Vienna, VA -- (ReleaseWire) -- 03/04/2014 -- CEL-SCI Corporation 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). 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, we are 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.
“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,” stated CEL-SCI Chief Executive Officer Geert Kersten.
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 $10 million into the ongoing Phase III clinical trial. Ergomed will be repaid from future sales of Multikine, following regulatory approval.
Multikine (Leukocyte Interleukin, Injection) is an immunotherapeutic agent that is being tested in a randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer – one that appears to have the potential to work with the body's natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100-110 clinical centers in about 20 countries.
In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also announced that it entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.
About CEL-SCI Corporation 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. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit http://www.cel-sci.com.
* 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 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 in progress.
When used in this report, the words "intends," "believes," "anticipated", “plans” and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10- K for the year ended September 30, 2013. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.