CEL-SCI Corporation (CEL-SCI) has initiated clinical study for hospitalised H1N1 patients at The Johns Hopkins University School of Medicine (Johns Hopkins). The study is being led by Principal Investigator, Jonathan Zenilman.
The initial study is expected to involve taking blood from 20 hospitalised, laboratory-confirmed H1N1 patients and activating their cells with the LEAPS-H1N1 investigational therapy. This is to assess the cells’ response as the basis for the planned future treatment of this patient population under a next-stage clinical trial protocol.
Reportedly, the study will involve taking blood from 20 healthy individuals not infected with H1N1 and activating their cells with the LEAPS-H1N1 investigational therapy to serve as a control for the patient group in the study.
The company said that the initiation of CEL-SCI’s rapidly-accelerated LEAPS-H1N1 clinical development program builds on CEL-SCI’s pioneering work with its LEAPS technology in the context of H1N1. CEL-SCI’s LEAPS (Ligand Epitope Antigen Presentation System) technology allows the company to direct an immune response against specific disease epitopes.
LEAPS technology is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize, non-recombinantly, proprietary immunogens. The technology combines a small peptide that activates the immune system with a small peptide from a disease-related protein, such as the H1N1 hemagglutinin molecule, to make an investigational product that induces defined immune responses.
In September, FDA had indicated that the company could commence this study. In order for FDA to fully consider a next-stage clinical trial to evaluate LEAPS-H1N1 treatment of hospitalised patients with laboratory-confirmed H1N1 Pandemic Flu under an Exploratory IND, FDA has asked CEL-SCI to submit a detailed follow-up regulatory filing with extensive additional data.
Geert Kersten, CEO of CEL-SCI, said: “We are pleased that we have been able to move so fast with this first study of our LEAPS-H1N1 treatment. As we move forward, we hope that our investigational immunotherapy can be shown to modulate patients’ immune responses to be effective without the cytokine storm that CEL-SCI’s scientists believe may be responsible for so many deaths.”