SAN MARINO, Calif., May 24 (SEND2PRESS NEWSWIRE) — Epeius Biotechnologies Corporation (epeiusbiotech.com) today announces the results of the clinical study entitled “Phase I and II Studies of Intravenous Rexin-G as Monotherapy for Gemcitabine-resistant Metastatic Pancreas Cancer” at the ASCO Annual Meeting on June 6, 2010. The presentation will be discussed by Dr. Howard W. Bruckner, Bruckner Oncology, New York, NY.
STUDY SUMMARY: The goals of the Phase I/II study were to evaluate the over-all safety and efficacy of intravenous infusions of Rexin-G, a tumor-targeted retrovector bearing a cytocidal anti-cyclin G1 construct, in gemcitabine-resistant pancreas cancer. A Phase II “run in” study was integrated by adaptive design wherein additional cycles were given if the patient had Grade 1 or less toxicity. Twenty patients received escalating doses of Rexin-G intravenously three times a week for four weeks.
Analysis of safety showed no dose-limiting toxicity and no cumulative toxicity in patients treated up to 18 months. Analysis of efficacy in evaluable patients revealed significant tumor responses: 100% tumor control rate (TCR) was observed at all doses tested, and 24% partial response (PR) or complete response (CR) by RECIST criteria in the high dose cohorts.
A dose-dependent relationship between overall survival and Rexin-G dosage was demonstrated, which was significant at the 5% statistical level by log rank test (p = 0.03). Median survival was 9.3 months and one-year survival was 33% in the high dose groups. Remarkably, one patient exhibited a complete response with the (adaptive) repeated cycles, attaining clinical remission after 9 months of continued treatment with Rexin-G.
These findings indicate that intravenous Rexin-G is safe and well-tolerated with no cumulative toxicity and that Rexin-G controls tumor growth and may prolong over-all survival in a dose-dependent manner in patients with gemcitabine-resistant pancreas cancer.
About Epeius Biotechnologies:
Epeius Biotechnologies Corporation (www.epeiusbiotech.com) is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its lead products, Rexin-G and Reximmune-C, and its high-performance gene delivery systems. To learn more about these agents and/or ongoing clinical trials, please contact Dr. Erlinda M. Gordon at email@example.com.
News issued by: Epeius Biotechnologies Corporation
Original Image: https://www.send2press.com/mediaboom/10-0504-epeiusbio_72dpi.jpg
# # #
Original Story ID: (5957) :: 2010-05-0524-004
Original Keywords: Epeius Biotechnologies Corporation, Phase I and II Studies of Intravenous Rexin-G as Monotherapy for Gemcitabine-resistant Metastatic Pancreas Cancer, Dr Howard W Bruckner, tumor-targeted retrovector bearing a cytocidal anti-cyclin G1 construct, gene delivery systems Epeius Biotechnologies Corporation San Marino California SAN MARINO, Calif.
Alternate Headline: ASCO 2010: Epeius Tumor-targeted Rexin-G Prolongs Survival in Gemcitabine-resistant Metastatic Pancreas Cancer in Advanced Phase I and II Studies
NEWS ARCHIVE NOTE: this archival news content, issued by the news source via Send2Press Newswire, was originally located in the Send2Press® 2004-2015 2.0 news platform and has been permanently converted/moved (and redirected) into our 3.0 platform. Also note the story “reads” counter (bottom of page) does not include any data prior to Oct. 30, 2016. This press release was originally published/issued: Mon, 24 May 2010 18:44:14 +0000
News Source: Epeius Biotechnologies Corporation