FeRx Receives Phase I SBIR Grant To Develop MagneTarg System To Treat Pancreatic Tumors
Use of Magnetic Targeted Carriers™ (MTCs) for Localized Delivery of Gemcitabine May Lead to Improved Treatment Over Currently Available Systemic Approaches
SAN DIEGO – October 28, 2003 – FeRx Incorporated, a targeted drug delivery company, today announced that it has been awarded a $100,000 Phase I Small Business Innovation Research (SBIR) grant from the National Cancer Institute of The National Institutes of Health (NIH). The grant, entitled “Targeted Delivery of Gemcitabine to Pancreatic Tumors”, supports research to evaluate the use of FeRx’s proprietary MagneTarg™ drug delivery system in the site-specific localization of gemcitabine, a chemotherapeutic agent already approved for the systemic treatment of pancreatic tumors, as a potential improvement for treatment of pancreatic cancer.
This initial research could eventually lead to pre-clinical and clinical development of an MTC-Gemcitabine product.
“This grant award recognizes the need to develop an efficient, site-specific delivery and sustained release system aimed at improving the response rate and therapeutic outcome in the treatment of pancreatic tumors,” said Jacqueline Johnson, Ph.D., President and CEO of FeRx. “The proposed approach will attempt to maximize the concentration of gemcitabine in pancreatic tumors while minimizing systemic exposure through site specific delivery.”
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 has previously received Phase I and Phase II SBIR grant awards from the National Cancer Institute to investigate radiolabeled Magnetic Targeted Carriers™ (MTCs) for the treatment of liver tumors. This latest grant will allow the Company to continue its efforts to expand the MagneTarg™ oncology product portfolio by focusing on tumors found in another organ of the human body. The Principal Investigator on the grant is Yuhua Li, Ph.D., Principal Scientist at FeRx.
About Pancreatic Cancer
Pancreatic cancer is presently the fifth most common cause of cancer related mortality. According to the American Cancer Society, approximately 30,000 Americans are annually diagnosed with pancreatic cancer and an almost equal number die of the disease. While survival rates have improved, it is still considered incurable. For all stages of pancreatic cancer, the one-year survival rate is 20% and the five-year rate is 4%. Surgical resection is the preferred treatment, but this curative option is possible in less than 15% of patients at the time of diagnosis. Additional therapies include surgical resection with intra-operative radiation therapy and palliative surgery followed by external radiation therapy. When surgery or complete resection is not an option, radiation and chemotherapy are used alone or in combination. Radiation is often used for pain palliation while chemotherapy is prescribed to reduce the rate of tumor growth, prolonging survival.
The two chemotherapeutic agents used most commonly are 5-fluorouracil (5-FU) and gemcitabine. Several randomized clinical trials have shown that gemcitabine (Gemzar®, Eli Lilly and Co.) was slightly better with an overall response rate of 17% and median survival of 5.7 months. The current chemotherapy treatment requires systemic treatment once weekly for seven weeks. In addition to IV administration of chemotherapeutics, a few clinical studies have investigated local-regional intra-arterial delivery of gemcitabine to the pancreas alone or in combination with other chemotherapeutic agents. Results have been encouraging, with reported increases in response rates of up to 54% and a median survival of up to 10 months. Such results provide impetus for the development of a technology that could localize and sustain higher gemcitabine concentrations in pancreatic tumors.
About FeRx
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.
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, please visit the FeRx web site.
10/29/2003
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