CEL-SCI Corporation's Manufacturing and Laboratory Operations Deemed Compliant with GMP Requirements
CEL-SCI Corporation's Manufacturing and Laboratory Operations Deemed Compliant with GMP Requirements Following Audit by European Union Qualified Person for a Second Time
VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE MKT: CVM) announced today that following an audit of its Multikine® manufacturing plant and laboratories by a European Union (EU) 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 EU and the International Conference on Harmonization (ICH). This inspection follows a successful inspection by a different QP in late 2010.
The EU, unlike other countries included in CEL-SCI's ongoing 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 to be released by a QP to ensure the product's safety and compliance with the EU Directives. 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, which has conducted this QP Audit, is providing QP service to CEL-SCI for the clinical Lot certification, and is engaged in releasing the clinical lots of the investigational drug Multikine for use in the EU. The most recent audit concluded that CEL-SCI appears a well-managed organization with a clear commitment to the quality of its product, having well qualified and trained staff, and that both the manufacturing and laboratory facilities are of high caliber and more than adequate for their intended purpose.
About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy 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 possible emergence 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.
Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 2012. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Gavin de Windt, 703-506-9460
KEYWORDS: United States Europe North America Virginia
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