Researchers to Present Positive Phase I Study Results for AmpliMed's(TM) Amplimexon(R) (imexon inj.) in Patients with Advanced Solid Tumors.TUCSON, Ariz. -- Scientists See Preliminary Evidence of Anti-Tumor Activity and Minimal Toxicity AmpliMed(TM) today announced that preliminary results of its Phase I trial of its lead drug candidate, Amplimexon(R) (imexon inj.), in patients with advanced solid tumors will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, which is being held this week in Philadelphia. The multi-center study involved 48 patients with a variety of solid tumors including melanoma, pancreatic, ovarian, colon, uterine, lung and prostate cancers. Patients were administered a range of doses from 20-1000 mg/m(2)/day of Amplimexon as a 30 minute infusion daily X 5 days every two weeks. The Maximum Tolerated Dose (MTD MTD Mounted MTD Maximum Tolerated Dose MTD Memory Technology Device MTD Month To-Date MTD Methadone (drug screening) MTD motion to dismiss (legal) MtD Mountain Dew MTD Memory Technology Driver ) of this schedule of administration was determined to be 875 mg/m(2)/day. Results showed that Amplimexon was well tolerated and there was preliminary evidence of antitumor an·ti·tu·mor also an·ti·tu·mor·al adj. Counteracting or preventing the formation of malignant tumors; anticancer. Adj. 1. activity. Several Phase I/II studies both in combination with chemotherapy and as monotherapy are underway, and combination chemotherapy Phase II and III studies are planned. Dr. Tomislav Dragovich, MD, Ph.D, assistant professor of Medicine at the Arizona Cancer Center, and the lead investigator of the study, will present the results during a poster presentation on November 17th in Philadelphia. An important experimental finding in the Phase I study was a significant dose-related reduction in the plasma levels of sulfur-containing compounds (thiols) in patients administered Amplimexon. This is consistent with previous findings in cell culture that suggest that the drug acts by reducing thiol thiol: see mercaptan. levels in cancer cells, leading to a build up in toxic reactive oxygen species reactive oxygen species, n molecules and ions of oxygen that have an unpaired electron, thus rendering them extremely reactive. Many cellular structures are susceptible to attack by ROS contributing to cancer, heart disease, and cerebrovascular disease. (ROS ROS, n.pr See reactive oxygen species. ) inside the cancer cell and ultimately to 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 , or apoptosis. In a second poster at the same meeting, Dr. Amanda F. Baker 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. Cancer Center reports the results of experiments designed to explore the changes in gene expression in patients' white blood cells White blood cells A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system. Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies exposed to Amplimexon. The findings of this study also help support the hypothesis that Amplimexon acts by increasing ROS levels in cancer cells. The data suggests that cells exposed to Amplimexon upregulate the expression of those genes that are associated with the response to oxidative stress oxidative stress, n an imbalance of the prooxidant antioxidant ratio in which too few antioxidants are produced or ingested or too many oxidizing agents are produced. , which would be the reaction that would be anticipated if Amplimexon was causing an increase in intracellular ROS levels. "We are delighted that the Phase I study confirmed our expectations that Amplimexon would be well tolerated in humans, and the establishment of an MTD is an important milestone in our development program," said Robert A. Ashley, chairman, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and president of AmpliMed. "This data will help us in the design and conduct of current and future clinical trials, which include several studies in which Amplimexon(R) is combined with other cancer therapy, as well as single-agent studies. Studies already underway in pancreas cancer, 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 , lung, breast and prostate cancer are enrolling rapidly and will lead to a clear understanding of the potential for Amplimexon to make a significant contribution to cancer therapy in the future." About Amplimexon Amplimexon(R) is AmpliMed's(TM) 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, 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(R) (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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