Expanded Access Policy
ABOUT ONCXERNA’S EXPANDED ACCESS
OncXerna is developing next-generation treatments (biologics and small molecule medicines) using cutting edge approaches to patient selection and clinical trial design. In order to develop these investigational medicines, we conduct clinical trials to determine the safe and effective use of these investigational medicines (or treatments). Regulatory approvals are required before drugs can be made available to patients outside of a clinical trial setting.
Clinical trials are controlled research studies designed to determine if an investigational medicine is safe and effective. OncXerna believes participating in clinical trials is the optimal way for patients to access investigational medicines prior to regulatory approval. Various efforts including, but not limited to, conduct of global clinical trials and posting on clinicaltrials.gov, ensures awareness of our clinical trials and the opportunity to participate to interested patients.
Providing access to investigational medicines via clinical trials is not always possible, so when it is not possible for a patient to participate in a clinical trial and all other available medical options have been exhausted, the patient’s physician may seek special access to investigational medicines outside of the clinical trial setting. These situations are often referred to as expanded access, early access, pre-approval access, compassionate use and emergency use.
REQUESTS AND DECISIONS ON EXPANDED ACCESS
Making decisions about requests for expanded access to an investigational medicine is always complex. OncXerna endeavors to make these decisions as ethically and fairly as possible, taking into consideration the patient’s case, the available medical and scientific information about the investigational medicine, and the probability and timing of a regulatory approval. The most important factor when evaluating requests for expanded access to investigational medicines is to ensure patients are not exposed to unnecessary harm or risk.
OncXerna will consider an expanded access program, or a single request for expanded access of an investigational medicine, only if all of the following criteria are met:
- Patient’s licensed physician submits an unsolicited request; and
- Patient has a serious or life-threatening illness and that the patient is in critical need; and
- All approved therapies have been tried by the patient, and no remaining treatment options exist for the disease or condition; or there is no available;
- Patient is ineligible for, or otherwise unable to, participate in a clinical trial for the investigational product of request; and
- Expanded access is permitted under applicable law; and
- The investigational medicine has already been studied in at least one clinical trial; and
- There is sufficient and meaningful data to support a preliminary assessment that the potential benefits to the patient outweigh the potential risks; and
- The staff and other required resources are available to provide the product, and there is a sufficient amount of product available; and
- Providing the product will not jeopardize regulatory approval or clinical development of the product; and
- Expanded access will only occur in a country where OncXerna expects to file for regulatory approval and for a disease for which OncXerna is developing the product as a potential (investigational) treatment.
HOW TO REQUEST EXPANDED ACCESS
OncXerna encourages patients to speak first with their licensed physician about their eligibility to enroll in a clinical trial. If a treating physician believes expanded access may be the only option for a patient, the physician should contact OncXerna to make a formal request on behalf of the patient. 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. Requests for expanded access may only be made by licensed physicians through the below email address and will be evaluated by OncXerna Clinical Leadership. OncXerna will acknowledge receipt of requests within five business days.
OncXerna is committed to evaluating all requests for expanded access in a fair and equal manner.
All requests will be evaluated by medical professionals and decisions will be made based on scientific evidence available to the company at the time of the request.
Please contact OncXerna if you have questions about or requests for expanded access to OncXerna investigational compounds. Please contact [email protected].