Thursday, February 19, 2015 11:36:47 AM
http://ih.advfn.com/p.php?pid=nmona&article=65550651&symbol=CVM
CEL-SCI’s Phase III Head & Neck Cancer Trial Cleared to Begin Patient Enrollment in Malaysia, the 20th Country to Join the,...
CEL-SCI Corporation (NYSE MKT: CVM) today announced the Ministry of Health Malaysia has cleared the Company to commence patient enrollment for its Phase III head and neck cancer trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in Malaysia. Malaysia is the 20th country to approve CEL-SCI’s Phase III trial, which now has over 350 patients enrolled.
“Our plan called for having the trial cleared and conducted in a total of 21 countries, the United States plus 20 other countries. We are almost there,” stated CEL-SCI Chief Executive Officer Geert Kersten.
About Multikine Phase III Study
The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.
About Multikine
Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary (not yet treated) head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015.
In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the U.S. Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. The Phase I trial started enrolling patients in September 2014. CEL-SCI also entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in HIV/HPV co-infected women and for peri-anal warts in HIV/HPV co-infected men and women.
About CEL-SCI Corporation
CEL-SCI’s work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. CEL-SCI believes that the best way may be to activate the immune system of patients before they have received surgery, radiation and/or chemotherapy. Its lead investigational therapy Multikine (Leukocyte Interleukin, Injection) is currently being studied in a pivotal Phase III clinical trial against head and neck cancer. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied, the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Navy under a CRADA.
CEL-SCI is also developing its LEAPS technology for the treatment of pandemic influenza and as a potential therapeutic vaccine against rheumatoid arthritis. CEL-SCI received a Phase I SBIR Grant from the National Institutes of Health to develop LEAPS as a potential treatment for rheumatoid arthritis with researchers from Rush University Medical Center in Chicago, Illinois. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our 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 (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
When used in this report, 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 which 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 and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 2014. 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.
CEL-SCI Corporation
Gavin de Windt, 703-506-9460
“The two most powerful warriors are patience and time.”
- Leo Nikolaevich Tolstoy
Recent CVM News
- CEL-SCI Appoints Mario Gobbo to Its Board of Directors • Business Wire • 04/23/2024 01:00:00 PM
- CEL-SCI’s LEAPS Vaccine Offers Promising New Paradigm to Treat Rheumatoid Arthritis: Published in Frontiers in Immunology • Business Wire • 03/19/2024 01:00:00 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 03/07/2024 04:33:42 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/07/2024 04:33:13 PM
- CEL-SCI Corporation Issues Letter to Shareholders • Business Wire • 03/06/2024 01:45:00 PM
- CEL-SCI Corporation Reports First Quarter Fiscal 2024 Financial Results • Business Wire • 02/15/2024 01:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/14/2024 09:31:12 PM
- CEL-SCI Announces Closing of $7.75 Million Public Offering of Common Stock • Business Wire • 02/13/2024 05:00:00 PM
- CEL-SCI Announces Pricing of $7.75 Million Public Offering of Common Stock • Business Wire • 02/09/2024 01:30:00 PM
- CEL-SCI Completes Commissioning of Its Multikine Manufacturing Facility for Commercial Scale Production of Head & Neck Cancer Drug • Business Wire • 02/06/2024 02:00:00 PM
- European Medicines Agency Grants CEL-SCI a Waiver of Strict Pediatric Requirements, Clearing the Path Towards Marketing Authorization for Multikine® • Business Wire • 01/31/2024 02:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 02:06:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 02:03:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 02:00:11 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 12/22/2023 09:01:06 PM
- CEL-SCI Reports Fiscal 2023 Financial Results and Clinical & Corporate Developments • Business Wire • 12/22/2023 01:00:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 12/21/2023 09:15:39 PM
- 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 • Business Wire • 12/04/2023 01:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/20/2023 10:25:18 PM
- CEL-SCI Announces Closing of $5 Million Public Offering of Common Stock • Business Wire • 11/20/2023 09:15:00 PM
- CEL-SCI Announces Pricing of $5 Million Offering of Common Stock • Business Wire • 11/16/2023 01:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 09:01:26 PM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM
Avant Technologies Launches Advanced AI Supercomputing Network and Expansive Data Solutions • AVAI • Apr 23, 2024 8:00 AM
BestGrowthStocks.com Issues Comprehensive Analysis of Triller Merger with AGBA Group Holding Limited • AGBA • Apr 22, 2024 1:00 PM
Cannabix Technologies to Present Marijuana Breathalyzer Technology at International Association for Chemical Testing (IACT) Conference in California • BLO • Apr 22, 2024 8:49 AM