I think there was viral rebound in all the people. They are now trying to make changes to the trail protocol and start phase 2 where they start an ati quicker than they did in phase 1
em:
just received an email on this today
AGT Newsletter Graphics vol 16-2 Clinical Trial Progress Update American Gene Technologies® has recorded data that meets the primary and secondary endpoints of its AGT103-T Phase 1 trial. The Phase 1 trial demonstrated that AGT103-T — an autologous T cell product that has been modified with the AGT103 lentiviral vector for HIV resistance — was well-tolerated in humans and that these enhanced T cells persist in the body, ready to respond to HIV. Data from this first-in-human study of AGT103-T has been published in Frontiers.
Having collected data from the Phase 1 clinical trial, we expect to submit the final Phase 1 trial report to the U.S. Food and Drug Administration (FDA) in 2023. American Gene is currently writing the Phase 2 protocol for FDA consideration to continue the clinical development of this potential HIV cure.
Does not seem encouraging or optimistic data disclosure. If this had been major success I would think there would be more information. Potential cure meaning in need of money for research and lots of time to get real results toward a cure. Rather disappointing
Jim Allen:
--- Quote ---Does not seem encouraging or optimistic data disclosure. Potential cure meaning in need of money for research and lots of time to get real results toward a cure. Rather disappointing --- End quote ---
--- Quote ---was well-tolerated in humans --- End quote ---
With respect and not trying to sound harsh, but did you really expect much? You and I are not newbies to living with HIV, so we have heard the novel cure, new technology and approach speech a dozen times and more before during the Petri-dish stages and phase 1/2 human testing.
It's phase 1/2, making sure they don't kill the patients, and it sounds like it was well-tolerated, so they didn't kill anyone yet. As for the rest of the data, it's only a few weeks of interruption under a tiny sample of people. Even if AGT103-T gene therapy does nothing, you could have some people or all of them show no rebound under 4-5 months.
If it gets into phase 2 and then phase 3 by then, data might be more interesting.