Alentis Therapeutics Expanded Access Policy
Alentis Therapeutics (“Alentis”) is a clinical-stage biotechnology company developing treatments for Claudin-1 positive tumors and organ fibrosis. We are working hard to move our programs through clinical development and obtain regulatory approval to provide broad access to our treatments.
Right up to getting regulatory approval, clinical trials are the primary way to gain access to Alentis’ investigational therapies. For more information about our clinical trials, please visit www.ClinicalTrials.gov.
Expanded access, also referred to as compassionate use, allows patients with serious or immediately life-threatening diseases or conditions to be treated with investigational drugs outside of clinical trials when no comparable or satisfactory alternative therapy options are available. The primary purpose of expanded access programs is to diagnose, prevent or treat a serious condition (i.e., a condition associated with morbidity that has substantial impact on day-to-day functioning). This is different from a clinical trial that seeks to obtain safety and efficacy information on an investigational drug product.
Considering the early stage of our clinical programs, Alentis believes that participation in our clinical trials is the appropriate way for patients to access our investigational therapies. Consequently, Alentis does not provide expanded access at this time.
Should you have any questions, please speak with your doctor or send an email to ExpandedAccess@alentis.ch. We aim to acknowledge receipt of email correspondence within five business days.
Alentis reserves the right to revise this policy at any time, as authorized by and in accordance with the 21st Century Cures Act.