Cel-Sci stock darts upwards on clinical trial hope
- Cel-Sci has announced a small step forward for its Multikine leukocyte interleukin injection; it has now responded to the Food and Drug Administration's May 2017 communication about the clinical hold on its Phase 3 head and neck cancer study, initially put in place in September 2016.
- Following the FDA's most recent missive in May 2017, Cel-Sci has revised the "Dear Investigator" letter and the Investigator Brochure, based on very specific directions from the regulatory authority, and hopes that this will trigger the lifting of the clinical hold.
- Getting Multikine to the market is proving to be a long road for the company – the agent has been in clinical trials since 2003 or earlier.
Cel-Sci has to be a very patient company. Multikine is its only clinical stage project, and it has been in clinical trials since at least 2003, when the first data was published. In the 13+ years since then the company has seen its stock price as high as $16.30 and as low at $0.06, but the news yesterday has triggered an almost 30% climb up to $0.10. Not huge, but more hopeful that it has been for the struggling biotech, which has seen at 79% drop in its stock value over the last year.
"If the FDA finds the revisions made to the two documents to be satisfactory, Cel-Sci is hopeful that all of the clinical hold issues have now been addressed, and the FDA will consider lifting the clinical hold," the company said in a press release.
Multikine was in a Phase 3 trial in 928 patients with squamous cell carcinoma of the head and neck when, back in September 2016, the FDA asked Cel-Sci to put the study on partial hold. Following a Type A meeting with the FDA in February 2017, in April 2017 Cel-Sci filed a response, including an update to the investigator's brochure and the "Dear Investigator" letter.
However, in May 2017, the FDA said that the company hadn't resolved items raised in the October 2016 communications, and that there were new deficiencies in the April 2017 submission. The study was also deemed to be on full clinical hold at that point, not just partial, although already-recruited patients could still be treated. Multikine is also being assessed in early clinical trials in human papilloma virus (HPV) related disease, but this work is unaffected.
- Cel-Sci Statement
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