|Clinical Study of Investigational LEAPS-H1N1 Treatment Will Take Place at Johns Hopkins University School of Medicine|
|By Staff and Wire Reports|
|Friday, 06 November 2009 03:00|
One of several expected key news developments has been announced by CEL-SCI Corporation (NYSE Amex: CVM), today. An Institutional Review Board of The Johns Hopkins University School of Medicine (Johns Hopkins) has given clearance for the Company's first clinical study involving the much talked about L.E.A.P.S.™ H1N1 investigational therapy.
Johns Hopkins will host the study, which will be led by Principal Investigator Jonathan M. Zenilman, MD, Professor of Medicine, Johns Hopkins School of Medicine and Chief of Infectious Diseases Division, Johns Hopkins Bayview Medical Center. As previously announced, this initial study will involve taking blood from hospitalized, laboratory-confirmed H1N1 patients and activating their cells with the LEAPS H1N1 investigational therapy in order to assess the cells' response as the basis for the planned future treatment of this patient population under a next-stage clinical trial protocol.
In the case of CEL-SCI's investigational LEAPS-H1N1 treatment, this involves non-changing regions of the H1N1 Pandemic Flu as well as the Avian Flu (H5N1), and the Spanish Flu.
"We are pleased that such a prestigious medical center has given clearance to proceed with this first study of our LEAPS-H1N1 treatment," said Geert Kersten, CEL-SCI's Chief Executive Officer. "Given the nature and severity of the virus, we are working diligently with our CRO and Johns Hopkins, and actively preparing submissions to the FDA, to support the fastest and most effective way to conduct clinical trials going forward for this unique investigational treatment."
In September, the company announced that the FDA had indicated that they could commence this study and scientists at the company have been working hard on various aspects of what is expected to be the first of several upcoming expedited steps to get this treatment authorized and out to those hospitalized patients who desperately need it.
President Obama's national emergency declaration due to the H1N1 pandemic gave Health and Human Services Secretary Kathleen Sebelius the authority to bypass federal rules in order to get treatments like this one to patients who may need them. Most recently, the FDA announced emergency use authorization for BioCryst's intravenous peramivir, an investigational antiviral drug, for use in adult and pediatric patients, even though the drug had not completed all of the normal steps required for approval. In fact, the drug is not technically yet approved by the FDA. Emergency use authorization for the product will last until the emergency declaration is terminated or until the FDA revokes the privilege.
"Many millions" of Americans have had swine flu so far, according to CDC Director Dr. Thomas Frieden and the number is growing, causing many hospitals to overflow with sick patients. “Vaccine production is much less predictable then we wish. We are nowhere near where we thought we’d be by now,” Friedan said. “As public health professionals, vaccination is our strongest tool. Not having enough of it is frustrating to all of us.”
As reported months ago, the growing pandemic of H1N1 has had members of the Obama administration working behind the scenes for months trying to keep the problem from cripling an already fragile economy.
This news has made the company the biotech sector's intraday top performer as of the time of this publication: