Frontier Biotechnologies Co. received official approval from the China State Food and Drug Administration for initiating a Phase I trial of Albuvirtide in China on March 16, 2008.
Albuvirtide belongs to a new class of drugs known as viral entry inhibitors. This drug targets gp-41, a viral protein that serves as a portal of entry of healthy cells by HIV, the virus that causes AIDS. The Phase I trial, to be performed in Beijing, is designed to evaluate the tolerability, pharmacokinetics, and antiviral activity of Albuvirtide in HIV-infected patients.
"Current AIDS drugs are limited by emergence of multi-drug resistant viruses, significant side effects, and complicated treatment regimens. These problems are amplified in China as the most newly approved and more efficacious drugs distributed in the U.S. and Europe are not yet available in China," said Dr. Dong Xie, Chairman and Chief Scientific Officer of Frontier Biotechnologies. "Albuvirtide is an HIV entry inhibitor that shows potent and broad-spectrum anti-HIV activity. In the laboratory, it exhibits a good safety profile and allows a potential regimen of one administration every two weeks in humans. If proven in the Phase I trial, the drug can significantly improve the quality of life of patients, and reduce the cost of treatment."
Frontier Biotechnologies Co. is a US biopharmaceutical company with operations in Chongqing, China which focuses on the development and commercialization of innovative peptide-based drugs to treat infectious diseases.
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