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Press Release
AmpliMed™ Receives Orphan Drug Designation for Amplimexon™ Injection (Imexon Injection) in the Treatment of Pancreatic Cancer
Tucson, Arizona, December 4, 2003 – AmpliMed, a privately-held, Tucson-based pharmaceutical company today announced that its novel compound Amplimexon has been granted orphan drug designation for the treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA). Amplimexon has already been granted orphan drug designation for the treatment of metastatic malignant melanoma and multiple myeloma. The drug is currently undergoing a Phase I dose-escalation study to establish safety and tolerability, and it is anticipated that Phase II clinical studies will begin in 2004 in at least two cancer indications.
Pancreatic cancer affects an estimated 30,000 people in the United States. The disease is often very aggressive and has a particularly poor prognosis with 5-year survival rates below 5%. Early stage disease which is uncommon is treated with surgical resection if possible, followed by chemotherapy and radiotherapy. Most patients present with locally advanced or advanced disease and are treated with chemotherapy. Cell-based and animal studies have suggested that Amplimexon may be of value as part of a chemotherapeutic regimen in the treatment of pancreatic cancer.
Orphan drug designation is granted to applicants when the prevalence of the disease occurs in less than 200,000 patients in the United States. The benefit of orphan drug designation includes exclusive marketing rights in the United States for seven years following marketing approval and enables the company to apply for research funding, tax credits for certain research expenses and a waiver from the fees associated with New Drug Application to the FDA. These advantages are intended to encourage sponsors to develop drugs for patients with rare diseases.
"We are particularly pleased that Amplimexon has been granted orphan drug designation for pancreatic cancer, as this disease is poorly served by other therapeutic approaches available to us in the clinic", said Evan Hersh, M.D., CEO of AmpliMed. "Based on our pre-clinical data we believe that Amplimexon may prove, after appropriate clinical trials, to be an important addition to our armamentarium of drugs against a disease which has a very poor prognosis".
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For additional information about AmpliMed Corporation, please contact Mr. Wayne Morrison at (520) 529-1000.
AmpliMed®, Amplimexon® and Amplizone™, are United States trademarks of AmpliMed Corporation.
