Written by: Justin Hinton
MONTGOMERY COUNTY, Md. (ABC7) — A Montgomery County-based biotechnology company has announced it received approval from the FDA to begin human trials for its HIV cure program.
American Gene Technologies has been developing its program for 12 years. The company submitted their request to the FDA in October to begin human trials which are slated to start at the end of September or the beginning of October.
"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," Chief Science Officer David Pauza said in a news release. "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."
The company's work builds off of a previous study by Sangamo Therapeutics which clipped part of the protein that plays a major part in HIV infection.
AGT's method adds a gene to block that protein.
"If it somehow integrates, it won't matter, because it can't express. If it can't express, it can't make new HIV virions. It can't move to take over the whole body," said CEO Jeff Galvin.
Galvin says it will start with a blood draw from a participant whose infected white T-cells will be modified to fight the virus and then reinfused into the patient after 73 days to make sure it's safe.
"The number of HIV T-cells that we're returning to the body, that fight HIV, that are immune to HIV, is 2000:1.
He feels really good about it based on the progress so far, but he's remaining cautiously optimistic.
Matt Sharp is also cautiously optimistic.
He participated in the Sangamo Therapeutics trial.
"It's a better way than before. We have a 2-prong strategy and maybe um, let's wait and see," said Sharp.
Even if it doesn't work out this time around, both Sharp and Galvin say it's another step in the right direction to finding a cure.
Six people will participate in the study's initial phase.
They will still need to take their anti-retroviral medication for safety.
"We want to see safety data," said Galvin.
Galvin says 45 days must pass before re-infusing the next person.
He says hospitals will choose the patients and the enrollment process will open by the end of the month.
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