FeRx Presents Results of Phase I/II Trial of MTC-DOX in Patients with Hepatocellular Carcinoma At EORTC-NCI-AACR.

Business Editors & Health/Medical Writers

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SAN DIEGO--(BUSINESS WIRE)--Nov. 20, 2002

FeRx Incorporated:

-- Study suggests intra-arterial administration of MTC-DOX in

either single or multiple treatment cycles has no clinically

significant toxicities, and warrants further clinical

investigation in patients with hepatocellular carcinoma 

FeRx Inc., a targeted drug delivery company, today reported results of a multi-center, Phase I/II trial of hepatic intra-arterial delivery of doxorubicin hydrochloride adsorbed to magnetic targeted carriers (MTC-DOX) in patients with hepatocellular carcinoma.

The data were reported at the third annual symposium entitled "Molecular Targets and Cancer Therapeutics," organized jointly by the European Organization for Research and Treatment of Cancer (EORTC), the U.S. National Cancer Institute (NCI) and the American Association of Cancer Research (AACR), held in Frankfurt, Germany.

Response data from the study entitled "A Multicenter, Phase I/II Trial of Hepatic Intra-Arterial Delivery of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers in Patients with Hepatocellular Carcinoma" showed that in 21 lesions (19 patients) treated at doses greater than or equal to 0.4 mg of doxorubicin/cm2 of tumor area, there was 1 complete response, 2 partial responses, 7 minor responses, 7 patients with stable disease and 4 patients with progressive disease. The median survival time in this same patient group was 11.0 months.

"This study provides encouraging data on the potential of MTC-DOX for the treatment of patients with hepatocellular carcinoma, for which there is currently no approved therapy," said Dr. Alan Venook, Professor of Clinical Medicine and Director of the Clinical Research Office, UCSF Cancer Center, one of the study's lead investigators. "The study suggests that if additional investigations prove successful, this approach may provide a means to increase the safety and tolerability of doxorubicin, potentially allowing MTC-DOX to become a front line therapy for non-resectable liver cancer."

The Phase I/II dose escalation study was conducted in 33 patients, most treated as outpatients, at 7 centers throughout the United States under a trial design developed to test the safety, maximum tolerated dose (MTD), pharmacokinetic profile and preliminary tumor response following selective arterial infusion of MTC-DOX under magnetic guidance. MTC-DOX was delivered to the tumor site via selective arterial catheterization. An external magnet with a field strength of 5 kilogauss was positioned over the tumor to capture, and then extravasate, the material into the selected tumor parenchyma.

Delivery to the targeted tumor was confirmed by magnetic resonance imaging. A range of tumors with cross-sectional areas of 4 cm2 to 222 cm2 was treated. Hepatic computed tomography imaging (CT) was obtained prior to and greater than or equal to 28 days following therapy and analyzed for tumor response in accordance with NCI criteria.

Patients were followed for survival and data was censored as of November 2002. Importantly, pharmacokinetic measurements show minimal evidence of doxorubicin in systemic circulation, with the most common adverse event being gastrointestinal and abdominal pain (64 percent).

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. Approximately 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.

Since HCC is a serious disease that currently does not have an approved drug therapy, and the MTC-DOX product could potentially address this unmet medical need, FeRx has received Orphan Drug and Fast Track designations from the US Food and Drug Administration and Orphan Medicinal Product designation from the European Agency for the Evaluation of Medicinal Products.

As a follow up to receiving these Fast Track and Orphan Drug designations in the U.S., in October of this year, FeRx was awarded a clinical research grant from the U.S. Food and Drug Administration's Office of Orphan Products Development to financially support FeRx's clinical studies of MTC-DOX in patients with HCC. This peer-reviewed, highly competitive grant acknowledges the promise of MTC-DOX as a treatment for HCC.

The EORTC-NCI-AACR presentation was co-authored by Alan Venook, M.D., of the UCSF Medical School; Eric Walser, M.D., of the University of Texas Medical Branch; Scott Goodwin, M.D., of UCLA Medical School; and Joy Koda, Ph.D., of FeRx.

Following completion of the Phase I/II study described in this presentation, FeRx initiated an international, multi-center Phase II/III clinical trial of MTC-DOX in patients with HCC. This trial is currently being conducted at clinical sites in North America, Europe and Asia.

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.