Azaya Therapeutics gets FDA approval for
clinical study

December 10, 2009 4:03 PM ET

The U.S. Food and Drug Administration has given its approval to Azaya Therapeutics Inc. to begin a Phase I clinical study for a new application of its lead cancer therapy drug.

Known as ATI-1123, Azaya’s compound aims to make docetaxel — the generic name for one of the most prescribed chemotherapy drugs, Taxotere — more effective on tumors and more tolerable for patients. Taxotere is a leading chemotherapy drug with worldwide annual sales of over $2.8 billion.

Azaya’s Phase I clinical study will open for enrollment at two cancer research centers in Texas: South Texas Accelerated Research Therapeutics at the START Center for Cancer Care in San Antonio and The Mary Crowley Cancer Research Center in Dallas. Patients with solid tumors that have not responded to treatment with other anti-cancer agents will be enrolled in the study.

“The FDA’s acceptance of our (clinical study) is an important milestone in the commercialization of this important and innovative new cancer treatment,” says Michael T. Dwyer, president and CEO of Azaya. “Developing a cancer treatment such as ours takes an extraordinary amount of time and effort, and I am pleased to initiate our Phase I trial for patient enrollment.”

Azaya Therapeutics is a San Antonio-based emerging pharmaceutical company. Earlier this year, the Texas Emerging Technology Fund announced a $1 million investment in Azaya Therapeutics to help the company commercialize a new treatment for fighting cancerous tumors.

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