NeoPharm, Inc., a biopharmaceutical company dedicated to the research, discovery and commercialization of new and innovative cancer drugs for therapeutic applications, reported that its investigational tumor-targeting agent - IL13-PE38 - was designated as a fast track drug development program by the U.S. Food and Drug Administration (FDA) for the treatment of malignant glioma, a brain cancer for which there is no known cure.
NeoPharm has exclusively licensed IL13-PE38 from the National Cancer Institute and the FDA, and is developing the agent under a Cooperative Research and Development Agreement (CRADA) with the FDA's Center for Biologics Evaluation and Research (CBER). The compound received orphan drug designation from the FDA in November 2001 and is currently in two ongoing Phase I/II clinical trials.
The fast track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are showing positive progress in treating serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Specifically, fast track program designation allows for the early submission of sections of a drug's marketing application before a complete application is submitted, which may potentially accelerate the review process. Sponsors must design and perform studies that can determine whether the compound can fulfill the unmet medical need. The fast track classification does not apply to a product alone, but pertains to a combination of the product and the indication for which it is being studied. It is therefore the development program for a specific drug for a specific indication that receives fast track designation.
"We're very pleased to receive the FDA's designation of IL13-PE38 for the fast track drug development program," said James M. Hussey, NeoPharm's President and CEO. "Based on the encouraging preliminary data we've seen from our early Phase I/II human clinical studies, we believe the agent has potential for treating malignant glioma - a devastating disease which claims the lives of approximately 17,500 Americans every year. We're committed to working with the FDA in advancing IL13-PE38 into Phase II/III trials this year so that we can find a better treatment for patients with this deadly disease." Most people with malignant glioma usually live for less than one year after diagnosis, as there are very limited treatment options to prevent rapid recurrence of the cancer once the tumor is surgically removed from the brain.