Maryland State Wire

American Gene Technologies issued the following announcement Nov. 9.

American Gene Technologies (AGT), a clinical-stage biotechnology company, announced that the independent Data Safety and Monitoring Board (DSMB) overseeing the trial of AGT’s HIV gene therapy found no serious adverse events (SAEs) from the treatment for the third patient and voted unanimously to allow AGT’s HIV cure program to continue at a faster pace, eliminating the requirement of DSMB reviews between each participant and moving to quarterly DSMB safety meetings. AGT and trial sites will monitor participants for any adverse events and report them to the DSMB, however, the pace of enrollment and treatment can be increased.

“This is a very exciting moment in our trial,” said AGT CEO Jeff Galvin. “With no serious adverse effects observed in the third participant, we’re seeing a verifiable trend in the data that gives reasonable confidence that the treatment has low risk of adverse events. Once three more participants are treated in November and December, we can start studying efficacy data. We expect to see objective markers from studies of treated participants’ blood tests by the end of the year, and hopefully will have a functionally cured patient by next summer.”

Designated as the RePAIR trial (Restore Potent Antiviral Immune Responses, NCT04561258), participants receive a single infusion of their own HIV-specific CD4 T cells after those cells were enriched and genetically modified to resist infection. Without any observed negative or adverse events, the DSMB has allowed the trial to continue without adjustments or delays.

Original source can be found here.

Source: American Gene Technologies