TUCSON, Ariz. -- AmpliMed today announced that the Company has begun to enroll patients in a new clinical trial that will evaluate its lead candidate, Amplimexon(TM) (imexon inj.) in combination with the drug dacarbazine (DTIC) in patients with unresectable Stage III or Stage IV malignant melanoma who have not been previously treated with chemotherapy for their metastatic disease. Melanoma is the most serious form of skin cancer and, during the past ten years, the number of cases has increased more rapidly than that of any other cancer.
Dacarbazine (DTIC) is a chemotherapeutic agent that interferes with the growth of cancer cells. It is one of only two drugs approved for sale in the United States as first line therapy for the treatment of metastatic malignant melanoma. Prior studies have demonstrated that Amplimexon can potentiate the cytotoxic effects of DTIC on tumor cells in vitro and in animal models of melanoma tumor growth. This clinical trial has been designed first to determine patient tolerance of the combination of Amplimexon and DTIC, followed by the enrollment of a significant number of patients at the maximum tolerated dose of the combination to enable a meaningful comparison with historical controls of DTIC alone. Should the outcome prove positive, this may lead to the design of a randomized clinical trial to more rigorously evaluate the benefits of the combination.
The study is being conducted at six centers of excellence in melanoma therapy across the United States. It is anticipated that approximately 60 patients will be enrolled in the Phase I and Phase II components combined during the next 12 months.
Amplimexon has a unique way of attacking cancer cells that appears to avoid serious bone marrow toxicity and drug resistance that limits the usefulness of other chemotherapies. Amplimexon appears to kill cancer cells 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.
"Our lead drug candidate Amplimexon has proven to be synergistic with several drugs in pre-clinical studies, and this Phase I/II trial will study the drug in combination with DTIC in patients with malignant melanoma," said Robert Ashley, chairman, president and chief executive officer at AmpliMed. "Melanoma is the fastest growing cancer worldwide and there are few new drugs available today to treat the metastatic form of this disease. Should the drug combination prove to be well tolerated by patients, and should there be hints of efficacy, we plan to move rapidly into a randomized Phase II clinical trial in an effort to demonstrate incremental clinical benefit."
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 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. The first of these, using Amplimexon in combination with gemcitabine in patients with untreated pancreatic adenocarcinoma is currently underway.
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.
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