- CEL-SCI on Monday hit pause on a Phase 3 clinical trial of a drug aimed at treating head and neck cancer at the request of the Food and Drug Administration, after verbal notice from the agency.
- The Vienna, VA-based company is testing the drug, called Multikine, a leukocyte interleukin injection, as a potential treatment for squamous cell carcinoma in the head and neck. The company is also testing the drug in cervical dysplasia in women co-infected with HIV and HPV, as well as for peri-anal warts in men and women co-infected with HIV and HPV.
- The drug has been in clinical testing for more than a decade, with the earliest data from Phase 1 trials published in 2003.
CEL-SCI did not reveal why the FDA placed a hold on the trials in a Sept. 26 statement. The company also did not make clear what affects the hold will have on Phase 1 clinical trials testing Multikine’s effect on cervical dysplasia. According to the website clinicaltrials.gov, a safety trial in peri-anal warts was previously terminated.
Interestingly, the company said in its statement that the FDA is allowing the roughly 926 patients already enrolled in the Phase 3 study to continue to receive treatment. Under FDA regulations, ongoing clinical investigations placed on hold may not recruit new patients to the study and must stop administering treatment to current patients unless otherwise advised by the agency.
Multikine is CEL-SCI’s only clinical-stage therapy. The drug is part of a rapidly growing immuno-oncology market, which develops therapeutics aimed at helping the body’s immune system fight cancer. The company has spent nearly $32 million on direct costs associated with Multikine’s Phase 3 clinical trials, according to its most recent quarterly filing with the Securities and Exchange Commission.
Following the announcement of the trial hold, CEL-SCI shares fell nearly 40%, from 44 cents per share to 27 cents per share, between close of market on Monday and Tuesday. Shares remained 27 cents per share as of mid-Wednesday. The company has a current market cap of $42.1 million.