Clinical Study of Investigational LEAPS-H1N1 Treatment Will Take Place at Johns Hopkins University School of Medicine Print E-mail
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.

The initiation of CEL-SCI's rapidly-accelerated LEAPS-H1N1 clinical development program builds on CEL-SCI's pioneering work with its  L.E.A.P.S.™ technology in the context of H1N1. As previously discussed in this space by Dr. Daniel Zimmerman, inventor of the L.E.A.P.S.™ technology, the technology allows the Company to direct an immune response against specific disease epitopes. The technology's reach will go beyond the H1N1 space, into fields of treatment like rheumatoid arthritis since those responses can be designed to be directed at a great number of human diseases.

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.

In order for FDA to fully consider a next-stage clinical trial to evaluate LEAPS-H1N1 treatment of hospitalized 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.

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.

Investors, who have sent the stock price up on the news, apparently also view the news as a much needed credibility boost in light of recent attacks by a single columnist. Company lawyers are reportedly "taking steps to correct the misleading attacks designed to help short the stock each time positive news is announced."

Despite those attacks, shares of the company have risen dramatically in the past few months and that trend is expected to continue as the company moves forward on several fronts, including a pending launch of Phase III trials for Multikine®, CEL-SCI's flagship cancer immunotherapeutic agent, which is being developed as a first-line standard of care cancer treatment.

This news has made the company the biotech sector's intraday top performer as of the time of this publication:

Industry Top Performers

Intraday Price Performance % Change Market Cap
CEL-SCI CORP [CVM] +19.51% $152.5 M
ZymoGenetics, Inc. [ZGEN] +10.92% $354.2 M
Cardiovascular Systems, Inc. [CSII] +9.90% $56.1 M
INOVIO BIOMED CORP [INO] +9.82% $114.2 M
Obagi Medical Products, Inc. [OMPI] +7.74% $232.1 M


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