Is Cel-Sci The Cheapest Company In A Phase III Trial?

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CEO Geert Kersten of Cel-Sci (CVM) believes his company's valuation is significantly lower than warranted. In the following interview by Peter Epstein, Mr. Kersten candidly addresses important questions about Cel-Sci. This interview was conducted by phone and email in the first week of March. Peter Epstein has no existing or prior relationship with Cel-Sci, but he does own shares of the company.

Please give an overview of Cel-Sci for readers who don't know the story.

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 as compared to subjects treated with the 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 (Cooperative Research and Development Agreement).

If your team believes that Multikine is so important, why is it taking CEL-SCI so long to get Multikine to market? 

Beta blockers, Erbitux and Copaxone took about 30 years to come to the market. In our case the largest factor was lack of money. Other reasons were 1) doing something that has never been done before, 2) the product is very complex and 3) sometimes you have to wait until the time is ripe. Still, it was mostly lack of funding that slowed us down. We also had to switch our Clinical Research Organization, "CRO" in 2013, which was a significant set back as enrollment was essentially stalled and investors lost patience. The reputational impact was as bad as the decline in our stock price.

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Disclosure:  I have no prior or existing relationship with any company listed herein. I may or ...

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