FeRx Announces Global Opening Of Phase II/III Clinical Trial For Treatment Of Primary Liver Cancer
San Diego - June 2, 2003 - FeRx Incorporated today announced that enrollment has commenced at more than 30 clinical sites in a global multi-center Phase II/III clinical trial utilizing the Company's proprietary MagneTarg(tm) drug delivery system with its lead compound, MTC-Doxorubicin (MTC-DOX), in patients with primary liver cancer (hepatocellular carcinoma or HCC).
The multinational trial, designated the MAGNET trial, will enroll 240 patients at clinical sites in North America, Europe and Asia. The primary objective of this study is to detect a clinically and statistically significant increase in median survival time for MTC-DOX treated patients relative to patients treated with IV doxorubicin, the comparator arm in this study. Secondary endpoints are time-to-progression (TTP), duration of survival, tumor response classification, conversion rate to resection or transplantation, quality of life, and safety in patients with non-resectable HCC.
"These HCC patients with non-resectable tumors represent a problem for which there is an urgent need for a safe and effective treatment," commented Thomas Leung, MD, Associate Professor, Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong, and Principal Investigator on the MAGNET trial. "We are hopeful that the development of the MTC-DOX product will enhance significantly the medical prognosis and quality of life of these patients."
Results from a Phase I/II trial in non-resectable HCC patients were presented at the EORTC/NCI/AACR meeting in November 2002 and at the SIR meeting in March 2003. In this trial, median survival time was 11.5 months in patients receiving from one to three treatments of MTC-DOX at the doses being used in the Phase II/III trial. Pharmacokinetic measurements showed minimal evidence of doxorubicin in systemic circulation, with the most common adverse event being gastrointestinal and abdominal pain.
"Patients diagnosed with HCC have few treatment options and with the exclusion of surgery, the treatment of solid tumors is often limited by the debilitating side effects caused by systemic circulation of chemotherapeutic agents," commented Jacqueline Johnson, Ph.D., President and CEO of FeRx. "Clinical results from our Phase I/II study in HCC patients have been encouraging and preliminary evidence indicates that MTC-DOX may provide a tolerable and potentially new therapy for treating this disease."
In addition, a 30 patient Phase I/II study in non-resectable HCC is currently nearing completion at three sites in China under a U.S. IND as well as under an IND approved by China's State Drug Administration. The study endpoint in this trial is time to tumor progression, with secondary endpoints of duration of survival, tumor response classification, and safety.
"Data from our two Phase I/II safety and dose escalation clinical trials in non-resectable HCC patients successfully showed localization of MTC-DOX in the tumor," said Dr. Johnson. "With the global opening of our Phase II/III clinical trial, we hope to further validate the MTC-DOX product for use in treating solid tumors in this patient population."
FeRx retains all rights to the MagneTarg drug delivery system and is actively looking for strategic partners to complete development and commercialize the MTC-DOX product in North America, Europe and Asia.
The MagneTarg system includes a Magnetic Applicator consisting of a small permanent magnet that is used for the targeting of drug loaded Magnetic Targeted Carriers ("MTCs"). MTCs are microparticles, composed of metallic iron and activated carbon, which serve as delivery vehicles for the site specific targeting, retention, and release of therapeutic agents. The physical force created by the magnetic field draws the arterially injected MTC-drug combination through the capillary bed wall into the targeted disease site. This process, known as extravasation, results in localization and retention of the therapeutic agents at the targeted site even after the magnetic field has been removed.
Estimates by the World Health Organization and the American Cancer Society suggest that the incidence of HCC approaches 1,000,000 new cases each year, with more than 1,250,000 deaths worldwide caused by all forms of liver cancer. Primary liver cancer is particularly prevalent in Asia, Southern Europe and in developing countries, where primary risk factors for the disease include hepatitis-B, hepatitis-C, and aflatoxin. However, HCC is also increasing in western countries at an 8% annual rate due to hepatitis-C.
The prognosis for liver cancer is generally poor, current treatment options are limited and there is no chemotherapeutic agent specifically approved for treatment of the disease.
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 received Orphan Drug and Fast Track designations from the FDA and Orphan Medicinal Product designation from the European Agency for the Evaluation of Medicinal Products.
As a follow up to receiving Fast Track and Orphan Drug designations in the U.S., FeRx was awarded a clinical research grant from the FDA's Office of Orphan Products Development to financially support its 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.
FeRx Incorporated is a privately held drug delivery company pursuing the development and commercialization of its proprietary MagneTargTM 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.
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. Clinical trials are being conducted for the treatment of primary and metastatic liver cancers; however, 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 information, please visit the FeRx web site.
6/2/2003
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