Phase III Clinical Trial Monthly Enrollment Chart
Number of Patients Enrolled per month since the transfer to the new CROs.
THE CEL-SCI STORY
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system.
CEL-SCI's lead investigational therapy, Multikine® (Leukocyte Interleukin, Injection), is an immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. Data from Phase I and Phase II clinical trials suggest that Multikine simulates the activities of a healthy person's immune system, enabling it to use the body's own anti-tumor immune response. 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*.
Multikine has been cleared by the regulators in 12 countries around the world, including the U.S., for a global Phase III clinical trial in advanced primary (not yet treated) head and neck cancer patients. This trial is expected to be the largest head and neck cancer clinical study ever conducted. The following is a brief summary of the key operational successes:
- The first and second interim review of the safety data from the Phase III study of Multikine by an Independent Data Monitoring Committee (IDMC) has raised no safety concerns. The IDMC also indicated that no safety signals were found that would call into question the benefit/risk of continuing the study.
- 86 clinical sites in 24 countries on three continents participate in the global Phase III study.
- Patients have been enrolled in the study on all three continents (North America, Europe and Asia).
- Our partners Teva Pharmaceuticals Industries (Israel) and Orient Europharma (Taiwan) have enrolled patients in their respective territories.
- We have produced multiple lots of Multikine in our manufacturing facility near Baltimore, Maryland, USA and provided drug in sufficient amounts at all clinical sites.
It is also thought to be the first Phase III study in the world in which immunotherapy is given to cancer patients first, i.e. prior to their receiving any conventional treatment for cancer, including surgery, radiation and/or chemotherapy. This could be shown to be important because conventional therapy may weaken the immune system, and may compromise the potential effect of immunotherapy. Because Multikine is given before conventional cancer therapy, when the immune system may be more intact, we believe the possibility exists for it to have a greater potential likelihood of activating an anti-tumor immune response under these conditions. This potential is one of the clinical aspects being evaluated in the ongoing global Phase III clinical trial. Read more about our trial
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: Multikine is a defined mixture of cytokines; it is a combination immunotherapy, possessing both active and passive properties.
Phase I and II clinical trial data suggest that Multikine has the potential to directly affect/kill the tumor cells. These data also indicate that it appears to be able to activate the patient's own anti-tumor immune response. During the early investigational phase, in Phase I and Phase II clinical trials in a total of over 220 subjects who received the investigational therapy Multikine in (daily) doses of 200 to 3200 IU as IL-2 (over 2-3 weeks in Phase II and up to a few months in early-Phase I), no serious adverse events were reported (by the clinical investigators) as being expressly due to administration of this investigational therapy Multikine. Adverse events which were reported included pain at the injection site, local minor bleeding and edema at the injection site, diarrhea, headache, nausea, and constipation. No "abnormal" laboratory results were reported following Multikine treatment - other than those commonly seen by treating physicians in this patient population - regardless of Multikine administration. Similarly, in these early-phase clinical studies in patients, there was no reported increased toxicity of follow-on treatments as a result of Multikine administration. No complications following surgery (such as increased time for wound healing) were reported. No definitive conclusions can be drawn from these data about the safety or efficacy profile of this investigational therapy, and further research is required and the global Phase III study is ongoing in an effort to confirm these results. Currently, Multikine has not yet 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.
Multikine is manufactured in CEL-SCI's state-of-the-art "Cold-Fill" manufacturing facility outside of Baltimore. Read more about the investigational therapy Multikine.
CEL-SCI's other investigational immunotherapy products (L.E.A.P.S.(TM)** conjugates) are currently in various stages of development, primarily at the pre-clinical stage (in animal studies). These preclinical products/therapies have been shown to protect animals from infection or disease by a number of viruses and parasitic agents. In animal models of the disease, CEL-2000 has shown promise for development as a therapeutic vaccine for rheumatoid arthritis. The potential of CEL-1000, another product candidate, to provide protection prior to an unanticipated exposure to unknown infectious agents makes it particularly suitable for research and development as a possible bio-defense agent, or for potential use in protecting individuals at very high risk of unknown infections. Further preclinical research and development is required to elucidate the way these compounds work and is currently ongoing.
* 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.
** L.E.A.P.S. is the trademark of CEL-SCI for this investigational platform technology, and this proprietary name is subject to FDA review. No L.E.A.P.S. product has been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans. The safety or efficacy of these products has not been established for any use. Lastly, no definitive conclusions can be drawn from these early-phase, preclinical-trials data involving these investigational products.