European Committee for Orphan Medical Products Recommends Orphan Drug Status for AmpliMed's Amplimexon for Pancreatic Cancer

TUCSON, Ariz.--Aug. 5, 2005--AmpliMed Corporation today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) has recommended the granting of orphan medicinal product designation for Amplimed's lead drug, Amplimexon(TM) (imexon inj.) for the treatment of pancreatic cancer.

The orphan drug status becomes effective when the European Commission approves this recommendation. Amplimexon is currently in Phase I/II clinical trials evaluating the safety and efficacy in combination with gemcitabine in patients with previously untreated advanced pancreatic adenocarcinoma and 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.

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.

"The benefits of orphan designation in Europe are even more significant than in the United States, where Amplimexon already has orphan designation for the treatment of pancreas cancer," noted Robert A. Ashley, Chairman, CEO and President of AmpliMed Corporation. "Therefore, it is encouraging that the COMP has formed a positive opinion of our submission for orphan designation of Amplimexon as a treatment for pancreatic cancer. Our ongoing Phase I/II study in patients with previously untreated pancreatic cancer, in which Amplimexon is being used in conjunction with gemcitabine, is proceeding according to plan and should provide additional evidence of the value of this novel treatment for this devastating disease early in 2006. If positive, these data will lead to more extensive clinical studies to confirm the initial findings."

About Amplimexon(TM)

Amplimexon is AmpliMed's trademarked name for imexon injection, an injectable formulation of 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. They discovered that the drug disrupted mitochondria, the energy producing factories of the cancer cells, resulting in the leakage of toxic substances which ultimately resulted in cell death. 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 activity 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, which, if positive, will lead to the conduct of additional large-scale clinical studies to confirm the initial data.

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(TM) (imexon inj.), is undergoing NDA-directed clinical development. Other products in the company's portfolio include Amplizone(TM), 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.

AmpliMed, Amplimexon and Amplizone are United States trademarks of AmpliMed Corporation.