Clinical Studies

We are conducting a number of important clinical studies, in a wide range of cancer types, and in leading medical centres around the world. Some of the key opinion leaders in cancer treatment are taking part in our studies.

Our lead product SEPREHVIR® is a very versatile agent. The way in which it works means it can be used in a wide range of cancers and also its route of administration can be adapted to suit the site of the cancer. In our clinical studies SEPREHVIR® is given directly into a localised cancer or into the organ in which the cancer is situated. In future studies we plan to administer SEPREHVIR® intravenously to treat widespread cancers.

VIRTTU actively continues to conduct the necessary research and development work to support the clinical development programme for SEPREHVIR® (HSV1716).

Our current clinical studies are shown in the table below. The cancers chosen can be difficult to treat and represent a real unmet medical need. 

Products in clinical development

Product	Indication	Research & Pre-clinical	Phase I	Phase II	Phase III	Status
SEPREHVIR® (HSV1716)	Malignant brain tumours	Completed	3x Ph I Completed	In preparation		Orphan Drug Status (EMA) Study in primary GBM planned
SEPREHVIR®  (HSV1716)	Squamous cell carcinoma of head and neck	Completed	Ph I Completed			Phase I trial completed
SEPREHVIR®  (HSV1716)	Malignant melanoma	Completed	Ph I Completed			Phase I trial completed
SEPREHVIR®  (HSV1716)	Hepatocellular carcinoma	Completed	In Preparation			Due to commence Q4 2011
SEPREHVIR®  (HSV1716)	Malignant pleural mesothelioma	Completed	In Preparation			Due to commence Q4 2011
SEPREHVIR®  (HSV1716)	Paediatric and young adults with Non-CNS solid tumours (eg neuroblastoma or sarcoma)	Completed	Ongoing			Recruiting at Cincinnati Children's Hospital Medical Center

 

VIRTTU’s HSV1716 Clinical Studies - Publications

Rampling R, Cruickshank G, Papanastassiou V, et al. Toxicity evaluation of replication­competent herpes simplex virus (ICP 34.5 null mutant 1716) In patients with recurrent malignant glioma. Gene Therapy 2000;7(10):859-66.

Papanastassiou V, Rampling R, Fraser M, et al. The potential for efficacy of the modified (ICP 34.5(-)) herpes simplex virus HSV1716 following intratumoural injection into human malignant glioma: a proof of principle study. Gene Therapy 2002;9(6):398­406.

Harrow, S., Papanastassiou, V., Harland, J., Mabbs, R., Petty, R., Fraser, M., Hadley, D., Patterson, J., Brown, S. M., Rampling, R. HSV1716 injection into the brain adjacent to tumour following surgical resection of high-grade glioma: safety data and long-term survival. Gene Therapy 2004; 11(22): 1648-584.

MacKie, R., Stewart, B., and Brown, S. (2001). Intralesional injection of herpes simplex virus 1716 in metastatic melanoma. Lancet 357: 525-526.

Mace, A. T., Ganly, I., Soutar, D. S., and Brown, S. M. (2008). Potential for efficacy of the oncolytic Herpes simplex virus 1716 in patients with oral squamous cell carcinoma. Head Neck 30: 1045-1051.