News & Information | START In The News

January 8th, 2010
San Antonio Business Journal
By: Mike W. Thomas

Azaya Therapeutics awaits results of cancer-drug study

The first patient in the Phase I clinical study for Azaya Therapeutics’ new cancer therapy drug was treated last week in Dallas. Now the San Antonio-based pharmaceutical company is waiting to see the results before proceeding with a second patient and/or a second dosage.

The U.S. Food and Drug Administration gave its approval to Azaya Therapeutics to begin Phase I clinical studies late last year and now it will be at least a year’s worth of “wait and see” for the company as the clinical trials continue.

Michael Dwyer, president and CEO of Azaya, says the trials are expected to take from 12 to 15 months to complete — during which time an estimated 20 to 24 patients could be treated with the company’s compound known as ATI-1123.

Dwyer says the FDA’s acceptance of the firm’s clinical study was a major milestone for the company, which has been working toward this goal for the past three years.

“It took a long time to develop all the work and precedence to get to this point,” Dwyer says. “Getting this validation from the FDA was very critical for us.”

The clinical trials are being carried out at the Mary Crowley Cancer Research Center in Dallas, where the first patient was treated, and at South Texas Accelerated Research Therapeutics, or the START Center for Cancer Care, in San Antonio. Patients with solid tumors that have not responded to treatment with other anti-cancer agents are eligible to be enrolled in the study.

“Developing a cancer treatment such as ours takes an extraordinary amount of time and effort,” Dwyer says. The Phase 1 study is only concerned with the safety of the patients. The initial goal is to determine the maximum tolerated dosage that can be given to patients. If all goes well during this first year of testing, then the company will move to Phase 2, allowing it to begin to target specific kinds of tumors.

Azaya’s new drug is actually a delivery system for other drugs. Using proprietary nanotechnology techniques, the company discovered how to develop a certain kind of liposomes, or fatty cell, that can be used to encapsulate another kind of drug. In this case, they are encapsulating docetaxel — the generic name for one of the most prescribed chemotherapy drugs, Taxotere. Taxotere is a leading chemotherapy drug with worldwide annual sales of more than $2.8 billion.

The goal is to seal the drug inside the fatty cells so that it does not make the patient sick and release it at the source of the cancer. This way they can get more of the drug’s impact on the tumor and not on the rest of the body. Last year, Azaya raised about $3 million selling stock and also received a $1 million grant from the Texas Emerging Technology Fund. Those funds are supporting the research that will be ongoing for the rest of the year.

Read more: Azaya Therapeutics awaits results of cancer-drug study - San Antonio Business Journal