For Physicians

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*.

At CEL-SCI our mission is to improve the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system.

  • We strive to develop innovative investigational therapies that have the potential to address unmet medical needs.
  • We are tenacious, dedicated, long-term and "out-of-the-box" thinkers. We develop our investigational therapies using the most rigorous, scientific approaches to increase the potential for successful development and subsequent regulatory approval.
  • Our clinical trials strictly adhere to the international standards for Good Clinical Practices (GCPs).
  • The Investigational Products and clinical supplies are manufactured/supplied to GMP/ICH standards.

Our lead investigational therapy, Multikine, is the very first immunotherapeutic agent being developed as a first-line treatment for advanced primary head and neck cancer. Multikine has been cleared by regulators in 24 countries around the world, including the United States, for study in a global pivotal Phase III clinical trial in advanced primary (not yet treated) head and neck cancer patients. This trial the largest head and neck cancer clinical trial conducted is currently in the follow-up phase for gathering protocol clinical outcomes. In addition, the Phase III trial will also require the collection of an extensive amount of pathology data. It is expected that these data will provide a large amount of information that has the potential to be helpful to the head and neck cancer community world-wide.

The ongoing Multikine Phase III clinical trial is referred to as the "IT-MATTERS" trial. "IT-MATTERS" is an acronym for Immuno-Therapy Multikine Anti-Tumor Treatments.  The investigational therapy is given to patients shortly after diagnosis, ahead of surgery or any other cancer treatment.  If your patient has already undergone surgery, or any other treatment for his/her head and neck cancer, your patient will definitely not be eligible for the current IT-MATTERS Phase III clinical trial. Please note accrual for the Phase III Study has completed and at present the patients are in the follow-up phase of the protocol.

Nine-hundred twenty-eight (928) patients with previously untreated advanced primary squamous cell carcinoma of head and neck (oral cavity/soft palate) worldwide were enrolled in the IT MATTERS trial.  Enrollment is complete and patients are currently in follow up. It is an open-label, randomized, controlled multi-center study and with sites in about 100 centers in 24 countries on 3 continents. Read more about this trial.

Also see http://www.clinicaltrials.gov for the detailed IT-MATTERS trial description.
Physicians who participated in the IT-MATTERS trial had one of the following credentials:

  • Board certified head and neck surgeons in good standing with the knowledge, experience and skills to perform major head and neck procedures.
  • Board Certified Medical Oncologists or Radiation Oncologists who work in a group that treats these type of patients and have a certified head and neck surgeon on the team who is qualified to perform these operations (as above).

Investigators also had to be able to:

1. Speak English,
   
2. Obtain coverage from an Institutional Review Board (Human Ethics Committee),
   
3. Use email and have internet access,
   
4. Demonstrate the ability to maintain subjects in long-term follow-up,
   
5. Demonstrate they have an active practice to enable rapid patient enrollment.


General surgeons who are experienced in Head and Neck Cancer with an active Head and Neck Cancer practice were considered since they appropriately demonstrated basic knowledge of the clinical disorder under investigation, basic clinical skills required, and could follow the trial procedures and protocol.

Each Investigator had a suitably equipped clinical facility and sufficient administrative and other required staff that could support the study protocol. Clinical scientists, biostatisticians, or epidemiologists contributed to protocol development and conduct but were not study investigators.

 

* 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 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 in progress.