Adamis Pharmaceuticals Corporation (OTCBB: ADMP) announced today that it enrolled the first patient in its Phase 1/2a clinical prostate study. Adamis' drug, APC-100, will be used to treat men with castrate-resistant prostate cancer (CRPR). Each patient will be assessed for toxicity, biochemical (Prostate Specific Antigen), radiographic and clinical responses. The study began at the University of Wisconsin Carbone Cancer Center and will 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. They capitalize 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 been shown 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 and other characteristics make APC-100 a first-in-class compound for the potential treatment of both castrate-sensitive and castrate-resistant prostate cancer.
APC-100 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 (now called PREVENT), to what it believes to be the most promising new preventative/therapeutic anti-cancer drugs.
Dr. Dennis J. Carlo, President and CEO of Adamis Pharmaceuticals, stated, "Moving APC-100 into human clinical trials is yet another major milestone for the Company. It not only moves the prostate program forward, it also substantially increases the value of Adamis. Because of its mechanism of action, APC-100 can be used either as a stand-alone treatment or be used to enhance the activity of existing or upcoming new anti-prostate cancer products. I believe we are laying the foundation to achieve our objective of building a substantial cancer franchise and becoming a multi-billion dollar company. Our subsidiaries, Adamis Therapeutics and Adamis Labs, create a structure that permits each division to complement one another by providing a combination of pharmaceutical revenue and biotechnology blockbuster potential."
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