On August 15, 2022 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2022, as well as key clinical and corporate developments (Press release, Cel-Sci, AUG 15, 2022, View Source [SID1234618387]).
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Clinical and Corporate Developments include:
The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) published two abstracts related to CEL-SCI’s pivotal randomized controlled Phase 3 Multikine (Leukocyte Interleukin, Injection)* head and neck cancer clinical trial for presentation at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting to be held June 3-7, 2022 in Chicago, Illinois. The abstract titles are:
"Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and neck (SCCHN): Using pretreatment data only." – View Source
"Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study." – View Source
Multikine is given for three weeks after cancer diagnosis, but before surgery and other treatments. In the peer-reviewed abstract presented at ASCO (Free ASCO Whitepaper), a clear survival advantage for patients treated with Multikine prior to surgery in the surgery-plus-radiation arm of the IT-MATTERS study was described. The survival advantage was driven by objective data derived from patients in the intent-to-treat (ITT) population who had a significant number of early complete and partial tumor responses which occurred prior to surgery. Five patients in the study had their tumors completely disappear (confirmed by pathology) before surgery. In the ITT population as a whole, 8.5% of all Multikine-treated patients had a tumor response before surgery, but not a single tumor response before surgery was seen in the ITT control group before surgery, statistically a highly significant finding (p-value of less than 0.00000000001). This indicates that the likelihood of seeing these results by chance is less than 1 in ten billion. These results confirm findings from the Phase 1 and 2 studies with Multikine and provide direct evidence of Multikine’s anticancer activity.
Additional results from the Phase 3 study of Multikine in advanced primary head and neck cancer have been submitted to the U.S. government clinical trial website www.clinicaltrials.gov. That data is expected to be released to the public in the near future.
CEL-SCI’s dedicated current Good Manufacturing Practice (cGMP) facility in which it manufactures Multikine is now undergoing validation following the completion of its commercial scale build out during the first quarter of 2022. The construction was designed to ensure the facility will be compliant with all U.S. Food and Drug Administration’s (FDA) GMP and European regulations.
"Advanced primary squamous cell carcinoma (cancer) of the head and neck is a horrible disease for which FDA has not approved a new treatment in many decades. Many leading drugs have failed in studies for the treatment of advanced primary head and neck cancer. Our Phase 3 study shows an almost 4-year median survival benefit for the patients who received Multikine treatment before surgery and radiation. We believe that this represents a meaningful clinical impact for those patients for whom no treatment has imparted a significant survival benefit in decades. We are looking forward to additional peer-reviewed publications of this data," stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported an operating loss of $27.1 million for the nine months ended June 30, 2022 versus an operating loss of $27.7 million for the nine months ended June 30, 2021. Net cash used during the nine months ended June 30, 2022 was $13.3 million. This represents a decrease of $0.7 million compared to the nine months ended June 30, 2021. CEL-SCI reported an operating loss of $8.7 million for the three months ended June 30, 2022 versus an operating loss of $10.5 million for the three months ended June 30, 2021.