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"Improved therapeutic options are greatly needed for patients with metastatic pancreatic cancer, as currently used chemotherapeutics offer minimal effects on survival and none are curative," said Evan Hersh, M.D., Executive Vice President and Chief Medical Officer of AmpliMed. "Amplimexon has demonstrated the ability to overcome resistance and offer an improved safety profile when combined with gemcitabine in preclinical studies of pancreatic cancer, and we look forward to evaluating the impact of this treatment in this randomized clinical trial."
The multicenter, randomized Phase 2 trial will evaluate Amplimexon plus gemcitabine vs. gemcitabine plus placebo in approximately 124 chemotherapy naïve patients with metastatic pancreatic cancer. The purpose of the study is to determine if Amplimexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone. The study will also evaluate and compare the tolerability and toxicity of the two treatment arms.
"We are excited about the potential of Amplimexon in combination with gemcitabine since it has demonstrated synergistic benefits in preclinical studies and no recent combination studies with gemcitabine have shown efficacy," said Robert T. Dorr, Ph.D. R. Ph., Chief Executive Officer of AmpliMed. "In addition, there is a significant need to improve upon the current median survival benefit of six to seven months established with gemcitabine or gemcitabine plus erlotinib (Tarceva). Along with this trial in pancreatic cancer, we also plan to advance Amplimexon into Phase 2 trials in non small cell lung cancer and metastatic melanoma later this year."
Amplimexon has been evaluated in nearly 300 patients and has demonstrated clinical activity both as a monotherapy and in combination with other therapies. Amplimexon is a small molecule drug that increases oxidative stress in tumor cells leading to mitochondrial damage and apoptosis (cell death). Preclinical studies shows that combined use of Amplimexon and certain other chemotherapeutics resulted in a significant increase in efficacy compared to either drug alone. Amplimexon appears to suppress the activity of bone marrow only at the highest doses and may thus avoid some of the toxic side effects that limit the use of other chemotherapeutics.
Amplimexon is currently being evaluated in an ongoing Phase 1 trial in previously untreated metastatic pancreatic cancer patients. The multicenter, dose-escalation trial has completed enrollment of 105 patients and determined a maximally tolerated dose of both agents. Importantly, full doses of both drugs were tolerated in this combination regimen. These preclinical and clinical trials results of Amplimexon in pancreatic cancer must be confirmed and expanded upon in a controlled and randomized trial.
About Pancreatic Cancer
Approximately 37,000 people in the United States are diagnosed annually with pancreatic cancer. Because the pancreatic cancer causes few symptoms early in the course of the disease, many patients are often diagnosed when the disease is locally advanced or metastasized. Pancreatic cancer has the highest fatality rate of all cancers, with an estimated 33,700 deaths annually in the United States.
About AmpliMed Corporation
AmpliMed Corporation is a privately held company 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, multi-drug resistance and cardiac toxicity, frequently associated with current cancer therapies. The company's lead product, Amplimexon, is in Phase II clinical trials. For more information about AmpliMed, please visit www.amplimed.com.
Note that the data represented is this press release is provided as a snapshot of unaudited data, and thus final results may be marginally different after all auditing activities are concluded.
AmpliMed, Amplimexon and Amplizone are United States trademarks of AmpliMed Corporation.
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