NV100V163547.570.58675.598.5
NV101V173864.593.586.59596
NV102V184085.55869
NV103V1954505672.564.5
NV104V20264265106
NV105V21did not present
NV106V2233.545.5
NV107V2382
NV108V2417
0.00388804070.05145904570.30687968230.44061529060.63902523620.72097308930
Mean45.565217391371.904761904893.3947368421105.470588235395.4666666667102.357142857197.25
Stdev26.169163127930.399267691736.368705620933.46755452538.274603042939.816129593722.4805471464
Count2321191715146
Sqrt4.79583152334.5825756954.35889894354.12310562563.87298334623.74165738682.4494897428
SEM5.4566477166.63366406048.34355328998.11707425529.882460011210.64130824349.1776449412
0.02345634050.5131632142
0.04717082220.7605079717
Laura:recurrence/off study
Laura:no dose reduction
Laura:off study
Laura:OFF TX
Local Reaction
5.4566477165.456647716
6.63366406046.6336640604
8.34355328998.3435532899
8.11707425528.1170742552
9.88246001129.8824600112
10.641308243410.6413082434
9.17764494129.1776449412
*
Orthogonal Mean (mm)
E39 Local Reaction
Max Toxicity
Max ToxicityLocal GradeSystemic Grade
NV015V3VAX#11Induration0No adverse eventLocalSystemic0123401234
NV015V3VAX#21Erythema0No adverse eventNV015V3110%96%4%0%0%9%56.5%26.1%4.30%4.30%
NV015V3VAX#21PruritusNV005V112red numbers are for graph purposes only
NV015V3VAX#21IndurationNV033V211
NV015V3VAX#31Erythema0No adverse eventNV009V411
NV015V3VAX#31PruritusNV025V511
NV015V3VAX#31IndurationNV032V611
NV015V3VAX#41Induration1FatigueNV030V712
NV015V3VAX#41Pruritus1MalaiseNV016V811
NV015V3VAX#41ErythemaNV054V912
NV015V3VAX#51Erythema0No adverse eventNV060V1013possibly related
NV015V3VAX#51PruritusNV061V1110
NV015V3VAX#51IndurationNV062V1211
NV015V3VAX#61Erythema0No adverse eventNV070V1312
NV015V3VAX#61PruritusNV064V1412
NV015V3VAX#61IndurationNV065V1522
NV005V1VAX#11Induration1HeadacheNV100V1611
NV005V1VAX#11FlushingNV101V1711
NV005V1VAX#21Erythema1FlushingNV102V1814possibly related
NV005V1VAX#21PruritusNV103V1911
NV005V1VAX#21IndurationNV104V2011
NV005V1VAX#31Erythema1NauseaNV16V8 had a grade 3 SAE for low WBC, but the attribution is unlikely related, so it isn't includedNV106V2211
NV005V1VAX#31Pruritus1FlushingNV107V2310
NV005V1VAX#31IndurationNV108V2411
NV005V1VAX#41Erythema1Arthralgias
NV005V1VAX#41Pruritus2Joint Effusion
NV005V1VAX#41Induration
NV005V1VAX#51Erythema1Arthralgias
NV005V1VAX#51Pruritus1Joint Effusion
NV005V1VAX#51IndurationGradeLocalSystemic
NV005V1VAX#61Erythema1Arthralgias000.00%28.7%
NV005V1VAX#61Pruritus12296%1356.5%
NV005V1VAX#61Induration214%626.1%
NV033V2VAX#11Induration1Fatigue300%14.3%
NV033V2VAX#11Erythema400%14.3%
NV033V2VAX#11Pruritus2323
NV033V2VAX#21Erythema1Flushing
NV033V2VAX#21Pruritus
NV033V2VAX#21Induration
NV033V2VAX#31Erythema1Headache
NV033V2VAX#31Pruritus1Dizziness
NV033V2VAX#31Induration
NV033V2VAX#41Erythema0No adverse event
NV033V2VAX#41Pruritus
NV033V2VAX#41Induration
NV033V2VAX#51Erythema0No adverse event
NV033V2VAX#51Pruritus
NV033V2VAX#51Induration
NV033V2VAX#61Erythema0No adverse event
NV033V2VAX#61Pruritus
NV033V2VAX#61Induration
NV009V4VAX#11Pruritus0No adverse event
NV009V4VAX#11Induration
NV009V4VAX#21Erythema1Arthralgias
NV009V4VAX#21Pruritus
NV009V4VAX#21Induration
NV009V4VAX#31Erythema1Bone Pain
NV009V4VAX#31Induration1Fatigue
NV009V4VAX#31Pruritus1Headache
NV009V4VAX#41Erythema0No adverse event
NV009V4VAX#41Pruritus
NV009V4VAX#41Induration
NV009V4VAX#51Erythema1Bone Pain
NV009V4VAX#51Induration1Headache
NV009V4VAX#61Erythema1Headache
NV009V4VAX#61Pruritus
NV009V4VAX#61Induration
NV009V4Booster#11Erythema1Arthralgias
NV009V4Booster#11Pruritus1Back Pain
NV009V4Booster#11Induration1Fatigue
NV025V5VAX#11Erythema1Diarrhea
NV025V5VAX#11GI pain
NV025V5VAX#21Erythema0No adverse event
NV025V5VAX#21Pruritus
NV025V5VAX#2
NV025V5VAX#31Erythema0No adverse event
NV025V5VAX#31Pruritus
NV025V5VAX#31Induration
NV032V6VAX#11Erythema1Back Pain
NV032V6VAX#11Pruritus1Diarrhea
NV032V6VAX#11Induration
NV032V6VAX#21Erythema1Back Pain
NV032V6VAX#21Pruritus
NV032V6VAX#21Induration
NV032V6VAX#31Erythema0No adverse event
NV032V6VAX#31Pruritus
NV032V6VAX#31Induration
NV032V6VAX#41Erythema1Fatigue
NV032V6VAX#41Induration1Headache
NV032V6VAX#41Nausea
NV032V6VAX#51Erythema0No adverse event
NV032V6VAX#51Induration
NV032V6VAX#51Bruising
NV032V6VAX#61Erythema0No adverse event
NV032V6VAX#61Induration
NV032V6Booster#11Erythema1Bone Pain
NV032V6Booster#11Pruritus
NV032V6Booster#11Induration
NV030V7VAX#11Erythema0No adverse event
NV030V7VAX#11Induration
NV030V7VAX#11Bruising
NV030V7VAX#21Erythema0No adverse event
NV030V7VAX#21Pruritus
NV030V7VAX#21Induration
NV030V7VAX#21Burning
NV030V7VAX#31Erythema0No adverse event
NV030V7VAX#31Pruritus
NV030V7VAX#31Induration
NV030V7VAX#41Erythema0No adverse event
NV030V7VAX#41Pruritus
NV030V7VAX#41Induration
NV030V7VAX#51Erythema0No adverse event
NV030V7VAX#51Pruritus
NV030V7VAX#51Induration
NV030V7VAX#61Erythema0No adverse event
