PsiOxus Therapeutics Comments on Phase III Results from Amgen’s Oncolytic
LONDON -- March 20, 2013
PsiOxus Therapeutics today issued a statement in response to initial results
from Amgen's (Nasdaq: AMGN) phase III study of talimogene laherparepvec in
patients with unresected stage IIIB, IIIC or IV metastatic melanoma compared
to treatment with subcutaneous granulocyte-macrophage colony-stimulating
factor (GM-CSF). Talimogene laherparepvec is a novel oncolytic vaccine that
represents a new class of anticancer agents known as oncolytic vaccines.
The therapy, now referred to as TVEC, was administered by injection into
visible tumor masses, and acts both by directly lysing the tumor, as well as
by stimulating a systemic immune response against the malignant cells. Hitting
its primary endpoint, the study has shown that 16 percent of trial patients on
the oncolytic vaccine had a durable response compared with only 2 percent of
those on the control therapy GM-CSF.
Amgen also revealed a trend toward overall survival in favor of its vaccine
compared with GM-CSF in a pre-planned interim analysis and furthermore
reported that these results were expected to mature later in 2013. Amgen
acquired TVEC following the $1 billion acquisition of Biovex in 2011 and early
this year announced that TVEC was one of the most important advanced therapies
in its pipeline.
PsiOxus Therapeutics, Ltd. (PsiOxus), another emerging pioneer in oncolytic
vaccines, has initiated a phase I/II clinical program of ColoAd1, a
systemically available oncolytic vaccine. As an oncolytic vaccine, ColoAd1
functions with a similar mechanism to TVEC but unlike TVEC it can be
administered intravenously for metastatic cancer. ColoAd1 was developed using
the evolutionary principle of natural selection to generate an oncolytic
vaccine with optimal anti-cancer properties. ColoAd1 is currently in clinical
development for metastatic colorectal cancer with plans to initiate further
clinical development in ovarian cancer later this year.
Commenting on today’s Amgen/TVEC phase III data, Dr John Beadle, CEO of
PsiOxus, commented: “We are delighted by these impressive results of the TVEC
phase III trial, which firstly signals another significant step forwards for
treating patients with melanoma, but also demonstrates the huge potential for
the broader oncolytic vaccine field. By killing cancer cells through an
entirely new mechanism, oncolytic vaccines can provide an entirely new mode of
cancer treatment and one that overcomes many of the limitations of current
cancer therapies. The Amgen approach now opens the way for follow-on oncolytic
approaches, such as ColoAd1, which can be used systemically as well as through
About PsiOxus Therapeutics, Ltd.
PsiOxus Therapeutics is an Oxford, UK-based development stage biotechnology
company using non-traditional approaches to develop novel therapeutics that
address cancer and other clinically unmet diseases. ColoAd1 is an oncolytic
vaccine for the systemic treatment of metastatic cancer, which has
demonstrated exceptional anti- cancer properties in late pre-clinical
development and is now in phase I clinical development. MT-102 is a dual
action Anabolic Catabolic Transforming Agent (ACTA) in phase II clinical
development for the treatment of cachexia and sarcopenia. The Company is also
developing treatments based upon the research phase vaccine platform PolySTAR,
which combines recombinant viral vectors with polymers to shield them from the
immune system, and the research phase adjuvant and immunotherapeutic platform
PolyMAP, which combines polymers with synthetic adjuvants to significantly
enhance the effectiveness of vaccines.
Dr. John Beadle is CEO of PsiOxus. Dr. Beadle was previously a co-founder of
PowderMed, which was sold to Pfizer, Inc. for more than $300 million in 2006.
Dr. Michael Moore, the former CEO of Piramed, which was acquired by Roche in
2008, serves as Chairman of the Board of Directors.
PsiOxus is advised by a distinguished Scientific Advisory Board that includes
Prof Len Seymour (Chair of Gene Medicine at Oxford University and Secretary
General of the European Society for Gene and Stem Cell Therapy); Dr. Kerry
Fisher (an internationally-recognized specialist in molecular medicine, also
of Oxford University); Dr Terry Hermiston is the Vice President of Biologics
at Bayer Healthcare Pharmaceutical, Inc; Prof Stefan Anker (Professor of
Cardiology and Cachexia Research at Charité Medical School, Berlin and
President of the Society on Sarcopenia, Cachexia and Wasting Diseases); and
Prof Andrew Coats (Norwich Research Park Professor-at-Large, University of
Dr. John Beadle, Chief Executive Officer
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