WHITEHOUSE STATION, N.J., Oct. 23, 2007 -
As previously reported, on September 21, 2007, Merck & Co., Inc, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the NIAID-funded HIV Vaccine Trials Network (HVTN) announced that vaccination in the STEP clinical trial of Merck's HIV vaccine candidate would be discontinued.See http://www.merck.com/newsroom/press_releases/
research_and_development/2007_0921.html.The decision was based on recommendations made by an independent Data and Safety Monitoring Board (DSMB) for the STEP trial, which concluded that the vaccine could neither prevent HIV infection nor reduce the amount of virus in those who became infected with HIV.
On Tuesday, October 23, the NIAID announced that the DSMB for the Phambili study, a second clinical trial being conducted in South Africa of the same vaccine candidate, recommended that vaccination and enrollment in the South Africa trial be permanently discontinued. For more information, please see the NIAID statement at: http://www3.niaid.nih.gov/news/newsreleases/2007/step_update.htm.
The Phambili DSMB also recommended that Phambili volunteers be told whether they received the vaccine or placebo, be strongly encouraged to return to study sites for protocol-related tests, and be counseled about the possibility that those who received the vaccine might have an increased susceptibility to HIV infections. STEP volunteers will also be counseled about this possibility, and discussions are underway to define the details of continued follow-up for STEP volunteers, including when STEP volunteers will be unblinded. Detailed analyses of the available data are being conducted, including analyses to better understand if there may be an increased susceptibility to HIV infection among those volunteers who received the vaccine. The vaccine itself does not cause HIV infection.
Merck, NIAID, Merck and HVTN are moving quickly to broadly disseminate the available information from STEP. The first detailed review of the STEP data will occur on November 7, 2007, at a special open scientific session of the HVTN in Seattle. Additional information about registering for this session will become available at www.hvtn.org.
Merck Forward-Looking Statement
This statement contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995.These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements.The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec.31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
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