TLSR:. . .With the data Athersys has accrued so far, and with the relationships it already has with regulators in Japan, is it possible to get conditional approval using data from the studies it's already done in the U.S.?
JK: That's a good question. The short answer is yes. . .if management could enroll a handful of Japanese patients, and they could be part of the current phase 2 trial, that could create an accelerated pathway to the marketplace. Based on phase 2 results that include Japanese nationals, which could be reported, let's say, at the end of 2014, a product could potentially be commercialized in Japan in 2015."
The company has two very important trials in progress, either of which would be transformative with good data. As I mentioned before, Athersys is partnered with Pfizer in an ulcerative colitis program. Athersys' cell therapy product, MultiStem, is being used to treat these patients. I believe that even before we see data from the phase 2 trail, we could see Pfizer make a decision to expand its relationship with Athersys based on the recognition of what it already knows about the company and the product.
Athersys is one of only a handful of companies that has spelled out in detail the mechanism of action. . .the idea of being so specific with mechanism of action, with dose, with where it's delivered and with when it's delivered, becomes critical for the company, a differentiating factor. Athersys also has an interesting small molecule program, with 5HT2c receptors and agonists for obesity or schizophrenia. That's not on the regenerative medicine side. This is a neat little company that has a great management team and deep science bench."
"Ischemic stroke is another indication Athersys is looking at. That's a highly significant indication, because physicians have a short window of opportunity to help patients regain function. If not treated right away, disability problems are exacerbated, and stroke leads to outcomes that are, once again, dealt with in a palliative and watchful fashion, which is unaffordable in the current healthcare environment. This is a phase 2 program, and it's unpartnered."