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CEL-SCI to Pursue Canada’s Conditional Approval Pathway for Multikine in the Treatment of Head & Neck Cancer
Follows pre-submission meeting with Canada’s regulator Health Canada
Plans to pursue marketing approval in other countries while preparing its BLA application for U.S. FDA
CEL-SCI Corporation (NYSE American: CVM) today announced it has held a productive pre-submission meeting with Canada’s regulator to determine the best regulatory path toward market approval. Based on the existing data that was summarized and presented, Health Canada advised CEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions policy. Additional discussions explored how patients at lower risk for recurrence could be targeted for treatment, and what sort of post-market commitments could help ensure that only the most suitable patients would be treated with Multikine®* (Leukocyte Interleukin Injection), based on the best available evidence.
“The Notice of Compliance with Conditions” policy facilitates earlier access for physicians and patients to promising new drugs for patients suffering from serious, life-threatening or severely debilitating diseases. Acceptance of promising evidence of clinical effectiveness of Multikine as an initial therapy for patients with advanced primary head and neck cancer would allow for the filing of an eligible drug submission earlier than normally possible because it promises to fulfil an unmet medical need,” stated CEL-SCI CEO, Geert Kersten. “We continue to prepare our Biologics License Application for U.S. FDA approval, while also pursuing marketing approval in other countries.”
Canada was one of over 20 countries in which CEL-SCI’s global pivotal Phase 3 IT-MATTERS study enrolled a total of 928 head and neck cancer patients (locally advanced primary squamous cell carcinoma of the head and neck (SCCHN)). The IT-MATTERS study was designed to determine if Multikine was safe and provided survival and other clinical benefits.
Multikine is the first investigational cancer immunotherapy developed as a first-line neo-adjuvant treatment to be provided to previously untreated locally advanced primary disease SCCHN patients before they receive surgery. As demonstrated in the IT-MATTERS study, Multikine is the first of its kind with substantial survival benefit in a randomized Phase 3 trial in locally advanced primary SCCHN. Patients receiving Multikine for 3 weeks prior to surgery and radiotherapy (deemed at lower risk for recurrence per NCCN Guidelines) showed the following advantages over lower risk for recurrence control who had the same treatment, but did not get Multikine:
A median overall survival improvement of 46.5 months—nearly four years
62.7% of Multikine patients were alive after five years vs. 48.6% in the control group
Nearly 1 of every 6 patients had their tumors shrink by more than 30% in just 3 weeks prior to surgery vs. no reported tumor shrinkage in the control group
5 patients treated with Multikine had their tumors completely disappear in just 3 weeks
Tumor shrinkage/disappearance in 3 weeks significantly reduced the death rate
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the IT-MATTERS’ Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine first, BEFORE they received surgery and radiotherapy or surgery plus concurrent radiotherapy and chemotherapy (the current standard of care for these patients). This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of locally advanced primary head and neck cancer.
Multikine is designed to help the immune system “target” the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. The Phase 3 study was started in early 2011 and was fully enrolled with 928 patients in September 2016. To test for an overall survival benefit, the study required CEL-SCI to wait until at least 298 (deaths) events had occurred among the two main comparator groups.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
