On April 23, 2013, CEL-SCI Corporation announced that the company hired two clinical research organizations, Aptiv Solutions and Ergomed, to manage the Multikine phase III study. Both CROs will help CEL-SCI expand the trial by 60 to 80 clinical sites globally. Aptiv Solutions and Ergomed have replaced the CRO currently managing the study.
Under a co-development agreement, Ergomed, which will be responsible for most of the new patient enrollment, will contribute up to $10 million towards the study. Ergomed will perform clinical services in exchange for milestone and royalty payments (single digit %) up to a specified maximum amount.
To date, the phase III trial has enrolled 117 patients at 39 centers in eight countries, including three centers in Israel, and nine centers in Taiwan.
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CEL-SCI Corporation (NYSE: CVM), headquartered in Vienna, Virginia, is a development stage biopharmaceutical company focused on unique immunotherapies that address unmet needs in significant patient populations.
In recent years, the company’s R&D has centered on immunotherapy for head and neck cancer, which now absorbs practically all of its R&D spending. Product development includes work on LEAPS (Ligand Epitope Antigen Presentation System) technology treatments for a range of influenzas and a vaccine against rheumatoid arthritis.
The company’s lead drug candidate, Multikine®, is a synthesized combination, non-specific immunotherapy currently being evaluated in a phase III study as neoadjuvant therapy for advanced primary (untreated) head and neck cancer.
Multikine is under study in a 48-center, 800+ subject phase III clinical trial that aims to demonstrate that it can, in combination with follow-on surgery, radiation and chemotherapy, reduce mortality in advanced head and neck cancer cases by 10%. The therapy aims to reduce mortality by eradicating micro-metastases, microscopic tumors that survive the therapy, are difficult to detect, and are arguably the underlying cause of disease recurrence.
Multikine has orphan drug status in the US.
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