CEL-SCI to Participate in Upcoming Investor Conferences
Event: 38th Annual JP Morgan Healthcare Conference
Date: January 13-16, 2020
Location: San Francisco, CA
Event: BIO CEO & Investor Conference
Date: February 10-11, 2020
Location: New York, NY
“We look forward to partnering and networking meetings at both the JP Morgan and the BIO CEO conferences. As we approach the end of our global pivotal Phase 3 advanced primary head and neck cancer study, this is an opportune time to meet with key industry stakeholders regarding our cancer immunotherapy Multikine*, which could potentially become the first FDA approved drug for this indication in about 60 years,” Mr. Kersten stated.
About CEL-SCI Corporation
CEL-SCI believes that boosting a cancer 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 newly diagnosed patients with advanced primary head and neck cancer with its investigational product Multikine right after diagnosis, BEFORE they received surgery, radiation and/or chemotherapy, the current standard of care for this indication. This approach is unique. Most other cancer immunotherapies are administered only after surgery etc have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has 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 head and neck cancer, about 6% of the world’s cancer cases. Per the study’s protocol, newly diagnosed, treatment naïve patients with advanced primary head and neck cancer are treated with the Multikine treatment regimen for 3 weeks prior to receiving the Standard of Care (SOC) which involves surgery plus radiation or surgery plus concurrent radiochemotherapy. 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 better be able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body’s immune system to fight the tumor prior to SOC. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups.
The Company’s experimental LEAPS technology is currently being developed as a potential therapeutic vaccine for rheumatoid arthritis and is supported by grants from the National Institutes of Health. The Company has operations in Vienna, Virginia, in and near Baltimore, Maryland.
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, including statements with respect to Multikine and the Phase 3 clinical trial of Multikine in patients with advanced primary squamous cell carcinoma of the head and neck. 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 trials or nonclinical 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/A for the year ended September 30, 2019. 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.
Gavin de Windt
Source: CEL-SCI Corporation