January 31, 2015 3:50 AM ET

Pharmaceuticals

Company Overview of PsiOxus Therapeutics, Ltd.

Company Overview

PsiOxus Therapeutics, Ltd., a biotechnology company, develops novel therapeutics that address cancer and other clinically unmet diseases. The company provides MT-102, a dual action anabolic catabolic transforming agent for the treatment of cancer cachexia and sarcopenia; and ColoAd1, a chimeric oncolytic virus for the systemic treatment of metastatic cancer. It also offers PolySTAR, a research phase vaccine platform that combines recombinant viral vectors with polymers to shield them from the immune system; and PolyMAP, a research phase adjuvant and immunotherapeutic platform that combines polymers with synthetic adjuvants for immunogenicity. PsiOxus Therapeutics, Ltd. was formerly known as ...

154B Milton Park

Abingdon,  OX14 4SD

United Kingdom

Founded in 2006

Phone:

44 1235 835 328

Fax:

44 1869 238 001

Key Executives for PsiOxus Therapeutics, Ltd.

Chief Executive Officer and Director
Founder and Member of Scientific Advisory Board
Finance Director
Chief Operating Officer
Vice President of Pharmaceutical Development
Compensation as of Fiscal Year 2014.

PsiOxus Therapeutics, Ltd. Key Developments

PsiOxus Therapeutics, Ltd. Announces European Medicines Agency Grants Positive Opinion for Orphan Drug Status for Ovarian Cancer Oncolytic Vaccine

PsiOxus Therapeutics Ltd. has been granted a positive opinion from the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) for an orphan medicinal product designation of its oncolytic vaccine, enadenotucirev (previously known as ColoAd1) for the treatment of platinum-resistant epithelial ovarian cancer. Enadenotucirev is currently undergoing phase I/II testing in platinum-resistant ovarian cancer patients across multiple UK cancer centers. The OCTAVE (Ovarian Cancer Treated with Adeno Vaccine Enadenotucirev) phase I/II clinical trial aims to assess the safety and efficacy of PsiOxus’ novel oncolytic vaccine. Enadenotucirev is also under investigation in two further European clinical studies in patients with colorectal cancer, bladder cancer, non-small cell lung cancer and renal cancer. The EMA defines rare diseases as life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the EU and where no satisfactory treatment is available. Orphan designation applications are evaluated by the Agency's COMP, which provides its opinion on whether or not the medicine qualifies as an orphan medicine for the treatment, prevention or diagnosis of a rare disease. If the COMP issues a positive opinion, the European Commission may then grant the medicine orphan status. The EMA grant an orphan drug designation to promote the development of products that demonstrate promise for the treatment of rare diseases or conditions. Orphan drug designation provides ten years of market exclusivity in the EU due to various regulatory and economic benefits. As well as assessing how effective intraperitoneal enadenotucirev is for treating ovarian cancer, it 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.

PsiOxus Therapeutics Ltd. Initiates 'OCTAVE' Ovarian Cancer Study for Oncolytic Vaccine Enadenotucirev

PsiOxus Therapeutics Ltd. 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 phase 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. 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.

PsiOxus Therapeutics Announces Positive Study Results of Oncolytic Vaccine Enadenotucirev

PsiOxus Therapeutics, Ltd. announced that updates for its on-going international multicentre clinical program of the oncolytic vaccine enadenotucirev (previously known as ColoAd1) were presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Enadenotucirev is an oncolytic Ad11/Ad3 chimeric group B adenovirus that has previously been shown to selectively destroy metastatic solid tumours at low concentrations in pre-clinical models. The EVOLVE (EValuating OncoLytic Vaccine Efficacy) trial is a phase I/II trial of intravenous administration of enadenotucirev to patients with epithelial cancers. Dr. Emiliano Calvo from START Madrid, Centro Integral Oncológico Clara Campal, Hospital Madrid, Spain, presented A Phase I Study of Enadenotucirev, an Oncolytic A11/Ad3 Chimeric Group B Adenovirus, Administered Intravenously in Patients with Metastatic Epithelial Tumours, which evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of enadenotucirev. In this study, enadenotucirev was delivered intravenously to end stage cancer patients. Tumour origins in these patients included colorectal, parotid, oropharynx, liver, stomach, gall bladder and breast. This is the first reported clinical study where live replicating oncolytic virus has been recovered directly from the blood stream of cancer patients. This confirms previously published pre-clinical data showing that unlike other viruses, enadenotucirev is not inactivated by antibodies or other human blood constituents.

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