AmpliMed Receives Orphan Drug Designation for Amplimexon in the Treatment of Ovarian Cancer.TUCSON, Ariz. -- AmpliMed, a privately-held, Tucson-based pharmaceutical company, today announced that its lead drug Amplimexon(TM) (imexon inj.) has been granted 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 designation for the treatment of ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast by the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). Orphan drug designation is granted to applicants when the prevalence of the disease is 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 FDA's application user fee. These advantages are intended to encourage sponsors to develop drugs for patients with rare diseases. 22,200 new cases of ovarian cancer are expected in the United States in 2005. The disease accounts for nearly three percent of all cancers among women and ranks second among gynecologic cancers, following cancer of the uterine uterine /uter·ine/ (u´ter-in) pertaining to the uterus. u·ter·ine adj. Of, relating to, or in the region of the uterus. corpus. An estimated 16,210 women will die from ovarian cancer in 2005, and the disease causes more deaths than any other cancer of the female reproductive system reproductive system, in animals, the anatomical organs concerned with production of offspring. In humans and other mammals the female reproductive system produces the female reproductive cells (the eggs, or ova) and contains an organ in which development of the fetus . Current treatment options include surgery, radiation therapy and chemotherapy. Overall, nearly 80 percent of new ovarian cancer patients survive one year after diagnosis; the five year relative survival rate for all stages is 53 percent. Pre-clinical studies have indicated that Amplimexon is effective at killing ovarian cancer cells in doses which can be achieved following administration of the drug to humans. In addition, the drug has been shown to act synergistically syn·er·gis·tic adj. 1. Of or relating to synergy: a synergistic effect. 2. Producing or capable of producing synergy: synergistic drugs. 3. with other drugs commonly used to treat ovarian cancer, such as taxotere and platinum-containing anti-cancer drugs. "While significant advances in the treatment of ovarian cancer have been made in recent years, the disease often becomes resistant to commonly used therapies," said Evan Hersh, Executive Vice President and Chief Medical Officer of AmpliMed. "Our research with Amplimexon has suggested the possibility that the drug may resensitize certain types of ovarian cancer to these therapies and enable patients to experience an extended period of clinical response. While these preclinical findings will have to be confirmed in future clinical trials, the granting of orphan status for Amplimexon for the treatment of ovarian cancer provides AmpliMed with additional incentive to pursue these trials in the near future." Amplimexon has already been granted orphan drug designation for the treatment of 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. 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. , multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility and 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 drug is currently completing a Phase I dose-escalation study to establish safety and tolerability, and Phase I/II clinical studies in combination with gemcitabine for the treatment of pancreatic cancer, and in combination with dacarbazine in the treatment of metastatic melanoma. 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 lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. , 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) and Carbendazim, both of which are expected to enter the clinic in 2006, and a portfolio of derivatives of each of the lead compounds for future development. AmpliMed Corporation is based in Tucson, Arizona and is on the Web at http://www.amplimed.com. AmpliMed(TM), Amplimexon(TM) and Amplizone(TM), are United States trademarks of AmpliMed Corporation. |
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