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| |  Atrigel Successful In Decreasing Testosterone In Advanced Prostate Cancer FORT COLLINS, CO -- January 19, 2000 -- Atrix Laboratories, Inc. announced that it has achieved successful results in the ongoing Phase III human clinical trials for the treatment of prostate cancer. This innovative product uses the company's patented Atrigel(R) drug delivery technology to administer leuprolide acetate over a 30-day period to treat patients with advanced prostate cancer.
"This is a major milestone for Atrix," said David Bethune, vice chairman and chief executive officer of Atrix. "This clinical study shows that the Atrigel technology works in delivering drugs systemically, and paves the way for its use in additional therapeutic areas. Leuprolide and similar drugs account for more than $1 billion in worldwide product sales each year for prostate cancer and endometriosis, and the new Atrix product offers improvements over currently available therapies." With the new Atrix product, an Atrigel formulation containing leuprolide acetate is injected subcutaneously as a liquid, where it solidifies and releases a predetermined dose of leuprolide continuously over a 30-day period as it is bioabsorbed. The sustained levels of leuprolide result in a marked decrease in testosterone levels, which in turn suppresses tumor growth in patients with hormone-responsive prostate cancer. "To date, in the multi-center Phase III trial, 36 patients have received multiple injections of the Atrix product. Drug administration was well-tolerated and raised no safety issues," said Dr. Steven Garrett, Atrix's vice president of clinical research. "Testosterone was reduced in these patients to levels known to inhibit tumor growth in prostate cancer." He noted that more than 180,000 American men are diagnosed with prostate cancer annually, and as part of their treatment regimen, most patients receive some form of drug therapy to reduce testosterone levels. "We are pleased with these initial findings, and plan to enroll additional subjects in the next phase of this study," said Dr. Garrett. He noted that Atrix is also in the process of developing leuprolide formulations for delivery over longer time periods. Now that the Atrigel technology has been proven successful for systemic drug delivery (delivering medications throughout the body), the company believes that this technology offers a safe, effective, and low-cost alternative for delivering new drugs throughout the body.
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