CEL-SCI’s Phase 3 clinical trial, which is evaluating its experimental drugs Multikine for patients suffering from squamous cell cancer of the neck and head (SCCHN) recently was put in a partial clinical hold from the U.S. Food and Drug Administration. The company has since presented its case to the FDA in the hope that they will remove its partial clinical hold and allow patients to resume enrollment, as per the press announcement.
Multikine (Leukocyte Interleukin Injection), CEL-SCI’s leading treatment for investigation, is being developed to be a potential treatment of neck warts, cancers of the peri-anal region and cervical dysplasia (a precancerous disease) in patients who are co-infected with the human immunodeficiency virus (HIV) and the human HPV. (HPV). It is a specific mixture of small proteins known as cytokines, that stimulate robust immune responses. They are capable of activating both active and passive immune systems.
CEL-SCI is the first to seek Multikine approval as a alternative treatment in SCCHN patients. The reason for the administration prior to radiation, surgery or chemotherapy rests in the widely accepted notion that this is the time where the anti-tumor immune system is likely to be activated more fully.
The worldwide Phase 3 study ( NCT01265849) was designed to evaluate the efficacy and safety of Multikine and the standard of care treatment (surgery with radiotherapy followed by simultaneous radiochemotherapy) against standard of care for 880 patients with an advanced SCCHN. The primary goal of the study was survival overall, while other outcomes included progression-free survival local regional control, and the quality of quality of life.
As per the site of the company the website of the company, on August. 31st in 2016, CEL-SCI revealed that the total number of deaths during the study was less than expected, which means the study will be longer than anticipated to conclude.
To lessen the impact, CEL-SCI decided to extend the study to 1,273 patients, resulting in 1,146 patients able to be evaluated to allow for the trial to conclude in faster method. In accordance with the laws, CEL-SCI has submitted an amendment to its existing phase 3 protocols to authorities in the countries in which this Phase 3 study is currently being carried out.
The protocol change as well as it’s Phase three study have been put in a partial hold by the FDA stopping enrollment of patients. Participants who were already part of the study received Multikine as per the schedule.
Today, CEL-SCI is working to convince authorities at the FDA to remove the temporary clinical hold and allow enrollment to resume.
In light of the fact that Multikine is given the status of an orphan drug This Phase 3 study might be enough to have it approved as a treatment for more advanced primary SCCHN patients who haven’t had any other treatment.
Other potential clinical applications for Multikine are also being researched. A Phase 1 study that focuses on Multikine treatment in HIV/HPV co-infected females who suffer from cervical dysplasia was carried out at University of Maryland, showing promising efficacy and an acceptable safety assessment.
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