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2016-02-17

Athersys, Inc.: One-Year Results From Phase 2 Stroke Study of MultiStem® Cell Therapy Demonstrate a Significantly Higher Rate of Complete or Nearly Full Recov

Data Presented at 2016 International Stroke Conference Demonstrate
Statistically Significant Improvement in Excellent Outcomes When Evaluating
All Subjects and Key Subgroups

CLEVELAND, Feb. 17, 2016 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq: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 greater than or
equal to 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 (greater
than or equal to 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
(greater than or equal to 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.
Seewww.strokecenter.org/professionals/stroke-diagnosis/stroke-assessment-sc...
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.

About the Disease Condition

Ischemic stroke is caused by a blockage of blood flow to the brain. A leading
cause of death and disability globally, each year more than 15 million people
are estimated to suffer a stroke, including more than two million people in
the United States, Japan and European Union, combined. According to the
American Heart Association, ischemic strokes comprise more than 85% of all
strokes. Current standard of care for ischemic stroke involves the
administration of a thrombolytic (clot dissolving) agent within three to four
hours after a stroke has occurred, a narrow window that results in only a
small percentage of patients receiving such treatment.

About MultiStem

MultiStem cell therapy is a patented regenerative medicine product that has
shown the ability to promote tissue repair and healing in a variety of ways,
such as through the production of therapeutic factors produced in response to
signals of inflammation and tissue damage. MultiStem therapy's potential for
multidimensional therapeutic impact distinguishes it from traditional
biopharmaceutical therapies focused on a single mechanism of benefit. The
product represents a unique "off-the-shelf" stem cell product that can be
manufactured in a scalable manner, may be stored for years in frozen form,
and is administered without tissue matching or the need for immune
suppression. Based upon its efficacy profile, its novel mechanisms of action,
and a favorable and consistent safety profile demonstrated in both
preclinical and clinical settings, MultiStem therapy could provide a
meaningful benefit to patients, including those suffering from serious
diseases and conditions with unmet medical need. Athersys has forged
strategic partnerships and a broad network of collaborations to develop
MultiStem cell therapy for a variety of indications, with an initial focus in
the neurological, cardiovascular and inflammatory and immune disorder areas.

About Athersys

Athersys is an international biotechnology company engaged in the discovery
and development of therapeutic product candidates designed to extend and
enhance the quality of human life. The Company is developing its MultiStem®
cell therapy product, a patented, adult-derived "off-the-shelf" stem cell
product, initially for disease indications in the cardiovascular,
neurological, inflammatory and immune disease areas, and has several ongoing
clinical trials evaluating this potential regenerative medicine product.
Athersys has forged strategic partnerships and collaborations with leading
pharmaceutical and biotechnology companies, as well as world-renowned
research institutions to further develop its platform and products. More
information is available at www.athersys.com.

Athersys Forward Looking Statements

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 that involve risks and
uncertainties. A number of known and unknown risks, uncertainties, and other
factors could affect the accuracy of these statements and may cause our
actual results, levels of activity, performance, or achievements to differ
materially from any future results, levels of activity, performance, or
achievements expressed or implied by these forward-looking statements,
includin...

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