Adamis submits APC-100 IND to FDA for treatment of prostate cancer

Adamis Pharmaceuticals Corporation (OTCBB: ADMP) announced today that it has recently submitted to the FDA an Investigational New Drug (IND) application for APC-100 to treat prostate cancer (PCa). Following approval by the FDA of the IND, 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 extend 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 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. When tested side by side in the TRAMP prostate cancer mouse model (spontaneous prostate cancer model), APC-100 gave 90% efficacy versus the marketed Standard of Care giving 55% efficacy. In addition to increasing time to tumor progression and survival, APC-100 also induced a significant decrease in PSA production. Adamis believes these characteristics make APC-100 a first-in-class compound for the potential treatment of castrate-sensitive and castrate-resistant prostate cancer.

Dr. Jeremy P. Cetnar, M.D., Principal Investigator for the study, stated, "Since this molecule was originally developed at the University of Wisconsin, we are very excited to be working with Adamis as we move the drug from the basic research bench into the clinical stages of development. It is well established that androgen signaling pathways are directly involved in the production of high oxidative stress in the prostate and both androgen blockade and the reduction of oxidative stress and inflammatory processes are well recognized targets for therapeutic intervention in prostate cancer patients. The attributes of APC-100 make this drug an ideal candidate to enter clinical testing since it has been shown to exhibit multiple mechanisms of action as both an inhibitor of the androgen signaling pathways as well as a potent anti-inflammatory oxidative stress modulator."

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, Ph.D., President and CEO of Adamis, stated, "We have assembled a substantial prostate cancer franchise which includes both small molecules (APC-100, 200 and 300) as well as a prostate cancer vaccine technology. Over time, the recognition and importance of these assets should create substantial shareholder value. In anticipation of beginning clinical studies with our second compound, APC-200 and our prostate vaccine, manufacturing has already begun on both products."