US Phase I study is extended to include systemic delivery of oncolytic virus.

Virttu Biologics Limited, a UK biotechnology company with expertise in the field of oncolytic viruses, is pleased to announce at ASCO that an on-going clinical study in the USA with its oncolytic virus, SEPREHVIR® (HSV1716), in children and young adults with non-CNS tumours has received permission from the regulatory authorities to enrol patients to receive intra-venous administration of the virus.

The study is a Phase I dose escalation study of SEPREHVIR (HSV1716) in patients with refractory non central nervous system (Non-CNS) solid tumours. Typically, patients enrolled in the study have been suffering from sarcomas, such as rhabdomyosarcoma, osteosarcoma and Ewing sarcoma. The primary objective of this study is to determine whether SEPREHVIR is safe in children and young adults. The study is sponsored by Dr Timothy Cripe of Nationwide Children’s Hospital, Columbus (Ohio) and is being conducted at the Cincinnati Children’s Hospital, Cincinnati (Ohio) where the principal investigator is Dr. James Geller. The study has been supported by Solving Kids Cancer and a FDA Orphan grant.

To date, two cohorts of patients have received different dose levels with SEPEHVIR being administered by intra-tumoural injection. Now, based on safety data generated from this and other clinical studies with SEPREHVIR and the clinical needs of the patients, permission has now been granted to extend the study so as to administer the virus by intravenous injection to patients with metastatic disease or with a localised lesion not deemed suitable for direct injection.
Dr Cripe will be presenting a poster on the study at the ASCO meeting in Chicago on Saturday 1st June between 1pm and 5pm.
Commenting on this new development, Dr. Tim Cripe, said: “We and others have shown in animal models that virus given intravenously can reach and amplify in distant tumour sites, so this is an important first step in bringing this potential new therapy to patients with metastatic disease.”
Dr. Steven Powell, Virttu CEO, added: “This welcome decision by regulatory bodies, both further validates the safety profile of SEPREHVIR and demonstrates its potential broad utility. In addition to the non-CNS trial, we now plan to extend intravenous injection across our other clinical programmes where appropriate.”

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