NV030V7VAX#61Pruritus
NV030V7VAX#61Induration
NV030V7Booster#11Erythema1Neuropathy
NV030V7Booster#11Pruritus1Arthralgias
NV030V7Booster#11Induration1Headache
NV030V7Booster#11Malaise
NV030V7Booster#12Maculo-papular rash
NV016V8VAX#11Induration1Headache
NV016V8VAX#21Induration1Headache
NV016V8VAX#21Pruritus
NV016V8VAX#31Induration1Headache
NV016V8VAX#31Pruritus
NV016V8VAX#31Induration
NV016V8VAX#41Erythema1Headache
NV016V8VAX#41Pruritus1Nausea
NV016V8VAX#41Induration1Neuropathy
NV016V8VAX#41Dizziness
NV016V8VAX#41Insomnia
NV016V8VAX#51Erythema0No adverse event
NV016V8VAX#51Pruritus
NV016V8VAX#51Induration
NV016V8VAX#61Erythema0No adverse event
NV016V8VAX#61Pruritus
NV016V8VAX#61Induration
NV016V8Booster#11Erythema1Neuropathy
NV016V8Booster#11Pruritus
NV016V8Booster#11Induration
NV054V9VAX#11Erythema0No adverse event
NV054V9VAX#11Induration
NV054V9VAX#11Bruising
NV054V9VAX#21Erythema0No adverse event
NV054V9VAX#21Pruritus
NV054V9VAX#21Induration
NV054V9VAX#31Erythema2Neuropathy
NV054V9VAX#31Pruritus
NV054V9VAX#31Induration
NV054V9VAX#41Erythema2Neuropathy
NV054V9VAX#41Pruritus
NV054V9VAX#41Induration
NV054V9VAX#51Erythema2Neuropathy
NV054V9VAX#51Pruritus
NV054V9VAX#51Induration
NV054V9VAX#61Erythema0No adverse event
NV054V9VAX#61Pruritus
NV054V9VAX#61Induration
NV054V9Booster#11Erythema0No adverse event
NV054V9Booster#11Pruritus
NV054V9Booster#11Induration
NV060V10VAX#11Erythema1Arthralgias
NV060V10VAX#11Induration2Fatigue
NV060V10VAX#11Pruritus2Headache
NV060V10VAX#11Malaise
NV060V10VAX#11Dizziness
NV060V10VAX#21Induration1Arthralgias
NV060V10VAX#21Pruritus1Fatigue
NV060V10VAX#21Erythema2Headache
NV060V10VAX#21Nausea
NV060V10VAX#31Erythema1Arthralgias
NV060V10VAX#31Pruritus1Fatigue
NV060V10VAX#31Induration1Headache
NV060V10VAX#31Myalgias
NV060V103Cardiac disorder
NV061V11VAX#11Pruritus0No adverse event
NV061V11VAX#11Induration
NV061V11VAX#21Erythema0No adverse event
NV061V11VAX#21Induration
NV061V11VAX#21Pruritus
NV062V12VAX#11Induration1Bone Pain
NV062V12VAX#11Fatigue
NV062V12VAX#11Malaise
NV062V12VAX#11Myalgias
NV062V12VAX#11Nausea
NV062V12VAX#21Erythema0No adverse event
NV062V12VAX#21Induration
NV062V12VAX#21Pruritus
NV062V12VAX#31Erythema0No adverse event
NV062V12VAX#31Induration
NV062V12VAX#31Pruritus
NV062V12VAX#41Erythema1Headache
NV062V12VAX#41Induration1Malaise
NV062V12VAX#41Pruritus
NV062V12VAX#51Erythema1Headache
NV062V12VAX#51Pruritus1Malaise
NV062V12VAX#51Induration
NV062V12VAX#61Erythema1Fatigue
NV062V12VAX#61Pruritus
NV062V12VAX#61Induration
NV070V13VAX#11Erythema1Fatigue
NV070V13VAX#11Induration1Headache
NV070V13VAX#11Nausea
NV070V13VAX#21Erythema1Fatigue
NV070V13VAX#21Pruritus
NV070V13VAX#21Induration
NV070V13VAX#21Pain
NV070V13VAX#31Erythema1Arthralgias
NV070V13VAX#31Pruritus2Fatigue
NV070V13VAX#31Induration1Headache
NV070V13VAX#31Pain at site
NV070V13VAX#41Erythema1Arthralgias
NV070V13VAX#41Pruritus1Fatigue
NV070V13VAX#41Induration1Headache
NV070V13VAX#41Pain at site
NV070V13VAX#51Erythema1Arthralgias
NV070V13VAX#51Pruritus2Fatigue
NV070V13VAX#51Induration1Headache
NV070V13VAX#51Pain at site
NV070V13VAX#61Erythema1Arthralgias
NV070V13VAX#61Pruritus2Fatigue
NV070V13VAX#61Induration1Headache
NV070V13VAX#61Pain at site
NV064V14VAX#11Erythema0No adverse event
NV064V14VAX#11Induration
NV064V14VAX#11Pruritus
NV064V14Delayed2DUR: Urticarial lesion (Left buttock)
NV064V14VAX#21Erythema0No adverse event
NV064V14VAX#21Induration
NV064V14VAX#21Pruritus
NV064V14VAX#21Bruising
NV064V14VAX#31Erythema0No adverse event
NV064V14VAX#31Induration
NV064V14VAX#31Pruritus
NV064V14VAX#41Erythema0No adverse event
NV064V14VAX#41Pruritus
NV064V14VAX#41Induration
NV064V14VAX#51Erythema0No adverse event
NV064V14VAX#51Pruritus
NV064V14VAX#51Induration
NV064V14VAX#61Erythema0No adverse event
NV064V14VAX#61Pruritus
NV064V14VAX#61Induration
NV064V14Delayed2DUR: Urticarial lesion (Left buttock)
NV064V14Booster#11Erythema1Headache
NV064V14Booster#11Induration
NV065V15VAX#11Erythema1Fatigue
NV065V15VAX#11Pruritus
NV065V15VAX#11Induration
NV065V15VAX#21Erythema1Fatigue
NV065V15VAX#21Pruritus
NV065V15VAX#21Induration
NV065V15VAX#31Erythema1Fatigue
NV065V15VAX#31Pruritus
NV065V15VAX#31Induration
NV065V15VAX#42Erythema2Fatigue
NV065V15VAX#42Pruritus2Headache
NV065V15VAX#51Erythema1Arthralgias
NV065V15VAX#51Pruritus1Chills
NV065V15VAX#51Induration1Fatigue
NV065V15VAX#51Headache
NV065V15VAX#61Erythema1Arthralgias
NV065V15VAX#61Pruritus1Fatigue
NV065V15VAX#61Induration1Headache
NV0100V16VAX#11Erythema1Back Pain
NV0100V16VAX#11Pruritus1Malaise
NV0100V16VAX#11Induration
NV0100V16VAX#21Induration1Fatigue
NV100V16VAX#31Erythema1Malaise
NV100V16VAX#31Pruritus
NV100V16VAX#31Induration
NV100V16VAX#41Erythema1Abdominal pain
NV100V16VAX#41Pruritus
NV100V16VAX#41Induration
NV100V16VAX#51Erythema0No adverse event
NV100V16VAX#51Induration
NV100V16VAX#61Erythema0No adverse event
