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Azaya Therapeutics Reports Results of Phase I Clinical Trial

79% of heavily pretreated patients received benefit from ATI-1123 in Phase I study

SAN ANTONIO--(BUSINESS WIRE)--Jun 13, 2012 - Azaya Therapeutics, Inc. announced final results from the Phase I study of its anti-cancer drug, ATI-1123 (liposomal docetaxel), today. The results showed that 79 percent of heavily pretreated patients received benefit from ATI-1123. The 29 patients enrolled in the study suffered from a variety of solid tumors, including cervical, gastric, melanoma, non-small cell lung (NSCLD), ovarian, pancreatic, prostate, thyroid, urachal and uterine cancers.

Based on these very positive results, Azaya will begin the process to move ATI-1123 to Phase II clinical trials.

The Phase I study was conducted at the Mary Crowley Cancer Research Center in Dallas and the Institute for Drug Development at the Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio. The objectives of the study were to:


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

Study Population:


  • As noted, patients enrolled in the study had a variety of solid tumors including cervical, gastric, melanoma, non-small cell lung (NSCLC), ovarian, pancreatic, prostate, thyroid, urachal and uterine cancers
  • Nine of the enrolled study patients had been previously treated with standard docetaxel

Results for MTD and Dosing Objectives:


  • The MTD was observed at a dose of 90mg/m2 with an enhanced PK profile compared to docetaxel
    • No new toxicities were observed compared to the published toxicity profile of docetaxel
  • Given the observed activity, the recommended Phase II dose is 90 mg/m2

Results for Clinical Benefit Objective:


  • 76% of the study patients (22 patients) had stable disease and one patient had a partial response with a tumor reduction of 61.3%
  • Six pancreatic patients had stable disease and one had a 29% tumor reduction

Of the six patients previously treated with docetaxel, five of them had stable disease and one had a partial response when treated with ATI-1123.

John Nemunaitis, M.D., the Executive Director of the Mary Crowley Cancer Research Centers in Dallas, said: “Our cancer center treated 18 patients in this study. All of the patients tolerated the drug well. We had 2 patients with prostate cancer, one of them remained on treatment with ATI-1123 for 14 months, and we had 6 patients with pancreatic cancer, most maintained stable disease for at least 3 months. I am very encouraged about this product as a result of our patient outcomes."

Steve Weitman, M.D., Ph.D., Director of the Institute for Drug Development at CTRC in San Antonio, said: “This novel therapy clearly has shown anti-tumor activity in a very resistant and refractory patient population. These initial results are very encouraging and warrant further study.”

Michael Dwyer, President and CEO of Azaya, said: “The results reported in this Phase I study of ATI-1123 have met all of our scientific goals and exceeded our expectations for the benefits provided to patients. Further, because ATI-1123 uses an active ingredient – docetaxel – that is already in use with FDA-approval and kills tumors, it has a much lower development risk profile than a completely new chemical formulation.”

“Based on these study results,” Dwyer said, “ATI-1123 has the potential to be an alternative treatment for patients with advanced solid tumors. Additional Phase II clinical trials will be required to assess tumor response in a larger number of patients with specific solid tumor types. Azaya will be aggressively pursuing these opportunities to explore benefit for more patients.”

About Azaya Therapeutics:

Azaya Therapeutics ( is a San Antonio-based emerging biopharmaceutical 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 eliminate the use of toxic carriers and incorporates a naturally occurring protein to stabilize the liposomal encapsulated drug. Its unique and patented Protein Stabilized Liposome (PSL™) platform also addresses the significant problems associated with the delivery of water insoluble drugs. Azaya has leveraged this platform to develop a differentiated drug product for the global oncology market with docetaxel as its active ingredient. ATI-1123 is a patented human serum albumin-stabilized nanoparticle liposomal formulation of docetaxel. Docetaxel is available as a generic product and is also the active ingredient in Taxotere®. Docetaxel is one of the largest selling chemotherapy drugs in the world.

The Company is also developing a generic version of Doxil®, the first liposomal encapsulated chemotherapy drug approved by the FDA. There is currently a global shortage of Doxil due to problems at the manufacturing facility. 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.


Contact: Azaya Therapeutics
Michael T. Dwyer, CEO, 210-341-6600 ext. 204


Posted: June 2012