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Press Release
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, Arizona, April 27, 2006 AmpliMed today announced the initiation of a Phase I study of benzimate (oral solution) in patients with advanced refractory cancer. 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 that AmpliMed licensed from UAF Technologies and Research, L.L.C. (UTR) 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, but its use was limited by a formulation which exhibited low and variable oral absorption. Scientists at the University of Arizona (UA) College of Pharmacy 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 and President of AmpliMed. “This is a unique opportunity for us rapidly to 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 (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 C
orporation 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), 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
undergoing NDA-directed clinical development. Other products in the company's portfolio include
Amplizone™, which is anticipated to enter the clinic early in 2006, and a portfolio of derivatives
of both lead compounds for future development. AmpliMed Corporation is based in Tucson, Arizona and is on
the Web at http://www.amplimed.com. .
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AmpliMed, Amplimexon and Amplizone are United States trademarks of AmpliMed Corporation.
