APT recognizes that there are instances when a patient has a life-threatening disease with no available options for treatment; in such situations, emergency expanded access to an investigational therapy may be an option. APT is committed to reviewing requests for expanded access that meet the following criteria, including, but not limited to:
- The patient has a serious or life-threatening bacterial infection that is a potential target for PhageBank therapy.
- The patient has undergone appropriate standard treatments without success and there are no alternative treatments available.
- The patient is ineligible or unable to participate in a clinical trial using PhageBank therapy.
- The patient is willing and able to consent to therapy and the physician is willing and able to administer the therapy and complete the necessary regulatory and other documentation.
To be considered, the patient or treating physician should contact APT via the link below. The clinical team at APT reviews requests on a case-by-case basis to determine whether access can be pursued. Please note that all requests will be considered, however, APT cannot guarantee the provision of investigational therapy to any given patient. It is our goal to provide a response within three business days.
When seeking expanded access to any investigational medical product, it is critical that the patient and his/her treating physician consider all possible risks. Investigational medical products, by definition, have not yet been evaluated for safety or effectiveness by the FDA and have not yet been approved. An investigational medical product may cause unexpected side effects, some of which could be serious. Additional information regarding expanded access can be found at the FDA https://www.fda.gov/news-events/expanded-access/expanded-access-information-industry
Emergency Access Request Form:
Please fill out the following form to begin the application process.