The Dallas dermatologist who is leading the development of the world’s first, highly effective anti-cancer vaccine has said it will take at least six months to reach the FDA for approval.
Dr. Davien McQuaid, who is chief of the dermatology department at Memorial Sloan Kettering Cancer Center, said the vaccine would be ready to use in less than six months.
He said the clinical trials have already been completed and will be ready for a phase one trial of the vaccine.
“We have to have that, and then the trial is going to be done, and we can start moving forward with that,” McQuain said.
The vaccine is based on a compound called Dacarb, which is used in the anti-parasitic therapy Daraprim, and it’s also being used in an earlier version of the cancer vaccine called Lymphocell, which has been approved for use in patients with advanced cancers.
But McQuay says the new, much more potent vaccine will have to wait at least another six months before being ready for use.
He says he can’t wait until next year to begin the development phase of the new version.
McQuaid says the more powerful version of Dacab has been shown to be 100 times more effective at killing cancer cells than the older version, which he says is only 50 times more powerful.
He says the next stage of development will include a study to determine if the new formulation has the same success rate in killing cells as the older versions, and if it does.
He added that the research will take six months, and that his team has already completed three studies with a total of more than 200 participants.
“What I know is that the more potent version of this molecule is much more powerful than the earlier version, so we’ve had a long time to figure out how it works,” McConnel said.
McConnel says he expects that a clinical trial will be completed within a year, but he said he’s not ready to say when.
The drug was approved in November by the FDA.