CEL-SCI Addresses Warning Letter in Regard to Statements on Its Corporate Website
VIENNA, Va.--(BUSINESS WIRE)--Aug 18, 2011 - CEL-SCI Corporation (NYSE AMEX: CVM) announced today that it has received and responded to a Warning Letter issued to the Company by the Division of Drug Advertising Marketing and Compliance (DDMAC) U.S. Food and Drug Administration (FDA) regarding certain statements made about the Company's investigational therapy Multikine (Leukocyte Interleukin, Injection)* on its corporate website. The Warning Letter was issued by DDMAC on August 5, 2011. The letter identifies specific statements on various pages of the CEL-SCI website as promoting this investigational therapy as safe and effective for the purposes for which it is being investigated.
CEL-SCI has already taken a series of actions to address the DDMAC letter. In CEL-SCI's response to the DDMAC, dated August 17, 2011, CEL-SCI detailed the specific actions taken by the Company to a) revise the statements identified by the Agency, b) disseminate the revised statements and c) identify the revised web pages on the CEL-SCI website. Furthermore, CEL-SCI's response letter describes additional actions that the Company is implementing to ensure that its website and the statements about the Company's R&D activities and investigational therapies on its website are in full compliance with FDA (DDMAC) requirements related to drug promotion and advertising.
Geert Kersten, CEO of CEL-SCI, said, “CEL-SCI is fully committed to compliance with the law and to strict adherence with all governing laws, regulations, and policies, particularly those which are implemented and enforced by FDA, as well as those implemented and enforced by the other regulatory agency that shares significant regulatory oversight of our Company, the Securities and Exchange Commission (SEC). Consistent with CEL-SCI's longstanding compliance policies and procedures, CEL-SCI is particularly committed to assuring that statements regarding CEL-SCI's investigational medicinal products such as those cited in DDMAC's letter – which are directed at fulfilling our SEC-imposed disclosure obligations, while also engaging in a full exchange of scientific information and thereby advancing scientific knowledge and fostering scientific research in medical fields relating to products we are developing – are truthful, scientifically accurate, complete, and non-misleading. CEL-SCI's commitment and approach in these regards apply equally to communications online as they do to all other forms of communication. As a data-driven, research-based biopharmaceutical company, CEL-SCI has always actively engaged in a full exchange of scientific information, including disseminating scientific findings and communicating them through lay media outlets consistent with FDA's regulations on investigational drugs. We have now stepped up our proactive compliance initiatives to ensure that we remain within the regulatory framework for such scientific-information-exchange.”
About CEL-SCI Corporation
CEL-SCI Corporation is developing investigational products that are being studied for their potential to empower immune defenses. Its lead investigational product is Multikine (Leukocyte Interleukin, Injection), currently in a pivotal Phase III clinical trial. CEL-SCI is also developing an investigational immunotherapy (LEAPS-H1N1-DC) that is being evaluated for its potential to be used in the treatment of H1N1 hospitalized patients as well as an investigational vaccine (CEL-2000) that is being evaluated 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.
For more information, please visit www.cel-sci.com.
* 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.
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, 2010. 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.
Contact: CEL-SCI Corporation
Gavin de Windt, 703-506-9460
Posted: August 2011