Athersys Reports Alignment of Key Regulators for Pivotal Registration Study in Stroke
MultiStem® stem cell technology receives Positive Opinion from
Adds to Special Protocol Assessment and Fast Track designation in
means that, in the three major pharmaceutical markets,
"We are excited about receiving the positive opinion on our pivotal, registrational
stroke study, MASTERS-2, and we thank the EMA for its continued support of our efforts to develop an important new treatment option for patients in this area of significant unmet medical need," commented Dr.
About EMA Scientific Advice
Scientific Advice is a procedure offered by EMA to stakeholders for clarification of questions arising during development of medicinal products. The scope of Scientific Advice spans scientific issues that may be related to quality, non-clinical, and/or clinical aspects of the concerned medicinal product under development. The advice is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients and helps to ensure that developers perform the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the
marketing-authorization application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorization. Following the Agency's advice increases the probability of a positive outcome. For more information on the Scientific Advice process, please visit:
About Special Protocol Assessments
The Special Protocol Assessment process is a procedure by which the
About Fast Track Designation
Fast Track is a process designed by the
About the SAKIGAKE Designation
The Strategy of the Pharmaceutical and Medical Devices Agency's SAKIGAKE designation consists of the following two measurements and its coverage ranges from basic research to clinical research/trials, approval reviews, safety measures, insurance coverage, improvement of infrastructure and the environment for corporate activities, and global expansion.
- SAKIGAKE Designation System: promoting research and development in
Japanaiming at early practical application for innovative pharmaceutical products, medical devices and regenerative medicines.
- Scheme for Rapid Authorization of Unapproved Drugs: accelerating the practical application of unapproved/off-label use of drugs for serious and life-threatening diseases by expanding the scope of the
Council on Unapproved Drugs/Off-label Useto include unapproved drugs in the western countries if certain conditions are satisfied, and by improving the environment for companies to undertake development of such drugs.
For more information on the SAKIGAKE process, please visit:
About Ischemic Stroke
Stroke represents an area where the clinical need is particularly significant, since it is a leading cause of death and serious disability worldwide, with a substantially impaired quality of life for many stroke victims. Currently, there are nearly 17 million people that suffer a stroke globally and, on average, someone in
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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates,"
"expects," "intends," "may," "plans," "potential," "should," "suggest," "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, such as the uncertainty regarding regulatory approvals and market acceptance of our product candidates and our ability to generate revenues, including MultiStem for the treatment of ischemic stroke, acute myocardial infarction, spinal cord
injury and acute respiratory distress syndrome and other disease indications, including graft-versus-host disease. These risks 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. Other important factors to consider in evaluating our forward-looking statements include: the success of our collaboration with Healios and others, including our ability to reach milestones and receive milestone payments, and whether any products are successfully developed and sold so that we earn royalty payments; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our collaborators' ability to continue to fulfill their obligations under the
terms of our collaboration agreements; the success of our efforts to enter into new strategic partnerships or collaborations and advance our programs; our ability to raise additional capital; results from our MultiStem ongoing and planned clinical trials, including the MASTERS-2 Phase 3 clinical trial and the Healios TREASURE clinical trial in
Contact: William (B.J.) Lehmann President and Chief Operating Officer Tel: (216) 431-9900 firstname.lastname@example.org David Schull
Russo Partners, LLCTel: (212) 845-4271 or (858) 717-2310 David.email@example.com Investor Contact: Peter Vozzo Westwicke PartnersTel: 443-213-0505 or 443-377-4767 (mobile) firstname.lastname@example.org
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