MADISON, Wis.--(BUSINESS WIRE)--Madison Vaccines Incorporated (MVI), a clinical stage biopharmaceutical company, today announced expansion of the Phase 1 clinical trial of MVI-118 with the addition of a trial site at Rutgers Cancer Institute of New Jersey. Enrollment is now underway. MVI-118 targets the human androgen receptor, which is the critical biological target that drives the progression of prostate cancer and, in many cases, is responsible for the resistance to current therapies. The vaccine is being developed to prolong the duration of disease control gained from standard hormone deprivation therapies. This is the second site for this trial that began enrolling patients at the University of Wisconsin – Madison last year at this time.
This investigator-sponsored clinical trial is funded by MVI and run by the University of Wisconsin-Madison under the overall direction of Douglas McNeel, MD, PhD. whose laboratory developed the vaccine. The Principal Investigator at UW is Christos Kyriakopoulos, MD and the Principal Investigator at Rutgers Cancer Institute is Anna Ferrari, MD. Initial data from the first 13 patients enrolled in this Phase 1 trial, is being presented at the Annual Prostate Cancer Foundation Retreat today, Oct 27th.
“This expanded clinical trial gives us an important opportunity to evaluate the safety of serial vaccinations with the vaccine and to see if we can slow the progression of prostate cancer in patients receiving standard of care therapy for their disease,” said Dr. Ferrari. “A well-tolerated treatment that slows disease progression while it diminishes resistance to current therapies, would be a much-needed addition to our options. We are pleased to give patients here in NJ the chance to take part in this early testing.”
MVI-118 is one of two DNA plasmid vaccines being developed for prostate cancer by MVI. MVI plasmid vaccines can be rapidly and inexpensively manufactured, are relatively more stable than other types of vaccines upon storage, and don’t have to be tailored to each individual patient.
The second vaccine, MVI-816, is being evaluated in a fully-enrolled Phase 2 study, in men whose cancer shows signs of recurrence through rising PSA levels after initial treatment. Currently their options are to watch and wait, or to start some form of hormonal deprivation (castration) therapy. MVI-816 is intended to offer a third option with tolerable treatment at this stage of the disease. It is also being tested in late stage metastatic cancer in combination with a PD-1 inhibitor that exposes the cancer cells to attack by the immune system. PD-1 inhibitors have not worked alone in prostate cancer. Emerging data from this trial that combines a PD-1 inhibitor with a vaccine will be presented at the at the Society for Immunotherapy of Cancer annual meeting in November.
“MVI is developing our two DNA vaccines for men throughout the spectrum of progressive prostate cancer, in pre-metastatic, in early metastatic, and in late-stage disease," said Richard Lesniewski, PhD, President and CEO of MVI. “We are pleased with the progress we are making with expansion of our clinical trials and positive trends in the early data. We expect to report final Phase 2 data on our lead vaccine, MVI-816, in 2018.”
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.