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Press Release
AmpliMed™ Initiates Multi-Center, Phase I/II Study of Amplimexon plus Gemcitabine in Patients with Previously Untreated, Advanced Pancreatic Adenocarcinoma
Study Marks First Human
Trial to Evaluate Amplimexon™
in Combination with Commonly Prescribed Cancer Therapeutic
Tucson, Arizona, March 3, 2005 - AmpliMed today announced that patient enrollment has begun for a multi-center, Phase I/II clinical trial that will study its lead candidate, Amplimexon™ (imexon inj.), in combination with gemcitabine as a treatment for patients with previously untreated advanced pancreatic adenocarcinoma. Pancreatic adenocarcinoma is one of the deadliest forms of cancer and afflicts more than 30,000 patients in the United States each year. For patients diagnosed with stage IV disease, 12 month survival is less than 15 percent.
The AmpliMed study will determine the maximum tolerated doses of Amplimexon as well as its toxicity in combination with gemcitabine in patients with advanced pancreatic adenocarcinoma, in preparation for subsequent Phase II clinical trials. Data on tumor response and clinical benefit will also be collected and compared against historical control data in order to help establish the parameters for future clinical development.
The study is being conducted at five research sites, including the Anschutz Cancer Pavilion of the University of Colorado Cancer Center and the University of Michigan Cancer Center.
Amplimexon has a unique way of attacking cancer cells that appears to avoid bone marrow toxicity and drug resistance that limits the usefulness of other chemotherapies. Amplimexon appears to do this by causing the disruption of mitochondria, the energy producing factories of the cancer cell, resulting in the leakage of toxic substances which kill cancer cells.
“This is the first protocol specifically designed to establish the patient tolerance of a combination of Amplimexon and a commonly prescribed cancer chemotherapeutic,” said Evan Hersh, M.D., Vice President for Clinical Affairs and Chief Medical Officer of AmpliMed. “Preclinical findings in models of resistant pancreatic cancer have suggested that the combination of Amplimexon and gemcitabine may be significantly more effective than either drug alone and well tolerated. We are delighted that such prestigious institutions have agreed to participate in this important clinical trial for patients with pancreatic cancer.”
"New treatments that combine standard therapy with relatively non-toxic treatments such as Amplimexon are urgently needed to improve the prognosis of patients who suffer from advanced pancreatic cancer," noted Robert Ashley, Chairman, Chief Executive Officer and President of AmpliMed. "During the next few months we plan to initiate several Phase I/II trials to help understand the safety and efficacy of combination therapy with Amplimexon and other commonly used chemotherapeutics in various cancer patient populations."
About Amplimexon
Amplimexon is AmpliMed’s trademarked 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), is undergoing NDA-directed clinical development. Other products in the company's portfolio include Amplizone™, which is anticipated to enter the clinic later in 2005, 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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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.