UK’S National Institute for Health and Care Excellence (NICE) Selects CEL-SCI’s Multikine as Potential New Standard of Care for Head & Neck Cancer

Rhea-AI Summary

CEL-SCI Corporation (CVM) announced that the British National Institute for Health and Care Excellence (NICE) has selected Multikine to be evaluated as the potential new standard of care for squamous cell carcinoma of the head and neck (SCCHN) in the UK. NICE posted a detailed report from the UK’s National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced that the British National Institute for Health and Care Excellence (NICE) has selected Multikine* (Leukocyte Interleukin, Injection) to be evaluated as the potential new standard of care for squamous cell carcinoma of the head and neck (SCCHN) in the UK. NICE posted a detailed report from the UK’s National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK. This published report informs UK doctors, patients, and other interested parties that NICE has started the review of Multikine and is soliciting public comment.

As stated on NICE’s website (click here), the reason for selecting Multikine is the following:

“Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources”

A detailed Health Technology Briefing prepared by the NIHR posted on NICE’s website (click here) titled “Leukocyte interleukin with cyclophosphamide, indomethacin, and zinc for neoadjuvant therapy of squamous cell carcinoma of the head and neck” can viewed in full HERE.

The NICE briefing includes the following statements:

• “The current standard of care for locally advanced SCCHN is an aggressive combined modality therapy. With current treatment the risk of recurrence, distant metastases, and death (5-year survival rate) for patients remains high.”
• “With current standard of care, most patients with SCCHN still experience disease recurrence or develop distant metastases (spread to distant organs or lymph nodes), therefore novel treatment options are needed.”
• “The LI injection [Multikine] utilizes naturally occurring, immune-regulating cytokines, and could be the first investigational immunotherapeutic to be used in locally advanced SCCHN. Results from phase III clinical trial (NCT01265849) indicated a statistically significant 5-year survival benefit with LI immunotherapy produced in patients receiving surgery plus radiotherapy, representing approximately 40% of the study population.”
• “If licensed, LI [Multikine] will offer the first-line neoadjuvant treatment in previously untreated patients with SCCHN prior to standard of care.”

Dr. Mehmet Sen, MD, FRCR, one of Europe’s leading head and neck oncologists treating patients for more than 30 years, and Consultant Clinical Oncologist and Honorary Senior Lecturer at the St. James Institute of Oncology in Leeds, UK, commented, “There is a clear and imperative need for a new treatment for newly diagnosed head and neck cancer patients in the UK and worldwide. Multikine’s efficacy and safety data are clear and compelling. Moreover, because Multikine can be administered before the current standard of care of surgery and radiation, it has strong potential to be additive to survival at minimal additional risk, if any, to the patient.”

“We are highly encouraged that NICE has selected Multikine for evaluation as a potential new standard of care for head and neck cancer. This is a big step forward in the UK,” stated CEL-SCI CEO Geert Kersten.

NICE is an executive non-departmental public body of the Department of Health and Social Care in the UK. NICE publishes guidelines in four areas:

• the use of health technologies within England's National Health Service (NHS) and NHS Wales (such as the use of new and existing medicines, treatments and procedures)
• clinical practice (guidance on the appropriate treatment and care of people with specific diseases and conditions)
• guidance for public sector workers on health promotion and ill-health avoidance
• guidance for social care services and users.

These appraisals are based primarily on evidence-based evaluations of efficacy, safety and cost-effectiveness in various circumstances.

According to Cancer Research UK, an average of 12,400 cases of head and neck cancer are diagnosed each year in the UK.

About CEL-SCI Corporation

CEL-SCI is a clinical-stage biotechnology company focused on activating the immune system of cancer patients to fight cancer before surgery, radiation and chemotherapy have damaged it. The Company’s lead investigational therapy Multikine completed a pivotal Phase 3 clinical trial involving head and neck cancer, for which the Company has received Orphan Drug Status from the FDA. The Company has operations in Vienna, Virginia, and near 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, 2022. 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. 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/20231204232873/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

What is the significance of NICE selecting Multikine for evaluation in the UK?

NICE selecting Multikine for evaluation in the UK indicates the potential for it to become a new standard of care for head and neck cancer, addressing the imperative need for a new treatment in the UK and worldwide.

What are the key findings of the Health Technology Briefing prepared by the NIHR regarding Multikine?

The Health Technology Briefing includes the potential of Multikine to offer the first-line neoadjuvant treatment in previously untreated patients with SCCHN prior to standard of care, with statistically significant 5-year survival benefit in patients receiving surgery plus radiotherapy.

Who is Dr. Mehmet Sen, and what is his opinion on Multikine?

Dr. Mehmet Sen is a leading head and neck oncologist in Europe, and he commented that there is a clear and imperative need for a new treatment for newly diagnosed head and neck cancer patients in the UK and worldwide, and that Multikine’s efficacy and safety data are clear and compelling.

What is the role of NICE in the UK, and why is their evaluation of Multikine important?

NICE is an executive non-departmental public body of the Department of Health and Social Care in the UK, and their evaluation of Multikine is important as it could potentially lead to the adoption of Multikine as a new standard of care for head and neck cancer in the UK.

How many cases of head and neck cancer are diagnosed each year in the UK?

According to Cancer Research UK, an average of 12,400 cases of head and neck cancer are diagnosed each year in the UK.