NV100V16VAX#61Induration
NV0101V17VAX#11Pruritus0No adverse event
NV0101V17VAX#11Induration
NV0101V17VAX#21Pruritus0No adverse event
NV0101V17VAX#21Induration
NV0101V17VAX#31Erythema1Neuropathy
NV0101V17VAX#31Pruritus
NV0101V17VAX#31Induration
NV0101V17VAX#31Pain at site
NV0101V17VAX#41Erythema0No adverse event
NV0101V17VAX#41Pruritus
NV0101V17VAX#41Induration
NV0101V17VAX#51Erythema0No adverse event
NV0101V17VAX#51Induration
NV0101V17VAX#61Erythema0No adverse event
NV0101V17VAX#61Pruritus
NV0101V17VAX#61Erythema
NV102V18VAX#11Induration2Fatigue
NV102V18VAX#12Fever
NV102V18VAX#12Headache
NV102V18VAX#12Malaise
NV102V18VAX#21Erythema1Fatigue
NV102V18VAX#21Pruritus1Fever
NV102V18VAX#21Induration1Malaise
NV102V18VAX#24Sepsispossiblydelayed
NV102V18VAX#31Erythema1Fatigue
NV102V18VAX#31Induration
NV102V18VAX#24Cellulitispossiblydelayed
NV102V18VAX#41Erythema0No adverse event
NV102V18VAX#41Pruritus
NV102V18VAX#41Induration
NV103V19VAX#11Erythema0No adverse event
NV103V19VAX#11Induration
NV103V19VAX#21Erythema0No adverse event
NV103V19VAX#21Induration
NV103V19VAX#21Discomfort
NV103V19VAX#31Erythema0No adverse event
NV103V19VAX#31Induration
NV103V19VAX#41Erythema1Chills
NV103V19VAX#41Induration
NV103V19VAX#51Erythema0No adverse event
NV103V19VAX#51Pruritus
NV103V19VAX#51Induration
NV104V20VAX#11Induration1Chills
NV104V20VAX#11Neuropathy
NV104V20VAX#11Nausea
NV104V20VAX#21Erythema0No adverse event
NV104V20VAX#21Pruritus
NV104V20VAX#21Induration
NV104V20VAX#31Erythema0No adverse event
NV104V20VAX#31Induration
NV104V20VAX#41Erythema1Chills
NV104V20VAX#41Pruritus1Headache
NV104V20VAX#41Induration
NV106V22VAX#11Induration0No adverse event
NV106V22VAX#21Induration1Bone Pain
NV106V22VAX#21Fatigue
NV107V23VAX#11Erythema0No adverse event
NV107V23VAX#11Induration
NV108V24VAX#11Induration1Headache
NV108V24VAX#11Bruising
Laura:delayed
Laura:possibly related
Laura:possibly related
Max Toxicity
% of Subjects
E39 Maximum Toxicity
Recurrence
VaccineControl
Number of Recurrences911
Total patient2922
% recurred31.0%50.0%
Recurrence
% of Subjects
Recurrence
Chart1
0.3103448276
0.5
*p=0.17
% of Subjects
Recurrence
Demographics
Enroll DateDOBAge at EnrollCohortDosageBooster CohortBooster DoseTumor Size (cm)GradeCytology# pos nodedStatusStatus CommentDate offRecurrence TypeLast VaxVax Date
NV005V15/24/127/10/6250Group 1100mcg E39 + 250mcg GM-CSF13poorlypositivenaCompletePt recurred with primary cancer11/7/13TreatedV612/4/12
NV033V23/29/126/19/5161Group 1100mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF8poorlypositive1
NV015V39/21/126/22/5656Group 1100mcg E39 + 250mcg GM-CSF3poorlypositive0CompletePt recurred with primary cancer12/18/13TreatedV62/4/13
NV009V411/27/123/13/4271Group 2500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF5.5poorlyunknownnaCompletePt recurred with primary cancer3/18/14Treated
NV025V511/29/127/18/5656Group 2500mcg E39 + 250mcg GM-CSF6.5poorlypositive0CompletePt recurred with primary cancer2/7/13EarlyV32/5/13
NV032V612/3/121/11/5360Group 2500mcg E39 + 250mcg GM-CSFArm 1500mcg E39 + 250mcg GM-CSF6poorlypositive1
NV030V71/24/132/20/4073Group 3500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF15moderatenegative0
NV016V82/11/139/28/5557Group 31000mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF3.5well-differentiatedpositive
NV054V93/4/138/2/3875Group 31000mcg E39 + 250mcg GM-CSFArm 1500mcg E39 + 125mcg GM-CSFcannot be determinedpoorlyunknown
NV060V105/2/132/23/5261OBD500mcg E39 + 250mcg GM-CSF1.7moderateunknown0Off TreatmentIntercurrent Illness8/16/13(patient hospitalized for NSTEMI and subsequent CABG)
NV061V115/23/137/23/5261OBD500mcg E39 + 250mcg GM-CSF7.3poorlypositive0CompletePt recurred with primary cancer7/10/13EarlyV27/9/13
NV062V125/30/139/23/6449OBD500mcg E39 + 250mcg GM-CSF3poorlyunknown1CompletePt recurred with primary cancer3/7/14Treated
NV070V137/11/137/21/4568OBD500mcg E39 + 250mcg GM-CSF4.5poorlynegative0CompletePt recurred with primary cancer12/23/13TreatedV611/18/13
NV064V146/3/136/14/3974OBD500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF3poorlyunknown4
NV065V156/4/135/11/4271OBD500mcg E39 + 250mcg GM-CSF8moderatepositive3CompletePt recurred with primary cancer11/14/13TreatedV610/1/13
NV100V1612/30/134/6/5163OBD500mcg E39 + 250mcg GM-CSF7poorlypositivena
NV101V172/3/147/16/5955OBD500mcg E39 + 250mcg GM-CSF11.5moderatenegative3
NV102V182/24/1410/12/7340OBD1000mcg E39 + 250mcg GM-CSFperitoneal carcinomatosispoorlyunknown13
NV103V192/27/148/29/4766OBD1000mcg E39 + 250mcg GM-CSF9well-differentiatednegative0
NV104V203/24/145/28/7539OBD1000mcg E39 + 250mcg GM-CSF10poorlyunknown0
NV105V215/5/144/29/5361OBD1000mcg E39 + 250mcg GM-CSF8poorlypositive19Off StudyWithdrawn5/8/14
NV106V224/25/142/26/6252OBD1000mcg E39 + 250mcg GM-CSF6poorlyatypical cells0
NV107V235/19/1410/5/4767OBD1000mcg E39 + 250mcg GM-CSF10poorlypositivena
