SOURCE: Adamis Pharmaceuticals Corporation

May 18, 2010 09:30 ET

Adamis Pharmaceuticals Announces Plans to Develop Its First Prostate Drug Candidate

SAN DIEGO, CA--(Marketwire - May 18, 2010) -  On February 25, 2010, Adamis Pharmaceuticals Corporation (OTCBB: ADMP) announced the signing of a definitive agreement with Colby Pharmaceuticals Corporation to acquire exclusive license rights covering three small molecule compounds for the possible treatment of prostate cancer (PCa). Following the completion of the transaction, the compounds, formerly CPC -100, 200, and 300, will be re-named APC-100, 200, and 300.

Adamis intends to submit an Investigative New Drug Application (IND) with the FDA in the third calendar quarter of this year and is targeting the initiation of a Phase I/IIa clinical study with APC-100 at the University of Wisconsin before year-end. If the initial study is completed satisfactorily, further studies will be extended to other Cancer Centers of Excellence. Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "In a relatively short period of time, we should obtain important information regarding safety and activity." In this Phase I/IIa study, routine disease assessments will consist of monitoring prostate specific antigen (PSA), radiographic assessments (bone scans and/or CT imaging) and the detection of circulating prostate tumor cells (CTC). In addition to Radiographic assessments, recent studies have indicated that the number and changes in the number of CTC's following treatment are prognostic in terms of patient outcome.

Recently, researchers at the University of California San Diego and the Engelhardt Institute of Molecular Biology in Moscow (published in Nature 464, 302-305, March 11, 2010) reported that in their study, the inflammatory response elicited by dying primary prostate tumor cells actually contributed to the failure of initial anti-prostate therapy and actually promoted the second, more severe form of the disease -- castrate resistant prostate cancer (CR-PCa). Men with prostate cancer often take drugs that turn off the production of testosterone, which leads to tumor cell death. The death of the tumor cells leads to chronic inflammation and the introduction of immune cells known as B cells. The B cells then secrete molecules, some of which assist in the growth of a second wave of more deadly prostate cancer cells that are resistant to hormone therapy. The authors of the Nature paper suggested that chronic inflammation induced by the dying of primary tumor cells adds to the failure, rather than the previously reported success of anti-cancer (prostate) therapy. Better understanding of the mechanisms leading to the progression of disease could lead to more effective therapies.

Adamis believes that the APC-100 compound could be included in the next new generation of therapies for the treatment of prostate cancer, assuming successful results in clinical trials. APC-100 is an orally bioavailable pharmaceutical drug candidate which received the National Cancer Institute's multi-year, multi-million dollar RAPID Award in 2006. This award is given annually by the NCI Division of Cancer Prevention to what it believes are the most promising new preventative/ therapeutic anti-cancer drugs. APC-100 has shown desirable pharmacological properties and a good safety profile in mice, rats and dogs, and has also shown higher therapeutic activity than the current marketed Standard of Care anti-androgens. When tested side by side in the TRAMP PCa mouse model (spontaneous prostate cancer model), APC-100 gave 90% efficacy versus the Standard of Care giving 55% efficacy.

In addition to these positive activities, APC-100, in pre-clinical studies, has been shown to inhibit signal transduction and have very potent multi-inflammatory activities. Dr. Carlo explains, "This may be one of the reasons that APC-100 works in both castrate-sensitive and castrate resistant PCa models. In addition to increasing time to tumor progression and survival, and decreasing PSA production, we believe that the robust anti-inflammatory activities make APC-100 a first-in-class compound for the potential treatment of prostate cancer." Adamis is currently seeking a suitable partner that will assist in bringing these new drugs to the market and making them available to men with prostate cancer.

About Adamis Pharmaceuticals

Adamis Pharmaceuticals has two wholly owned subsidiaries, Adamis Laboratories and Adamis Viral Therapies. Adamis Labs expects to launch a series of niche prescription products in the allergy and respiratory therapeutic area, including its Epinephrine Injection USP 1:1000 (0.3mg Pre-Filled Single Dose Syringe) product launched last year. Adamis Viral Therapies is focused on the development of patented, proprietary technologies and recently entered into an agreement with Colby Pharmaceutical Company to acquire exclusive license agreements covering three small molecule compounds for the potential treatment of human prostate cancer.

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 relate to future events or our future results of operations or future financial performance, including, but not limited to the following statements: the company's ability to obtain sufficient funding to acquire rights to APC-100 pursuant to the company's agreement with Colby Pharmaceuticals and to fund the clinical trials and the company's other operations; the absence of regulatory issues or delays with the FDA; the company's beliefs concerning the safety and effectiveness of the compounds and drug product candidates described in this press release; the results of any future clinical trials that the company may conduct relating to the licensed compounds; the ability to fund future product development; future success of any of the licensed compounds, assuming that they are developed and approved for marketing by the FDA and other regulatory authorities; and the intellectual property protection that may be afforded by any patents or patent applications relating to the licensed compounds. 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. Certain of these risks, uncertainties, and other factors 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 Adamis expressly disclaims any intent to update any forward-looking statements.

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