BioCryst begins intravenous peramivir phase 1 trial as possible avian flu vaccine

By E. Janene Geiss

Philadelphia, March 9 - BioCryst Pharmaceuticals, Inc. announced Thursday that it has begun a phase 1 clinical trial of peramivir, the company's lead influenza neuraminidase inhibitor, to determine the pharmacokinetics and safety of single and multiple doses of an intravenous formulation of the drug in healthy volunteers.

This double-blind, randomized, dose-escalating study of peramivir is being conducted in association with the National Institute of Allergy and Infectious Diseases at the National Institutes of Health at the NIH Clinical Center in Bethesda, Md., according to a company news release.

Part of a new class of antiviral agents, peramivir works by inhibiting viral neuraminidase, an enzyme essential for the influenza virus to spread and infect its hosts.

The drug was designed to treat and prevent various types of flu and in laboratory tests has been shown to be a potent and selective inhibitor of influenza A and B neuraminidases, officials said.

Additionally, in preclinical studies, peramivir has shown encouraging activity against H5N1 avian influenza, leading researchers to believe that in the proper formulation, the drug may be effective against that virus, as well as against other life-threatening influenza strains that infect humans.

This open-label study is scheduled to enroll about 70 volunteers and consists of two parts, a single-dose safety and tolerability study and a multi-dose safety and tolerability study.

In the initial single-dose study, volunteers will receive either a placebo or a single dose infusion of peramivir ranging from 0.5 mg/kg to 5.0 mg/kg.

In the multi-dose safety and tolerability study, patients will receive one daily dose of either peramivir or a placebo for five consecutive days. The multi-dose study will use two of the doses selected from the single-dose study.

"These phase 1 studies are a precursor to further clinical studies we ... have planned for later this year. Those studies will examine peramivir in the treatment of influenza infected patients in Southeast Asia," Charles E. Bugg, chairman and chief executive officer of BioCryst, said in the release.

The influenza virus is a member of the orthomyxovirus family and causes an acute viral disease of the respiratory tract. Unlike the common cold and some other respiratory infections, seasonal flu can cause severe illness, resulting in life-threatening complications. According to the Centers for Disease Control and Prevention, every year in the United States more than 200,000 people are hospitalized from flu complications and about 36,000 people die from flu. Most at risk are young children, the elderly and people with seriously compromised immune systems.

H5N1 avian influenza is caused by a subtype of the influenza A virus. Circulating among birds worldwide, the virus is considered extremely contagious in birds. It is believed that all species of birds are susceptible to avian influenza, but domestic poultry, including chickens and turkeys, are among the most susceptible to the highly pathogenic strain. At least 175 people have contracted H5N1 avian influenza, of which 96 have died. Almost all of these infections have resulted from contact with infected poultry, officials said.

BioCryst is a Birmingham, Ala., biopharmaceutical company focused on the development of small-molecule pharmaceuticals to prevent, treat and control cancer, cardiovascular diseases and viral infections.

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