FeRx Files U.S. IND for Phase 1/2 Clinical Testing of MagneTarg System to Deliver Mitomycin C for Treatment of Lung Cancer.

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SAN DIEGO--(BUSINESS WIRE)--Jan. 9, 2004

Use of Magnetic Targeted Carriers(TM) (MTCs) for Localized

Delivery of Mitomycin (MMC); May Lead to Improved Treatment for

Localized Disease

FeRx Inc., a targeted drug delivery company, today announced that the U.S. Food and Drug Administration (FDA) has allowed the Phase 1/2 clinical trial submitted in an investigational new drug (IND) application using the company's proprietary MagneTarg(TM) drug delivery system to deliver Magnetic Targeted Carriers(TM) (MTCs) combined with the chemotherapeutic agent mitomycin C (MTC-MMC) to patients with non-small cell lung cancer (NSCLC) via intra-arterial administration.

The proposed study is a Phase 1/2 escalating, single dose cohort trial in up to 50 patients with symptomatic advanced NSCLC and who are no longer responsive to conventional treatment. These patients will receive a single dose of MTC-MMC, administered by pulmonary artery infusion. MTC-MMC will be targeted and retained at the tumor site by the placement of an external magnet for a short period of time.

The primary objective of the proposed study is to determine the safety and maximum tolerated dose of MTC-MMC. The secondary objectives are to assess the pharmacokinetics of mitomycin and the preliminary evidence of antitumor activity in patients with unresectable NSCLC. The study is expected to begin shortly.

"With the entry of MTC-MMC into clinical development, we have met our goal of commencing clinical studies with a second MTC product by 2004," commented Jacqueline Johnson, Ph.D., president and CEO of FeRx. "The planned study also presents an opportunity to demonstrate the versatility of the FeRx technology beyond our current clinical trials in the liver by targeting the lung as another organ in the body accessible to the MagneTarg drug delivery platform."

About MMC

Mitomycin C (MMC) is a generic oncolytic drug that is an antibiotic isolated from streptomyces caespitosus. It is activated in vivo to a bifunctional and trifunctional alkylating agent. Binding to DNA leads to cross-linking and inhibition of DNA synthesis and function.

MMC is very potent and its action is not affected by cell cycle. Over the years, MMC has been used routinely to treat bladder, gastric and colorectal cancers. Other uses include the treatment of breast cancer, cervical cancer, head and neck cancer, non-small cell lung cancer, ovarian cancer, pancreatic cancer and osteogenic sarcomas.

The most common routes of administration for MMC are intravenous and intravesical. Intra-arterial administration into most major arteries has also been used. MMC delivered systemically has a severe toxic side effect profile and results in a high incidence of bone marrow suppression and hemolytic uremic syndrome, a potentially fatal disease. Therefore, selective targeting of MMC using MagneTarg(TM) could potentially improve the tolerability and increase the efficacy of this potent drug.

About Non-Small Cell Lung Cancer

According to the World Health Organization, there are more than 1.2 million cases worldwide of lung and bronchial cancer each year, causing approximately 1.1 million deaths annually. Approximately 171,900 new cases of lung cancer were diagnosed in 2003 in the U.S. The 5-year survival rate with lung cancer is less than 15%, and approximately 157,000 patients die from lung cancer annually in the U.S., making lung cancer the most common cause of cancer deaths in the U.S. (American Cancer Society 2003). Similar rates of lung cancer are seen in Europe and Australia. Non-small cell lung cancer is the most common form of the disease and accounts for almost 80 percent of all lung cancer.

About FeRx

FeRx Inc. 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 other 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 the current 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, please visit the FeRx Web site at: www.FeRx.com.