Athersys anti stroke drug 36 hours trial#

The relative improvement in Excellent Outcome was even more pronounced in the study subjects who received MultiStem treatment within 36 hours of the stroke. Achievement of an Excellent Outcome is important because it means that a patient has substantially improved (i.e., receiving an вЂњExcellentвЂќ score 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.

Athersys anti stroke drug 36 hours trial#

The one-year follow-up data from the Phase 2 trial demonstrated that MultiStem-treated subjects on average continued to improve through one year and had a significantly higher rate of вЂњExcellent Outcome,вЂќ as defined below, compared to placebo subjects at one year when evaluating all of the intent-to-treat subjects enrolled in the study. This effect is consistent with our hypothesis regarding mechanisms of action and related preclinical data, and with the clinical data suggesting faster and improved recovery for MultiStem-treated patients relative to current standard of care. Furthermore, analysis of biomarker data obtained from samples of study subjects indicated that MultiStem treatment reduced post-stroke inflammation compared to placebo, and the results suggest that this effect was more pronounced for subjects who received MultiStem earlier within the treatment window. In addition, analyses show that patients who received MultiStem treatment earlier in the studyвЂ™s treatment window (24 to 36 hours post-stroke, in accordance with the original study protocol) had better recovery in comparison to placebo. Not achieve the primary endpoints for the intent-to-treat population, MultiStem treatment was associated with lower rates of mortality and life-threatening adverse events, infections and pulmonary events, and a reduction in hospitalization and time in the intensive care unit, or ICU. In contrast to traditional pharmaceutical products or biologics that generally act through a single biological mechanism of action, MultiStem cell therapy may enhance healing and tissue repair through several distinct mechanisms acting in parallel, resulting in a more effective therapeutic response. These cells appear to be responsive to the environment in which they are administered, by homing to sites of injury and/or organs involved in injury response and providing active disease response, while producing proteins that may provide benefit in both acute and chronic conditions and regulate other cell types. MultiStem treatment has shown the potential to enhance tissue repair and healing in multiple ways, including reducing inflammatory damage, protecting tissue that is at risk following acute or ischemic injury, and promoting formation of new blood vessels in regions of ischemic injury.

We believe our MultiStem cell therapy represents a potential breakthrough in the field of regenerative medicine and stem cell therapy and could be used to treat a range of disease indications. These represent major areas of clinical need, as well as substantial commercial opportunities. Our current clinical development programs are focused on treating critical care and other conditions where current standard of care is limited or inadequate for many patients. Our most advanced program is focused on the treatment of ischemic stroke, which is currently being evaluated in a registrational trial in Japan, and an ongoing Phase 3 clinical trial in North America under a Special Protocol Assessment, or SPA, and Europe. Our MultiStem В® cell therapy, a patented and proprietary allogeneic stem cell product, is our lead platform product and is currently in clinical development. We are committed to the discovery and development of best-in-class therapies designed to extend and enhance the quality of human life and have established a portfolio of therapeutic product development programs to address significant unmet medical needs in multiple disease areas. We are an international biotechnology company that is focused primarily in the field of regenerative medicine.