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either got buspirone by itself, or a placebo. Patients took the drugs for six weeks. There was no direct comparison to one of the big SSRI drugs, like paroxetine (Paxil) or sertraline (Zoloft).
Even without that comparison, there was a lot of interest in Fava’s presentation last week at the NCDEU meeting because “it was so surprisingly effective,” he says.
We first wrote about BrainCells back in December, describing how it was built on research that says if you can stimulate new neurons that grow, migrate, differentiate, and survive in the brain, you may help fight off lots of mental disorders.
I followed up after the latest clinical trial data with BrainCells CEO Jim Schoeneck. The company discovered this unusual combination of drugs based on screening them in a lab dish full of human neural stem cells, Schoeneck says. These drugs caused the cells to proliferate and differentiate into neurons. Then they tried the same drugs in animals and found the same thing, Schoeneck says.
BrainCells hypothesizes that its drug is working because it stimulates growth of neurons, although it can’t say with certainty this is why BCI-952 helped people with depression. To prove that connection, you’d need to slice open people’s brains and run experiments on the tissues. As you might imagine, that won’t fly at the ethics board. Noninvasive brain imaging technologies at the moment don’t quite have the ability to see new cells growing, although BrainCells is collaborating with researchers at Columbia University on improving the imaging.
Promising as the data is, BrainCells isn’t nearly ready to plow ahead into the final stage of clinical trials. This 142-patient study involved giving people separate pills of buspirone and melatonin, and the company wants to make its own proprietary formulation in a pill or capsule that will simplify dosing, Schoeneck says.
Once it makes the new formulation, then BrainCells will probably run another Phase II clinical trial to measure effectiveness again, Schoeneck says. The company might also form a partnership to continue developing the drug, since BrainCells got a few inquiries “within minutes” after Fava’s presentation, Schoeneck says.
The finish line for developing this drug is still so far out as to be unmentionable, but the clinical trial result gave Schoeneck a little extra energy the day we talked by phone. “This is one where I wish I had a video phone so you could see me smiling,” he says. “This is really important news for the company.”
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