CEL-SCI Appoints Dr. Gail Naughton to Its Board of Directors
Pioneer in the field of regenerative medicine who brought four products from concept through FDA approval and market launch
Dr. Naughton has been a pioneer in the field of regenerative medicine for over 35 years. She was the founder of Advanced Tissue Sciences (NASDAQ:ATIS) where she oversaw the design and development of the world’s first up-scaled manufacturing facility for cell-based products, established corporate development and marketing partnerships with companies including Smith & Nephew, Medtronic, and Inamed Corporation, was pivotal in raising over $350 million from the public market and corporate partnerships, and brought four human cell-based products from concept through FDA approval and market launch. She founded Histogen (NASDAQ:HSTO) in 2007 and holds more than 125 U.S. and foreign patents and has been extensively published in the field. Dr. Naughton served as Dean of the College of Business Administration at San Diego State University from 2002 until 2011 where she helped to make SDSU the first US campus to establish a Ph.D./MBA in life sciences. In 2000, Dr. Naughton received the 27th Annual National Inventor of the Year award by the Intellectual Property Owners Association in honor of her pioneering work in the field of tissue engineering and regenerative medicine. Dr. Naughton received her Ph.D. and M.S. from NYU Medical Center and an MBA from UCLA. She currently sits on the Board of directors of Therapeutics MD (NASDAQ: TXMD) and is the Chair of the Board of the La Jolla Institute for Immunology.
“A highly accomplished visionary in biotechnology, Dr. Naughton has brought several FDA approved products to market, and we are very pleased to welcome her to our board. Her unparalleled expertise will be very helpful to CEL-SCI,” stated CEL-SCI CEO Geert Kersten.
Dr. Naughton commented, “Based on the results of the largest study of its kind, Multikine can significantly improve outcomes for patients with newly diagnosed head and neck cancer. CEL-SCI’s management team and board have been tenacious in advancing an immune therapy that can have the greatest beneficial impact on patients—when they are first diagnosed with cancer. I look forward to contributing my guidance as the company transitions through regulatory approval and into delivering treatments that can help extend patient lives.”
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine* first, BEFORE they received surgery and radiotherapy or surgery plus concurrent radiochemotherapy (the current standard of care for these patients). This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of advanced primary head and neck cancer.
Multikine is designed to help the immune system “see” the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. The Phase 3 study was started in early 2011 and was fully enrolled with 928 patients in September 2016. To prove an overall survival benefit, the study required CEL-SCI to wait until at least 298 (deaths) events had occurred among the two main comparator groups. The study results announced in June 2021 showed excellent survival benefit for those patients who received Multikine treatment regimen plus surgery and radiation. When chemotherapy was added to radiotherapy following surgery the survival benefit was negated.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. 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's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2021. 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.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's 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.
Gavin de Windt