with the platform to show it can regularly reproduce results like that.
As it happens, the company will soon find the answer to that question. The company expects mid-stage clinical results from its second drug candidate, BCI-540, before the end of March. This is a drug candidate originally developed by Japan-based Mitsubishi Pharmaceuticals for Alzheimer’s, Schoeneck says. The product failed in a mid-stage study of that use. BrainCells obtained a license to the product after its platform suggested it could be effective for patients with both depression and anxiety, a tough group of patients to effectively treat. This time, BrainCells is trying two different versions—one pill taken once daily, versus another that’s taken three times a day.
As with any clinical trial, this isn’t a sure thing. “We unfortunately don’t have the data available yet,” Schoeneck says. “This” pointing to a bandage on his finger “is actually not from biting my fingernail. I accidentally cut myself at home the other day,” he joked.
Obviously, the BCI-540 data will be critical to what kind of year BrainCells has. The company has enough cash to operate until the first or second quarter of 2011, since it pocketed a hefty $50 million in venture capital back in April 2008. It will either need to raise more capital, or secure a Big Pharma partnership, at some point, Schoeneck says.
Cash requirements could be considerable. BrainCells doesn’t know yet how many patients will be required to enroll in clinical trials for its drugs, but since a new depression treatment has the potential to be used by millions of people, the agency may require a really large database to prove the safety of the BrainCells drugs in clinical trials. But even without that, BrainCells says the data from August has grabbed the attention of folks in Big Pharma.
“Certainly the clinical information from us last year has taken their interest up fairly dramatically,” Schoeneck says. “Now they are trying to figure out, how do we plug this into our discovery platforms, what’s the best place to utilize it.”
