Azaya Therapeutics, Inc. announced today that it has been selected by the National Cancer Institute (NCI) for a research collaboration to study Azaya’s lead cancer therapy, ATI – 1123. The research will be conducted by the NCI’s Nanotechnology Characterization Laboratory (NCL), part of a major program, the Alliance for Nanotechnology in Cancer, to advance the medical applications of nanotechnology. The initial NCL efforts will focus on the characterization of Azaya’s product for its absorption, distribution and toxicity properties in both in vitro and in vivo studies.
The intent of these studies is to produce data for Azaya to support its filings with the U.S. Food and Drug Administration (FDA). The cost of these studies is paid for by the NCL. The agreement is part of NCI’s Advanced Technology Partnerships Initiative, which seeks to accelerate the delivery of new products to cancer patients.
“We are pleased to partner with the National Cancer Institute and the NCL in our efforts to make safer and more effective cancer therapies,” said Michael T. Dwyer, Azaya’s President and CEO. “These studies will enable us to better understand the physical and biological properties of our primary product. We would expect further studies by the NCL to support other products in our pipeline. Our proprietary nanotechnology platform has given us the ability to formulate and encapsulate many different water insoluble compounds including chemotherapy products to make them safer and more efficacious. Collaboration with the NCI will allow us to leverage a broad array of scientific resources that are important as we move toward the initiation of Phase I human trials later this year,” he added.
Azaya's initial product, ATI – 1123, is an advanced liposomal formulation of the widely prescribed chemotherapy drug Taxotere (docetaxel), used for the treatment of breast, gastric, head and neck, ovarian, prostate and non-small cell lung cancer. Azaya’s initial studies of ATI - 1123 demonstrate that is has dramatically improved the pharmacokinetic profile of Taxotere and is more effective in reducing tumor burden in animal studies.
The NCL has developed a series of protocols that produce a detailed characterization profile for many different kinds of nanoparticles with potential medical applications. These characterization profiles ensure that biomedical researchers have precise information about the particles, such as size, morphology, purity, chemical composition and stability. These protocols include toxicology tests that have been adopted as standards by ASTM International.
Azaya Therapeutics (http://www.AzayaTherapeutics.com) is a San Antonio-based emerging pharmaceutical company whose innovative technology platform makes chemotherapy drugs safer and more effective. Its unique and proprietary Protein Stabilized Nanoparticle (PSN) platform addresses the significant problems associated with delivery of water insoluble drugs. Azaya has leveraged this platform to develop differentiated drug products to address the global oncology market. 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 ILEX drug, Campath (alemtuzumab).
The National Cancer Institute (NCI) established the Nanotechnology Characterization Laboratory in 2005 — in collaboration with the National Institute of Standards and Technology and the U.S. Food and Drug Administration — to perform preclinical efficacy and toxicity testing of nanoparticles. NCL serves as a national resource and knowledge base for all cancer researchers to facilitate the regulatory review of nanotechnologies intended for cancer therapies and diagnostics. NCL, part of NCI’s Alliance for Nanotechnology in Cancer, works to accelerate the transition of basic nanoscale particles and devices into clinical applications.
