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pVAXrcPSAv53l

Phase 1

Prostate Cancer | Monoclonal antibody | Oncology |Pulse Biosciences, Inc|Last Updated: Mar 17, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

pVAXrcPSAv53l · 1 trial · 1 indication

Phase 1 1
NCT00859729Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate CancerProstate Cancer
COMPLETED15 Analytics
PHASE1COMPLETED
Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Assess the feasibility and safety of escalating doses of pVAXrcPSAv53l DNA vaccine, administered intradermally in combination with electroporation in patients with relapse of prostate cancer.
From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination

Secondary Endpoints

Assess the safety and functionality of the DERMA VAX™ in vivo electroporation DNA vaccine delivery system.
From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
Evaluate the PSA-specific immune response induced by the vaccine.
From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
Identify an anti-tumor effect of the vaccine.
From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort IEXPERIMENTAL50 µg DNA/dose, 3 patients
Cohort IIEXPERIMENTAL150 µg DNA/dose, 3 patients
Cohort IIIEXPERIMENTAL400 µg DNA/dose, 3 patients
Cohort IVEXPERIMENTAL1000 µg DNA/dose, 3 patients
Cohort VEXPERIMENTALOptimal dose to be determined, 6 patients

Interventions

NameTypeDescription
pVAXrcPSAv53l (DNA encoding rhesus PSA)BIOLOGICAL5 doses, 4 weeks apart
DERMA VAX™ intradermal DNA delivery systemDEVICEin vivo electroporation is applied after each DNA injection
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male patients. Age \>18 years. * HLA-A\*0201 positive. * Histologically confirmed prostate cancer. * Minimum two (2) and maximum four (4) years after treatment with curative or salvage radiotherapy. * Serum testosterone within normal range. * Increasing PSA from a previous ref...

Countries:Sweden
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Competitive Landscape -Prostate Cancer 252 trials

Frequently asked questions about pVAXrcPSAv53l

What is pVAXrcPSAv53l used for?

pVAXrcPSAv53l is an investigational DNA vaccine being studied for the treatment of prostate cancer. It is currently in Phase 1 clinical development. The drug is being evaluated in a dose-finding study that has been completed, with a total enrollment of 15 participants.

What does pVAXrcPSAv53l target?

pVAXrcPSAv53l is a monoclonal antibody modality, though its specific molecular target is not disclosed in the available information. The drug is being investigated for its potential role in prostate cancer treatment, delivered via intradermal electroporation as part of a DNA vaccine approach.

Who makes pVAXrcPSAv53l?

pVAXrcPSAv53l is being developed by Pulse Biosciences, Inc, a company traded on the stock exchange under the ticker symbol PLSE. The company is conducting clinical research on this investigational drug for prostate cancer.

What phase is pVAXrcPSAv53l in?

pVAXrcPSAv53l is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients with prostate cancer.

What clinical trials is pVAXrcPSAv53l in?

pVAXrcPSAv53l has been studied in one clinical trial, identified as NCT00859729, titled "Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate Cancer." This Phase 1 trial was completed and enrolled 15 male participants aged 18 years and older in Sweden.

Is pVAXrcPSAv53l the same as a DNA vaccine?

pVAXrcPSAv53l is a DNA vaccine, as indicated by its clinical trial description. The drug is delivered using intradermal electroporation, a technique that uses electrical pulses to enhance the uptake of the DNA vaccine into cells. It is being studied for prostate cancer.