Albany Molecular Research, Inc.(AMRI) has announced the selection of a compound from its proprietary oncology research programme for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application (IND) with the US Food and Drug Administration in 2007.
AMRI's drug candidate is a novel analog of an established class of tubulin inhibitors, which kill cancer cells by preventing cell mitosis. In preclinical disease models, AMRI's compound showed greater efficacy than marketed members of this class. Significant tumor growth delay was seen against human colon, lung and prostate solid tumours (as xenografts in mice) and against leukemia in mice.
Pending favourable results in toxicity and safety pharmacology testing, AMRI estimates that it will submit an IND for this compound in late 2007. Subject to FDA review, the submission of an IND would allow subsequent initiation of phase I human clinical trials.
"This new drug candidate from our internal oncology research program continues to demonstrate AMRI's ability to deliver compounds with promising pharmaceutical utility from our labs, whether the compound is for one of the customers we serve or from our own internal R&D efforts," said AMRI Chairman, CEO and president Thomas E. D'Ambra, Ph.D. "This particular research programme leveraged AMRI's unique biocatalysis technology platform, natural products chemistry expertise, and high potency development capabilities."
Today's announcement marks the second time in two years that AMRI has transitioned early stage, internal drug leads into clinical candidates. In May 2005, AMRI selected two compounds from its proprietary biogenic amines programme for advanced preclinical testing. This programme was subsequently the subject of a licensing arrangement with Bristol-Myers Squibb Company (BMS) announced in October 2005. The program continues to make progress under BMS' leadership.
AMRI's latest compound is a cytotoxic agent and a semi-synthetic derivative of a natural product originally extracted from the Madagascar periwinkle flower. The cytotoxic anticancer market is estimated to be in the multibillion dollar range.
AMRI filed patent applications in 2004 to protect the intellectual property associated with this compound, and plans to ultimately seek a licensee to commercialize this technology.
Albany Molecular Research, Inc. is a global drug discovery company that provides chemistry services to pharmaceutical and biotechnology companies and conducts its own proprietary R&D programs.