AmpliMed Initiates Phase I Clinical Study of Benzimate in Patients with Advanced Refractory Cancer; New Formulation of Promising Cancer Drug Joins Amplimexon as Second Clinical-stage Compound in AmpliMed Portfolio.TUCSON, Ariz. -- AmpliMed today announced the initiation of a Phase I study of benzimate (oral solution) in patients with advanced refractory cancer refractory cancer Oncology Cancer that is unresponsive to treatment. See Radioinsensitive. . The study is designed to establish the safety and tolerability of benzimate and is anticipated to enroll approximately 50 patients at a single clinical center in the United States. Information about the study can be obtained by calling AmpliMed at 520-382-0230. Benzimate (previously designated FB642) is the leading clinical candidate arising from a portfolio of patents, intellectual property and other assets other assets Assets of relatively small value. For financial reporting purposes, firms frequently combine small assets into a single category rather than listing each item separately. that AmpliMed licensed from UAF UAF University of Alaska Fairbanks UAF Unite Against Fascism (UK) UAF University of Arkansas at Fayetteville UAF Union de l'Action Feminine (French) Technologies and Research, L.L.C. (UTR UTR Untranslated Region (genetics) UTR Unicode Technical Report UTR Unique Taxpayer Reference (UK Inland Revenue) UTR Unable to Reach UTR Unable to Reproduce UTR University Technical Representative ) in August 2005. The compound has been shown to be active in cell based studies and in a variety of cancers in animal model studies, as well as showing promise in early clinical trials as an anticancer drug anticancer drug see antineoplastic. anticancer drug Chemotherapeutic, see there , but its use was limited by a formulation which exhibited low and variable oral absorption. Scientists at the University of Arizona (body, education) University of Arizona - The University was founded in 1885 as a Land Grant institution with a three-fold mission of teaching, research and public service. (UA) College of Pharmacy A college of pharmacy generally refers to a tertiary educational institution (or part of such an institution) which is involved in the education of future pharmacists and pharmaconomists. successfully reformulated the drug, and AmpliMed has conducted additional toxicology studies, manufactured clinical supplies and amended the investigational new drug (IND) application for benzimate to enable a Phase I study to be carried out using the improved formulation. "To bring benzimate back to the clinic within 8 months of licensing the product from UTR is a tribute to the talent and diligence of the manufacturing, regulatory and clinical team at AmpliMed," noted Robert A. Ashley, Chairman, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and President of AmpliMed. "This is a unique opportunity for us to rapidly establish the absorption and pharmacokinetics of the drug and to then build on the extensive preclinical characterization and prior clinical promise of this novel, orally-administered cancer drug." About Benzimate Benzimate is a compound for the potential treatment of patients suffering from certain types of cancer. Benzimate appears to possess a novel mechanism of action which inhibits the growth of certain cancer cells in cell based studies and in animal models of cancer. Preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. (Hammond LA et al, J Cancer Res Clin Oncol 127: 301-313, 2001) have shown that benzimate is active in p53 positive and negative tumor cell lines and in tumor cells with multi-drug resistance to other agents. Further, it appears to induce cell cycle arrest at the G2/M phase portion of the cell cycle. About AmpliMed Corporation AmpliMed Corporation was founded in 1989 with the support of the University of Arizona Technology Development Corporation and is focused on the clinical development of chemotherapeutic agents for cancer. AmpliMed's strategy is to develop anti-cancer drugs with novel mechanisms of action designed to overcome some of the limitations, such as myelosuppression (suppression of blood cell counts blood cell count, n an estimation of the number and types of circulating blood cells (e.g., red blood cells [erythrocytic series], white blood cells, differential). ), multi-drug resistance (treatment-induced resistance to many cancer drugs) and cardiac toxicity, frequently associated with current cancer therapy. The company's lead product, Amplimexon (imexon inj.), is in Phase II clinical trials. Along with benzimate, other products in the company's portfolio include Amplizone(R) (ethonafide inj.), which is expected to enter the clinic in 2007, and a portfolio of derivatives of each of the lead compounds for future development. AmpliMed Corporation is based in Tucson, Arizona and is on the Web at http://www.amplimed.com. AmpliMed(R), Amplimexon(R) and Amplizone(TM) are United States trademarks of AmpliMed Corporation. |
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