NV108V246/3/149/29/5955OBD1000mcg E39 + 250mcg GM-CSF8.5poorlypositivena
NV109V256/16/146/25/3876OBD1000mcg E39 + 250mcg GM-CSF3.5poorlyunknown0
NV0279/13/121/11/5063controlNApoorlyatypical cells3CompletePt recurred with primary cancer8/22/13
NV0315/5/124/10/5656control4poorlypositive4CompletePt recurred with primary cancer11/28/12
WR02312/5/117/22/6942control9poorly0CompletePt has completed 18 months on trial12/19/13
NV0083/23/126/10/7042control10poorlypositiveNACompletePt recurred with primary cancer11/1/12
NV0189/19/1210/25/5359control14poorlypositivenaCompletePt recurred with primary cancer6/4/14
NV0363/23/128/10/4666control15poorlypositiveNACompletePt recurred with primary cancer10/26/12
NV0201/8/132/23/7439control10well-differentiatedunknownNAOff StudyWithdrawn: Pt refuses participation in control group1/9/13
NV0291/24/135/3/4271control11poorlyunknownnaOff StudyWithdrawn: screen failure1/25/13
NV0012/12/1311/4/5854control7.5poorlyatypical cellsnaCompletePt recurred with primary cancer6/13/14
NV0232/14/1310/11/5062controlnot measurablepoorlypositive1CompletePt recurred with primary cancer8/16/13
NV0131/23/133/15/6647control8well-differentiatedunknown0
NV0112/28/132/17/5063control5poorlyunknownnaCompletePt recurred with primary cancer10/14/13
NV0636/25/139/8/3776control5.2poorlypositivena
NV0666/26/136/13/6152control9.5poorlypositivenaCompletePt recurred with primary cancer11/14/13
NV0676/25/139/27/5162control8poorlypositivena
NV0687/3/135/9/5954control8poorlypositive0
NV0982/10/145/8/5163control10poorlynegative0
NV0992/6/147/4/5361control12poorlypositive0
NV0973/27/144/4/6153control1.5poorlypositive0
NV0964/8/142/1/4866control3.5poorlypositive0CompletePt recurred with primary cancer6/13/14
NV0955/8/143/8/4965control5moderateunknown1
NV0946/4/143/4/2886control5moderateunknown2
AgeSizePoorly graded, mod, wellCytologyNodesStage IIIStage IIStage IStage IV
Vac6119,4,212 pos2.515334
Cont5918,2,212 pos0.916666666711335
pvalue10.33672648630.73,0.67, 10.770.2308385170.56110.714
Demographics
VaccinatedControl
n2522
Age (mean)6159p=1
Nodes30.92p=0.23
Poor Grade1918p=0.73
Mod Grade42p=0.67
Well Differentiated22p=1
Stage I33p=1
Stage II33p=1
Stage III1511p=0.56
Stage IV45p=0.714
Laura:diffuse cannot be determined
Path_Stage
Study IDSyncronous 1* Malignancies1* SiteFIGOTNMMetastasis LocationHistologyEpithelial1Epithelial2Epithelial3Endometrial1
NV005V1NoOvarianIIIC3cNxM1transverse 2nd sigmoid colonOvarianAdenocarcinoma
NV0033V2NoOvarianIIIC3bN1MxOvarianPapillary Serous Carcinoma
NV015V3NoOvarianIIIC3cNxMxOvarianEndometrioid CystoadenocarcinomaMixed Epithelial TumorPapillary Serous Carcinoma
NV009V4NoOvarianIIIC3cNxM0OvarianSerous Cystoadenocarcinoma
NV025V5NoOvarianIC1cN0MxOvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor
NV032V6NoOvarianIIIC3cN1M0OvarianSerous Cystoadenocarcinoma
NV030V7NoOvarianIIA1aN0M0OvarianEndometrioid Cystoadenocarcinoma
NV016V8NoOvarianIIIA3aNxM1Gall BladderOvarianSerous Cystoadenocarcinoma
NV054V9NoOvarianIIB2bNxMxOvarianMixed Epithelial Tumor
NV060V10NoEndometrialIV4N0M1PulmonaryEndometrialEndometriod Adenocarcinoma
NV061V11NoOvarianIIIC3CNxMxOvarianSerous Cystoadenocarcinoma
NV062V12NoPeritonealIIIC3cN1MxPrimary PeritonealSerous CystoadenocarcinomaClear Cell Cystoadenocarcinoma
NV070V13NoEndometrialIIIC11aN1M0EndometrialCarcinosarcoma
NV064V14NoFallopian TubeIIIC1aN1MxFallopian tubeSerous Cystoadenocarcinoma
NV065V15NoOvarianIIIC3CN1MxOvarianSerous Cystoadenocarcinoma
NV100V16NoOvarianIIIC3cNxMxOvarianSerous Cystoadenocarcinoma
NV101V17NoEndometrialIVB4N2M1PulmonaryEndometrialEndometrioid Adenocarcinoma
NV102V18NoPeritonealIV4N2(13)M1LO, RO, liver parenchyma, splenic serosa, peripancreatic LN, pericecal adispose tissue, anterior abdominal wall fascia & subcutaneous tissue, uterine serosa, omentumPrimary PeritonealSerous Cystoadenocarcinoma
NV103V19NoOvarianIC1cN0MxOvarianEndometrioid Cystoadenocarcinoma
NV104V20NoOvarianIIIC3cN0M0OvarianSerous Cystoadenocarcinoma
NV105V21NoOvarianIV4N2M1SpleenOvarianSerous Cystoadenocarcinoma
NV106V22NoOvarianIICTxNxMxOvarianClear cell cystoadenocarcinoma
NV107V23NoOvarianIIIC3cNxMxOvarianSerous Cystoadenocarcinoma
NV108V24NoOvarianIIIC3cNxMxOvarian
NV109V25NoEndometrialIA1aN0MxEndometrialEndometrioid Adenocarcinoma
NV008NoOvarianIIIC3bNxMxOvarianCarcinosarcoma
NV018NoOvarianIIIB3bN0MxOvarianSerous Cystoadenocarcinoma
NV020NoOvarianIA1aNxMxOvarianMucinous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor
NV027NoEndometrialIVB3bN2M1IntraperitonealEndometrialEndometrioid Adenocarcinoma
NV031NoOvarianIV4NxM1skin implants in abdominal wall where intraperitoneal port would be placedOvarianSerous Cystoadenocarcinoma
NV036NoOvarianIIIC3cNxMxOvarianCarcinosarcoma
WR023NoOvarianIC1cNxMxOvarianSerous CystoadenocarcinomaEndometrioid Cystoadenocarcinoma
