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Press Release
Researchers to Present Positive Phase I Study Results for
AmpliMed™’s Amplimexon® (imexon inj.) in Patients with Advanced Solid Tumors
Scientists See Preliminary Evidence of Anti-Tumor Activity and Minimal Toxicity
AmpliMed’s Amplimexon (imexon inj.) in Patients with Advanced Solid Tumors Scientists See Preliminary Evidence of Anti-Tumor Activity and Minimal Toxicity
Tucson, Ariz.—November 16, 2005—AmpliMed today announced that preliminary results of its Phase I trial of its lead drug candidate, Amplimexon (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) 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 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 17 th 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 levels in cancer cells, leading to a build up in toxic reactive oxygen species (ROS) inside the cancer cell and ultimately to programmed cell death, or apoptosis.
In a second poster at the same meeting, Dr. Amanda F. Baker of the University of Arizona Cancer Center reports the results of experiments designed to explore the changes in gene expression in patients’ white blood cells 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 suggest that cells exposed to Amplimexon upregulate the expression of those genes that are associated with the response to oxidative stress, 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 and president of AmpliMed. “These data will help us in the design and conduct of current and future clinical trials, which include several studies in which Amplimexon is combined with other cancer therapy, as well as single-agent studies. Studies already underway in pancreas cancer, malignant melanoma, multiple myeloma, 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 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.
