Date: 2013-05-31
Type of information: Initiation of preclinical development
phase: 1
Announcement: authorization of an extension of the study
Company: Virttu Biologics (UK)
Product: Seprehvir® (HSV1716)
Action
mechanism: oncolytic virus/oncolytic immunotherapy. Seprehvir® is an engineered oncolytic herpes simplex virus designed to selectively target and destroy cancerous cells whilst leaving healthy cells unharmed.
Disease: sarcomas, such as rhabdomyosarcoma, osteosarcoma and Ewing sarcoma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: 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 whetherSeprehvir® 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.
Latest
news: * On May 31, 2013, Virttu Biologics has announced 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.To date, two cohorts of patients have received different dose levels with Seprehvir® 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.