NV029NoOvarianIIIC3cNxM0OvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor
NV023NoOvarianIV3cN1M1Cardiophrenic LNOvarianSerous Cystoadenocarcinoma
NV013NoOvarianIIC2cN0M0OvarianSexcord Stromal
NV001NoOvarianIA1aNxMxOvarianClear cell cystoadenocarcinoma
NV011NoOvarianIV4NxM1lungsOvarianSerous Cystoadenocarcinoma
NV063NoOvarianIIIC2cNxMxOvarianSerous Cystoadenocarcinoma
NV066NoOvarianIIIB3bNxM0OvarianClear cell cystoadenocarcinoma
NV067NoOvarianIIIC3cNxMxovarianSerous Cystoadenocarcinoma
NV068NoOvarianIIC2cN0MxOvarianSerous Cystoadenocarcinoma
NV098NoOvarianIIIB3bNxMxOvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor
NV099NoOvarianIIIC3cN0MxOvarianSerous Cystoadenocarcinoma
NV097NoOvarianIIIB3bNxMxOvarianSerous Cystoadenocarcinoma
NV096NoOvarianIIB2bN0MxOvarianSerous Cystoadenocarcinoma
NV095NoEndometrialIV4N1M1Hernia and omentumEndometrialEndometrioid Adenocarcinoma
NV094NoEndometrialIIIC3bN2MxEndometrialEndometrioid Adenocarcinoma
DTH
R0 E39RO NSSR6 E39R6 NSSR0 E39RO NSSR6 E39R6 NSSR0R6
NV005V113.50480n242414147.145833333315.8214285714
NV033V24000median20130
NV015V37.509.50mean7.14583333332.1915.82142857145.5357142857
NV009V440230Stdev8.363324654415.7182000619
NV025V500Count2414
NV032V6162.52622.5Sqrt4.89897948563.7416573868
NV030V718.50250SEM1.70715649644.2008656692
NV016V8210390
NV054V91701100.0723360654
NV060V1000
NV061V1117.50
NV062V1215000
NV070V13020015
NV064V1418301520
NV065V1519.5000
NV100V160000
NV101V17002520
NV102V1800
NV103V1900
NV104V2000
NV105V2100
NV106V2200
NV107V2300
NV108V2400
joyceog wendynew wendy
NV030V72523.518.5
NV016V822.52621
NV054V923.52717
Laura:off study
Laura:off study
Laura:off treatment
DTH
1.7071564964
4.20086566924.2008656692
Orthogonal Mean (mm)
E39 DTH Response (mm)
Local Reaction
R0R1R2R3R4R5B1
NV015V33884.515077.550105Vax 1Vax 2Vax 3Vax 4Vax 5Vax 6B1
NV005V152.5101.5106171200210.5n1515141212125
NV033V228143.5137154.514165median42.56982.59495100.7597.5
NV009V41483.5120.512861127.5103.5mean45.565217391371.904761904893.3947368421105.470588235395.4666666667102.357142857197.25
NV25V50087
NV032V6759103134.510011491.5
NV030V749113190136102126135
NV016V842.578.579147.51219875.5Vax 1Vax 2Vax 3Vax 4Vax 5Vax 6Booster 1
NV054V951.592.5112.58897.5112103.5median42.56982.59495100.7597.25
NV060V1073.59846.5
NV061V117062.5
NV062V127059.581.594111.510374.5
NV070V13456963.564.576.545
NV064V146845.572.57274.574
NV065V15113.584.582.5105.56258.5
NV100V163547.570.58675.598.5
NV101V173864.593.586.59596
NV102V184085.55869
NV103V1954505672.564.5
NV104V20264265106
NV105V21did not present
NV106V2233.545.5
NV107V2382
NV108V2417
0.00388804070.05145904570.30687968230.44061529060.63902523620.72097308930
Mean45.565217391371.904761904893.3947368421105.470588235395.4666666667102.357142857197.25
Stdev26.169163127930.399267691736.368705620933.46755452538.274603042939.816129593722.4805471464
Count2321191715146
Sqrt4.79583152334.5825756954.35889894354.12310562563.87298334623.74165738682.4494897428
SEM5.4566477166.63366406048.34355328998.11707425529.882460011210.64130824349.1776449412
0.02345634050.5131632142
0.04717082220.7605079717
Laura:recurrence/off study
Laura:no dose reduction
Laura:off study
Laura:OFF TX
Local Reaction
5.4566477165.456647716
6.63366406046.6336640604
8.34355328998.3435532899
8.11707425528.1170742552
9.88246001129.8824600112
10.641308243410.6413082434
9.17764494129.1776449412
*
Orthogonal Mean (mm)
E39 Local Reaction
Max Toxicity
Max ToxicityLocal GradeSystemic Grade
NV015V3VAX#11Induration0No adverse eventLocalSystemic0123401234
NV015V3VAX#21Erythema0No adverse eventNV015V3110%96%4%0%0%9%56.5%26.1%4.30%4.30%
NV015V3VAX#21PruritusNV005V112red numbers are for graph purposes only
NV015V3VAX#21IndurationNV033V211
NV015V3VAX#31Erythema0No adverse eventNV009V411
NV015V3VAX#31PruritusNV025V511
NV015V3VAX#31IndurationNV032V611
NV015V3VAX#41Induration1FatigueNV030V712
NV015V3VAX#41Pruritus1MalaiseNV016V811
NV015V3VAX#41ErythemaNV054V912
NV015V3VAX#51Erythema0No adverse eventNV060V1013possibly related
NV015V3VAX#51PruritusNV061V1110
NV015V3VAX#51IndurationNV062V1211
NV015V3VAX#61Erythema0No adverse eventNV070V1312
NV015V3VAX#61PruritusNV064V1412
NV015V3VAX#61IndurationNV065V1522
NV005V1VAX#11Induration1HeadacheNV100V1611
NV005V1VAX#11FlushingNV101V1711
NV005V1VAX#21Erythema1FlushingNV102V1814possibly related
NV005V1VAX#21PruritusNV103V1911
NV005V1VAX#21IndurationNV104V2011
NV005V1VAX#31Erythema1NauseaNV16V8 had a grade 3 SAE for low WBC, but the attribution is unlikely related, so it isn't includedNV106V2211
NV005V1VAX#31Pruritus1FlushingNV107V2310
NV005V1VAX#31IndurationNV108V2411
NV005V1VAX#41Erythema1Arthralgias
NV005V1VAX#41Pruritus2Joint Effusion
NV005V1VAX#41Induration
NV005V1VAX#51Erythema1Arthralgias
NV005V1VAX#51Pruritus1Joint Effusion
NV005V1VAX#51IndurationGradeLocalSystemic
NV005V1VAX#61Erythema1Arthralgias000.00%28.7%
