CEL-SCI Corporation (NYSEMKT:CVM)
The European patent office has confirmed it will award CEL-SCI Corporation (NYSEMKT:CVM) a patent for its investigational cancer immunotherapy, Multikine. The patent relates to a new way of altering the composition of a tumor infiltrating mononuclear cells as well as increasing CD4+/CD8+RATIO.
Multikine Clinical Trials
Thanks to the new investigational cancer immunotherapy, CEL-SCI Corporation (NYSEMKT:CVM) believes tumors should become more visible thereby making it easy to come up with a sustainable anti-tumor immune response. Multikine is also designed to work with the body’s natural immune system and is currently being tested in a pivotal Phase 3 clinical trial as the first line of treatment for squamous cell carcinoma.
The phase 3 trial is currently on partial clinical hold. The company is currently working with the U.S. Food and Drug Administration (FDA) to have the clinical hold lifted after having already enrolled 928 patients. However, for the hold to be lifted, the company will have to furnish the FDA with an updated investigator’s brochure and current procedures for compliance.
The FDA also requires the company to furnish a list of major protocol deviations that might affect the study results. In addition to enrolling new patients for the study the company also has to follow patients until the targeted 298 deaths between two comparison groups is achieved.
The Investigational immunotherapeutic agent is also being tested at the University of California as a potential treatment for peri-anal warts in HIV/HPV.
“Our patent portfolio for Multikine consists of multiple patents issued in the United States, Europe, China, and Japan. In addition to these patents that offer certain protections for Multikine, the method of manufacture for Multikine held by CEL-SCI as trade secret offers additional protections,” said CEO, Geert Kersten.
CEL-SCI CRO Arbitration
Separately CEL-SCI Corporation (NYSEMKT:CVM) says arbitration against the former CRO who ran the Phase 3 study is nearing its end. The company had sued the CRO for breach of contract, common law fraud, as well as fraud in the inducement, and is consequently seeking $50 million in damages. CEL-SCI is not incurring any legal cost as result of the ongoing arbitration as Lake Whillans, Litigation Finance LLC is financing the case.
CEL-SCI Corporation (NYSEMKT:CVM) stock was a big mover in Friday’s trading session having edged higher by 21.18% to close the week at highs of $0.1213 a share.
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About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.