Re: Farmas USA
ATHX
"I believe that Athersys Inc.'s MultiStem (multipotent adult progenitor cells), an allogeneic, off-the-shelf stem cell product, is going to prove viable, and will change the paradigm for treating stroke. . . My understanding and expectation is that, in light of the termination, we will see a new Japanese partner step into the breach. My confidence level that this is going to happen is higher now that Astellas Pharma has decided to acquire Ocata Therapeutics.
Athersys CEO Gil Van Bokkelen, whom I've known for the last 10 years, is a straight shooter. I know that he's in Japan a great deal of the time. . .it is very likely we will see the emergence of a major company working with Athersys in Japan. I have no special knowledge, but I believe it makes sense based on the ischemic stroke data from Athersys' Phase 2 trial.
I'm also aware that stroke is a massive unmet medical need in Japan. The Japanese have no choice but to invest in this space. Remember that in Japan, people still consume a traditional diet that's high in salt (lots of soy sauce). The reality is that hypertension—maybe a result of this high salt diet—results in a higher incidence of stroke, and Japan's is the highest in the world. I think it is very likely we will see the emergence of a major company working with Athersys in Japan. I have no special knowledge, but I believe it makes sense based on the ischemic stroke data from Athersys' Phase 2 trial.
TLSR: My understanding is that the Pharmaceuticals and Medical Devices Agency (PMDA), which comes under the Ministry of Health and Welfare and is equivalent to the FDA, is requiring about 25% of patients be either in Japan or Japanese. Is it reasonable to assume that Athersys could begin a pivotal study in ischemic stroke in Japan by, let's say, mid-2016?
JK: Yes. Based on slices of data from Athersys' 136-patient Phase 2 trial in ischemic stroke, the sooner you treat patients, the better the outcome. We saw the readout of that trial back on April 17. The data point to a 36-hour window for treatment with MultiStem following a stroke would be a tremendous advantage over the 3-hour window we see with recombinant tissue plasminogen activator (tPA). That timeframe would be a huge advantage for patients who have had a stroke. Remember, too, that tPA is a powerful clot buster, and patients face multiple risks when it is used.
Now, I'll grant that this 36-hour window hypothesis is a post-hoc analysis, and we always worry about looking at data after the fact, but time is hard on a brain that has had an infarct. Other than tPA or a mechanical thrombectomy, where you unblock an ischemic artery in the brain with a reperfusion catheter and aspirate the clot, there is very little that can be done to improve recovery. What we're seeing is that Athersys' allogeneic stem cells may have a significant impact on the recovery time, but that it's important to treat the right segment of patients.
