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Incyte Begins Phase I Study of New HIV Drug in Healthy Volunteers
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WILMINGTON, Del.--(BUSINESS WIRE)--May 10, 2006--Incyte Corporation (Nasdaq:INCY) today announced that it has initiated a Phase I clinical trial of INCB9471, a new orally available CCR5 antagonist that is being developed as a treatment for patients infected with human immunodeficiency virus (HIV-1), the retrovirus that causes acquired immune deficiency syndrome. CCR5 antagonists are a new class of antiretroviral compounds that have been shown to block entry of the HIV virus into the cell, unlike nearly all of the existing HIV drugs that prevent viral replication within the cell. Because these compounds act through a different mechanism, they are active against strains of the virus that are resistant to currently used HIV treatments.
The Phase I trial is a double-blind, placebo-controlled, single rising dose study designed to assess the safety and pharmacokinetics of INCB9471 in healthy volunteers. A Phase I multiple dose study, also in healthy volunteers, is expected to begin in July. A Phase IIa trial involving HIV patients is scheduled to initiate later this year.
INCB9471 is a proprietary oral compound that in preclinical studies has shown potent anti-viral activity as well as excellent pharmacokinetic properties that are consistent with convenient once-daily dosing as part of a HAART regimen.
About CCR5 Antagonists
Chemokine receptors expressed on the surface of immune cells are known to play a critical role in HIV infection and transmission. Antagonists of these receptors act differently than other classes of HIV drugs by preventing HIV from entering and infecting cells, rather than trying to eradicate HIV after the virus has already infected a cell. CCR5 and CXCR4 receptors act with the CD4 receptor on the surface of T cells to facilitate entry of HIV into cells. Previous research has suggested that individuals who lack a functional CCR5 receptor are largely resistant to HIV infection. Additionally, patients who have acquired HIV and have only one normal copy of the CCR5 gene frequently have a slower rate of progression of HIV disease. As a result, the CCR5 receptor has been a target of investigation for the development of new anti-HIV therapies.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based drug discovery and development company with a growing pipeline of oral compounds to treat oncology, inflammation, HIV and diabetes.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including the expected utility of Incyte's CCR5 antagonist compound INCB9471, and the expected plans and timing for Phase I and Phase IIa trials for INCB9471, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the results of further research and development, the risk that results of clinical trials may be unsuccessful or insufficient to meet applicable development and regulatory standards, the high degree of risk associated with drug development, the ability of Incyte to compete against parties with greater financial or other resources and other risks detailed from time to time in Incyte's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2006. Incyte disclaims any intent or obligation to update these forward-looking statements.
CONTACT: Incyte Corporation, Wilmington
Pamela M. Murphy, 302-498-6944
SOURCE: Incyte Corporation
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