




Press Release
AmpliMed Announces Interim Phase I/II Trial Results for Amplimexion plus Dacarbazine for Treatment of Malignant Melanoma
Encouraging Data Presented at Perspectives in Melanoma X and the Third International Melanoma Research Congress in The Netherlands
Tucson, Ariz. – September 14, 2006 – AmpliMed today announced interim results from the ongoing Phase I/II clinical trial of its lead drug candidate Amplimexon (imexon, inj.) in combination with the drug dacarbazine (DTIC) in patients with advanced malignant melanoma. The results are being presented by study investigator Dr. Jeffrey. Weber of the USC/Norris Comprehensive Cancer Center at a poster session of September 14th – 16th at the congress of Perspectives in Melanoma X and the Third International Melanoma Research Congress.
The authors reported that, of 27 patients evaluable for response, there were 5 patients with partial responses and 7 with stable disease, for a 44.4 percent “clinical benefit” rate (defined as the sum of the total responding and stable patients). Responses were seen in skin, nodal, soft tissue, lung and liver lesions. The longest response was reported to be in excess of 11 months. Two of the five responding patients showed continuing regression of disease with each follow up assessment.
“If further development of Amplimexon reveals that its’ combination with DTIC can make a significant difference in patient survival without compromising quality of life this may prove to be an important breakthrough in the treatment of metastatic melanoma,” remarked Dr. Weber.
“The preliminary findings from the combination of Amlimexon and DTIC in patients with metastatic melanoma confirm that Amplimexon is well-tolerated,” commented Evan M. Hersh, Executive Vice President and Chief Medical Officer of AmpliMed. “Should the final results from the Phase II portion of the study continue to compare favorably with standard therapy for metastatic melanoma, and remain consistent with those presented by Dr. Weber in this poster, we would plan to move rapidly into a randomized Phase III clinical trial to evaluate more rigorously the benefits of this approach to the treatment of this most serious form of skin cancer.”
At the time of the interim analysis the phase I portion of the study was complete, having enrolled 24 patents. An additional 32 patients (out of target enrollment of 45) had been enrolled in the phase II portion, of which seven have had their first imaging assessment.
The MTD and phase II dose was determined with the most common toxicities reported (nausea, vomting, fatigue and myelosuppression) being generally mild in nature.
“The progression of Amplimexon into Phase II efficacy studies represents a significant milestone for AmpliMed,” said Robert A. Ashley, Chairman, CEO and President of AmpliMed Corporation. “It is indicative of the continuing evolution of our clinical strategy and our understanding of the role that Amploimexon will play in the treatment of various types of cancer, both as a single agent and in combination with other commonly used cancer drugs.”
The ongoing Phase I/II study reported by Dr. Weber is being conducted at 15 centers of excellence in melanoma therapy across the United States. The study population consists of patients with stage III and IV melanoma which could not be freed of disease by surgery and who have not received prior chemotherapy. Amplimexon is administered intravenously over 30 minutes followed by infusion of DTIC over 30 minutes for each of five consecutive days every three weeks. The Phase I portion of the trial assessed the safety of the combination of DTIC and Amplimexon, and determined the maximum tolerated dose (MTD). During the Phase II portion of the study, patients are being administered the combination at the MTD in order to provide an indication of efficacy relative to historical control data and to guide design of future randomized Phase III trials.
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. According to the American Cancer Society, more than 62,190 new cases of melanoma will be seen in the United Stats in 2006 with approximately the same number in Europe. Dacarbazine is a chemotherapeutic agent that interferes with the growth of cancer cells and is one of only three drugs approved for sale in the U.S. as first line therapy for the treatment of metastatic malignant melanoma. AmpliMed’s Amplimexon has shown activity in pre-clinical melanoma models and as a single agent in a Phase I dose escalation study in patients with various solid tumors.
About Amplimexon
Amplimexon is AmpliMed's name for imexon injection, a cyanoaziridine compound which showed promising 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 a 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 in Phase II clinical trials. Other products in the company's portfolio include benzimate which entered a Phase I study in 2006, Amplizone, for which
Phase I studies are planned in 2007, 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, Amplimexon and Amplizone are United States trademarks of AmpliMed Corporation.
Media Contact:
Julie Rathbun
Rathbun Communications
(206) 769-9219
julie@rathbuncomm.com