Key Developments For Athersys, Inc.
Athersys, Inc. (ATHX.O) (Consolidated Issue listed on NASDAQ Capital Market)
Athersys Receives IND Authorization For Multistem In Treatment Of Ischemic Stroke
Athersys announced that it has received authorization from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial evaluating the safety of administration of its off-the-shelf adult stem cell product, MultiStem, in the treatment of ischemic stroke. The Phase I study will be a double blind, placebo controlled dose escalation trial evaluating the safety and maximum tolerated dose of single-dose administration of MultiStem following an ischemic stroke. The trial is designed to include up to 48 patients and will be conducted at multiple clinical centers in the United States. This authorization will allow commencement of the third clinical study for MultiStem, a stem cell product candidate that was recently recognized by Frost & Sullivan as the Product Innovation of the Year for North America. MultiStem is being developed as a biologic therapy that can be manufactured on a large-scale and may be used off-the-shelf, similar to a pharmaceutical product.
Athersys Announces Initial Patient Dosing Of MultiStem In Phase I Acute Myocardial Infarction Trial
Athersys announced the presentation of data from its ongoing phase I clinical trial of MultiStem for individuals following acute myocardial infarction (AMI). Dr. Penn reported that MultiStem was delivered safely and tolerated well by the patient following administration. The phase I clinical trial is an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of single dose administration of allogeneic MultiStem following an AMI. Following standard treatment, enrolled patients receive MultiStem delivered via a Cricket Micro-Infusion Catheter. The Cricket catheter enables rapid and efficient delivery of MultiStem into the region of damage in the heart. Athersys has evaluated the safety and ability of MultiStem to improve heart function in multiple animal models, including well-validated preclinical models of AMI. Based on this preclinical work, the Company believes that MultiStem may be administered safely and has the potential to improve heart function in patients following severe heart attacks.
Athersys Announces Update On ATHX-105 Development Plans and Results of Recent Clinical Studies
Athersys announced that the U.S. Food and Drug Administration (FDA) has requested additional information relating to the Company's Investigational New Drug (IND) application for a 12-week Phase II clinical trial of ATHX-105, the Company's lead product candidate for obesity, and has placed the study on partial hold. Athersys believes that the comments made by the FDA can be addressed with data from ongoing or recently conducted studies, including two recently completed Phase I studies which are described below. These studies provide further safety and tolerability data for ATHX-105 and also indicate that the drug is well absorbed throughout the gastrointestinal tract, thereby demonstrating the potential for development of a once-per-day controlled release formulation. The Company plans to submit data from these additional studies, address the FDA's questions and comments, and discuss the clinical development plans for ATHX-105 with the agency.
Athersys Announces Summary Results For Phase 1 Safety Study Of Its Novel Obesity Drug
Athersys announced that the results from its Phase 1 clinical trial of ATHX-105, its orally administered drug candidate for the treatment of obesity. ATHX-105 was well-absorbed, providing good drug exposures, well-tolerated up to high doses, and had no negative effect on cardiovascular, hematology or other clinical parameters. The Phase 1 clinical study was a randomized, double-blinded, placebo controlled study in healthy male and female volunteers to evaluate the safety, tolerability, and pharmacokinetics of ATHX-105. The study was carried out in two parts -- a single ascending dose portion and a multiple ascending dose portion, evaluating daily dosing for 7 days, and was conducted in the United Kingdom.
Athersys Receives FDA Authorization For MultiStem In Acute Myocardial Infarction
Athersys announced that it has received authorization from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial evaluating the safety of MultiStem administration in the treatment of acute myocardial infarction (AMI).