NV005V1VAX#61Pruritus12296%1356.5%
NV005V1VAX#61Induration214%626.1%
NV033V2VAX#11Induration1Fatigue300%14.3%
NV033V2VAX#11Erythema400%14.3%
NV033V2VAX#11Pruritus2323
NV033V2VAX#21Erythema1Flushing
NV033V2VAX#21Pruritus
NV033V2VAX#21Induration
NV033V2VAX#31Erythema1Headache
NV033V2VAX#31Pruritus1Dizziness
NV033V2VAX#31Induration
NV033V2VAX#41Erythema0No adverse event
NV033V2VAX#41Pruritus
NV033V2VAX#41Induration
NV033V2VAX#51Erythema0No adverse event
NV033V2VAX#51Pruritus
NV033V2VAX#51Induration
NV033V2VAX#61Erythema0No adverse event
NV033V2VAX#61Pruritus
NV033V2VAX#61Induration
NV009V4VAX#11Pruritus0No adverse event
NV009V4VAX#11Induration
NV009V4VAX#21Erythema1Arthralgias
NV009V4VAX#21Pruritus
NV009V4VAX#21Induration
NV009V4VAX#31Erythema1Bone Pain
NV009V4VAX#31Induration1Fatigue
NV009V4VAX#31Pruritus1Headache
NV009V4VAX#41Erythema0No adverse event
NV009V4VAX#41Pruritus
NV009V4VAX#41Induration
NV009V4VAX#51Erythema1Bone Pain
NV009V4VAX#51Induration1Headache
NV009V4VAX#61Erythema1Headache
NV009V4VAX#61Pruritus
NV009V4VAX#61Induration
NV009V4Booster#11Erythema1Arthralgias
NV009V4Booster#11Pruritus1Back Pain
NV009V4Booster#11Induration1Fatigue
NV025V5VAX#11Erythema1Diarrhea
NV025V5VAX#11GI pain
NV025V5VAX#21Erythema0No adverse event
NV025V5VAX#21Pruritus
NV025V5VAX#2
NV025V5VAX#31Erythema0No adverse event
NV025V5VAX#31Pruritus
NV025V5VAX#31Induration
NV032V6VAX#11Erythema1Back Pain
NV032V6VAX#11Pruritus1Diarrhea
NV032V6VAX#11Induration
NV032V6VAX#21Erythema1Back Pain
NV032V6VAX#21Pruritus
NV032V6VAX#21Induration
NV032V6VAX#31Erythema0No adverse event
NV032V6VAX#31Pruritus
NV032V6VAX#31Induration
NV032V6VAX#41Erythema1Fatigue
NV032V6VAX#41Induration1Headache
NV032V6VAX#41Nausea
NV032V6VAX#51Erythema0No adverse event
NV032V6VAX#51Induration
NV032V6VAX#51Bruising
NV032V6VAX#61Erythema0No adverse event
NV032V6VAX#61Induration
NV032V6Booster#11Erythema1Bone Pain
NV032V6Booster#11Pruritus
NV032V6Booster#11Induration
NV030V7VAX#11Erythema0No adverse event
NV030V7VAX#11Induration
NV030V7VAX#11Bruising
NV030V7VAX#21Erythema0No adverse event
NV030V7VAX#21Pruritus
NV030V7VAX#21Induration
NV030V7VAX#21Burning
NV030V7VAX#31Erythema0No adverse event
NV030V7VAX#31Pruritus
NV030V7VAX#31Induration
NV030V7VAX#41Erythema0No adverse event
NV030V7VAX#41Pruritus
NV030V7VAX#41Induration
NV030V7VAX#51Erythema0No adverse event
NV030V7VAX#51Pruritus
NV030V7VAX#51Induration
NV030V7VAX#61Erythema0No adverse event
NV030V7VAX#61Pruritus
NV030V7VAX#61Induration
NV030V7Booster#11Erythema1Neuropathy
NV030V7Booster#11Pruritus1Arthralgias
NV030V7Booster#11Induration1Headache
NV030V7Booster#11Malaise
NV030V7Booster#12Maculo-papular rash
NV016V8VAX#11Induration1Headache
NV016V8VAX#21Induration1Headache
NV016V8VAX#21Pruritus
NV016V8VAX#31Induration1Headache
NV016V8VAX#31Pruritus
NV016V8VAX#31Induration
NV016V8VAX#41Erythema1Headache
NV016V8VAX#41Pruritus1Nausea
NV016V8VAX#41Induration1Neuropathy
NV016V8VAX#41Dizziness
NV016V8VAX#41Insomnia
NV016V8VAX#51Erythema0No adverse event
NV016V8VAX#51Pruritus
NV016V8VAX#51Induration
NV016V8VAX#61Erythema0No adverse event
NV016V8VAX#61Pruritus
NV016V8VAX#61Induration
NV016V8Booster#11Erythema1Neuropathy
NV016V8Booster#11Pruritus
NV016V8Booster#11Induration
NV054V9VAX#11Erythema0No adverse event
NV054V9VAX#11Induration
NV054V9VAX#11Bruising
NV054V9VAX#21Erythema0No adverse event
NV054V9VAX#21Pruritus
NV054V9VAX#21Induration
NV054V9VAX#31Erythema2Neuropathy
NV054V9VAX#31Pruritus
NV054V9VAX#31Induration
NV054V9VAX#41Erythema2Neuropathy
NV054V9VAX#41Pruritus
NV054V9VAX#41Induration
NV054V9VAX#51Erythema2Neuropathy
NV054V9VAX#51Pruritus
NV054V9VAX#51Induration
NV054V9VAX#61Erythema0No adverse event
NV054V9VAX#61Pruritus
NV054V9VAX#61Induration
NV054V9Booster#11Erythema0No adverse event
NV054V9Booster#11Pruritus
NV054V9Booster#11Induration
NV060V10VAX#11Erythema1Arthralgias
NV060V10VAX#11Induration2Fatigue
NV060V10VAX#11Pruritus2Headache
NV060V10VAX#11Malaise
NV060V10VAX#11Dizziness
NV060V10VAX#21Induration1Arthralgias
NV060V10VAX#21Pruritus1Fatigue
NV060V10VAX#21Erythema2Headache
NV060V10VAX#21Nausea
NV060V10VAX#31Erythema1Arthralgias
NV060V10VAX#31Pruritus1Fatigue
NV060V10VAX#31Induration1Headache
NV060V10VAX#31Myalgias
NV060V103Cardiac disorder
NV061V11VAX#11Pruritus0No adverse event
NV061V11VAX#11Induration
NV061V11VAX#21Erythema0No adverse event
NV061V11VAX#21Induration
NV061V11VAX#21Pruritus
NV062V12VAX#11Induration1Bone Pain
NV062V12VAX#11Fatigue
NV062V12VAX#11Malaise
NV062V12VAX#11Myalgias
NV062V12VAX#11Nausea
NV062V12VAX#21Erythema0No adverse event
NV062V12VAX#21Induration
NV062V12VAX#21Pruritus
NV062V12VAX#31Erythema0No adverse event
NV062V12VAX#31Induration
NV062V12VAX#31Pruritus
NV062V12VAX#41Erythema1Headache
NV062V12VAX#41Induration1Malaise
NV062V12VAX#41Pruritus
NV062V12VAX#51Erythema1Headache
NV062V12VAX#51Pruritus1Malaise
NV062V12VAX#51Induration
