What is expanded access?
Expanded access, also called compassionate use, is the use of an experimental drug to treat patients outside of a clinical trial. This is different from using an experimental drug in a clinical trial, where more comprehensive safety and efficacy data are collected. To qualify for expanded access, patients must have a serious or life-threatening illness, must have received available approved treatments without success (or no approved treatments exist), and cannot meet eligibility criteria for existing clinical studies.
Why are clinical trials used to test experimental drugs?
Biotech companies have an ethical obligation to develop safe and effective drugs and biologic therapies and make them available to all patients as quickly as possible. Clinical trials are carefully designed to evaluate experimental drug treatments in order to gain information about the safety and efficacy of those treatments. Sufficient clinical information about safety and efficacy is needed to answer important medical and scientific questions and allow drugs to be reviewed and approved for use by regulatory agencies, such as the U.S. Food and Drug Administration (FDA). The required information must be gathered through rigorous and carefully-controlled testing in clinical trials.
What is the current status of clinical testing of MCY-M11?
MaxCyte is working to develop safe and effective drug treatments as quickly as possible for patients who need additional treatment options. MaxCyte’s experimental drug treatment MCY-M11 is currently being tested in an early (Phase 1) clinical trial for certain patients with ovarian cancer or peritoneal mesothelioma. Information about this trial and which patients may be eligible to enroll is posted at www.clinicaltrials.gov.
Is expanded access available for MaxCyte’s MCY-M11?
MaxCyte is committed to developing safe and effective treatments to help transform the lives of patients with severe cancers. Our goal remains to provide access to our investigational therapies at the appropriate time and in the appropriate manner for our patients.
Currently, MaxCyte is not able to provide our experimental drug to patients outside of our clinical trial. At this early stage in the development and testing of MCY-M11, participation in the clinical trial is the only way for patients to gain access to this experimental drug therapy.
Will expanded access to MCY-M11 be available in the future?
We appreciate the urgency felt by patients and their families facing a serious or potentially life-threatening illness when existing approved treatment options are not available or have failed. As more information about the clinical safety and efficacy of this drug is gathered, we will continue to evaluate whether allowing expanded access to some patients is appropriate. In line with the 21st Century Cures Act, MaxCyte may revise this policy at any time. Any changes to the expanded access policy will be posted on this website.