Cancer - The Investigational Therapy Multikine« (Leukocyte Interleukin, Injection)
Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this page as Multikine*.
CEL-SCI's lead investigational therapy Multikine is currently being developed as a potential therapeutic agent directed at using the immune system to produce an anti-tumor immune response. Data from Phase I and Phase II clinical trials suggest that Multikine may simulate a healthy person's immune system, enabling it to use the body's own anti-tumor immune response. If it were to be approved for use following completion of our clinical development program, Multikine would be a different kind of therapy in the fight against cancer: one that is designed with the intent to employ our body's natural ability to fight tumors. CEL-SCI is currently conducting a large Phase III clinical study with Multikine in head and neck cancer patients with advanced disease who are treatment na´ve (i.e., have received no prior treatment).
On September 26, 2016, CEL-SCI received verbal notice from the FDA that the Phase 3 clinical trial has been placed on clinical hold. On October 21, 2016, CEL-SCI issued a press release stating that, "following up on our press release issued on September 26, 2016, we have received the Partial Clinical Hold letter from the FDA. CEL-SCI is working on a response to the FDA and will work diligently with the FDA to seek to have the partial clinical hold lifted." Updated information on the partial clinical hold is available on CEL-SCI's Form 8-K filed with the SEC on December 22, 2016.
The current standard of care for initial treatment of these patients according to the NCCN guidelines (published by the National Comprehensive Cancer Network) is surgery followed by radiotherapy or surgery followed by combined radiochemotherapy - depending on pathology assessment of the resected tumor following surgery. In CEL-SCI's ongoing study, Multikine is administered to patients before these other treatments are given. At the completion of CEL-SCI's clinical development program, if the results indicate that this investigational therapy met its pre-specified endpoints, a Biologics License Application will be prepared and submitted to the FDA by CEL-SCI.
Multikine has the potential to be the first of a new class of cancer immunotherapy drugs. It is thought to be the first known combination immunotherapy, possessing both active and passive properties.
Multikine is designed to directly affect both the tumor cells themselves and activate an anti-tumor immune response. Read more about Multikine
CEL-SCI's business strategy is to create genuinely new and innovative therapies that meet unmet medical needs, as opposed to minor innovations to existing therapies or 'me-too' products.
In order to truly understand the potential for Multikine to be an innovative immunotherapy product, we invite you to read a brief summary of the field of cancer immunotherapy, which briefly summarizes the different therapies in this field.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or by any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data summarized on this page or elsewhere on this website involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently on Partial Clinical Hold by the US FDA.