Albany Molecular Research, Inc. (AMRI) has selected a compound from its proprietary oncology research program for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application (IND) to the FDA 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 tumors (as xenografts in mice) and against leukemia in mice. Pending favorable results in toxicity and safety pharmacology testing, the company plans to 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's chairman, chief executive officer and president, Thomas E. D'Ambra, Ph.D. "This particular research program leveraged AMRI's unique biocatalysis technology platform, natural products chemistry expertise, and high potency development capabilities."
This 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 program for advanced preclinical testing. This program was subsequently the subject of a licensing arrangement with Bristol-Myers Squibb, announced in October 2005.
AMRI's latest compound is a cytotoxic agent and a semi-synthetic derivative of a natural product originally extracted from the Madagascar periwinkle flower.