Atrix Laboratories Inc announced the publication by Pfizer of preclinical data on CP-533,536, the novel bone growth/healing compound that incorporates Atrix's proprietary Atrigel drug delivery technology.
The major finding in the peer-reviewed scientific publication is that, in a non-human fracture model, CP-533,536 in the Atrigel formulation promotes healing, as measured by increased mineral content and density, as well as accelerates healing of fractured bone. While the pre-clinical data are encouraging, extensive human clinical testing and analysis will be required to determine the safety and effectiveness of the product in humans.
CP-533,536 in the Atrigel delivery system is currently in Phase I human clinical testing. Atrix continues to support the product through production of clinical supplies and consultation.
David Bethune, Atrix's chairman and chief executive officer commented, "The formulation of this bone growth product with the Atrigel extended-release technology is a perfect example of the critical need for sophisticated drug delivery solutions to enable commercialization of new and exciting compounds. We will continue to support Pfizer's efforts to bring this and other innovative drugs to the market under the terms of our strategic alliance."
The Atrigel drug delivery system consists of biodegradable polymers, similar to those used in biodegradable sutures, dissolved in biocompatible carriers. Following application of the liquid product into accessible tissue sites, a solid film or implant is formed. The drug encapsulated within the implant is then released in a controlled manner as the polymer matrix biodegrades with time. Depending upon the medical needs, the Atrigel system can deliver small molecules, peptides, or proteins over a time period ranging from days to months. This technology is also used in the Eligard (leuprolide acetate for injectable suspension) prostate cancer product line.
In August 2000, Atrix signed a comprehensive research and worldwide licensing agreement with Pfizer Inc, under which Pfizer evaluates certain compounds in its development pipeline using Atrix's unique drug delivery systems. As part of the agreement, Atrix retains manufacturing rights and would receive royalties based on sales of any product successfully commercialized under the agreement. CP-533,536 is the first compound under this broad strategic alliance to advance into human clinical trials.