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AMRI Begins Phase I Trial for Cancer Compound

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By: Tim Wright

Editor-in-Chief, Contract Pharma

AMRI initiated a Phase I study of ALB109564(a), a tubulin inhibitor designed to kill cancer cells by preventing cell mitosis. The study will be conducted at four trial sites for a period of nine to 12 months and will include as many as 40 subjects. The drug will be administered intravenously to cancer patients with advanced solid tumors in an ascending dose study to evaluate safety, tolerability and pharmacokinetic profile of the drug.
   
In preclinical testing, the compound has been shown to demonstrate improved and potentially superior efficacy over existing members of its class, which are currently used extensively in anticancer chemotherapy. Significant tumor growth delay was seen against human colon, lung and prostate solid tumors (as xenografts in mice) and against leukemia in mice.  
   
“We are pleased to begin the process of enrolling patients and commencing Phase I clinical trials of our compound and are hopeful that this first clinical step will ultimately lead to a new weapon in the fight against cancer,” said AMRI chairman, president and chief executive officer, Thomas E. D’Ambra. “The initiation of this study demonstrates the company’s ability to leverage its full spectrum of scientific capabilities to generate new products with commercial potential and to execute on the R&D portion of our strategic plan to provide value to stakeholders.”

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