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Press Release
AmpliMed® Begins Enrollment of Phase I Trial of Amplimexon® in Patients with Multiple Myeloma
Tucson, Arizona, March 28, 2006 AmpliMed® today announced that it has begun enrollment of patients in the Phase Ib component of a Phase Ib-II clinical trial to evaluate its lead candidate, Amplimexon® (imexon inj.), as a stand-alone therapy in patients with multiple myeloma whose disease has begun to progress following at least two prior therapeutic campaigns, either conventional or experimental. The study is open at two centers in the United States. Information about the study can be obtained by calling AmpliMed at 520-382-0230.
Cell-based studies have shown that Amplimexon induces programmed cell death (apoptosis) in certain myeloma cell lines and in fresh myeloma cells taken from patients. Amplimexon may have the potential to slow or prevent the progression of myeloma without causing further bone marrow damage in patients in whom prior therapy has already caused serious damage. This clinical trial has been designed to determine the tolerance of escalating doses of Amplimexon in this patient population, and to provide guidance on dosing for future clinical studies in multiple myeloma patients. Once the maximum tolerated dose has been established, the study will continue as a Phase II study. Should the outcome prove positive, this may lead to the design of a randomized clinical trial to more rigorously evaluate the benefits of the drug in this patient population.
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.
““This is our first study evaluating the potential clinical benefit of Amplimexon as a monotherapy in a particular type of malignancy,” said Robert Ashley, chairman, president and chief executive officer of AmpliMed. “While there are many new drugs under development to address earlier stages of multiple myeloma, the safety profile of Amplimexon coupled with its potency against myeloma cells in culture suggests that it may have particular value in patients with preexisting bone marrow damage, who have progressed despite prior treatment. Should the drug be well tolerated without further compromise to bone marrow function, and should there be hints of efficacy, we plan to move rapidly into a Phase II clinical trial in an effort to demonstrate prolonged disease stabilization and survival.”
About Amplimexon
Amplimexon is AmpliMed’s 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 inj.), is undergoing NDA-directed clinical development. Other products in the company's portfolio include Amplizone™, 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.
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AmpliMed, Amplimexon and Amplizone are United States trademarks of AmpliMed Corporation.
