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
CONTACT: Erlinda M. Gordon, M.D. of Epeius
Biotechnologies,
+1-626-441-6695, egordon@epeiusbiotech.com
Web Site: http://www.epeiusbiotech.com/
Posted: October 2009
