ABOVE: Photo via American Gene Technologies’ Facebook page.
American Gene Technologies, the Rockville, Md., biotech company, has announced that the first patient to receive its genetically engineered treatment therapy aimed at curing people of HIV/AIDS encountered no adverse side effects from the treatment.
In an Aug. 2 statement, AGT said that based on the data obtained from Patient One in its Phase 1 human trial of its HIV treatment called AGT103-T, the U.S. Food and Drug Administration’s Data and Safety Monitoring Board voted unanimously to allow AGT to continue its HIV cure program without modification.
“The AGT103-T pipeline is a therapy for treating HIV disease,” the company’s statement says. “The therapy is designed to induce durable viral suppression by delivering therapeutic genes to the recipient’s immune cells,” it says. “The resulting immune cells are expected to survive attack by HIV and durably suppress the virus at undetectable levels without the need for antiretroviral treatment.”
The thumbs up decision by the Data and Safety Monitoring Board allows the company to continue its clinical trial with more participants to further confirm the HIV treatment’s safety outcome. The next phase in the trials will be to determine the treatment’s effectiveness in fully protecting the human body from HIV.
“We have six more patients,” said AGT CEO Jeff Galvin in referring to the patients who will be tested for possible adverse side effects in the coming weeks. Galvin spoke at a July 29 gathering to celebrate the success of Patient One at AGT’s headquarters offices in Rockville.
“If this works, they will be permanently immune from HIV,” he said. “Just think what this can do with the epidemic. We all have something to be excited about,” he told the gathering of about 100 people.
“Keep your fingers crossed. Let’s all keep hoping and praying,” Galvin said. “We will know by the middle of next year,” he said, referring to when the human trials will likely determine whether the AGT103-T treatment, which has successfully stopped HIV from infecting human cells in laboratory experiments, will work just as effectively on people with HIV.
