Oncolytic Virus Specialist Virttu Biologics Initiates Phase I/II SEPREHVIR™ Study in Mesothelioma

Glasgow, September 11th 2012: Virttu Biologics Limited, a UK biotechnology company with expertise in the field of oncolytic viruses, has announced that it has initiated a Phase I/II clinical trial tobegin clinical development of its oncolytic virus, SEPREHVIR™ (HSV1716) for the treatment of malignant pleural mesothelioma. The trial will be conducted at the Sheffield Teaching Hospitals NHS Foundation Trust under the clinical leadership of Professor Penella Woll. The primary objective of the study will be to determine the safety and tolerability of SEPREHVIR when given both as single and repeat intrapleural doses in patients with inoperable, malignant pleural mesothelioma (“MPM”); a form of lung cancer that is almost exclusively caused by occupational exposure to certain types of asbestos

SEPREHVIR (HSV1716), is a variant of Herpes Simplex Virus 1 that has been engineered to kill cancer cells while leaving normal cells unharmed. CEO Dr Steven Powell commented: “Virttu is pursuing a virocentric development strategy because SEPREHVIR is highly lytic and the mechanism by which the virus gains specificity for tumour cells over normal cells is highly effective. This has been demonstrated in over 75 patients in Phase I/II studies in a number of solid tumour indications including high grade glioma, melanoma and head and neck cancer. Our on-going research programme has demonstrated clinical synergy when SEPREHVIR has been combined with a broadrange of chemotherapeutic agents and we will seek to exploit these synergies in this MPM study and future, planned clinical trials.”

This latest study will be a single centre, open label study in two parts. Initially, the first cohort of patients with inoperable malignant pleural mesothelioma will receive a single dose of SEPREHVIR by intrapleural administration via an indwelling catheter into the pleural cavity. Safety data will be reviewed at least 2 weeks post dosing before patients can progress to the second part of the study in which two cohorts of patients will receive either 2 or 4 doses of the virus via the indwelling catheter. The Company expects to report on the study in the second half of 2013.

Malignant pleural mesothelioma (MPM) has a long latency (30-60years from occupational exposure) and Virttu estimates that around 9,500 new cases of MPM occur each year in the US and the larger EU member states. Furthermore, the incidence is predicted to continue to rise in more recently industrialized nations, including China and India. MPM survival is influenced by disease stage, patient age and overall health and management is largely palliative and multimodal, combining surgery, radiotherapy and chemotherapy.

In addition to MPM, Virttu is pursuing Phase I and Phase II studies in high grade glioma and hepatocellular carcinoma.

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