I really didn't expect this but the 365 year data is significantly better than the 90 day data that tanked the stock in April. This might end up being the breakthrough the stem cell sector has been looking ofr:
CLEVELAND, Feb. 17, 2016 (GLOBE NEWSWIRE) -- Athersys, Inc.(ATHX) today announced positive results from the analysis of one-year follow-up data from its Phase 2 clinical study of the intravenous administration of MultiStem® cell therapy to treat patients who have suffered an ischemic stroke. Dr. David Hess, lead clinical investigator of this study and a stroke specialist and Chairman of the Department of Neurology at the Medical College of Georgia, Augusta University, presented the summary results today at the 2016 International Stroke Conference in Los Angeles. The one-year data demonstrates that MultiStem-treated subjects on average continued to improve through one year and had a significantly higher rate of “Excellent Outcome” (defined clinically as attaining mRS 0-1, NIHSS 0-1 and BI ≥95) compared to placebo subjects at one year when evaluating all subjects enrolled in the study (p=0.02), i.e., the intent-to-treat population. The relative improvement in Excellent Outcomes was even more pronounced in the patients who received MultiStem treatment within 36 hours of the stroke (p <0.01).
“We are particularly excited by the one-year follow-up results because they show that MultiStem treatment can significantly increase the number of patients who have an Excellent Outcome, meaning complete or nearly full recovery, over the standard of care when considering all subjects in the trial,” commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. “The one-year data continues to confirm that MultiStem treatment is well tolerated and is associated with continued improvement of other measures of function through one year. As we saw in the 90-day interim analysis results announced last April, patients who received MultiStem treatment within 36 hours of the stroke did substantially better than placebo patients and later treatment MultiStem subjects. As a result, we will continue to focus our ongoing clinical development on treatment within 36 hours of the stroke.”
Data highlights from the 365-day follow-up data analysis include:
MultiStem treatment continued to be well tolerated through 365 days;
Among all subjects who received MultiStem treatment (n=65), 23.1% of patients achieved an Excellent Outcome at 365 days, compared to 8.2% of patients who received placebo (n=61), and the 14.9% difference was statistically significant (p=0.02) and compared favorably to the 8.8% difference at 90 days;
Among patients who received MultiStem treatment within 36 hours following the stroke, 29.0% achieved Excellent Outcomes (n=31), and compared to all placebo subjects (n=61), the 20.8% difference was significant (p<0.01) and also greater than the 9.5% difference at 90 days;
Proportion of Subjects with Excellent Outcome at Day 90 and Over One Year
Subjects Day 90 Day 365
All MultiStem (n=65) 15.4 % 23.1 %
All Placebo (n=61) 6.6 % 8.2 %
Difference with all placebo 8.8 % 14.9%*
Early Treatment with MultiStem (n=31) 16.1 % 29.0 %
Difference with all placebo 9.5 % 20.8%**
*p = 0.02, **p<0.01
Substantial improvements were also observed in the Barthel Index, which is the clinical scale used to assess the ability of patients to live independently. Among all subjects (65 MultiStem, 61 placebo), 61.5% of MultiStem patients had an excellent outcome in the Barthel Index (≥95), compared to 44.3% of placebo patients (p=0.05); furthermore, 67.7% of the subset of MultiStem patients who had treatment within 36 hours (n=31) achieved an excellent Barthel outcome, representing a 23.4% difference with the incidence for all placebo patients (p=0.03); and
Among MultiStem patients who did not achieve an Excellent Outcome at 365 days, there appears to be meaningful benefit from the treatment relative to standard of care, with reductions in average initial hospitalization days, mortality, life threatening adverse events and infections. For example, comparing all such MultiStem and placebo subjects, MultiStem-treated patients had 1.6 fewer average hospitalization days, and an 11% lower proportion of patients with death or life threatening adverse events. In addition, when comparing subjects receiving early treatment with MultiStem against all placebo subjects, MultiStem patients had an average of 2.9 fewer hospitalization days, and an 11.4% lower incidence of death or life threatening adverse events. Further, such MultiStem patients appear to have better functional improvement than these placebo patients over one year, as evidenced by a higher proportion of excellent Barthel Index outcomes (≥95), 50% for MultiStem subjects (and 55% for early treatment MultiStem), compared to 39% for placebo subjects.
“Achievement of an Excellent Outcome is important because it means that a patient has substantially improved in each of the three clinical rating scales used to assess patient improvement and has regained the ability to live and function independently with a high quality of life,” continued Van Bokkelen. “Furthermore, when evaluating patients that either received no reperfusion therapy, treatment with tPA alone, or mechanical reperfusion alone, we observed a greater than five-fold increase in the proportion of patients that achieved an Excellent Outcome at one year when comparing subjects that received MultiStem treatment within 36 hours versus placebo.”
