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ACT Biotech says FDA accepts IND for anti-cancer medicine ACTB1003.


22 January 2010 - US biotechnology company ACT Biotech Inc said today that the US Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for ACTB1003, a first-in-class anti-cancer therapeutic.

The company said it has now assembled a complete preclinical package, including manufacturing and toxicology studies, allowing ACTB1003 to enter a clinical trial.

ACTB1003 is a novel oral kinase inhibitor that targets cancer cells through multiple modes of action. ACTB1003 inhibits cancer cell growth by targeting the FGF receptor family, which are mutated in a number of human cancer types. ACTB1003 also directly induces apoptosis by targeting the RSK and S6K kinases in the PI3K pathway, all at low nanomolar concentrations.

CEO Wolf Busse said that in the first half of 2010, the company will decide whether it will enter into Phase I trials on its own or with a partner.

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Publication:M2 Pharma
Date:Jan 22, 2010
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