FeRx's MTC Technology May be Useful in Treating Gastrointestinal Disease.

Business Editors & Health/Medical Writers

BIOWIRE2K

SAN DIEGO--(BW HealthWire)--May 22, 2002

Study Reports Promising Results for Potential Treatment of

GI Diseases Such as IBD or for Cancerous Tumors of the

Esophagus, Stomach and Colon

FeRx Inc. reported encouraging data this week at the 2002 Digestive Disease Week (DDW) conference, from studies using its proprietary Magnetic Targeted Carrier (MTC) technology.

Preclinical results suggest that the company's MTCs are a feasible tool for drug delivery to the gastrointestinal (GI) tract and may be useful in the treatment of GI diseases, such as inflammatory bowl disease (IBD) and cancerous tumors of the esophagus, stomach and colon, via an intra-luminal route of administration. FeRx has previously demonstrated delivery of MTCs via intra-arterial and intra-vesical routes of administration, possibly leading to the treatment of a variety of solid tumors, including those of the liver and bladder.

As many as two million Americans suffer from IBD, the blanket term used to describe Crohn's disease and ulcerative colitis, while cancers of the GI tract are common and represent one of the leading causes of death in the U.S., Europe and, increasingly, in Japan.

"Although therapeutic approaches exist for IBD and colon cancer, the treatments associated with them have undesirable systemic side effects which often limit their usefulness," said Beverley Greenwood-Van Meerveld, Ph.D., FACG, Scientific Director, Oklahoma Foundation for Digestive Research Basic Science Laboratories. "Based on this initial study, we believe that use of the MTC technology provides a means to avoid these systemic effects, represents a feasible approach for the delivery of drug complexes to specific regions of the GI tract and may prove to be a novel methodology for conditions such as IBD or cancerous tumors of the GI tract."

Data from the study entitled "Feasibility for Site-Specific Drug Delivery to the Gastrointestinal Tract Using Magnetically Targeted Carriers" (Abstract Number 103065) showed that MTCs can be concentrated and confined to the intra-luminal surface of rat jejunal and colonic mucosa without causing functional or histological damage to the intestinal epithelium. The presentation was co-authored by Beverley Greenwood-Van Meerveld, Ph.D., Kalina Venkova, Ph.D., and Anthony C. Johnson of the Oklahoma Foundation for Digestive Research Basic Science Laboratories, VA Medical Center; S. Terence Dunn, Ph.D., of the Department of Pathology, Oklahoma University Medical Center, Oklahoma City; and, Tina Leakakos, Ph.D., of FeRx. The research was conducted under a grant from the Small Business Innovation Research (SBIR) Program of the National Institutes of Health.

Delivery through the GI tract is the most common method by which drugs are presented for systemic therapeutic effects in the body. The upper small intestine is the major site of absorption for most drugs, but drug absorption can take place along the entire GI tract and many drugs are selectively absorbed in other regions. This absorption can be complicated by a number of factors, including enzymatic and penetration barriers, transit times, redox potential, microflora and pH changes in different GI regions. Thus, the complexity of the GI tract and the fact that lesions and tumors can occur in any part of it make it difficult to deliver an efficacious dose to a specific GI lesion. The purpose, then, of the current study is to demonstrate the potential utility of the MTC technology in overcoming these difficulties to treating GI diseases.

"We are encouraged by this data that points to an expansion of our MTC technology platform to include the potential treatment of GI diseases," said Jacqueline Johnson, Ph.D., president and CEO of FeRx. "Delivering therapeutic agents absorbed to MTCs directly to the GI tract via an intra-luminal route of administration, serves to emphasize the versatility of the technology and its potential to deliver a broad range of pharmaceutical agents while avoiding systemic side effects."

The Oklahoma Foundation for Digestive Research (OFDR) Basic Science Laboratory is part of a private, non-profit research foundation whose mission is to advance basic science and clinical research in GI disease, treat patients with such diseases, participate in the training of physicians and to educate the public about GI illnesses. For additional information, visit the OFDR Basic Science Laboratory Web site at www.gutresearch.com.

FeRx Inc. is a privately held targeted drug delivery company focused on research, development, commercialization and manufacturing of therapeutic agents for the treatment of cancer. Based on its proprietary Magnetic Targeted Carrier ("MTC") drug delivery technology, FeRx products are designed to limit the debilitating side effects caused by systemic circulation of chemotherapeutic drugs in the treatment of solid tumors. 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 efficacious 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 Inc. Web site at: www.FeRx.com.