Expanded Access Policy
AmpliPhi Biosciences Corporation is a clinical-stage biotechnology company focused on treating antibiotic-resistant infections using its proprietary and investigational bacteriophage-based technology. AmpliPhi’s investigational medicines target multidrug-resistant Staphylococcus aureus and Pseudomonas aeruginosa.
AmpliPhi may elect to provide physician-requested expanded access to its investigational medicines in the U.S. and other countries where AmpliPhi intends to submit an application for marketing authorization of the requested product. Treating physicians and patients should note that investigational medicines do not have established safety and efficacy, so all potential risks and benefits should be carefully evaluated before seeking expanded access to unapproved medicines.
To be considered for expanded access, the request must be submitted to AmpliPhi by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational medicine. Treating physicians should contact AmpliPhi by emailing firstname.lastname@example.org with “Expanded Access Request” in the subject line, and include in the email the treating physicians name, organization/hospital/institution, physical address, email address, telephone number, and a brief description of the indication/condition. AmpliPhi will acknowledge receipt of requests from treating physicians, within 72 hours of receiving the request for information. Physicians will then be directed to submit additional required documentation to AmpliPhi. Once AmpliPhi obtains all required information, AmpliPhi will consider the following criteria to determine if expanded access is appropriate for a particular patient, as permitted by applicable law, within five business days. In all cases, the potential benefit to the patient must outweigh the risks:
- The patient has a serious or immediately life-threatening Staphylococcus aureus or Pseudomonas aeruginosa infection for which no alternative treatment(s) are currently available.
- The patient is ineligible for, or otherwise unable to, participate in a clinical trial.
- The investigational medicine is currently in clinical development – that is, it is currently being studied in humans via clinical trials or expanded access.
- Providing investigational medicine through expanded access will not compromise clinical trials or the regulatory pathway to approval.
- Such other factors as deemed appropriate by AmpliPhi.
Physicians who receive an AmpliPhi investigational medicine for their patient(s) through expanded access must comply with all applicable laws and regulations, contractual conditions, safety reporting required by regulatory agencies, and protection of intellectual property.
AmpliPhi cannot guarantee that the investigational therapy will be available to a particular patient. Any approval of expanded access to investigational medicine must always comply with the applicable country-specific laws and regulations, including importation requirements, approvals from applicable regulatory bodies and notification or approval by Institutional Review Board or Ethics Committee, as deemed appropriate per institutional policies and regional laws.
Pursuant to the 21st Century Cures Act: the posting of policies by manufacturers and distributors shall not serve as a guarantee of access to any specific investigational medicine for any individual patient.
This policy is subject to change. AmpliPhi will revisit the policy periodically and amend it as appropriate. It’s also important to know that the expanded access of an investigational medicine may be discontinued at any time at the discretion of the treating physician, the patient or their caregiver, the local regulatory agency, such as the FDA, or AmpliPhi.
For more information from the FDA about Expanded Access in the United States, click here.
In addition, you or your licensed physician can find more information on existing Expanded Access programs in the United States by searching for Expanded Access records on www.clinicaltrials.gov.