FDA approves Azaya Therapeutics' Taxotere for Phase I clinical study

Azaya Therapeutics, Inc. announced today that the Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its lead product “ATI-1123,” a novel and improved formulation of Taxotere^® (docetaxel), a leading chemotherapy drug with worldwide annual sales of over $2.8 billion.

Azaya’s Phase I clinical study will now open for enrollment at two premier 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 study is designed as an open-label, dose-escalation study that will determine the safety, tolerability and pharmacokinetics of the drug. The study also provides for the collection of efficacy data.

“The FDA’s acceptance of our IND package is an important milestone in the commercialization of this important and innovative new cancer treatment,” said 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,” he added.

Azaya utilizes a proprietary manufacturing process to produce liposome-encapsulated chemotherapeutics that eliminates the use of toxic carriers and incorporates a naturally occurring protein to stabilize the liposomal encapsulated drug. Preclinical studies have demonstrated improvement in the toxicology profile and an enhanced efficacy of ATI-1123 compared to Taxotere^® in a number of tumor models.