UK Government Awards £1.7M Grant to PsiOxus Therapeutics for Second Phase I/II Clinical Trial of Cancer Vaccine

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 UK Government Awards £1.7M Grant to PsiOxus Therapeutics for Second Phase I/II Clinical Trial of Cancer Vaccine

'OCTAVE' Study Will Assess ColoAd1 in Patients with Ovarian Cancer

OXFORD, England--PsiOxus Therapeutics, Ltd. (PsiOxus), a development stage biotechnology company, today announced the award of a £1.7 million ($2.7 million) grant from the UK government-backed Biomedical Catalyst to initiate a Phase I/II clinical trial to assess the use of ColoAd1 in the treatment of platinum-resistant, recurrent ovarian cancer. The OCTAVE (Ovarian Cancer Treated with AdenoVirus) study will be the second clinical trial of the systemically available oncolytic vaccine ColoAd1, which is a highly potent, broad-spectrum, anticancer therapeutic capable of destroying tumour cells at minute concentrations.

    "Ovarian cancer is the fourth most common cause of cancer death for women in the UK"

The OCTAVE Phase I/II study will assess the safety and efficacy of ColoAd1 when given to patients by intra-peritoneal perfusion at multiple UK cancer centres beginning in 2013. The Principal Investigator of the OCTAVE study will be Professor Iain McNeish from the Institute of Cancer Sciences at the University of Glasgow. Over 50 ovarian cancer patients will receive multiple doses of intra-peritoneal ColoAd1 in this clinical trial and will be assessed for immunological responses as well as tumor response and survival.

"Ovarian cancer is the fourth most common cause of cancer death for women in the UK," said Iain McNeish, Professor of Gynecological Oncology at the University of Glasgow Institute of Cancer Sciences. "This funding for the OCTAVE study will enable us to evaluate in great detail the use of ColoAd1 as a very exciting potential new treatment for ovarian cancer."

The grant is part of the £180 million Biomedical Catalyst, a programme of public funding designed to deliver growth to the UK life sciences sector. Operated jointly by the Medical Research Council and the Technology Strategy Board, it aims to provide responsive and effective support for the best life science opportunities that demonstrate the highest scientific and commercial potential.

"We are delighted to be a recipient of this Biomedical Catalyst award in recognition of the important potential of our ColoAd1 oncolytic vaccine in addressing this global healthcare challenge. This form of matched funding is critical to help boost the UK life science sector and early stage biotechnology companies, such as PsiOxus," said Dr. John Beadle, CEO of PsiOxus Therapeutics. "This grant enables PsiOxus to examine this exciting cancer vaccine in a second form of metastatic cancer, thus demonstrating its medical and commercial potential as a broad spectrum anti-cancer therapeutic."

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.

ColoAd1 is highly effective at selectively targeting and killing cancer cells while having little or no activity on normal tissue. ColoAd1 has been shown to be up to 1,200 times more potent at killing human cancer cells than non-cancerous human cells. Standard chemotherapy agents are much less selective for cancer cells, accounting for the often-severe side effects of chemotherapy. ColoAd1 is currently being investigated in the phase I/II Evolve (EValuating OncoLytic Vaccine Efficacy) clinical trial for the treatment of metastatic solid tumours. The first three patients have so far been dosed, with initial results of this phase I component of the study expected by the end of 2013.

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.

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), Prof Andrew Coats (Norwich Research Park Professor-at-Large, University of East Anglia), and 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).

About the Biomedical Catalyst

The Biomedical Catalyst, announced by Prime Minister David Cameron in December 2011, is a programme of public funding designed to deliver growth to the UK life sciences sector. Delivered jointly by the Medical Research Council and the Technology Strategy Board, the Biomedical Catalyst provides responsive and effective support for the best life science opportunities arising in the UK. The programme is open to UK academics and SMEs and seeks to support those opportunities which demonstrate the highest scientific and commercial potential, irrespective of medical area. For further information please visit: http://www.innovateuk.org/content/competition/biomedical-catalyst.ashx

The Technology Strategy Board is the UK's innovation agency. Its goal is to accelerate economic growth by stimulating and supporting business-led innovation. Sponsored by the Department for Business, Innovation and Skills (BIS), the Technology Strategy Board brings together business, research and the public sector, supporting and accelerating the development of innovative products and services to meet market needs, tackle major societal challenges and help build the future economy. For more information please visit www.innovateuk.org.
Contacts

PsiOxus Therapeutics, Ltd.
Dr John Beadle, Chief Executive Officer
+44 (0) 7810 770 310
John.Beadle@psioxus.com
or
US Media Enquiries:
Chempetitive Group
Erik Clausen or Nicki Polatin
+1 781-608-7091 or +1 310-463-9383
PsiOxus@chempetitive.com
or
UK Media Enquiries:
Chempetitive Group
Dr Clare Russell
+44 (0) 7812 343 412
PsiOxus@chempetitive.com