SAN DIEGO, CA--(Marketwired - Aug 21, 2013) - Adamis Pharmaceuticals Corporation (
APC-100 is part of a Phase 1/2a clinical study in patients with advanced prostate cancer. Primary objectives of the trial are to evaluate the safety and tolerability of APC-100, as well as to determine the dose levels for subsequent trials. Secondary objectives of the trial include pharmacokinetic analyses as well as preliminary assessments of efficacy. To date the product has been shown to be safe and well tolerated. Although the Phase 1 trial as originally proposed has been substantially completed, an amendment to the IND has been filed. This amendment provides for administering additional higher doses to determine the maximum tolerated dose (MTD). The ongoing trial is being conducted at the University of Wisconsin Carbone Cancer Center and the Wayne State University Karmanos Cancer Institute. Both of these institutions are currently named within "The Prostate Cancer Clinical Trials Consortium."
APC-100 has multiple modes of action. It 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. 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 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 (now called PREVENT), to what it believes are the most promising new preventative/therapeutic anti-cancer drugs.
About Adamis Pharmaceuticals Corporation
Adamis Pharmaceuticals Corporation is a biopharmaceutical company engaged in the development and commercialization of specialty pharmaceutical and biotechnology products in the therapeutic areas of respiratory disease, allergy, oncology and immunology. In addition to the Taper technology, Adamis currently has four products in its specialty pharmaceutical product pipeline, including the Epinephrine Injection PFS syringe product for use in the emergency treatment of anaphylaxis, APC-1000 and APC-5000 for the treatment of asthma and chronic obstructive pulmonary disease, and APC-3000, an HFA inhaled nasal steroid product for the treatment of allergic rhinitis. The Company's biotechnology efforts are focused on the development of therapeutic vaccine product candidates and cancer drugs for patients with unmet medical needs in the multi-billion dollar global cancer markets. Its products under research and development include TeloB-VAX, a novel cell-based therapeutic cancer vaccine and three drugs: APC-100, APC-200, and APC-300, for the treatment of prostate cancer.
Forward Looking Statements
This press release may contain forward-looking statements that relate to future events or our future results of operations or future financial performance, including, but not limited to the following statements: the ability to fund future product development and business operations; future revenues expected from any of the company's product candidates, assuming that they are developed and approved for marketing by the FDA and other regulatory authorities; our ability to complete any future acquisitions of products, product candidates or technologies; and the intellectual property protection that may be afforded by any patents or patent applications relating to the company's technology. Certain of these risks, uncertainties, and other factors are described in greater detail in Adamis' filings from time to time with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov. Except as required by law, Adamis expressly disclaims any obligation to update any forward-looking statements.