Phase 2 Clinical Study Design
The randomized, double-blind, placebo-controlled Phase 2 clinical trial was conducted at sites in the United States and the United Kingdom. The study was conducted in two parts – a small dose selection phase involving 16 patients in two cohorts, followed by larger efficacy phase of 118 patients. The evaluable patient population included 8 patients from cohort 2 and the cohort 3 patients, which all received a high dose of treatment or placebo.
The study enrolled subjects who received intravenously either MultiStem treatment or placebo one to two days following the stroke. Functional and neurological deficit and recovery following the ischemic stroke were evaluated using three standard methods: the modified Rankin Score (mRS), a scale from 0-6 directed to assessing disability; the NIH Stroke Scale (NIHSS), a scale from 0-42 for evaluating neurological deficit; and the Barthel Index, assessing performance related to activities of daily living on a 100 point scale. See
for additional information on these assessment scales. Additionally, other clinical, safety and biomarker data was collected over the assessment period. Of the patients evaluated in the study, 65 patients were in the MultiStem treatment group and 61 patients were in the placebo group, and among the MultiStem subjects, 31 received MultiStem treatment within 36 hours following the stroke.
The following user(s) said Thank You: Joncon63, cytxer
Past couple of days of price action made me get more.... They always know!
“Furthermore, when evaluating patients that either received no reperfusion therapy, treatment with tPA alone, or mechanical reperfusion alone, we observed a greater than five-fold increase in the proportion of patients that achieved an Excellent Outcome at one year when comparing subjects that received MultiStem treatment within 36 hours versus placebo.”
After the continuous string of disappointments it is a weird feeling to see something really spectacular like this. How often does a clinicaly trial see such an improvement in 365 data over 90 day data?
I totally fucking concur ! this is BIG - if their stuff works , our stuff works 2 or 3 times better. Cytori will be a great success as long as we don't go out of business in the meantime ..... wowee ! I like it. forgot
Ps - I think our 1 year data vs 12 week data will be similar.
And ............. There is no fucking way Hedric can tell folks we'll be profitable in 2018 unless he has a CLEAR ( known ) reason that we'll even exist in 2018......and be profitable. I'd just like to see that reason for "profitability" in 2018 revealed.
The following user(s) said Thank You: Joncon63, mtpinman, fatboy
Congrats ATHX holders and also to the suffering stroke victims who were helped.
Have to admit the ATHX CEO got some respect from me when he sold the same indication twice while our bumbling circus still tries to get something right. Oh wait, cytxer said they are really really smart...LOL.
Still waiting for the last 4 scleroderma sites to come online.
I spoke to Gil directly about Chugai in the NYC Healios conference and also spoke to the CEO of Healios. Chugai is a big slow moving conglomerate and had no team with any knowledge of regmed or the new japanese laws. Healios is the exact opposite. The Chugai rejection, although painful at the time, was a blessing in disguise. It is amazing though.
It's amazing, all right... I have the same number of shares, for half the price, AFTER a great news...
I think - a couple of years ago - the first objective of the trial was lost in the translation.. They originally wanted to have a plan for people who get to the hospital beyond the window of current treatments, but Chugai lost the focus over the "earmarks", and lost it.
cytxer wrote: Seems that Adam and Co. shorted a ton of shares yesterday and now released that article.
There is some truth mixed with some BS.... time will tell I guess.
adam will do the same thing after Cytori releases any positive news
Shorts attack many companies, only some succumb and die. Those with better management that truly care about their science and not just boats and sex have a better chance of survival.
When shorts speak, one should stop grazing and pay attention. Not because they might be right (which most happen to be correct BTW), but because you know they smell blood.. maybe 50 cents worth, maybe more.. so, look around and check your back pocket when shorts speak... my 2 cents
Athersys shares, at least for now, have taken AF's hit piece and discarded it. Quite an accomplishment that shows that he can be marginalized in the short term if the counter arguments are legitimate and convincing. In the end it comes down to execution towards meeting the ultimate end game of approval with reimbursement. The likelihood of Japan approval looks really good, IMHO and the timeline will not be that long.
I know that if I was so unfortunate as to suffer a stroke I would surely opt for the Athersys therapy in the ambulance on the way to the hospital. Hopefully the data reinforces the theory and stroke victims are armed with an new tool to help them overcome some of the debilitating effects of this terrible illness.