Advanced U.S. Clinical Trial Confirms Single-Agent Efficacy of Rexin-G in Metastatic Pancreas Cancer: All Endpoints Achieved

Advanced U.S. Clinical Trial Confirms Single-Agent Efficacy of Rexin-G in
Metastatic Pancreas Cancer: All Endpoints Achieved
Epeius Biotechnologies Reports Dose-Dependent Efficacy and Survival Benefits

SAN MARINO, Calif., Oct. 14 /PRNewswire/ -- Epeius Biotechnologies
(www.epeiusbiotech.com) confirms the first real breakthrough for pancreatic
cancer seen in years; publishes a landmark report of tumor-targeted Rexin-G as
stand-alone therapy in chemotherapy-resistant pancreatic cancer. Following
Phase I studies at the Mayo Clinic, which affirmed the general safety of
Rexin-G, advanced U.S. Phase I/II studies were undertaken, which included a
Phase II efficacy component and examined progressive dose escalations of
Rexin-G, while monitoring objective tumor responses in a comprehensive manner.
Employing these higher doses of Rexin-G led to improved tumor responses, as
assessed by all available measures (RECIST, Intl. PET and CHOI criteria) and
nearly tripled the expected survival time, all in a dose-dependent manner.
Moreover, this U.S. study serves to establish a critical pharmacological
threshold of bioactivity, for this otherwise intractable disease, by
demonstrating an increase in overall survival time (measured as % surviving 12
months) from virtually nil using low doses to more than 28% of the patients
using high doses surviving beyond one year.

By meeting all primary and secondary study endpoints of safety and efficacy,
Epeius Biotechnologies' Rexin-G has succeeded in an area of clinical oncology
where many promising biologics have simply failed to deliver. By achieving
both progression-free survival and overall survival benefits in pancreas
cancer, while avoiding untoward systemic or dose-limiting toxicities, Rexin-G
has raised the bar for the entire biopharmaceutical industry, as it
inaugurates the emerging field of precision-targeted genetic medicine. The
outstanding results of this advanced U.S. clinical trial confirm the results
of previous preclinical and clinical studies conducted in the Philippines
(where Rexin-G is approved for all solid tumors), and demonstrate beyond
contestation that Rexin-G, at these effective dose levels, exhibits profound
anti-tumor activity when administered as a single therapeutic agent in
otherwise intractable Stage IV pancreatic cancer. The success of these
landmark studies is a tribute, not only to the clinical investigators who
"held the course" and the "cause" of a better medicine as a high standard, but
to the U.S. FDA who, by allowing across-the-board dose escalations in ongoing
trials for sarcoma, breast, and pancreas cancer (once general safety was
established), served to expedite the achievement of these effective doses, and
thus these heartening results. The full article, authored by Dr. Sant P.
Chawla et al., is now available online (Molecular Therapy, Oct 13, 2009; see
Advance Online Publications: www.nature.com/mt/).

About Epeius Biotechnologies
Epeius Biotechnologies Corporation 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

Erlinda M. Gordon, M.D. of Epeius Biotechnologies, +1-626-441-6695,
egordon@epeiusbiotech.com