CEL-SCI鈥檚 Multikine Head and Neck Cancer Immunotherapy Breakthrough Medicine Designation Filed in Saudi Arabia: Allows for Patient Access and Reimbursement/Sale Upon Granting of the Designation Which Takes Approximately 60 Days Based on SFDA Timeline
- Memorandum of Understanding (MOU) signed with a leading Saudi Arabian pharma company which submitted the Breakthrough Medicine Designation to the Saudi Food and Drug Authority (SFDA)
- Increasing interest in CEL-SCI from Saudi investment funds as Multikine advances through regulatory and drug distribution channels
Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. Its goal is to activate a person鈥檚 immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world鈥檚 largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to
According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in
The Saudi pharma company is well positioned to procure reimbursement and to accelerate Multikine鈥檚 sale and commercial launch.
Several leading Saudi funds have expressed interest in investing in Multikine, CEL-SCI, and a potential joint venture to serve the wider
Martin Bailey, Managing Director and Founder of First Berlin, the lead advisor, commented, 鈥淐EL-SCI鈥檚 prospective new partner is a prominent and innovative leader that has rendered many valuable healthcare services to the Kingdom. The Saudi pharma company鈥檚 keen interest in Multikine to make patients鈥� first cancer treatment more curative is very much in line with their forward-thinking approach and fits well with Saudi Arabia鈥檚 Vision 2030 and the National Biotechnology Strategy. We look forward to facilitating the signing of a final partnership agreement and making Multikine available to patients as quickly as possible.鈥�
鈥淭his MOU and the filing for Breakthrough Medicine Designation mark a significant advancement for Multikine鈥檚 global regulatory, patient access/sale and commercial roll out,鈥� stated CEL-SCI CEO, Geert Kersten. 鈥淲e鈥檝e had a highly productive working relationship with this prestigious Saudi pharma company, First Berlin, and the SFDA and hope to see Multikine improve longevity and well-being for head and neck cancer patients in Saudi Arabia.鈥�
About the SFDA鈥檚 Breakthrough Medicine Program
The SFDA Breakthrough Medicine Program aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia鈥檚 initiative. The program is voluntary and based on early dialogue with drug developers to optimize development plans and speed up evaluation. The goal is to ensure that promising medicines are available as soon as it can be concluded that the medicines鈥� benefits justify their risks.
Eligibility includes having to fulfill all of the following four criteria in order to gain a Breakthrough Medicine Designation:
- Target serious debilitating or life-threatening conditions with unmet medical need.
- The medicinal product is likely to offer major advantages over methods currently used.
- The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance.
- The product is not registered at any regulatory authority at the time of submission of the designation request.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient鈥檚 immune system before surgery, radiotherapy and chemotherapy have damaged it, should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" 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.
Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
The Company has operations in
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. 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, inability to finalize a partnering agreement 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, 2024. 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:
COMPANY CONTACT:
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
听
Source: CEL-SCI Corporation
