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Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (3109)	8/26/2002 8:27:17 AM
From: Icebrg	Respond to of 10345

FeRx Receives Fast Track Designation From FDA for MTC-DOX In Primary Liver Cancer Comments: This development is supposed to be run in a partnership between FeRx and Elan. (FeRx PR dated November 28, 2000). Either Elan has already closed this cooperation or they are looking to do so, as FeRx doesn't even mention Elan in the PR. Ice SAN DIEGO--(BUSINESS WIRE)--Aug. 26, 2002--FeRx Inc., a targeted drug delivery company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead product, MTC-DOX (doxorubicin), for the treatment of primary liver cancer (hepatocellular carcinoma -- HCC). FeRx is conducting an international, multi-center Phase II/III clinical trial of MTC-DOX in patients with HCC. Designation as a fast track product means that the FDA will facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. Specifically, fast track program designation allows for submission of sections of a company's marketing application in advance of the complete application, which may accelerate the review process. "We are pleased that the FDA has recognized the need for an accelerated clinical development and review period for MTC-DOX by granting this investigational product fast track status," said Jacqueline Johnson, Ph.D., FeRx's president and chief executive officer. "This designation, along with orphan drug status for MTC-DOX in the U.S. and Europe, represents an important regulatory milestone as we work to progress our Phase II/III global clinical study to the New Drug Application stage." HCC is the fifth most common cancer in the world, killing almost all affected patients within a year. The World Health Organization estimates that each year there are about 430,000 new cases of HCC worldwide, with an equal number of patients dying as a result of the disease. About three quarters of the cases of HCC are found in Asia (China, Hong Kong, Taiwan, Korea and Japan). The frequency of HCC in Asia is greater than 20 cases per 100,000 people. In contrast, the frequency of HCC in North America and Western Europe is much lower, less than 5 per 100,000 people. However, recent data show that the frequency of HCC in the U.S. and Europe is rising at an 8 percent annual rate. This increase is due primarily to chronic hepatitis C, an infection of the liver associated with an increased incidence of HCC. FeRx Inc. is a privately held, product-oriented, targeted drug delivery company dedicated to the development and commercialization of its proprietary Magnetic Targeted Carrier (MTC) technology to improve patient care, reduce toxicity and increase efficacy of known drugs for the treatment of cancer. MTCs are microparticles composed of metallic iron and activated carbon that serve as delivery vehicles for the site specific targeting, retention, and release of a variety of pharmaceutical agents, including small molecules, biologics and genetic vectors. The MTC technology uses a small, externally positioned magnet to create a localized magnetic field within the body. MTCs enable pharmaceutical agents to be magnetically targeted to specific sites in the body. The physical force created by the magnetic field draws the MTC-drug compound into the targeted disease area. This process results in localization and retention of the delivered pharmaceutical agents at the desired site following removal of the magnetic field. Current clinical studies of MTCs being conducted by FeRx are designed to demonstrate the intra-arterial delivery of magnetically targeted pharmaceuticals to specific areas of the body while reducing systemic toxicity and increasing the local concentration of drug at the target site. These trials are focused on the delivery of FeRx's lead product, MTC-DOX (doxorubicin), to primary liver tumors (hepatocellular carcinoma -- HCC) and to tumors that have metastasized to the liver. For additional company background, please visit the FeRx Web site at: www.FeRx.com.