Adamis Pharmaceuticals Corporation (OTCBB: ADMP.OB), today announced the technology which constitutes its compound APC-100 was recently granted a patent in the United States. A patent entitled "Chroman-Derived Compounds for the Treatment of Cancer" has been issued. This patent, together with earlier issued European and US patents, significantly strengthens the Adamis APC-100 patent portfolio for the use of APC-100 in the treatment of early and late stage prostate cancer. Claims include a method of: i.) inhibiting the growth of prostate cancer cells; ii.) delaying the progression of prostate cancer; and, iii.) preventing the recurrence of prostate cancer.
Adamis recently announced that it had received approval from the FDA to begin Phase 1/2a clinical studies with APC-100 in men with castrate resistant prostate cancer (CRPR). Each patient will be assessed for toxicity, biochemical responses (Prostate Specific Antigen), radiographic and clinical responses. The study is scheduled to begin shorty. It will start at the University of Wisconsin Carbone Cancer Center and then be extended to Wayne State University Karmanos Cancer Institute. Both of these Institutions are currently named within "The Prostate Cancer Clinical Trials Consortium". This Clinical Trials Consortium or Prostate Cancer Centers of Excellence is made up of a 13 member clinical trial research group that capitalizes on their scientific expertise and unique institutional resources in order to rapidly bring new discoveries to prostate cancer patients.
APC-100 has multiple modes of action. It is an orally available anti-androgenic/anti-inflammatory, signal transduction inhibitor drug. APC-100 has demonstrated to have higher therapeutic activity than the current marketed Standard of Care anti-androgens. Pre-clinical studies confirming the use of APC-100 for the treatment of prostate cancer were pioneered by Dr. George Wilding and his team. Dr. Wilding is the Assistant Dean for Oncology and Director of the University of Wisconsin Carbone Cancer Center. In addition to increasing time to tumor progression and survival, APC-100 also induced a significant decrease in PSA production. These characteristics make APC-100 a first-in-class compound for the potential treatment of both castrate-sensitive and castrate-resistant prostate cancer.
APC-100 has previously received the National Cancer Institute's (NCI) multi-year, multi-million dollar RAPID Award (Rapid Access to Preventative Intervention Development). Each year, this award is given by the NCI Division of Cancer Prevention, under the RAPID Program, to what it believes are the most promising new preventative/therapeutic anti-cancer drugs.
Previously, development of APC-100 has been funded by Michael Milken's Prostate Cancer Foundation (PCF, formerly CapCure), the Department of Defense's Congressionally Directed Medical Research Programs' (CDMRP) Prostate Cancer Research Program (PCRP), as well as grants and contracts from the NCI.
Dr. Dennis J. Carlo, President and CEO of Adamis stated, "We have assembled a substantial prostate cancer franchise and we will continue to aggressively strengthen our patent portfolio. Protecting our technology is of upmost importance and critical to our success. We continue to make advances on this front and just recently received European coverage that broadly protects our cancer vaccine program."
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