Number of Patients Enrolled per month since the transfer to the new CROs.
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 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 simulates the activities of a healthy person's immune system, enabling it to use the body's own anti-tumor immune response. Multikine is the trademark we have registered for this investigational therapy, and this proprietary name is subject to review by the U.S. Food and Drug Administration, or FDA, in connection with our future anticipated regulatory submission for approval.
Twenty four Regulatory Agencies, including leading regulators in the U.S., Canada and the United Kingdom, have allowed Multikine to be studied in a global Phase 3 clinical trial as a potential neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck, or SCCHN. This trial is currently primarily under the management of two clinical research organizations, or CROs, ICON Inc. (who acquired Aptiv Solutions, Inc., one of the two CROs), or ICON, and Ergomed Clinical Research Limited, or Ergomed. Ergomed is responsible for new patient enrollment and the clinical study management of the various study sites, although enrollment of new patients has been on hold since the Company received verbal notice of FDA's Partial Clinical Hold on September 26, 2016. 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 following is a brief summary of the key operational successes:
- 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.
In our Phase 3 clinical trial, Multikine is administered to cancer patients 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. 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 likelihood of activating an anti-tumor immune response under these conditions than administering it after radiation and/or chemotherapy. This likelihood is one of the clinical aspects being evaluated in the ongoing global Phase 3 clinical trial. Read more about our trial
The current standard of care, or SOC, treatment regimen for patients with SCCHN consists of surgical resection of the tumor and involved lymph nodes, followed by either radiotherapy alone or radiotherapy and concurrent chemotherapy. Our ongoing Phase 3 trial is testing the hypothesis that Multikine treatment, administered prior to such SOC treatment regimen, will extend overall survival, enhance the local/regional control of the disease and reduce the rate of disease progression in patients with SCCHN. 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.
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. It would be designed to make the first cancer treatment more successful. 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. 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.
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 immunotherapy platform technology L.E.A.P.S.** (Ligand Epitope Antigen Presentation System), or LEAPS, currently has multiple investigational therapies 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, the LEAPS product candidate CEL-2000 has shown promise for development as a therapeutic vaccine for rheumatoid arthritis. In addition, CEL-SCI is developing another potential LEAPS product candidate, LEAPS-H1N1-DC, a potential treatment for H1N1 influenza in hospitalized patients. 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 on Partial Clinical Hold by the US FDA.
** No LEAPS investigational therapy 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.