FREDERICK, Md., Nov. 9, 2010 /PRNewswire/ -- Vaccinogen BV, a wholly-owned subsidiary of Vaccinogen, Inc. has been granted a Hospital Exemption by the Dutch Ministry of Health, Welfare and Sport for its colon cancer vaccine, OncoVAX®. Hospital Exemption is based on EU and Member State regulations and can be granted for qualified Advanced Therapeutic Medicinal Products ("ATMP") to ease their availability to medical practitioners and individual patients.

To grant a hospital exemption for an ATMP, the Dutch require that the vaccines meet specific quality standards and are used in the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner.

The quality standards that are required are: GMP (good manufacturing practice); pharmacovigilance; traceability; and reporting requirements. This exemption is for one year from the date of the grant. A request for prolongation may be submitted.

Vaccinogen is planning to commence a multinational, OncoVAX® pivotal Phase III(b) clinical trial for Stage II colon cancer in 2011. The Netherlands is one of the locations where Vaccinogen plans to submit its protocol to the Dutch Authorities for approval.

Michael Kranda, Vaccinogen's CEO, commented, "We welcome this approval and view this as a validation of our approach to preparing OncoVAX® vaccines and the quality of our team in our clinical production facility in Emmen, the Netherlands, by one of the most respected medical authorities in Europe."

About OncoVAX®

OncoVAX® transforms the body's immune response to prevent the return of the disease after surgery. As published in the journal Human Vaccines, Stage II OncoVAX® patients achieve "a 57.1% relative risk reduction in the recurrence of colon cancer" vs. the control patients in a previous clinical trial.  

About Vaccinogen

Vaccinogen develops and commercializes cancer vaccines and other immunotherapeutic products –Turning Cancer on Itself™. Based in Frederick, MD, the Company has a portfolio of product candidates for the treatment of cancer in various stages of clinical development.

www.vaccinogeninc.com

SOURCE Vaccinogen, Inc.

Back to top

RELATED LINKS
http://www.vaccinogeninc.com