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Press Release
European Commission Grants Orphan Drug Status for AmpliMed’s Amplimexon® for the Treatment of Ovarian Cancer
Tucson, Arizona, January 11, 2006 – AmpliMed Corporation today announced that the European Commission has approved the recommendation of the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) to grant an orphan medicinal product designation for Amplimed’s lead drug, Amplimexon™ (imexon inj.) for the treatment of ovarian cancer.
Amplimexon is currently in Phase I/II clinical trials evaluating safety and efficacy in combination with gemcitabine in patients with previously untreated advanced pancreatic adenocarcinoma, in combination with dacarbazine in patients with unresectable Stage III or Stage IV malignant melanoma who have not been previously treated with chemotherapy for their metastatic disease, in combination with Taxotere® (docetaxel inj.) for the treatment of lung, breast and prostate cancer and as a monotherapy for the treatment of refractory multiple myeloma.
EMEA’s orphan drug program is designed to promote the development of drugs to treat rare life-threatening or very serious conditions that affect no more than five in every 10,000 people in the European Union (EU). The designation provides EU market exclusivity for up to ten years in the given indication, as well as a reduction in fees associated with various aspects of the regulatory process, including the application for marketing approval and EMEA guidance via the Scientific Advice Working Party for the development of the drug and clinical protocols relevant for approval.
“Amplimexon has now been granted two orphan designations in Europe, for the treatment of ovarian and pancreatic cancer, and four designations in the United States, for the treatment of melanoma, multiple myeloma, pancreatic and ovarian cancer,” noted Robert A. Ashley, Chairman, CEO and President of AmpliMed Corporation. “As we continue to invest in an extensive program of Phase I and Phase II clinical studies, and as the preliminary data continue to show promise, it is encouraging to know that, should Amplimexon gain approval for one of these indications, AmpliMed will benefit from the extended marketing exclusivity afforded by these designations.”
About Amplimexon
Amplimexon® is
AmpliMed’s™ name for imexon injection, a cyanoaziridine compound
which showed tantalizing evidence of activity in limited studies in lung cancer, melanoma and breast
cancer that were documented in publications in the 1980s. The potential of imexon as a cancer drug was
never fully explored, until 1994, when AmpliMed co-founding scientists Drs. Evan Hersh, David Alberts,
Robert Dorr and William Remers initiated a program to decipher Amplimexon’s novel mechanism of
action. This led to the initiation in 2003 of an ongoing Phase I clinical study of the drug as a
stand-alone therapy in late-stage cancer patients. Further preclinical research revealed that the
combined use of Amplimexon and certain other chemotherapeutics resulted in a significant increase in
efficacy compared to either drug alone. These findings are now being translated into a series of
Phase I/II clinical studies of combination therapy in patients with various types of cancer.
About AmpliMed Corporation
AmpliMed Corporation was founded in 1989 with the support of the University of Arizona Technology
Development Corporation and is focused on the clinical development of chemotherapeutic agents for cancer.
AmpliMed’s strategy is to develop anti-cancer drugs with novel mechanisms of action designed to
overcome some of the limitations, such as myelosuppression (suppression of blood cell counts), multi-drug
resistance (treatment-induced resistance to many cancer drugs) and cardiac toxicity, frequently associated
with current cancer therapy. The company’s lead product, Amplimexon® (imexon inj.), is
undergoing NDA-directed clinical development. Other products in the company's portfolio include
Amplizone™, which is anticipated to enter the clinic early in 2006, and a portfolio of derivatives
of both lead compounds for future development. AmpliMed Corporation is based in Tucson, Arizona and is on
the Web at http://www.amplimed.com.
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AmpliMed, Amplimexon and Amplizone are United States trademarks of AmpliMed Corporation.
