Finding Clears Way for Export of Multikine to European Union Clinical Trial Sites Participating in Phase III Cancer Trial for Multikine
VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE AMEX: CVM) announced today that following an audit of its Multikine® manufacturing plant and laboratories by a European Union Qualified Person (QP), the CEL-SCI facilities were found to be in a high level of compliance with the Good Manufacturing Practices (GMP) Directives of the International Conference on Harmonization (ICH). The QP’s finding clears the way for CEL-SCI to export Multikine to the European Union (EU) for use in its Phase III clinical trial in head and neck cancer patients.
The EU, unlike other countries included in CEL-SCI’s Phase III trial, requires every lot or batch of medicinal product intended for use in a clinical trial that is being conducted within its member states be released by a QP to ensure the product’s safety. Each QP must be certified individually by the EU regulatory body to become a QP and needs to have extensive training and an in-depth critical understanding of all the aspects associated with manufacturing and distribution of drug products. Penn Pharmaceutical Services Ltd, UK is providing QP service to CEL-SCI for the certification and release of Multikine for use in the EU and has conducted this QP Audit. The audit report also commended the CEL-SCI facilities and the Multikine product for being in compliance with the requirement of GMP for the safety, quality and efficacy of the product.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine. In Phase II clinical trials Multikine was shown to be safe and well-tolerated and to improve the patients' overall survival by 33 percent at a median of three and a half years following surgery. The pivotal Phase III study, scheduled to start soon, will involve about 48 clinical centers in nine countries on three continents and will be the biggest head and neck cancer Phase III trial ever conducted.
CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its LEAPS technology platform. The LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
Gavin de Windt, 703-506-9460
KEYWORDS: United States North America Virginia
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical