MHRA Authorizes Athersys to Expand Ongoing Phase 2 Clinical Trial of MultiStem Cell Therapy in Ischemic Stroke
CLEVELAND, OH, USA I April 17, 2013 I Athersys, Inc. (ATHX) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved Athersys’ application to expand its ongoing Phase 2 study evaluating the administration of MultiStem therapy to patients who have suffered an ischemic stroke. Enrollment at United Kingdom sites is expected to commence following final Ethics Committee review and the completion of final preparations at participating clinical centers.
“The MHRA authorization will enable us to bring several leading United Kingdom stroke centers into the study, which will help us to speed the completion of the stroke clinical trial,” said Dr. Gil Van Bokkelen, Chairman and Chief Executive Officer of Athersys. “The authorization is also noteworthy as it marks the initiation of MultiStem clinical development activity in the United Kingdom.”
The Phase 2 study is a double blind, placebo-controlled trial evaluating the safety and efficacy of MultiStem cells when administered to patients who have suffered a moderate to moderately severe stroke, as defined by a National Institutes of Health Stroke Scale (NIHSS) score of 8 to 20. Patients enrolled in the study receive a single intravenous dose of MultiStem therapy or placebo in the 24 to 36 hours following the stroke, which is a significant extension of the current treatment window over existing standard of care. The study is expected to enroll approximately 136 patients in total and is currently being conducted at multiple centers throughout the United States.
About MultiStem
MultiStem(R) cell therapy is a patented product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem has demonstrated therapeutic potential for the treatment of inflammatory and immune disorders, neurological conditions, and cardiovascular disease, as well as other areas, and 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. The product is extensively characterized for safety, consistency and potency. Athersys has forged strategic partnerships with Pfizer Inc. to develop MultiStem for inflammatory bowel disease and with RTI Biologics, Inc. to develop cell therapy for use with a bone allograft product in the orthopedic market.
About Athersys
Athersys is a clinical stage 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(R) cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The Company currently has several clinical stage programs involving MultiStem, including for treating inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft versus host disease. Athersys has also developed a diverse portfolio that includes other technologies and product development opportunities, and has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products. More information is available at www.athersys.com.
SOURCE: Athersys
Post Views: 306
MHRA Authorizes Athersys to Expand Ongoing Phase 2 Clinical Trial of MultiStem Cell Therapy in Ischemic Stroke
CLEVELAND, OH, USA I April 17, 2013 I Athersys, Inc. (ATHX) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved Athersys’ application to expand its ongoing Phase 2 study evaluating the administration of MultiStem therapy to patients who have suffered an ischemic stroke. Enrollment at United Kingdom sites is expected to commence following final Ethics Committee review and the completion of final preparations at participating clinical centers.
“The MHRA authorization will enable us to bring several leading United Kingdom stroke centers into the study, which will help us to speed the completion of the stroke clinical trial,” said Dr. Gil Van Bokkelen, Chairman and Chief Executive Officer of Athersys. “The authorization is also noteworthy as it marks the initiation of MultiStem clinical development activity in the United Kingdom.”
The Phase 2 study is a double blind, placebo-controlled trial evaluating the safety and efficacy of MultiStem cells when administered to patients who have suffered a moderate to moderately severe stroke, as defined by a National Institutes of Health Stroke Scale (NIHSS) score of 8 to 20. Patients enrolled in the study receive a single intravenous dose of MultiStem therapy or placebo in the 24 to 36 hours following the stroke, which is a significant extension of the current treatment window over existing standard of care. The study is expected to enroll approximately 136 patients in total and is currently being conducted at multiple centers throughout the United States.
About MultiStem
MultiStem(R) cell therapy is a patented product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem has demonstrated therapeutic potential for the treatment of inflammatory and immune disorders, neurological conditions, and cardiovascular disease, as well as other areas, and 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. The product is extensively characterized for safety, consistency and potency. Athersys has forged strategic partnerships with Pfizer Inc. to develop MultiStem for inflammatory bowel disease and with RTI Biologics, Inc. to develop cell therapy for use with a bone allograft product in the orthopedic market.
About Athersys
Athersys is a clinical stage 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(R) cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The Company currently has several clinical stage programs involving MultiStem, including for treating inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft versus host disease. Athersys has also developed a diverse portfolio that includes other technologies and product development opportunities, and has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products. More information is available at www.athersys.com.
SOURCE: Athersys
Post Views: 306
