Studies indented to support filings with FDA
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US-based pharmaceutical company Azaya Therapeutics has announced that it has been selected by the National Cancer Institute for a research collaboration to study Azaya’s lead cancer therapy, ATI-1123.
The research will be conducted by the National Cancer Institute’s (NCI) nanotechnology characterization laboratory (NCL), part of a major program, 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 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.
Michael Dwyer, president and CEO of Azaya, said: We are pleased to partner with the National Cancer Institute and the NCL in our efforts to make safer and more effective cancer therapies. These studies will enable us to better understand the physical and biological properties of our primary product.
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 in later 2009.
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