Multikine®’s uses, efficacy and clinical trial status

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The first indication being pursued for Multikine®: Multikine® is currently being developed as first-line therapy for advanced primary head and neck cancer. This is a deadly cancer in which there is a clear unmet medical need.

The recurrence rate is high and about one out of every two patients die within three years. Currently used therapies (surgery followed by radiation, chemotherapy or radio-chemotherapy) fail to completely arrest the disease because they are unable to completely remove or kill all of the cancer cells. The persistence of these residual cells is responsible for the cancer’s recurrence or metastasis.

Multikine® is injected five times a week for three weeks around the tumor (peri-tumorally) as well as in the vicinity of the local lymph nodes (peri-lymphatically) prior to the patient’s tumor being removed surgically and the patient receiving any other therapy because these are the areas in which the cancer will recur and from which metastases will develop.

Multikine® unleashes and then harnesses and enhances the immune system’s ability to target and kill those tumor cells before they can cause recurrence or metastasize. Multiple indications will be pursued over time; it is the same principle for different cancers. Multikine® unleashes and empowers the immune system to mount a specific targeted anti-tumor immune response against the specific individual tumor within each patient treated with it.

The underlying principle for Multikine®’s mode of action will likely make it applicable for treating many other solid tumors and not just head and neck cancer.
Multikine® has already shown biological activity (in early clinical trials) in cervical dysplasia / neoplasia (pre-cancer and cancer of the cervix) and prostate cancer.

Other indications that will likely be pursued for Multikine® are breast cancer, skin cancer, cervical cancer, melanoma and enhancement of chemotherapy and radiation. Enhancement of chemotherapy and radiation is a particularly important indication because it may lead to an ability to reduce the amounts of radiation and chemotherapy given to patients.

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Efficacy seen in clinical trials conducted with Multikine®:


	•	33% improvement in median overall survival: In Phase II studies an impressive 33% improvement in median overall survival at a median of 3.5 years post surgery was seen in patients with locally advanced disease treated with Multikine® as first-line therapy (absolute survival rate 63%) over the 3.5 year median overall survival rates of the same cancer patient population determined from a review of 55 clinical trials reported in the scientific literature that were conducted between 1987 and 2007. To put this in context, most cancer blockbusters have been approved on a 10% increase in overall survival, so a 33% improvement over what can be expected from the current therapy is considered extraordinary. CEL-SCI’s Phase III clinical trial will need to demonstrate a 10% improvement in overall survival for Multikine® to be successful.

	•	Average of 50% reduction in tumor cells: The 3 week Multikine® treatment regimen used in Phase II studies killed, on average, about half of the cancer cells before the start of standard therapy like surgery, radiation and chemotherapy.

	•	12% complete response: In 12 % of patients the tumor was completely eliminated after only a 3 week treatment with Multikine® (as determined by histopathology).

	•	8% increase in the Local Regional Control (LRC): At 24 months follow-up after surgical resection of the tumor, patients treated with Multikine® had an 8% better LRC rate than the 2 year median LRC rate reported in the scientific literature for the same cancer patient population in 55 clinical trials conducted between 1987 and 2007.

		All the data from the Multikine Clinical Trial point to improvement in Clinical Outcome for the Patients without toxicity

Multikine® is the first combination immunotherapy:
A new class of immunotherapy drugs

Multikine®
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