Peramivir's Authorization May Signal Rush of Additional H1N1 Experimental Treatments
Written by Peter DePalma
Monday, 02 November 2009 15:38
The Food and Drug Administration (FDA) today officially announced the issuance of an Emergency Use Authorization (EUA) for BioCryst Pharmaceuticals, Inc's (NASDAQ:BCRX) peramivir for intravenous (IV) administration in certain adult and pediatric patients.
But the director of the FDA's division of antiviral products is urging caution in the use of a new flu drug that just won special permission to fight H1N1, according to a report from Mike Huckman of CNBC.
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In an Op-Ed piece in "The New England Journal of Medicine" the FDA's Dr. Debra Birnkrant writes that "alternatives should be considered."
Dr. Birnkrant points out that peramivir remains formally unapproved and adds, "No conclusions about efficacy can be drawn" from previous studies of peramivir on the seasonal flu. "There are very limited data available regarding the use of peramivir in seriously ill hospitalized patients."
While Peramivir is not approved, the FDA is issuing the Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of peramivir.
Peramivir is one of three flu-fighting drugs available to combat H1N1, but is the only IV treatment.
Tamiflu (oseltamivir phosphate) is available as capsules and as a powder for oral suspension. RELENZA is for administration to the respiratory tract by oral inhalation only.
Vienna, Virginia based Cel-Sci (AmexVM), is developing a novel H1N1 program directed at helping very sick patients infected with H1N1. Unofficially, those familiar with the accelerated program report that a great deal of positive progress has been made. The company's new drug is based on CEL-SCI’s L.E.A.P.S.™ (Ligand Epitope Antigen Presentation System) technology which allows them to direct an immune response against a specific disease epitope, in this case non-changing regions of H1N1. This would make it the only drug designed to avoid the problem of cytokine storm which is very much involved in the death of most H1N1 patients. When contacted for a comment, officials said CEL-SCI expects to make formal updated announcements on the program very soon.
Given the nature of the pandemic, it is not unrealistic to expect that other novel drugs could be rushed through human trials and approved for use since the public health emergency involving Swine Influenza has the significant potential to affect national security, according to documents released to the news media by the FDA on Monday. The basis of such determination justified the authorization of the emergency use of Peramivir, subject to the terms of any authorization issued under the act.
News expectations make CVM a tempting "buy"
Tuesday November 3, 2009 6:17 AM PST
By M.E. Garza
Vinny Cassano is a contributor at BioMedReports and authors the popular blog VFC's Stock House here he shares his thoughts wiith us on CVM.
The saga of Cel Sci continues, but I couldn't resist adding shares at eighty seven cents on Monday as the stock continued to slide. No news has been released to justify the recent price action, yet with so much possible news pending over the short to mid term, I couldn't help but add to my position of the stock near the low of the day.
Over the years I have accumulated CVM with strictly a long term outlook, but the lower the stock slides, then it becomes a decent short term play as well.
According to an article about BiCryst's Peramavir released on Monday, officials at Cel Sci will release an update on the H1N1 LEAPS program "very soon", and many longs of the stock have been 'long' awaiting an update. There are impatient investors out there who want to see the company respond to the day to day action of the stock price, but I'm the type that doesn't believe should issue news unless it's 'quality' news; meaning no fluff.
Remember, earlier this year I thought that Cel Sci was issuing some 'fluff' with the early swine flu PRs, but the one PR that indicated that the FDA had cleared the company to conduct some initial testing is the one that validated the 'LEAPS to potentially treat H1N1' platform, in my opinion.
Additional news that should be released within the next couple of months regarding Cel Sci is the validation of the Baltimore area facility and the commencement of the Multikine Phase III trial.
It's tough to predict day to day price action in a stock that is being played such as CVM, but I'm sure of one thing - the lower this one goes, then the more that I will buy.
My ultimate horizon for investing in CVM is for the long term - to see how Multikine plays out - but there's enough potential news that could hit the wires over the short term that the impatient investor could also be quickly satisfied.
CEL-SCI Corp. (CVM) - Shares of CVM spiked back over $1.00 on no news Tuesday. I am watching the 10 day moving average at $1.18 and the 50 day moving average located at $1.24. A close over these two levels would be bullish. I would then be placing a stop at $1.17.
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发表于 2-11-2009 09:48 PM
VM), is developing a novel H1N1 program directed at helping very sick patients infected with H1N1. Unofficially, those familiar with the accelerated program report that a great deal of positive progress has been made. The company's new drug is based on CEL-SCI’s L.E.A.P.S.™ (Ligand Epitope Antigen Presentation System) technology which allows them to direct an immune response against a specific disease epitope, in this case non-changing regions of H1N1. This would make it the only drug designed to avoid the problem of cytokine storm which is very much involved in the death of most H1N1 patients. When contacted for a comment, officials said CEL-SCI expects to make formal updated announcements on the program very soon.
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