VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced that two abstracts related to CEL-SCI’s pivotal Phase 3 head and neck cancer clinical trial were accepted at the American Society of Clinical Oncology (ASCO) meeting being held June 3-7, 2022 in Chicago, IL. After a two-year hiatus, ASCO comes alive in June 2022 under the theme, “Advancing Equitable Cancer Care Through Innovation.” ASCO is the largest cancer meeting in the world, bringing together thousands of cancer experts from academia, industry, patient advocacy and policy.
About Multikine
Multikine* (Leukocyte Interleukin, Injection) is an investigational cancer immunotherapy that is known to contain a mixture of natural human proinflammatory cytokines, the body’s immune system regulators including interleukins, interferons, chemokines, and colony stimulating factors which are elements of the body’s natural mix of defenses against cancer and other diseases. A patented, mass-produced, off the shelf, non-autologous biological investigational product, Multikine is manufactured using a proprietary process following Current Good Manufacturing Practice (cGMP) at CEL-SCI’s manufacturing facility near Baltimore, Maryland.
About Head and Neck Cancer
Approximately 890,000 new cases of head and neck cancer are diagnosed each year globally, of which approximately 68,000 are in the U.S. and 150,000 in Europe.
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 its pivotal Phase 3 study of Multikine in newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck the investigational product Multikine was administered BEFORE patients received surgery and radiotherapy or surgery plus concurrent radiotherapy and chemotherapy (the current standard of care (SOC) for these patients). This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed or to patients whose tumors have metastasized or are inoperable. 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 events (deaths) had occurred among the two main comparator groups. This study milestone occurred in late April 2020 and database lock occurred in December 2020.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
Forward-Looking Statements
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.
