Phase I/IIa Mesothelioma Study completes dosing of patients and further clinical updates

November 7, 2016 – VIRTTU BIOLOGICS, a biopharmaceutical company pioneering the discovery and development of oncolytic immunotherapy for treating cancer, today provided an update regarding its clinical development programme for SEPREHVIR®, an HSV-1 based oncolytic immunotherapy.

VIRTTU's Phase I/IIa company-sponsored study investigating the intrapleural administration of SEPREHVIR via indwelling pleural catheter in patients with malignant pleural mesothelioma (NCT01721018) has recruited and dosed its last patient on the study protocol and the study is now closed to recruitment of new patients.   Patient follow-up will continue with the last patient's final visit expected by 30 November 2016 prior to study close out.

The study, which recruited patients in the UK at the Weston Park Hospital, Sheffield and the Queen Elizabeth University Hospital, Glasgow, is investigating the safety and biological effect of different dosing schedules of SEPREHVIR.   Certain interim results have been presented and further details are available at www.virttu.com/posters-and-talks.

Mesothelioma is a malignancy of the pleural cavity linked to prior occupational exposure to asbestos.    The company intends to present the results of this study in support of applications for orphan medicinal product status from the European Medicines Agency and the US Food & Drug Administration in due course.

In a further update on the clinical development of SEPREHVIR, VIRTTU confirms that the Phase I study of SEPREHVIR in patients with refractory non-CNS solid tumors (NCT00931931), led by Dr Timothy P. Cripe (Nationwide Children’s Hospital, Columbus, Ohio) has completed patient recruitment, treatment and follow-up in the first part of the study in which SEPREHVIR was administered directly by image-guided intratumoral injection. The second part of the study, investigating the intravenous administration of SEPREHVIR in this patient group, has completed enrolment at the first dose level and, following a review of safety data, the second dose level is now open to recruitment.   

A further pediatric study of SEPREHVIR in high grade glioma (NCT02031965) has been terminated due to lack of recruitment and a Company decision to prioritise a new protocol for the treatment of glioma.

Virttu CSO Dr Joe Conner stated:

“VIRTTU is pleased to reach these recruitment milestones in the individual trials and in doing so SEPREHVIR® has now been administered to 100 patients.   We are particularly grateful to the patients, their families and the clinical teams for their continuing willingness to support our work.”

About VIRTTU Biologics

VIRTTU’s lead oncolytic product SEPREHVIR® has been administered to 100 patients ranging from 8 to 84 years with many different types of cancer including brain, melanoma, head and neck cancer, sarcomas, neuroblastoma and mesothelioma (a devastating lung cancer associated with asbestos exposure).  In these patients, SEPREHVIR can be administered by the route most suitable for their disease which includes systemic administration by intravenous infusion, direct intratumoral injection, and loco-regional infusion.  SEPREHVIR, which the company is interested in partnering for further development, is the first product from an active oncolytic immunotherapy platform technology (SEPREHVEC). VIRTTU’s in-house expertise has led to the development of techniques to engineer rapidly further therapeutic modalities into the SEPREHVIR backbone and VIRTTU now has a promising pipeline of next-generation clinical candidates. 

For more information about the Company visit www.VIRTTU.com