CEL-SCI Corporation Announces Reddit AMA with Geert Kersten

Rhea-AI Summary

CEL-SCI Corporation (NYSE American: CVM) announces CEO Geert Kersten will participate in a Reddit AMA at 12:30 PM ET today to discuss Multikine and recent ASCO 2022 publications.

Multikine, designed to enhance immune response in patients with advanced head and neck cancer, received FDA Orphan Drug designation for neoadjuvant therapy. The ongoing Phase 3 study, initiated in 2011, enrolled 928 patients and aims to demonstrate a survival benefit. Previous results showed positive outcomes for patients treated with Multikine plus standard therapies, although adding chemotherapy negated benefits.

Positive

• Multikine received FDA Orphan Drug designation for neoadjuvant therapy.
• The Phase 3 study is considered the largest of its kind for advanced primary head and neck cancer, with 928 patients enrolled.
• Previous results indicated a survival benefit for patients treated with Multikine in combination with surgery and radiation.

Negative

• Previous results showed that adding chemotherapy after surgery negated the survival benefits of Multikine.
• The company faces risks including regulatory approval challenges and the inability to replicate positive clinical results.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) announces that Geert Kersten, Chief Executive Officer, will be on Reddit AMA (“Ask Me Anything”) today at 12:30 PM ET to discuss Multikine and our recent publications at ASCO 2022.

Come ask him anything relevant at reddit.com/r/IAmA/.

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.

The Company’s LEAPS technology is being developed for rheumatoid arthritis. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220714005564/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

 

Source: CEL-SCI Corporation

FAQ

What is the focus of the Reddit AMA by CEL-SCI Corporation's CEO?

The AMA focuses on Multikine and CEL-SCI's recent publications related to ASCO 2022.

When is the Reddit AMA with CEL-SCI's CEO taking place?

The Reddit AMA is scheduled for today at 12:30 PM ET.

What does Multikine aim to achieve for patients with head and neck cancer?

Multikine is designed to boost the immune system's response to tumors before standard treatments like surgery and radiation.

How many patients were enrolled in CEL-SCI's Phase 3 study of Multikine?

The Phase 3 study enrolled 928 patients.

What designation did Multikine receive from the FDA?

Multikine received Orphan Drug designation for its use as neoadjuvant therapy.