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Abstract:
Liposomes Carrying Radiation Enable Extremely Precise Tumor Targeting, Likely to Greatly Improve Patient Outcomes

Azaya Therapeutics Licenses Promising Treatment for Head and Neck Cancers

San Antonio, TX | Posted on September 3rd, 2008

Azaya Therapeutics, Inc., announced today that it has signed a licensing agreement to further develop a breakthrough technology that uses liposomes to deliver radiation through direct injection into head and neck tumors, shrinking the tumor, delaying recurrence and avoiding the collateral tissue damage that often accompanies all other forms of radiation therapy. The company plans to begin a phase I clinical trial in early 2010.

Azaya is licensing the technology, now known as Azaya Liposomal Encapsulated Radiation Therapy (ALERT), from the University of Texas Health Science Center at San Antonio (UTHSCSA).

"This is a very synergistic opportunity for the university and for Azaya," said Azaya Therapeutics President and CEO Michael T. Dwyer. "They have more than 15 years of expertise working with liposomes and a patent-pending method of using them to deliver radiation to a very specific tumor location. And Azaya has a patented system for producing liposomes quickly and efficiently. Licensing this technology from UTHSCSA adds a very promising new asset to Azaya's product portfolio. This treatment potentially has broad applicability to many different cancers including those of the prostate, breast and brain. It could become quite disruptive to the current cancer treatment paradigm."

Liposomes - essentially extremely small bubble-like particles made of the same material as cell membranes - were engineered decades ago for use in the pharmaceutical industry but have always been difficult to size, load and produce on a large, commercially viable scale. Azaya Therapeutics' Protein Stabilized Nanoparticle (PSNTM) technology utilizes a one-step manufacturing process that eliminates these problems with liposomes and enhances the efficacy of known drug products. Pre-clinical studies of PSN technology have shown improved therapeutic potential, enhanced pharmacokinetics and inhibition of cancer tumors in animal models.

UTHSCSA scientists have been developing the radiation-infused liposome technology for the past six years.

"My research partners, Drs. Ande Bao and Beth Goins, and I are pleased to begin the translation of our new cancer therapy out of the laboratory and into patients with cancer," said Dr. William T. Phillips, who created the technology at the university. "We believe our nanoparticle-based local radiation therapy has great potential for the treatment of cancer patients. We are particularly pleased to be working with a local company whose leadership team has a proven track record of successfully translating new therapies from the bench to the bedside."

Phillips is a professor of radiology at the university. Goins is an associate professor of radiology while Bao is an assistant professor of otolaryngology - head and neck surgery. The three are also members of the Health Science Center's Cancer Therapy & Research Center (CTRC). They have worked closely on advancing the technology, including a June 2008 report published in Clinical Cancer Research that notes the "excellent tumor suppression and minimal side-effect profile" of liposomal therapeutic radionuclides, which are injected directly into a tumor.

Dr. Randal Otto, a clinical collaborator on the project, noted that external radiation treatments and chemotherapy often fail to eliminate residual tumors left behind after surgery to remove head and neck cancers. "ALERT could greatly increase the chance of eliminating all cancerous cells by using surgery and radiation therapy at the same time," said Dr. Otto, a CTRC member and chairman of the Department of Otolaryngology - Head-and-Neck Surgery at the Health Science Center.

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About Azaya Therapeutics, Inc.
Azaya Therapeutics, Inc., is an emerging pharmaceutical company with a novel drug delivery platform technology. Its proprietary Protein Stabilized Nanoparticles technology platform addresses the significant toxicity problems associated with delivery of cancer treatments. In addition to developing ALERT, the company is applying its PSN technology to produce a targeted, safer and more efficacious formulation of a marketed chemotherapy drug for the improved treatment of cancer.

The company’s management is highly experienced in biotechnology and oncology and has a track record of obtaining FDA drug approvals and successfully building companies. Dwyer previously held several key executive positions with Ilex Oncology, Inc. and was instrumental in the development and approval of the company’s drug, Campath® (alemtuzumab).

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Contacts:
Azaya Therapeutics
Michael T. Dwyer
210-341-6600
or
Dublin & Associates
Eric Whittington
210-227-0221 ext. 239

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