NV062V12VAX#61Erythema1Fatigue
NV062V12VAX#61Pruritus
NV062V12VAX#61Induration
NV070V13VAX#11Erythema1Fatigue
NV070V13VAX#11Induration1Headache
NV070V13VAX#11Nausea
NV070V13VAX#21Erythema1Fatigue
NV070V13VAX#21Pruritus
NV070V13VAX#21Induration
NV070V13VAX#21Pain
NV070V13VAX#31Erythema1Arthralgias
NV070V13VAX#31Pruritus2Fatigue
NV070V13VAX#31Induration1Headache
NV070V13VAX#31Pain at site
NV070V13VAX#41Erythema1Arthralgias
NV070V13VAX#41Pruritus1Fatigue
NV070V13VAX#41Induration1Headache
NV070V13VAX#41Pain at site
NV070V13VAX#51Erythema1Arthralgias
NV070V13VAX#51Pruritus2Fatigue
NV070V13VAX#51Induration1Headache
NV070V13VAX#51Pain at site
NV070V13VAX#61Erythema1Arthralgias
NV070V13VAX#61Pruritus2Fatigue
NV070V13VAX#61Induration1Headache
NV070V13VAX#61Pain at site
NV064V14VAX#11Erythema0No adverse event
NV064V14VAX#11Induration
NV064V14VAX#11Pruritus
NV064V14Delayed2DUR: Urticarial lesion (Left buttock)
NV064V14VAX#21Erythema0No adverse event
NV064V14VAX#21Induration
NV064V14VAX#21Pruritus
NV064V14VAX#21Bruising
NV064V14VAX#31Erythema0No adverse event
NV064V14VAX#31Induration
NV064V14VAX#31Pruritus
NV064V14VAX#41Erythema0No adverse event
NV064V14VAX#41Pruritus
NV064V14VAX#41Induration
NV064V14VAX#51Erythema0No adverse event
NV064V14VAX#51Pruritus
NV064V14VAX#51Induration
NV064V14VAX#61Erythema0No adverse event
NV064V14VAX#61Pruritus
NV064V14VAX#61Induration
NV064V14Delayed2DUR: Urticarial lesion (Left buttock)
NV064V14Booster#11Erythema1Headache
NV064V14Booster#11Induration
NV065V15VAX#11Erythema1Fatigue
NV065V15VAX#11Pruritus
NV065V15VAX#11Induration
NV065V15VAX#21Erythema1Fatigue
NV065V15VAX#21Pruritus
NV065V15VAX#21Induration
NV065V15VAX#31Erythema1Fatigue
NV065V15VAX#31Pruritus
NV065V15VAX#31Induration
NV065V15VAX#42Erythema2Fatigue
NV065V15VAX#42Pruritus2Headache
NV065V15VAX#51Erythema1Arthralgias
NV065V15VAX#51Pruritus1Chills
NV065V15VAX#51Induration1Fatigue
NV065V15VAX#51Headache
NV065V15VAX#61Erythema1Arthralgias
NV065V15VAX#61Pruritus1Fatigue
NV065V15VAX#61Induration1Headache
NV0100V16VAX#11Erythema1Back Pain
NV0100V16VAX#11Pruritus1Malaise
NV0100V16VAX#11Induration
NV0100V16VAX#21Induration1Fatigue
NV100V16VAX#31Erythema1Malaise
NV100V16VAX#31Pruritus
NV100V16VAX#31Induration
NV100V16VAX#41Erythema1Abdominal pain
NV100V16VAX#41Pruritus
NV100V16VAX#41Induration
NV100V16VAX#51Erythema0No adverse event
NV100V16VAX#51Induration
NV100V16VAX#61Erythema0No adverse event
NV100V16VAX#61Induration
NV0101V17VAX#11Pruritus0No adverse event
NV0101V17VAX#11Induration
NV0101V17VAX#21Pruritus0No adverse event
NV0101V17VAX#21Induration
NV0101V17VAX#31Erythema1Neuropathy
NV0101V17VAX#31Pruritus
NV0101V17VAX#31Induration
NV0101V17VAX#31Pain at site
NV0101V17VAX#41Erythema0No adverse event
NV0101V17VAX#41Pruritus
NV0101V17VAX#41Induration
NV0101V17VAX#51Erythema0No adverse event
NV0101V17VAX#51Induration
NV0101V17VAX#61Erythema0No adverse event
NV0101V17VAX#61Pruritus
NV0101V17VAX#61Erythema
NV102V18VAX#11Induration2Fatigue
NV102V18VAX#12Fever
NV102V18VAX#12Headache
NV102V18VAX#12Malaise
NV102V18VAX#21Erythema1Fatigue
NV102V18VAX#21Pruritus1Fever
NV102V18VAX#21Induration1Malaise
NV102V18VAX#24Sepsispossiblydelayed
NV102V18VAX#31Erythema1Fatigue
NV102V18VAX#31Induration
NV102V18VAX#24Cellulitispossiblydelayed
NV102V18VAX#41Erythema0No adverse event
NV102V18VAX#41Pruritus
NV102V18VAX#41Induration
NV103V19VAX#11Erythema0No adverse event
NV103V19VAX#11Induration
NV103V19VAX#21Erythema0No adverse event
NV103V19VAX#21Induration
NV103V19VAX#21Discomfort
NV103V19VAX#31Erythema0No adverse event
NV103V19VAX#31Induration
NV103V19VAX#41Erythema1Chills
NV103V19VAX#41Induration
NV103V19VAX#51Erythema0No adverse event
NV103V19VAX#51Pruritus
NV103V19VAX#51Induration
NV104V20VAX#11Induration1Chills
NV104V20VAX#11Neuropathy
NV104V20VAX#11Nausea
NV104V20VAX#21Erythema0No adverse event
NV104V20VAX#21Pruritus
NV104V20VAX#21Induration
NV104V20VAX#31Erythema0No adverse event
NV104V20VAX#31Induration
NV104V20VAX#41Erythema1Chills
NV104V20VAX#41Pruritus1Headache
NV104V20VAX#41Induration
NV106V22VAX#11Induration0No adverse event
NV106V22VAX#21Induration1Bone Pain
NV106V22VAX#21Fatigue
NV107V23VAX#11Erythema0No adverse event
NV107V23VAX#11Induration
NV108V24VAX#11Induration1Headache
NV108V24VAX#11Bruising
Laura:delayed
Laura:possibly related
Laura:possibly related
Max Toxicity
% of Subjects
E39 Maximum Toxicity
Recurrence
VaccineControl
Number of Recurrences911
Total patient2922
% recurred31.0%50.0%
Recurrence
% of Subjects
Recurrence
-
GALE-401
Anagrelide CR
-
GALE-401 ANAGRELIDE CONTROLLED RELEASE (CR)
Anagrelide
Active ingredient Reduces the elevated platelet count and the risk of thrombosis in patients with
myeloproliferative neoplasms (MPNs) MPNs are hematological malignancies in which the bone marrow cells develop and function
abnormally
Immediate Release
