The purpose of this Expanded Access Policy is to describe the principles, criteria and procedures that Oncoceutics will follow when considering a request for Expanded Access (sometimes called “Compassionate Use”).
Expanded Access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Investigational drugs have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.
Oncoceutics is committed to helping patients who have no available therapeutic options and may benefit from access to the investigational drug that the company is developing. Access to an Oncoceutics investigational product may be appropriate when all of the following apply:
- The patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- The requested Oncoceutics’ investigational product is under active clinical development and there is sufficient data available to identify an appropriate dose and formulation for the investigational drug therapy.
- Patient enrollment in a clinical trial with Oncoceutics’ product is not possible, i.e. treating physicians interested in treating their patients with Oncoceutics’ investigational products must first try to enroll the patient in a clinical trial.
- Providing the investigational product will not interfere with investigational trials that could support the development or marketing approval for the investigational product, and adequate supply of the investigational product exists for Expanded Access use after meeting the needs of clinical trials and other existing patients treated with the investigational product.
- Treating physician and Oncoceutics agree that a potential patient benefit justifies the potential risks of the investigational treatment.
- The treating physician submits a request for Expanded Access. The physician requesting Expanded Access to the investigational drug must be properly licensed and qualified to administer the product. The physician must comply with the company’s general requirements for expanded use and with restrictions defined by Oncoceutics for the particular patient and/or investigational drug.
- An agreement to treat the patient under the Expanded Access policy is able to be established with the treating institution (and/or physician).
To seek access to an investigational product via Expanded Access, the following steps must be followed:
- Treating physician interested in treating a patient with Oncoceutics investigational product that is under active clinical investigation must review Oncoceutics’ Expanded Access Policy herein and submit a written request to firstname.lastname@example.org. Physician is advised to not include any identifying personal health information (PHI).
- Making a request to Oncoceutics does not guarantee access to an investigational drug, and the company might ask the treating physician to evaluate the patient for ongoing clinical trials with the investigational drug.
- The time to ultimately deciding to grant or deny the request will depend on the completeness of the initial request and the ability of the treating physician to provide additional information as requested.
- After review, the treating physician will be informed of the results, and the request may be sent to the local IRB.
Oncoceutics is committed to a fair and impartial evaluation of each request for access to our investigational products by our medical team based on the scientific and clinical evidence available at the time of the request. Oncoceutics cannot guarantee the provision of the investigational product to a particular patient even if the criteria are met. In addition, as data and knowledge of Oncoceutics’ investigational products are constantly evolving, requirements for the Expanded Access program may change over time. The decision to provide investigational product lies ultimately at the discretion of Oncoceutics. At this time, the Expanded Access program is only available for patients who are being treated in the United States.