UK'S National Institute for Health And Care Excellence Selects CEL-SCI's Multikine As Potential New Standard of Care For Head & Neck Cancer

Author: Benzinga Newsdesk | December 04, 2023 09:38am

CEL-SCI Corporation (NYSE: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.

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