European Committee for Orphan Medical Products Recommends Orphan Drug Status for AmpliMed's Amplimexon for Pancreatic Cancer.TUCSON, Ariz. -- AmpliMed Corporation today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) has recommended the granting of orphan medicinal product designation for Amplimed's lead drug, Amplimexon(TM) (imexon inj.) for the treatment of pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. . The orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the 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 adenocarcinoma: see neoplasm. and in combination with dacarbazine in patients with unresectable Stage III or Stage IV malignant melanoma Malignant Melanoma Definition Malignant melanoma is a type of cancer arising from the melanocyte cells of the skin. Melanocytes are cells in the skin that produce a pigment called melanin. who have not been previously treated with chemotherapy for their metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. 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 European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community (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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 dev·as·tate tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates 1. To lay waste; destroy. 2. To overwhelm; confound; stun: was devastated by the rude remark. 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 tan·ta·lize tr.v. tan·ta·lized, tan·ta·liz·ing, tan·ta·liz·es To excite (another) by exposing something desirable while keeping it out of reach. 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 (body, education) University of Arizona - The University was founded in 1885 as a Land Grant institution with a three-fold mission of teaching, research and public service. 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. |
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