HIV Clinical Trial Update American Gene Technologies® has completed our Phase 1 clinical trial and we are currently preparing to submit the final report to the FDA. In the meantime, we are designing the Phase 2 clinical trial protocol and working to identify manufacturers and trial sites. As we review the Phase 1 data with…

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…

Clinical Trial Progress Update The analytic treatment interruption (ATI) protocol is generating important immunological data.   We are currently gathering and analyzing data from five out of the seven clinical trial participants. It takes a full three months to collect and analyze data once each participant’s ATI begins. So we expect further announcements at the…

Exciting HIV Clinical Trial Update American Gene Technologies® HIV Cure Clinical Trial Enters Critical Phase: Withdrawing Participants from Antiretrovirals. “This is a critical step in our mission to cure HIV using gene therapy,” said American Gene Technologies CEO Jeff Galvin. “We’ll monitor participants carefully, and within the next few months, we’ll begin to know how…

HIV Program Treatment Withdrawal Safety and efficacy blood markers have been recorded in the Phase 1 human trial for AGT’s HIV cure. We expect the antiretroviral treatment withdrawal studies to start this quarter. Six patients have received our gene therapy infusion. None of them exhibited any serious adverse events (SAEs), and all their blood marker…

HIV Program Update Five for Five! American Gene Technologies (AGT) announced that it has reached another important milestone in its HIV cure program. Five participants were treated with AGT103-T and are stably engrafted with genetically modified cells.   Laboratory studies confirmed substantial increases in virus-specific T cells consistent with improved immunity against HIV in all…

HIV Program Update Enrolled First Cohort Since our last Newsletter, AGT has enrolled its first cohort of six participants in its Phase 1 study of AGT103-T against HIV. Updates on the RePAIR Clinical Trial (AGT103-T) Clinical Update [RePAIR = Restore Potent Antiviral Immune Responses] Video Summary by AGT’s Anisha Mannan, Sommar Nettles, and Kelly Huang…

We’ve achieved a number of significant milestones this quarter, including the Food and Drug Administration (FDA) clearance to begin Phase 1 of our HIV cure program. The excitement hasn’t only been within our walls; AGT has appeared in publications and news stories across the country. The AGT Team’s commitment to our mission to help patients has…

FDA Progress The Path to the Clinic For the HIV Cure This month, AGT saw tremendous progress with the FDA.  FDA time and attention to our project has seemed to increase while agency review responses to our submissions have narrowed to unambiguous guidance, helping the HIV cure enter clinical trials. The recent response from the…

A STELLAR 2019 Has Positioned AGT For A SPECTACULAR 2020. I wanted to take a moment to sum up a great year of progress and success at AGT and to talk about potential milestones and significant inflection points in 2020. I’m sure you are aware that we filed the IND (investigations new drug) application for our HIV…

AGT’s HIV cure program is nearing a major milestone: Investigational New Drug (IND) submission. The IND is the key document that reports the safety data the FDA requires prior to a human trial. If the document meets the expected criteria, AGT will be authorized to begin the phase I human trial. At this time, the…

In wrapping up the year, AGT was proud to be featured as a State of Maryland “Success Story” for its growth in Maryland and achievements in the gene and cell therapy industry. Watch The Video 2018 has been a great year for American Gene Technologies: it added four new patents to its $2.4 billion-valuated IP…