CEL-SCI To Initiate First Clinical Study With Hospitalised H1N1 Infected Patients

The FDA has indicated that CEL-SCI can proceed with its first clinical trial to evaluate the effect of its investigational LEAPS-H1N1 treatment on the white blood cells of hospitalised H1N1 patients.

FDA has asked CEL-SCI to submit a detailed follow-up regulatory filing with extensive additional data. The company said that it is proceeding on an expedited basis with the substantial undertaking necessary to complete the next submission. CEL-SCI anticipates engaging in a detailed dialogue with FDA regarding the proposed LEAPS-H1N1 clinical-development program based upon this future filing.

Geert Kersten, CEO of CEL-SCI, said: “CEL-SCI recognises the importance of not only developing, but extensively testing an intervention that has the potential to treat Pandemic Flu. We appreciate the expedited review by the FDA of our initial submission, particularly given how much time and attention the expert scientists at FDA are directing to Pandemic Flu amidst all the other demands placed on the Agency in the course of fulfilling its critical public health mission.

“Moving forward, we also appreciate FDA’s willingness to consider CEL-SCI’s LEAPS-H1N1 clinical development program in detail on as expedited a basis as possible in the context of the evolving public health concerns posed by Pandemic Flu. As we prepare to initiate our first study, CEL-SCI expects to work closely with FDA and experts in the field in developing the necessary data and appropriate protocols to ensure that we rigorously meet the FDA regulatory requirements. We are all collectively trying to help those H1N1-infected patients who are at high risk of dying.”