Monday, June 6, 2011

• Phase I study conducted at two premier cancer research facilities in Texas
• $3.5 million convertible debt offering closed

SAN ANTONIO, Texas – Azaya Therapeutics, Inc. presented data from its ongoing Phase I study of ATI-1123 today at the annual meeting of the American Society of Clinical Oncology held in Chicago, IL.  ATI-1123 is a patented human serum albumin-stabilized nanoparticle liposomal formulation of docetaxel.  Docetaxel is the active ingredient in Taxotere® (docetaxel), one of the largest selling chemotherapy drugs in the world.  The Phase I study is continuing at the Mary Crowley Cancer Research Center in Dallas and the Cancer Therapy and Research Center (CTRC) at UTHSCSA in San Antonio.  Dr. Sushma Vemulapalli from the CTRC presented the data in a poster session. 

The objectives of the study were to:

• Determine the maximum tolerated dose (MTD) and dose limiting toxicities of ATI-1123
• Establish the Phase II dose of ATI-1123
• Establish the pharmacokinetics (PK) of the drug
• Observe patients for any evidence of anti-tumor activity

Studies results to date are highlighted as follows:

• The MTD was observed at a dose of 90mg/m2
• ATI-1123 had an acceptable safety profile in this heavily pretreated population of cancer patients
• All toxicities observed were expected based on the known profile of Taxotere
• The PK profile appears to enhance the exposure of docetaxel in ATI-1123 compared to Taxotere
• One patient had a partial response with a tumor reduction of 61.3% and 18  patients (64%) had stable disease
• ATI-1123 may represent an alternative treatment for patients with advanced solid tumors
• Additional Phase II clinical trials will be required to assess tumor response in a broader population of cancer patients

“The results reported to date in this Phase I study of ATI-1123 have met our scientific goals and exceeded our expectations for the benefits provided to patients” said Mike Dwyer, president and CEO of Azaya.  “We are excited about these results and the final completion of the Phase I study will move us into Phase II studies with even more enthusiasm for patient results”, he added.

On May 31, 2011 Azaya completed its $3.5 million offering of 5% convertible notes.  The notes were purchased by existing shareholders of the Company and one new investor.  These notes are due December 31, 2012 and are convertible at the option of the holder into preferred stock of Azaya.  “This funding round was important to complete two important milestones for the Company, (1) the Phase I study of ATI-0918 and (2) the development of our second product, ATI-0918, a generic version of Doxil, the first liposomal chemotherapy drug” said Mike Dwyer.  He also added, “Doxil currently has global sales over $500 million annually and we will file for FDA approval of ATI-0918 in 2012 to enter this market”.

About Azaya Therapeutics:         

Azaya Therapeutics (www.AzayaTherapeutics.com) is a San Antonio-based emerging pharmaceutical company whose innovative technology platform allows it to make safer and more effective cancer treatments. 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. Its unique and patented Protein Stabilized Nanoparticle (PSN™) platform also addresses the significant problems associated with delivery of water insoluble drugs. Azaya has leveraged this platform to develop a differentiated drug product for the global oncology market. The company’s management and advisor team is highly experienced in biotechnology and oncology and has a track record of obtaining FDA drug approvals and successfully building companies.