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PsiOxus Therapeutics initiates second clinical study of oncolytic vaccine

24th June, 2013

ColoAd1 study to compare direct intra-tumoral with intravenous injection in patients with non-metastatic colorectal cancer

OXFORD, UK – June 18, 2013 – PsiOxus Therapeutics, Ltd. (PsiOxus), a development stage biotechnology company, will initiate a clinical trial of ColoAd1, a systemically available oncolytic vaccine, to compare the effectiveness of direct intra-tumoral injection with intravenous injection in patients with non-metastatic colorectal cancer. The study aims to better understand the mechanism of action (MOA) of this highly potent, broad-spectrum, anti-cancer therapeutic capable of destroying tumour cells at minute concentrations.

The study is the second clinical trial of ColoAd1 currently underway and is expected to recruit up to 16 patients at two sites in Spain to compare direct intra-tumoral injection with intravenous injection. Tumour samples from the patients will then be examined for evidence of viral replication, viral spread, tumour necrosis and anti-tumoral immune responses.

PsiOxus previously initiated the Evolve (EValuating OncoLytic Vaccine Efficacy) study, the first clinical trial of the systemically available oncolytic vaccine ColoAd1 for the treatment of metastatic solid tumours. The study is designed for an initial dose escalation stage, followed by a dose expansion stage and ultimately, a phase II randomized stage. Preliminary data from the study’s phase I component was presented at The Seventh International Meeting On Replicating Oncolytic Virus Therapeutics in Old Quebec City, Canada, and shows evidence of virus replication within tumor sites following intravenous delivery. The study is currently enrolling additional patients to evaluate maximum-feasible dose levels and further to select a dose for the randomized phase II component of the study, which is planned to start early in 2014.

“We are very excited to begin enrolling patients in this very important second study of ColoAd1,” said Dr. John Beadle, CEO of PsiOxus Therapeutics. “While we know that ColoAd1 has a greatly improved selectivity for tumor cells in pre-clinical models, we will use this study to improve our understanding of how the virus works in humans and how this is impacted by the way the agent is delivered. By comparing direct intra-tumoral injection with intravenous injection, we will be able to ensure we capitalize on ColoAd1’s potency in the best way possible and forge a path to a new treatment option for patients with metastatic cancer.”

ColoAd1 was developed using the evolutionary principle of natural selection to generate an oncolytic vaccine with optimal anti-cancer properties. The vaccine is injected into the bloodstream, and is then delivered to the cancer sites, where it replicates inside of cancer cells and kills them. Each infected cell produces thousands of new copies of ColoAd1, which spread to nearby cancer cells and kills them, as well, while ignoring normal cells. The approach represents a new generation of so-called “self-amplifying” cancer therapy that has the effect of killing tumors and acting as a cancer vaccine.

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 Stefan Anker (Professor of Cardiology and Cachexia Research at Charité Medical School, Berlin and President of the Society on Sarcopenia, Cachexia and Wasting Diseases), Prof Andrew Coats (Norwich Research Park Professor-at-Large, University of East Anglia), Prof Len Seymour (Chair of Gene Medicine at Oxford University and Secretary General of the European Society for Gene and Stem Cell Therapy), and Dr. Kerry Fisher (an internationally-recognized specialist in molecular medicine, also of Oxford University).

Contacts:

PsiOxus Therapeutics Dr. John Beadle, Chief Executive Officer Tel +44 (0) 7810 770 310 John.Beadle@psioxus.com

US Media Enquiries: Erik Clausen or Nicki Polatin, Chempetitive Group Tel +1 781-608-7091 or +1 310-463-9383 PsiOxus@chempetitive.com

UK Media Enquiries: Dr. Clare Russell, Chempetitive Group Europe Tel: +44(0)1223 421 304 crussell@chempetitive.com

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