Docetaxel is an anticancer agent which interferes with the ability of cancer cells to divide. It is indicated for the treatment of patients with locally advanced or metastatic breast cancer after the failure of prior chemotherapy; in combination with prednisone for the treatment of hormone-refractory metastatic prostate cancer; as a single agent in patients with non-small cell lung cancer who have failed prior platinum-based chemotherapy; and in combination with cisplatin in previously untreated patients with non-small cell lung cancer. Prior studies by AmpliMed scientists at the Arizona Cancer Center have demonstrated that Amplimexon can potentiate the cytotoxic effects of docetaxel on tumor cells in vitro. This Phase I clinical trial has been designed to determine patient tolerance of the combination of Amplimexon and docetaxel, and to provide guidance on a patient population for future clinical studies of the combination of the two drugs. Should the outcome prove positive, this may lead to the design of a randomized clinical trial to more rigorously evaluate the benefits of the combination.

The Phase I study is being conducted at The University of Texas M. D. Anderson Cancer Center, Houston, TX. The Principal Investigator is Dr. Razelle Kurzrock. It is anticipated that approximately 30 patients will be enrolled in this study during the next 12 months, and the Phase I study is expected to continue for approximately 12 to 16 months.

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 the third study we have initiated to evaluate the potential clinical benefit of combinations of Amplimexon with other chemotherapeutic agents that have exhibited synergy in pre-clinical studies,” said Robert Ashley, chairman, president and chief executive officer of AmpliMed. “Docetaxel is widely used in several different types of cancer patients, so we have designed a trial which not only will give us an indication of patient tolerance of the combination, but will also help us to decide which patient population may benefit most from the combination to help direct future clinical studies. Should the drug combination prove to be well tolerated by patients, and should there be hints of efficacy in a particular patient group, we plan to move rapidly into a randomized Phase II clinical trial in an effort to demonstrate incremental clinical benefit.”

About Amplimexon

Amplimexon is AmpliMed’s trademarked name for imexon injection, an injectable formulation of 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. They discovered that the drug disrupted mitochondria, the energy producing factories of the cancer cells, resulting in the leakage of toxic substances which ultimately resulted in cell death. 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. The first two of these, in which Amplimexon is combined with gemcitabine in patients with untreated pancreatic adenocarcinoma and with dacarbazine (DTIC) in patients with metastatic malignant melanoma are currently underway.

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™ and Carbendazim, both of which are expected to enter the clinic in 2006, 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.

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AmpliMed®, Amplimexon® and Amplizone™ are United States trademarks of AmpliMed Corporation.

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