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news.CEL-SCI has reported accelerating progress in patient enrollment in the Phase III head and neck cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (leukocyte interleukin, injection).
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Approximately 146 patients have been enrolled in the Phase III study to date.
Over the past three months, patient screening by participating hospitals and patient enrollment have steadily increased. In fact, the company even now seeing patient enrollment at centers that had not enrolled any patients under the prior Clinical Research Organization (CRO), inVentiv Health.
CEL-SCI expects to see a further increase in the number of patients enrolled in the study at an accelerating pace as (i) the current centers finalize all logistical issues and (ii) an additional 50-60 centers are added throughout the world. Full enrollment of the planned 880 patients is expected by the end of 2015.
Per the study’s protocol design, four out of every seven patients enrolled are randomized to treatment with Multikine followed by the current standard of care (SOC) treatment, which is surgery plus radiotherapy or surgery plus concurrent radiochemotherapy.
The remaining three patients receive SOC only – the control-treatment comparator group. In accordance with the protocol design, of the approximate 146 patients enrolled, an estimated 84 have already been dosed with Multikine.
The study’s Independent Data Monitoring Committee (IDMC), a committee of prominent physicians and scientists from around the world, already has completed two interim reviews of the unblinded trial data. Following each review, the IDMC concluded that the patient data raised no safety concerns and recommended that the Phase III study continue unmodified.
CEL-SCI CEO Geert Kersten said: "We are very pleased with the acceleration of our study and based on what we are told by our current CROs Ergomed and Aptiv Solutions, we believe that both patient accrual and the study will continue to advance at a faster pace in the coming months."
Most of the patient enrollment is under the control of Ergomed who has signed three co-development agreements for Multikine with CEL-SCI. The agreement concerning head and neck cancer calls for an investment by Ergomed of up to $10m into the ongoing Phase III clinical trial. Ergomed will be repaid from future sales of Multikine, following regulatory approval.