Faeth is committed to developing groundbreaking treatments for patients living with cancer. Our discovery platform aims to match tumor genotypes with treatment regimens that combine therapeutic targets and precision metabolic optimization to improve patient outcomes. Currently, Faeth’s clinical product candidates are in clinical development and are not yet approved by health authorities such as the FDA and therefore are “investigational products”. This means that more clinical trials are required and that health authorities have not yet determined that these products are safe and effective for their intended use. We conduct well-designed clinical trials to establish the safety and efficacy of our investigational products, and we encourage patients to speak with their doctors about the benefits, risks, and eligibility to enroll in such studies. More information can be found at:
www.clinicaltrials.gov. We recognize, though, that there are circumstances where patients with serious or life-threatening diseases may not be eligible for, or are unable to participate in, one of our clinical trials. In such circumstances, as explained below, patients may be eligible to access Faeth Therapeutics’ investigational products through expanded access.
Expanded access (also referred to as compassionate use) is a potential pathway for people with life-threatening diseases to gain early access to an investigational product outside of a clinical trial when enrollment in a clinical trial is not an option and all currently available treatment options have been exhausted.
On a case-by-case basis, Faeth will consider the following criteria—which align with applicable FDA guidance and bioethicist review-- to determine if a Faeth investigational product will be made available for treatment outside of a clinical trial:
A request for expanded access must be submitted in writing by the patient’s treating physician to
info@faeththerapeutics.com. Please make sure that no patient identifying information is included. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals, if applicable, and to comply with all other safety, monitoring, and patient consent requirements specified by Faeth, and applicable laws and regulations.
Faeth Therapeutics will acknowledge receipt of all requests for expanded access to its investigational product within
five business days and will use best efforts to respond to the request within ten business days of receipt of a fully completed request; however, complicated requests may require additional consultation, discussion, and take more time. There is no guarantee that the investigational product will be available to a patient at any given time.
In light of the fact that investigational products have not yet received regulatory approval, and their safety and efficacy have not been established, doctors and patients are encouraged to carefully consider possible benefits and risks when seeking expanded access to investigational products.
Faeth reserves the right to modify or terminate this expanded access policy at any time.
