Adamis Pharmaceuticals Corporation announced that the FDA has accepted an Investigational New Drug (IND) application for APC-100 to treat Prostate Cancer (PCa). Adamis plans to begin phase I/II a 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 Centre 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 Defence 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: delays tumour progression and increases survival in mouse models of prostate cancer; blocks PSA secretion and inhibits androgen-related transcriptional activation; blocks binding of androgens to the androgen receptor; serves as an androgen antagonist; inhibits Reactive Oxygen Species (ROS) formation in prostate cancer cells; potent anti-oxidant; and higher therapeutic activity than the marketed Standard of Care anti-androgens. Dr George Wilding and his team at the University of Wisconsin Carbone Cancer Centre 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 Centre.

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 programme, to what it believes are the most promising new preventative/therapeutic anti-cancer drugs.

Dr Dennis J Carlo, PhD, 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.”