FeRx Receives Phase II SBIR Grant to Develop Targeted Radioactive Particles for Treatment of Liver Tumors.

Business Editors/Health/Medical Writers

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SAN DIEGO--(BUSINESS WIRE)--July 21, 2003

Delivery of Radionuclides Using FeRx Magnetic Targeted Carriers

(MTCs) Could Result in Localization of Radiation Dose In Tumor Sites,

Eliminating Exposure to Healthy Tissue or Organs

FeRx Inc., a targeted drug delivery company, today announced that it has been awarded a $640,000 Phase II Small Business Innovation Research (SBIR) grant from the National Cancer Institute of The National Institutes of Health (NIH). The grant, entitled "Targeted Radioactive Particles for Liver Tumor Therapy," supports research to continue the development of an intra-tumoral radiation therapy of liver lesions using FeRx's proprietary MagneTarg(TM) drug delivery system. Receipt of the entire grant award is contingent upon the achievement of certain research and development milestones.

The ultimate goal of the program is to fund pre-clinical and clinical development of an MTC-radionuclide product.

"This continuing grant award recognizes the need to develop an innovative product that could overcome the dosing limitations of current external and internal radiotherapies," said Jacqueline Johnson, Ph.D., president and CEO of FeRx. "While our initial clinical indication under investigation is the treatment of both primary and metastatic liver cancers, the characteristics of the MagneTarg system could also allow for other solid tumor types to be studied as well."

The NIH SBIR program is a competitive, peer-reviewed grant program that provides research support to small businesses to discover and develop innovative biomedical products for the treatment of serious unmet medical needs. FeRx previously received a $100,000 Phase I SBIR grant award from the National Cancer Institute to prepare and characterize in vitro radiolabeled Magnetic Targeted Carriers(TM) (MTCs) and then investigate in vivo the binding stability, targeting and retention of these radioactive particles. The Principal Investigator on the grant is Gilles Tapolsky, Ph.D., MBA, Senior Director of Research at FeRx.

Results from preclinical studies investigating the use of MTCs in the local delivery of the radionuclide 90Y to the livers of rabbits implanted with VX2 tumors were presented at the SIR meeting in March 2003 by Jeff Geschwind, MD, Associate Professor of Radiology, Oncology, and Surgery at The Johns Hopkins University School of Medicine, and Director of Interventional Radiology at The Johns Hopkins Hospital. In these studies, radioactivity measured in organs on various days post-dosing showed that the majority of the 90Y was localized in the liver. MRI performed 7 days after treatment showed the presence of MTCs in the tumors and microscopic examination of tissue showed that these particles were confined to the liver. Importantly, liver necrosis was greater in treated animals (greater than or equal to 70% necrosis) when compared to controls (50% necrosis), with complete tumor destruction seen at the highest dose administered. The study suggested the feasibility of intra-tumoral radiotherapy using magnetic targeting and provides the foundation for the additional investigations being conducted under the Phase II SBIR grant.

Existing data from clinical studies in humans indicate that MTCs can be efficiently targeted to and distributed within the tumor while remaining at the site of localization without redistribution. Thus, the MagneTarg drug delivery system may achieve the selective targeting needed to deliver radiation therapy to the desired site, while minimizing the radiation dose to the untargeted organs. An additional advantage to using MTCs is that larger doses of radiation could be delivered to the tumor site if radioactivity does not readily escape the magnetic targeting mechanism.

FeRx Incorporated is a privately held drug delivery company pursuing the development and commercialization of its proprietary MagneTarg(TM) system. MagneTarg offers a unique and simple method for localized delivery of a variety of pharmaceutical agents. FeRx believes the proprietary MagneTarg drug delivery system can efficiently deliver an increased concentration of drug to the desired site in the body while reducing the total amount of drug administered and limiting the toxic side effects commonly found in association with chemotherapy and other nonspecific systemic therapies. The MagneTarg System has applications across a range of therapeutic areas and provides a broad technology platform for targeted delivery of small molecules, radionuclides, biologics and genetic vectors.

Current clinical studies 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.

The company strategy is to initially focus on the use of MagneTarg drug delivery for the treatment of certain solid tumors for which there are few, if any, effective therapies today. FeRx will use potent anti-cancer drugs whose mechanism of action is well understood, but whose efficacy and use are often limited by the debilitating side effects of systemic circulation. In addition to the tumors treated in our ongoing clinical trials, other solid tumors such as those found in the lung, pancreas, kidney, bladder, head and neck and limb can also be treated with the MagneTarg system. The company believes that future applications beyond oncology could include targeted drug delivery in infectious disease, transplantation surgery and gene therapy.

For additional company background, visit the FeRx web site at www.FeRx.com.

--30--JS/

    CONTACT: FeRx Inc., San Diego
             Richard W. Keatinge, Ph.D., 858-677-7788
             [e-mail]

    KEYWORD: CALIFORNIA
    INDUSTRY KEYWORD: PHARMACEUTICAL BIOTECHNOLOGY GOVERNMENT
    SOURCE: FeRx Inc.