SAN DIEGO--(BUSINESS WIRE)--Adamis Pharmaceuticals Corporation (OTCBB: ADMP) announced today that the FDA has accepted an Investigational New Drug (IND) application for APC-100 to treat prostate cancer (PCa). Adamis plans 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 will start at the University of Wisconsin Carbone Cancer Center and then extended to Wayne State University Karmanos Cancer Institute. Both of these Institutions are currently named within “The Prostate Cancer Clinical Trials Consortium” (PCCTC). The PCCTC is made up of a 13 member clinical trial research group sponsored by the Prostate Cancer Foundation and the Department of Defense that capitalizes on their scientific expertise and unique institutional resources in order to rapidly bring new discoveries to prostate cancer patients.
APC-100 is an orally available drug and has demonstrated multiple activities in various model systems. Some activities include: (1) delays tumor progression and increases survival in mouse models of prostate cancer; (2) blocks PSA secretion and inhibits androgen-related transcriptional activation; (3) blocks binding of androgens to the androgen receptor; (4) serves as an androgen antagonist; (5) inhibits reactive oxygen species (ROS) formation in prostate cancer cells; (6) potent anti-oxidant; and (7) higher therapeutic activity than the marketed Standard of Care anti-androgens. Dr. George Wilding and his team at the University of Wisconsin Carbone Cancer Center conducted the majority of pre-clinical studies confirming the use of APC-100 for the treatment of prostate cancer. Dr. Wilding is the Assistant Dean of Oncology and Director of the University of Wisconsin Carbone Cancer Center.
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.
Dr. Dennis J. Carlo, Ph.D., President and CEO of Adamis Pharmaceuticals, stated, “Moving APC-100 into human clinical trials is another milestone for the company. I believe with our intense focus on the development of both therapeutic vaccines and small molecules for the treatment of prostate cancer, we are placing ourselves in the position to eventually become one of the leaders in the marketplace.”
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause Adamis’ actual results to be materially different from these forward-looking statements. There can be no assurance concerning, among other factors, whether the FDA will approve our IND for APC-100 or the timing of any such approval, when our clinical trials for APC-100 will begin, our ability to fully fund such a clinical trial without additional funding, or the outcome of those trials. Certain other risks, uncertainties, and other factors, as well as other risks and uncertainties relating to the company’s business are described in greater detail in Adamis’ filings from time to time with the SEC, all of which are available free of charge on the SEC's web site at http://www.sec.gov. Adamis expressly disclaims any intent to update any forward-looking statements.