Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Madison Vaccines Incorporated (MVI), a clinical stage biopharmaceutical company, has announced that enrollment has begun in the expansion of a Phase 2 clinical trial of its lead product candidate MVI-816 (pTVG-HP).
Subscribe to our email newsletter
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.