Madison Vaccines Incorporated, a clinical stage biopharmaceutical company focused on the development of therapeutic vaccine products for patients with prostate cancer, has begun enrolling patients for the expansion of the Phase 2 clinical trial of MVI-816, (pTVG-HP), its lead product candidate.
MVI-816 is a plasmid DNA vaccine that targets prostatic acid phosphatase (PAP), an enzyme produced by the prostate and highly expressed in men who have prostate cancer. The highest levels of this prostate antigen are usually found in patients suffering from metastasized prostate cancer.
This vaccine can be delivered by intradermal injection and can be produced in a cost-effective manner. Furthermore, the plasmid is very stable when compared to normal protein or peptide vaccines.
The original study cohort of 56 patients will be expanded with 50 more non-metastatic prostate cancer patients who have enhanced levels of prostate-specific antigen (PSA) after their primary surgery or radiation treatment, but before they are submitted to androgen deprivation therapy.
This study wants to gather clinical evidence that MVI-816 is able to delay the onset of metastatic disease in prostate cancer patients.
“Our goal is to help men with recurrent prostate cancer live longer with a better quality of life. The expansion of this Phase 2 trial represents a significant step forward for our young company and advances our efforts to establish clinical proof of concept toward a safe and approvable immune activation therapy for men with prostate cancer at this crucial stage of their disease,” Richard Lesniewski, PhD, President of MVI said in a company’s press release.
Additionally, MVI is developing MVI-118 (pTVG-AR), a second DNA vaccine targeting the human androgen receptor, one of the responsible molecules for prostate cancer progression and resistance to current therapies. This vaccine will target men suffering from early metastatic disease, with the main objective of increasing disease control resultant from androgen deprivation therapies.
Patient recruitment for the MVI-816 trial is currently underway at the University of Wisconsin, and future enrollment anticipated at the University of California San Francisco and at least one other site later this year.