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news.Cougar Biotechnology says its investigational new drug application for its multiple myeloma drug has been approved by the FDA.
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This will allow Cougar to conduct a Phase I clinical trial of CB3304, an orally active inhibitor of microtubule dynamics, for the treatment of relapsed or refractory multiple myeloma in the US.
Cougar expects to conduct the Phase I clinical trial at a number of clinical sites, including Weill Cornell Medical College and Columbia Presbyterian Medical Center.
CB3304 is an orally active alkaloid derived from opium. Preclinical studies demonstrate that CB3304 alters microtubule dynamics, blocks cell division (mitosis) and causes apoptosis (programmed cell death).
Alan Auerbach, CEO and president of Cougar biotechnology, commented, “this represents the second drug in Cougar’s pipeline to advance into clinical trials and also represents a key corporate objective for the company this year.”