CEL-SCI Corporation (NYSEAMERICAN: CVM) has issued a letter to shareholders addressing the confusion about the third phase study results in newly diagnosed advanced primary head and neck cancer released last week.
Multikine demonstrated statistical significance in five-year survival benefit
The company said that its Multikine immunotherapy showed statistically significant five-year survival benefit (14.1% in patients that received surgery and radiotherapy. This represents 40% of the study population which is around 155,000 patients per year. CEL-SCI explains that the confusion arises from whether the findings show benefit in one of the two treatment arms can be vitals in approval. The company explains that the analysts were pre-specified for the successful treatment arms in the protocol, and it happened before unblinding.
Therefore this implies that the data from the treatment arm can supper an application for FDA approval. But, most importantly, the company now has encouraging five-year survival data without any safety issues, and the company will use the data to seek FDA approval.
CEL-SCI to use data from radiation and surgery arm to file for FDA approval
CEL-SCI released phase 3 study results on June 28, 2021, showing that Multikine achieved all the necessary protocol benefits highlighted in the treatment arm of patients receiving radiation and surgery as standard therapies. As a result, the company plans to file for FDA approval to use Multikine in advanced primary head and neck cancer treatment.
In the letter, the company said that there had been misinterpretation and false assertions published by parties that didn’t understand the statistical analysis and protocol to manipulate the stock price. Among the false assertion peddled was that CEL-SCO couldn’t use the radiation and surgery treatment arm, despite being pre-specified, in filing for FDA approval which is incorrect and false.