AmpliMed Begins Enrollment of Phase I Trial of Amplimexon in Patients with Multiple Myeloma.TUCSON, Ariz. -- AmpliMed(R) 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(R) (imexon inj.), as a stand-alone therapy in patients with 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 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . 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 pro·grammed cell death n. See apoptosis. programmed cell death proposed system of cell death, often including poly(ADP)-ribosylation, ensures that a cell will not survive if it is so badly damaged that its recovery would harm the (apoptosis) in certain myeloma myeloma /my·elo·ma/ (mi?e-lo´mah) a tumor composed of cells of the type normally found in the bone marrow. giant cell myeloma see under tumor (1). 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 randomized clinical trial, n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies. to more rigorously evaluate the benefits of the drug in this patient population. Amplimexon has a unique way of attacking cancer cells cells once believed to be peculiar to cancers, but now know to be epithelial cells differing in no respect from those found elsewhere in the body, and distinguished only by peculiarity of location and grouping. See also: Cancer 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 pre·ex·ist or pre-ex·ist v. pre·ex·ist·ed, pre·ex·ist·ing, pre·ex·ists v.tr. To exist before (something); precede: Dinosaurs preexisted humans. v.intr. 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 Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II 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 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. 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 (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 blood cell count, n an estimation of the number and types of circulating blood cells (e.g., red blood cells [erythrocytic series], white blood cells, differential). ), 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 in Phase II clinical trials. Other products in the company's portfolio include ethonafide and benzimate which are expected to enter the clinic in 2006/7, 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 and Amplimexon are United States registered trademarks of AmpliMed Corporation. |
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