Tumor-Targeted Rexin-G Prolongs Survival in Gemcitabine-Resistant Metastatic Pancreas Cancer in Advanced Phase I and II Studies (ASCO 2010)
SAN MARINO, Calif., May 24 /PRNewswire/ -- Epeius
Biotechnologies Corporation (www.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 overall 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 egordon@epeiusbiotech.com.
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Source: Epeius Biotechnologies
CONTACT: Erlinda M. Gordon, M.D. of Epeius Biotechnologies
Corporation,
+1-626-441-6695, egordon@epeiusbiotech.com
Web Site: http://www.epeiusbiotech.com/
Posted: May 2010
