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Author Topic: Second-generation of CCR5 antagonist and NNRTI  (Read 1853 times)

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Offline John2038

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Second-generation of CCR5 antagonist and NNRTI
« on: February 07, 2008, 02:03:22 PM »
Thursday, February 07, 2008; Posted: 12:49 AM

Pfizer on Wednesday announced that the Phase I studies on two investigational second-generation compounds, a CCR5 antagonist and a non-nucleoside reverse transcriptase inhibitor, or NNRTI, demonstrated potential advances in the treatment of HIV that has become resistant to currently available therapies. The drug maker also noted that the ongoing Phase III trial on its first-in-class drug, Selzentry, strengthens its sustained efficacy and tolerability in treatment-experienced adults infected with CCR5-tropic HIV-1.

Selzentry, or maraviroc, also known as Celsentri outside U.S., was approved last year for use in treatment-experienced HIV patients infected with a certain type of HIV. In the U.S., Selzentry is indicated for combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 detectable, who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents.

The New York-based company noted that the new data from the study on PF-232,798, a second-generation CCR5 antagonist, suggested that the particular molecule was well tolerated in healthy volunteers with a dosing profile that holds the potential for once daily administration. Preclinical data on the molecule demonstrated its activity against a broad spectrum of HIV-1 subtypes with similar in vitro potency to Selzentry, as well as activity against isolates of HIV that showed resistance to Selzentry.

New data on the UK 453,061 molecule further characterized its profile in combination with other commonly used HIV medicines. This molecule is a second-generation NNRTI that has demonstrated in vitro activity against a variety of HIV-1 subtypes, including strains resistant to first-generation NNRTI treatments.

Additional data from the ongoing study on Selzentry strengthens its sustained efficacy and tolerability in treatment-experienced adults infected with CCR5-tropic HIV-1. A combined 48-week analysis of the MOTIVATE 1 and 2 trials shows that nearly three times as many patients receiving Selzentry, in addition to an optimized background regimen, achieved undetectable levels of virus compared with those receiving an optimized regimen alone.

Further, a subanalysis from the 48-week results of the MERIT trial, which was conducted in treatment-na´ve patients, suggested that Selzentry may have minimal impact on lipid profiles and is, at least, lipid neutral compared with efavirenz in this patient population.

The company reported that patients put on Selzentry treatment, although did not exhibit overall increase in serious liver function test abnormalities, reported hepatotoxicity with its use. There was also evidence of the occurrence of a systemic allergic reaction, e.g., pruritic rash, eosinophilia or elevated IgE, prior to hepatotoxicity development, the company added.

Martin Mackay, president of Pfizer Global Research and Development, said, "Viral resistance is a major issue in treating HIV. This past year, the community welcomed breakthrough therapies, including Selzentry, that are giving patients infected with resistant virus new hope of controlling this disease."

Offline John2038

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Re: Second-generation of CCR5 antagonist and NNRTI
« Reply #1 on: February 07, 2008, 02:27:58 PM »
For info (not related, but just to avoid to open another thread)

Bristol-Myers Reports Positive Results From HIV Study

2/6/2008 6:16:42 PM Bristol-Myers Squibb Company (BMY) announced results from the CASTLE study, in which 300 mg of once-daily REYATAZ taken with 100 mg of ritonavir showed similar antiviral efficacy to twice-daily lopinavir 400 mg and ritonavir 100 mg in previously untreated adult HIV-1 infected patients at 48 weeks, as part of HIV combination therapy.

In this study, 78% of the 440 patients in the REYATAZ/r arm met the primary endpoint of achieving undetectable viral load at 48 weeks, compared to 76% of the 443 patients in the lopinavir/r arm.


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