Modified Tue, Oct 27, 2009 04:54 AM
UNC to test new flu drug
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close xA small number of patients at UNC Hospitals will be asked to test a new flu drug that has shown promise in treating severe cases but is still under investigation.
Even as the clinical trial is about to launch, the anti-viral drug, Peramivir, was given emergency clearance last week by the U.S. Food and Drug Administration for hospitalized patients who cannot take approved flu-fighters such as Tamiflu and Relenza.
Patients at UNC Hospitals will be able to get the drug if they need it, even if they do not choose to participate in the clinical trial.
Only about six patients will be enrolled in the trial at UNC, said Dr. Christopher Hurt, an infectious disease doctor and the site's principal investigator.
"It's a really funny spot we're in at the moment," Hurt said, noting that the FDA's emergency declaration expands the arsenal to fight severe illness, even as researchers work to prove that the intervention is safe and effective.
The drug -- developed by a company called BioCryst Pharmaceuticals, which has its management team based in Durham -- is close to government approval in Japan and has been through two rounds of clinical trials in the United States.
Peramivir works on the same principle as Tamiflu and Relenza, blocking an enzyme in flu viruses that enables them to flourish and spread, said Robert Bennett, executive director of business development and investor relations for BioCryst.
But it's delivered in an intravenous drip, so it is being developed solely for hospital settings. Tamiflu, by contrast, comes as a pill, and Relenza is a nasal spray. Both are available to patients through pharmacies as prescription drugs.
Hurt said the advantage of Peramivir is in severe situations, when patients are so sick they can't swallow pills or are on a respirator and cannot inhale a drug. In addition, he said, an intravenous route may prove quicker to enter the blood stream.
"If you're in an intensive care unit setting, no one would put you on an oral antibiotic," Hurt said. "You would want an intravenous antibiotic. That's where this IV form has its niche."
Bennett said the company has received at least $180 million in federal grants to develop the drug. The FDA put it on a fast track in 2006, as health leaders feared that a deadly strain of avian flu would become the next flu pandemic.
He said the two initial trials of the drug have shown it to be safe and effective, and those results formed the basis of the FDA's emergency use declaration Friday.
The current trial involving UNC Hospitals will test the drug as an add-on to the current anti-viral therapies. Those results will be compared to the outcomes of patients who get the current treatments and a sugar pill.
Hurt said more than 300 patients will be enrolled in the phase 3 trial internationally. Results are expected by 2011, and the company could then petition the FDA to approve the drug.
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