A Cure For HIV?
FDA Approves Maryland-Based American Gene Technologies (AGT) to Move Forward with Phase 1 Clinical Trial of HIV Cure Program
Compiled by Maria Lopez-Bernstein
More than 40 years ago, a different pandemic that would be called AIDS slowly emerged. While antiretroviral therapies and other treatments have changed the trajectory of the human immunodeficiency virus (HIV) that causes AIDS from the death sentence it once was, nearly 38 million people worldwide have been infected, and the world is still waiting for a cure. Today, we may be one step closer to that reality.
AGT Overview the HIV Cure Program at the Harvard Club, NYC
Maryland-based American Gene Technologies (AGT) believes there is a high likelihood that participants in the upcoming trial recently approved by the FDA will be cured by a “one-and-done” gene and cell therapy developed by the company over the last decade in their Rockville, Maryland laboratories.
"This is momentous news that we have FDA approval to launch Phase 1 and conduct our first human trials. We are beyond excited to reach this milestone. This brings us closer to our goal of transforming lives with genetic medicines,” said Chief Science Officer David Pauza, Ph.D. “Based on our successful commercial-scale product manufacturing runs and features of the product observed in our labs, this therapy has a high potential to be effective.”
AGT developed a new treatment to repair immune system damage done by HIV and allow natural responses to control the virus. From its research, AGT believes a cure is attainable and is now taking the significant step of testing in humans.
The AGT103-T cell product is made from a person’s own blood cells using an 11-day process that increases the HIV-fighting T cells and uses a gene therapy to help these cells survive in the body. The product demonstrates the ability to clear itself of HIV when challenged with the virus and HIV-infected human cells.
AGT Overview the HIV Cure Program at the Harvard Club, NYC
The first patient will be selected as soon as September in the Baltimore/DC area, with the initial trial sites being the Washington Health Institute, University of Maryland, Institute of Human Virology and Georgetown University. By the end of 2020, AGT may know if that patient is functionally cured, meaning that although HIV is not eradicated in the body, it is completely controlled where patients experience no symptoms and cannot transmit HIV to others.
Maryland ranked fifth of all U.S. states and territories in HIV diagnosis rates, with nearly 1,000 new cases in 2018 alone according to the Maryland State Department of Health. The Washington, D.C. metropolitan area, including Baltimore, is a hotspot for HIV/AIDS. The clinical trial sites in the metro area will test AGT’s new treatment in populations hardest hit by HIV.
The National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), one of the top HIV labs in the world, has independently verified AGT’s data in its own labs, validating the remarkable potency of the therapy and its promise for curing HIV.
In AGT’s therapy, the number of HIV specific immune cells protected and returned to the participants will be nearly 2000 times the number that was achieved in the previous clinical trial by Sangamo Therapeutics, Inc., whose trial was effective in 10% of the treated patients.
According to AGT founder and CEO Jeff Galvin, “I am confident AGT103-T will be an important step towards an eventual cure for HIV.”
This is good news for the estimated 1.2 million people in the U.S. and 38 million people worldwide who are living with HIV.