Approved for the treatment of patients with thrombocythemia, secondary to MPNs IR formulation can cause unacceptable side effects believed to be Cmax-related and has largely
limited the use due to early treatment withdrawal
GALE-401
Controlled Release (CR) formulation may decrease the frequency or severity of side effects Phase 2, Proof-of-Concept Trial Results
Well tolerated with primarily Grade 1 and 2 toxicities Efficacy compares favorably to historical anagrelide IR
14
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ESSENTIAL THROMBOCYTHEMIA (ET):CURRENT STANDARD OF CARE
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Generally first line therapy for ET Cytotoxic Myelosuppressive drug (reduces
other blood cells as well) Increased risk of developing acute leukemia
after long term; avoided in younger patients About 25% of patients are
intolerant/refractory
Limited third line use Non cytotoxic drug Not used in most patients because requires
injection and has flu like symptoms Used mostly in pregnant women
Generally second line Non cytotoxic drug Decreases platelets formation Not associated with increased risk of
leukemia Side effects: palpitations, headaches About one-third are intolerant to Anagrelide
Hydroxyurea and/or Anagrelide Treatment Failure
Sources: Leukemia and Lymphoma Society: Essential Thrombocythemia Facts Cervantes, F. Hematology 2011; 215-221
Hydroxyurea
Anagrelide IR
Interferon alpha
Unmet Need
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CORPORATE OVERVIEW
16
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FINANCIAL OVERVIEW
Cash Position (as of June 30, 2016) $19.6 million
Debt Financing (May 10, 2016) + $24 million (restricted cash)
Litigation Settlement (July 1, 2016) - $2.3 million
Projected Quarterly Burn $9 - $11 million
Shares Outstanding (as of March 31, 2016) 182 million
Market Cap (as of July 12, 2016) ~$75 million
17
July 2016 Financing $11.7 million (net proceeds)
Common Stock Issued 28,000,000 shares
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2016 MILESTONES
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PROGRAM MILESTONEPROJECTED
DATE
NeuVax(nelipepimut-S)
PRESENT: Achieve 70 Qualifying DFS Events Fast Track Designation PRESENT: Interim analysis Stopped
Initiate DCIS trial Q2
Combo H&N 1+/2+ Interim safety data Q4
GALE-301GALE-302
Present 301/302 booster data Present GALE-301 Phase 2a two year data Orphan Drug Designation Present GALE-301 Biomarker & Dosing Data Q4
GALE-401 (anagrelide CR)
Present combined safety data Confirmation of 505(b)2 pathway 2H
Publish final Phase 2 report Q4
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LEADERSHIP TEAM
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Mark W. Schwartz, Ph.D., President & CEOApthera, Bayhill Therapeutics, Calyx Therapeutics, Trega Biosciences, Incyte Genomics, DuPont Diagnostics
Bijan Nejadnik, M.D., Executive Vice President, Chief Medical Officer Jazz Pharmaceuticals, Johnson & Johnson, Stanford, Johns Hopkins, UC Davis
Remy Bernarda, SVP, Investor Relations & Corporate CommunicationsIR Sense, Hana Biosciences, Knight Equity Markets, Bear Stearns, Goldman Sachs
Gavin Choy, Pharm.D., SVP, Clinical Sciences & OperationsOtsuka, Astex, SuperGen, Hana Biosciences, Gilead, Stanford University Medical Center, Department of Veteran Affairs
Tom Knapp, Esq., Interim General Counsel Sucampo, Exemplar Law Partners, NorthWestern Energy, Paul Hastings, The Boeing Company
Joe Lasaga, VP, Business Development & Alliance ManagementNektar Therapeutics, Rigel
Pat Murphy, VP, Regulatory Affairs & ComplianceNektar Therapeutics, Bayhill Therapeutics, Berlex Laboratories, Serono, Parexel, Biogen
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WHY WERE HERE
20Source: San Antonio Express E75 vaccine's final tests start in S.A. By Don Finley, January 22, 2012; Photo credit: Kin Man Hui/San Antonio Express-News/ZUMAPress
I've had several friends who've had (breast cancer) and thenit came back and they had to go through treatment again. So this would be wonderful, not to have to come back.
First NeuVax Phase 3 patient
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THANK YOU
2016 ANNUAL MEETING OF STOCKHOLDERSFORWARD LOOKING STATEMENTDEVELOPMENT PIPELINEPRESENT CURRENT STATUSIMMUNO-ONCOLOGY:UNLOCKING THE POWER OF THE T-CELLLACK OF REACTIVE T-CELLS MAY RENDER SOME TOOLS INEFFECTIVE IN MANY CANCERSOUR VACCINES STIMULATE T-CELL PROLIFERATION AND EXPANSIONNOVEL DEVELOPMENT STRATEGY: SECONDARY PREVENTION IN CANCER SURVIVORSNEUVAX: DEVELOPMENT COLLABORATIONSGALE-301 & GALE-302GALE-301 & GALE-302:CURRENT CLINICAL DEVELOPMENT GALE-301: OPTIMAL DOSE GROUP SHOWS PRELIMINARY EFFICACYGALE-401GALE-401 ANAGRELIDE CONTROLLED RELEASE (CR)ESSENTIAL THROMBOCYTHEMIA (ET):CURRENT STANDARD OF CARECORPORATE OVERVIEWFINANCIAL OVERVIEW2016 MILESTONESLEADERSHIP TEAMWHY WERE HERETHANK YOU