Commonwealth Biotechnologies, Vigen seek patent protection for herpes virus platform.

Commonwealth Biotechnologies, Inc. (Richmond, VA; 804-278-9901) a contract research organization, and Vigen, Inc., a Wisconsin-based company which specializes in commercialization of anti-viral technologies, announced that they had filed for patent protection of CBI's proprietary diagnostic platform for detection and quantitation of DNA attributable to any one of the 8 known human herpes viruses. CBI and Vigen formed a joint venture in April 2000 for the express purpose of commercializing high throughput rapid screening assays for the detection of Herpes and AIDS related viruses and test agents which affect virus replication. The patent filing is the direct outcome of the research program conducted at CBI on behalf of Vigen.

Included in the herpes viruses are the well-known simplex viruses, HSV 1 and HSV 2, but also the Varicellovirus (HHV 3), the Epstein Barr virus (EBV; HHV 4), the cytomegalovirus (CMV; HHV 5), HHV 6, HHV 7 (Roseolovirus) and HHV 8 (Rhadinovirus). HHV 4 is associated with infectious mononucleosis and cancer propagation in Burkitt's lymphoma and nasopharygeocarinoma. HHV5 causes infection in the lungs of immune-suppressed patients. HHV 6 is associated with roseola and infantum infections in children and is putatively associated with multiple sclerosis and chronic fatigue syndrome. HHV 7 seems to be co-incident with the occurrence of HHV 6 and HHV 8 is associated with Karposi's sarcoma of AIDs patients.

"CBI and Vigen recognized the importance of developing sensitive screening assays for the presence of these viral DNAs," explained Dr. Robert B. Harris, President of CBI, "so as to test for the presence of these viruses in patient samples, to monitor their course of treatment and to avoid current drawbacks plague existing assay methods. The assays have also proved extremely useful in helping to develop Vigen's anti-viral agents."

Through a unique bioinformatics approach, CBI scientists designed and then implemented the assays which afford full coverage of all viruses down to as little as 10 copies of viral DNA in serum, cerebrospinal fluid, or tissue samples. In the time since the assays were brought on-line at CBI, over 250 patient samples have been received from doctors across the United States and CBI is using the assay platform in support of a clinical trial of a new potential anti-herpes virus medication. With virtually no directed marketing to date, non-discounted revenues realized by CBI from the assay platform totaled nearly $150,000 over a 5-month period. Clinical support services compose a fundamental platform for the company contributing nearly $ 350,000 in revenue for the current year-to-date.

Mr. William Philip, VP Business Development of Vigen, added, "Bottom-line is that CBI has developed the "gold standard" for DNA analysis and monitoring of viral load for these widespread viruses. This will generate extraordinary benefits in patient care. As an example of one of the potential immediate benefits will be the ability for affordable regular monitoring of a patient's sexually related Herpes viruses which when potentially combined with treatment could reduce activation or shedding and consequently reduce the serious spread of this disease. But longer term this development provides the research community with an extraordinary effective and accurate tool to examine the Herpes viruses and their potential linkages to human genetics and related diseases such as breast cancer, non-Hodgkin's lymphoma, Nasopharyngeal carcinoma, Multiple Sclerosis, Chronic Fatigue Syndrome, etc. This is a serious step forward in both patient diagnostics and research of these viruses."