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 potential collaborators and partners, the response has been consistently enthusiastic to participate in the Phase 2. The analytic treatment interruption has already highlighted impressive viral suppression and immunological data for three out of the six participants who agreed to enroll from the Phase 1, and we are still collecting data on the other three participants. AGT plans to report more details this summer.
We expect to discuss the Phase 2 with the FDA this summer, and hope to initiate the trial this year. Pending FDA approval of the Phase 2, data-collection should complete late 2024 or early 2025.
In the News: Jeff Galvin Wins Life Sciences Voice Top Industry Leaders Award
We congratulate Jeff Galvin, CEO and founder of American Gene Technologies, on winning the Life Sciences Voice Top Industry Leaders Award. The award recognizes the most dynamic leaders in the life sciences industry, who are making the biggest impact in delivering transformation that is moving the industry forward.
“This is a wonderful honor, made possible thanks to the stellar collaboration and unwavering commitment of my talented colleagues and team members here at American Gene™. I am thrilled to receive this recognition for the work we have been doing using gene therapy to find cures for some of the world’s worst diseases.”
- Jeff Galvin
Women’s History Month: The Future is Written by Female Scientists – In Genetic Code
Our world has been revolutionized by biotechnologies powered by female scientists, and the results have reshaped industries from medicine to agriculture. The biological and biomedical sciences boast the highest concentration of women of all the scientific fields. For Women’s History Month, we’re shining a light on some of the women who have contributed world-altering work to the field. Despite these amazing achievements, women in STEM continue to face social and organizational challenges in their work. The extra effort, mental fortitude, and passion necessary to achieve greatness in the face of adversity is a testament to the powerful minds featured here.
In the Media: Principal Scientist, Gaspar Canepa, PhD, Featured in BioBuzz
In conversation with BioBuzz, AGT Principal Scientist Gaspar Canepa, discusses our phenylketonuria (PKU) program in-depth. He highlights what differentiates AGT's strategy to cure PKU. "AGT’s approach is unique because we’re using a lentiviral vector that integrates with the patient’s DNA, permanently fixing the problem at its source. Using a lentiviral vector is also important in the context of PKU because our livers grow as we age."
-Dr. Gaspar Canepa
BioBuzz Spotlight: Sabrina Campbell, AGT Lab Manager
With more than 30 years of expertise in a clinical lab environment, Sabrina Campbell manages the lab that helps fund AGT's cure pipelines. "Her exceptional skills are yielding financial rocket fuel to advanced genetic medicines, and her management style maintains the happiness and effectiveness of the lab’s staff. Local clinical labs provide the highest level of service to patients, which is why physicians partner with companies like AGT instead of the larger corporate labs."
The Cure Chronicles continues to shed light on the experiences of those living with HIV.
In the most recent episode, James Tison, a stand-up comedian, actor, HIV/LGBTQ+ advocate, and social media influencer, joins The Cure Chronicles for an inspiring conversation about educating others and reducing HIV stigma. Previous episodes feature Joseph Kibler, an actor, producer, writer, and HIV activist, Maria Mejia, a blogger, HIV advocate and activist, and Michael Fletcher, a passionate HIV advocate and Peer Advocate at “The Horizon Program''.
Catch Up on Episodes of The Cure Chronicles Below!