Policies

Expanded Access Policy

Athersys, Inc. is committed to addressing areas of significant unmet medical need through the development of innovative drugs and/or biologics that extend and enhance the quality of human life.  We are conducting clinical trials to assess the safety and efficacy of our investigational drugs or biologics, which if proven, will allow us to obtain the approvals from regulatory authorities necessary to provide the broader patient community with full access to these therapies.

We recognize that there are patients with these disease indications (or related conditions) for whom clinical trial enrollment is not an option.  These patients may be interested in seeking to utilize our investigational drugs or biologics prior to regulatory approval through expanded access authorization (i.e., compassionate use).

Athersys, Inc. has ethical responsibilities to ensure the quality and integrity of clinical trials and to minimize risks to current research participants and future patients. These ethical responsibilities required careful consideration in evaluation of the appropriateness of providing expanded access to our investigational drugs or biologics (i.e., compassionate use).  We have concluded that sustainable, long-term availability of our investigational drugs or biologics can be best achieved by demonstrating safety, tolerability, and effectiveness through the conduct of controlled clinical trials designed to address the requirements of regulatory agencies for approval. Offering expanded access outside of a controlled clinical trial at this time could jeopardize the conduct of our ongoing or planned clinical trials and thus prevent or delay access for other patients in need. Accordingly, we have reached the difficult decision that it is not appropriate to provide expanded access to our investigational drugs or biologics outside of our clinical trials at this time.

Athersys, Inc. reserves the right to review and amend this policy in the future.  If we do amend this policy in the future to provide such expanded access, we are under no obligation to continue to provide such access and may cease at any time.

For additional information about this policy, please contact info@athersys.com.  Responses will be provided within approximately one business week.

Policy Adopted:  April 2017

 

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