
As multiple HIV vaccines begin human trials, a Maryland biotech company's work on an HIV treatment moves forward as well with the FDA OK to expand human trials beyond one patient.
Rockville, MD's American Gene Technologies (AGT) announced earlier this month that it received unanimous approval from the U.S. Food and Drug Administration's Data and Safety Monitoring Board to continue human trials of its HIV/AIDS treatment, AGT103-T. The news comes as AGT revealed that the first patient to receive the AGT103-T treatment encoutered “no adverse side effects.”
AGT is now free to add more participants as it continues to test the efficacy and safety of the company's treatment in protecting human bodies from HIV infection. Trials have shown the therapy to be successful in stopping HIV infection in human cells in laboratory settings. According to the Washington Blade, AGT CEO Jeff Galvin stated that six more patients are scheduled to be added to the trials over the next weeks and months.
“If this works, they will be permanently immune from HIV,” Galvin said during a July 29 presentation at AGT headquarters. “Just think what this can do with the epidemic. We all have something to be excited about … keep your fingers crossed. Let's all keep hoping and praying.”
According to the company, AGT103-T treats HIV/AIDS by inducing “durable viral suppression” to HIV through “delivering therapeutic genes to the recipient's immune cells” that will help cells “survive attack by HIV and durably suppress the virus at undetectable levels.” If the treatment works as intended, it will usher in a new era of HIV/AIDS treatment that doesn't require the use of lifelong antiretroviral drugs.
“Since the late 1980s, antiretroviral drugs have prevented AIDS, HIV transmission, and mortality in persons living with HIV and, in some cases, have been used prophylactically to prevent new infections,” AGT said in a statement. “However, no approved treatments can cure HIV. AGT is committed to addressing this unmet medical need.”
The news comes as mRNA biotech research firm and Covid-19 vaccine developer Moderna prepares human trials of its mRNA HIV Vaccine. The University of Oxford is also enveloped in testing a separate HIV vaccine, HIVconsvX, in multiple European and African nations.
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