ESSA is committed to improving the lives for patients with prostate cancer. We aim to do this through partnership: by listening to patients, our supporters, and advocacy communities. Our goal is to provide patient access to our investigational monotherapy and combination therapies at an appropriate time in the drug development process.
ESSA recognizes that not every patient who wishes to participate in a clinical trial will meet the eligibility criteria. In rare cases when patients with serious diseases are unable to participate in clinical trials and have exhausted all available therapies, ESSA may consider providing an investigational drug outside of a clinical trial.
If you are a patient who is interested in accessing EPI-7386 as a monotherapy or as part of one of our combination therapies we are evaluating, please first speak with your physician. You may also learn more about our ongoing clinical trial by going to www.clinicaltrials.gov.
If you are a physician who is interested in learning more about our investigational drug, please submit a request to clinicaltrial@nullessapharma.com.
General Criteria: ESSA will evaluate and respond to a request that it receives on a case-by-case basis, applying the following criteria:
In the U.S., physicians may find additional information regarding expanded access to investigational therapies by visiting the U.S. Food and Drug Administration website: Expanded Access: Information for Physicians. Non-U.S. physicians must follow local laws and regulations appropriate for the country originating the request.
This posting of the policy shall not serve as a guarantee of access to any specific investigational drug for any patient. While we our goal is to help patients, please note that we cannot guarantee access to our unapproved medicines, even if we do decide to provide an early access program. Certain circumstances may arise that will prevent us from providing access to the unapproved medicine. For additional information, please contact: clinicaltrial@nullessapharma.com.