|[June 17, 2014]
PsiOxus Therapeutics Initiates 'OCTAVE' Ovarian Cancer Study for Oncolytic Vaccine Enadenotucirev
OXFORD, England --(Business Wire)--
Therapeutics Ltd. (PsiOxus), an award-winning
biotechnology company developing innovative new treatments for cancer,
today announced the first dosing of a patient in the OCTAVE (Ovarian
Cancer Treated with Adeno Vaccine Enadenotucirev)
study. OCTAVE is a phase I/II clinical trial to assess the safety and
efficacy of its oncolytic vaccine enadenotucirev (previously known as ColoAd1)
in platinum-resistant ovarian cancer patients at multiple UK cancer
centres beginning this month. Enadenotucirev has shown potent,
broad-spectrum, anti-cancer activity pre-clinically and is also in phase
I/II clinical trials in patients with colorectal tumours.
The OCTAVE study will examine the safety, tolerability, pharmacokinetics
and efficacy of administering the vaccine directly into the abdomen of
cancer patients, where ovarian cancer tends to recur (a process known as
intra-peritoneal or IP delivery). The phae I component of the study
will determine the dose of enadenotucirev to be used alone or in
combination with paclitaxel. The phase II component will be an open
label dose expansion of the combination regimen of enadenotucirev and
paclitaxel to determine whether this combination has a risk benefit
profile that supports further investigation in the treatment of patients
with platinum-resistant epithelial ovarian cancer.
Dr Iain McNeish, MD, Professor of Gynaecological Oncology�at the
Institute of Cancer Sciences at the University of Glasgow, is the
principal investigator of the OCTAVE study. The trial is co-funded by a
�1.7 million grant awarded to PsiOxus by the UK government-backed
Biomedical Catalyst. This programme is designed to deliver growth to the
UK life sciences sector and run jointly by the UK's innovation agency,
the Technology Strategy Board, and the Medical Research Council.
PsiOxus CEO Dr John Beadle commented: "Our enadenotucirev oncolytic
vaccine has enormous potential to treat a broad spectrum of solid cancer
types and starting this OCTAVE study is a key milestone as we progress
towards demonstrating its effectiveness in a second form of cancer with
a very significant unmet medical need."
Enadenotucirev was originally developed using a directed evolution
process, with the aim of generating an entirely novel virus with
optimised cancer-lytic properties. It has been shown to have little or
no activity in normal cells whilst keeping a very high level of
anti-cancer potency. As well as assessing how effective intraperitoneal
enadenotucirev is for treating ovarian cancer, PsiOxus is also carrying
out clinical studies evaluating its safety and efficacy via intravenous
injection in patients with colorectal cancer. The phase I/II EVOLVE
study (EValuating OncoLytic Vaccine Efficacy)
is currently underway and has shown some promising early results.
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.
Enadenotucirev 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 II
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 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. He was previously a co-founder of
PowderMed, which was sold to Pfizer, Inc. in 2006 for more than $300
million. Dr Michael Moore, the former CEO of Piramed, which was acquired
by Roche in 2008, serves as Chairman of the Board of Directors.
About the Biomedical Catalyst
The �180 million Biomedical Catalyst is an integrated translational
funding programme jointly operated by the Medical Research Council and
the Technology Strategy Board providing responsive and effective support
for the best life science opportunities arising in the UK. Support
through the Biomedical Catalyst is available to academics and UK SMEs
looking to develop innovative solutions to healthcare challenges either
individually or in collaboration.
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