La DSMB, organismo di controllo di sicurezza di tutti gli studi su maraviroc (anti-CCR5), molecola sviluppata dalla Pfizer, raccomanda la continuazione senza alcun cambiamento degli studi di fase III, dopo la riunione di aprile 2006.
Nessuna evidenza di epatotossicità, compreso nei pazienti che assumono tipranavir. Nessuna evidenza di forme tumorali, se non in linea con le percentuali di incidenza conosciute.
Questo il comunicato ufficiale:
Pfizer reported that the independent Data Safety Monitoring Board (DSMB) for maraviroc, Pfizer’s CCR5 antagonist in development for the treatment of HIV, met in April 2006 as part of their scheduled review of the phase 2b/3 development program. The maraviroc DSMB is an independent group that includes experts who specialize in the treatment of patients with HIV/AIDS. The ongoing review of data by the DSMB helps to ensure the safety of patients participating in the studies.
The clinical development program evaluating maraviroc for HIV/AIDS has enrolled more than 2000 patients representing more than 750 patient years of follow up observation that began in December 2004. The studies have been fully recruited and are closed to further enrollment.
Based on their April 2006 meeting the DSMB recommended that the four Phase 2b/3 clinical studies for the investigational drug continue as currently designed. The DSMB further reported that they continue to see no evidence of maraviroc associated hepatotoxicity, including those patients receiving concomitant tipranavir. Their review of HIV-associated malignancies such as Non-Hodgkin’s Lymphoma and Kaposi’s Sarcoma, observed within the maraviroc Phase 2b/3 development program, found the incidence to be consistent with known rates of these malignancies in similar HIV-infected populations.