Study results show no improvement in overall survival for combination of gemcitabine and Amplimexon

Jul 12 2010

AmpliMed Corporation, a cancer therapeutics company, today announced results from AMP-019, a randomized double-blind, placebo-controlled Phase II screening trial designed to determine if a Phase III trial was warranted for the combination of gemcitabine (Gemzar, Eli Lilly) plus Amplimexon (AmpliMed Corporation) in patients with advanced pancreatic ductal adenocarcinoma of the pancreas. The statistical design required a 40 percent improvement in overall survival, the primary endpoint, for a positive outcome. Unfortunately, the results showed no improvement in overall survival for the combination of gemcitabine and Amplimexon.

The trial began accrual in May of 2008 and accrual ended in May of 2009, with the 12 month follow-up period ending in late May 2010. The trial was conducted at 34 clinical sites across the U.S. and involved 142 patients with advanced, Stage 4 (metastatic) pancreatic cancer: 72 on the combination arm and 70 on the placebo arm. The trial was stratified to achieve a balance in those patients with ECOG performance status 0 and 1 (about 30 percent and 70 percent respectively, on each arm). The two arms were also well balanced for age (mean 66 years) and sex (mean 56 percent male). The therapy was generally well-tolerated on both arms of the study. The most common adverse event in the trial was fatigue, affecting about 67 percent of patients on both arms of the trial. There was increased nausea on the Amplimexon arm and increased neutropenia (low white blood cell count) on the gemcitabine-placebo arm. Both toxicities are well-known for these two agents.

Because of the results from AMP-019 and the current economic climate, both of which disfavor raising additional capital, AmpliMed is restructuring into a smaller entity and is considering strategic options for going forward. However, AmpliMed is working on a new Phase II trial in concert with a university consortium to evaluate Amplimexon as a single agent in the treatment of relapsed/refractory non-Hodgkin's lymphoma (NHL). This trial follows up on a single patient treated in an earlier Phase I trial of Amplimexon, wherein a complete remission was obtained that lasted almost 7 months in a patient with very refractory follicular NHL (T. Dragovich et al, J Clinical Oncology, Vol 25, No 13, pp:1779-1784, 2007). Worldwide there are 66,000 new cases of NHL each year with 19,500 deaths reported in 2009. Depending upon reviews, the trial might commence in the fourth quarter of 2010 and will be conducted at two university sites. If fully accrued, the trial could involve treating up to 36 patients with different types of NHL that have become resistant to all existing therapies.