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.