MADISON, Wisc.--(BUSINESS WIRE)--Madison Vaccines Incorporated (MVI), a clinical stage biopharmaceutical company, today announced enrollment has begun in the expansion of a Phase 2 clinical trial of its lead product candidate MVI-816 (pTVG-HP). The expansion will add 50 patients to the original cohort of 56 patients to produce more robust results. The trial is enrolling non-metastatic prostate cancer patients who have rising PSA after their primary treatment (surgery or radiation), but before patients require androgen deprivation therapy (castration therapy). The trial is seeking clinical evidence that MVI-816 can delay the onset of metastatic disease in these patients. The trial is funded by the company, with patient recruitment 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.
“Our goal is to help men with recurrent prostate cancer live longer with a better quality of life,” said Richard Lesniewski, PhD, President of MVI. “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.”
MVI-816 targets prostatic acid phosphatase (PAP), a well-defined prostate antigen. It is a plasmid DNA vaccine that can be delivered to patients by simple intradermal injection, is readily manufactured in a cost-effective manner, and is highly stable compared to protein or peptide vaccines. MVI is also developing a second vaccine for men with early metastatic disease, to help prolong the duration of disease control they receive from current androgen deprivation therapies.
The principal mission of Madison, Wisconsin-based MVI is the development of therapeutic plasmid DNA vaccine products for patients with prostate cancer. MVI has licensed patented technologies that were developed in the laboratory of Dr. Douglas McNeel at the University of Wisconsin-Madison. More information is available at www.madisonvaccines.com.