March 20, 2013 at 11:33 AM EDT
PsiOxus Therapeutics Comments on Phase III Results from Amgen’s Oncolytic Vaccine

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 local administration.”

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 East Anglia).

Contacts:

PsiOxus Therapeutics
Dr. John Beadle, Chief Executive Officer
Tel: +44 (0) 7810 770 310
John.Beadle@psioxus.com
or
US Media Enquiries:
Erik Clausen or Nicki Polatin, Chempetitive Group
Tel: +1 781-608-7091 or +1 310-463-9383
PsiOxus@chempetitive.com
or
UK Media Enquiries:
Dr. Clare Russell, Chempetitive Group Europe
Tel: +44(0)1223 421 304
crussell@chempetitive.com
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