Ischemic stroke clearly represents a major unmet medical need. Given that the world’s elderly population is rapidly growing in size due to the aging baby boomer generation, that number is expected to increase in the years ahead, since the risk of stroke increases with age. annually, and more than 2.2 million first time ischemic stroke victims in the U.S., Europe and Japan each year. Annually, there are some 800,000-stroke victims in the U.S. Ischemic strokes occur as a result of an obstruction within a blood vessel supplying blood to the brain. While there are six clinical programs underway with MultiStem in neurological, cardiovascular, and inflammatory and immune disorders, ischemic stroke is Athersys’ lead program.
The company’s patent estate covers more than 130 patents. “We have more than seven years of stability data and have shown that millions of doses can be produced from a clinical grade cell bank established from each donor.” And production is highly scalable, which is essential to successful commercialization. Once the product is made, it is kept in frozen form until needed. Studies have shown that the cells travel to sites of tissue damage or injury, as well as other relevant organs that play an important role after an injury has occurred. Van Bokkelen points out that MultiStem can be administered systemically or locally, depending on the indication. Multistem is a novel cell therapy formulated for “off-the-shelf” use, moving from the hospital pharmacy freezer to an iv bag to a patient in less than an hour.įor stroke, MultiStem is administered using a simple intravenous procedure. Based on published research and presentations at leading scientific conferences by Athersys and independent research teams, these effects include the simultaneous down regulation of an inflammatory cascade, emanating from the spleen that amplifies damage in the brain, and stimulation, or upregulation, of reparative immune responses and other repair mechanisms. MultiStem works by regulating multiple factors and pathways that are important to brain recovery following a stroke. In addition, MultiStem does not require tissue matching or any immune suppression drugs, he adds, making it a very simple and easy to administer. Van Bokkelen explains that MultiStem is a novel cell therapy formulated for “off-the-shelf” use, moving from the hospital pharmacy freezer to an IV bag to a patient in less than an hour.
#Athersys anti stroke drug 36 hours trial#
According to a recent filing on Clinicaltrials.Gov, Healios expects to release trial data from the study in the first half of 2018.ĭr. The trial will be conducted in accordance with a new, accelerated regulatory framework for cell therapies in Japan. “This trial will assess treatment with MultiStem within 18-to-36 hours after a stroke has occurred, which we believe would represent a major step forward for stroke victims by enabling treatment within a clinically practical time frame.”Īthersys’ Japanese partner, Healios K.K., an emerging leader in regenerative medicine, also plans to begin a confirmatory pivotal trial in Japan in early 2017, treating patients with MultiStem following an ischemic stroke. “Current treatment for stroke is limited to the first several hours after a stroke has occurred, and many patients don’t get to the hospital right away,” he adds. “Since each site would enroll about six patients on average, we think this is a study that could be conducted pretty efficiently,” Dr. The company intends to conduct the 300-patient study at approximately 50 leading stroke centers in the U.S., Europe and Canada. “It provides a clear, efficient path to success, by establishing the acceptability of the study to the FDA,” he adds. “This SPA represents a major de-risking event by specifying the precise criteria for approval from a successful pivotal trial,” chairman and CEO, Gil Van Bokkelen, says in an interview with BioTuesdays.
After receiving a Special Protocol Assessment (SPA) from the FDA at the end of September, Athersys (NASDAQ:ATHX) hopes to launch a pivotal trial next summer administering its intravenous MultiStem cell therapy in patients following an ischemic stroke.