Press Release

AmpliMed to Present Positive Phase I Study Results for Amplimexon (imexon for inj.) in Patients with Advanced Solid Tumors

 Results Demonstrating Encouraging Anti-Tumor Activity and Minimal Toxicity

Presented at European Organization for Research and Treatment of Cancer (EORTC)

 Tucson, Ariz. – November 9, 2006 – AmpliMed today reported final results from the Phase I trial of its lead drug candidate, Amplimexon (imexon for inj.), in patients with advanced solid tumors. The results are being presented by Tomislav Dragovich, MD, PhD, Assistant Professor of Medicine of the Arizona Cancer Center and lead investigator of the study, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, which is being held this week in Prague, Czech Republic.

 Data from the Phase I study show that Amplimexon is well tolerated and provides objective evidence of antitumor activity. The multicenter study involved 49 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/m2/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/m2/day. Pharmacokinetic studies revealed peak blood levels of imexon at the MTD that were well in excess of those shown to have antitumor effects in preclinical testing. Pharmacodynamic studies showed a correlation between a decrease in the plasma levels of cystine, a thiol-containing compound, and blood levels of imexon, providing additional support for the theory that imexon exerts its effects in part by binding thiols in cells and causing increased intracellular anti-oxidant levels.

 "The final results of our Phase I study hint at the potential for Amplimexon to provide clinical benefit with generally mild to modest toxicity in patients with a diverse spectrum of cancer types," said Evan M. Hersh, MD, chief medical officer of AmpliMed Corporation. "In particular, it is encouraging that a patient with chemotherapy-refractory follicular non-Hodgkin's lymphoma experienced a partial response with minimal residual disease following administration of Amplimexon as a monotherapy. Furthermore the response was maintained on therapy for six months with late, probably drug-related

myelosuppressive toxicity. Further clinical studies are planned or underway to confirm these preliminary findings."

 "This is an extremely exciting time for the company as we rapidly move ahead with the clinical development of Amplimexon," said Robert A. Ashley, chairman, CEO and president of AmpliMed. "We have recently completed enrollment in the Phase II portion of our Phase I/II trial of the drug in combination with dacarbazine in patients with advanced malignant melanoma. Preliminary results from the first phase of this study were presented at the recent Melanoma X conference in the Netherlands. Coupled with excellent progress in our Phase Ib study of Amplimexon in combination with gemcitabine in patients with pancreatic cancer we are continuing to define the future development of

Amplimexon in the treatment of these devastating diseases."

 About Amplimexon

Amplimexon is the name of AmpliMed's formulation of imexon for injection. Imexon is 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 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 for inj.), is in Phase II clinical trials. Other products in the company's portfolio include benzimate which entered the clinic in 2006, AmplizoneTM, expected to enter the clinic 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 Corportation.

 

Media Contact:

Julie Rathbun

Rathbun Communications

(206) 769-9219

julie@rathbuncomm.com

 

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