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news.AMRI has initiated its Phase I study of ALB109564, a novel tubulin inhibitor, which is designed to kill cancer cells by preventing cell mitosis.
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The study will be conducted at four clinical trial sites for a period of nine to 12 months and include up to 40 subjects.
The drug will be administered intravenously to cancer patients with advanced solid tumors in an ascending dose study to evaluate the compound’s safety, tolerability and pharmacokinetic profile.
The announcement marks the second compound from AMRI’s internally funded R&D portfolio to advance into Phase I clinical testing, following on the recent announcement of the submission of a Canadian clinical trial application by Bristol-Myers Squibb (BMS) for a compound licensed by BMS from AMRI’s central nervous system research program.
Thomas Ambra, chairman, president and CEO of AMRI, said: “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.”