Author: Sophia Paspal, Ph.D.; RAC Vice President of Regulatory Affairs and Quality Assurance
Approval: Jason Wu, Ph.D. Chief Operating Officer
Xynomic Pharmaceuticals, Inc. 3500 South DuPont Highway, Suite SS101 Dover, DE 19901 USA
Xynomic Pharmaceuticals, Inc.
Xynomic Pharmaceuticals, Inc. (Xynomic) is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness. Xynomic development resources are focused on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of our investigational products, and to obtain regulatory approval. Xynomic is committed to making investigational products available to seriously ill patients who have exhausted other treatment options. A treating physician, who is able to comply with the requirements that are stated in this document, may request information about how to apply for access to Xynomic investigational products by contacting the Company. The purpose of this policy is to describe the requirements for Expanded Access to Xynomic investigational products to patients outside of a clinical study.
This policy applies to provision of access to a Xynomic investigational product that is not approved for any purpose in the country from which the request is intended to be used. This also includes the time period between regulatory approval of an investigational product and its commercial availability in a country.
3. POLICY STATEMENT
Any use of a Xynomic investigational product outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including Xynomic policies and procedures. In general, where permitted by local regulation, the investigational product supplied via Expanded Access may no longer be provided by Xynomic when it becomes available via the local healthcare system. Xynomic may decide not to provide an investigational product under this policy if the Company does not intend to market the product in the country.
3.1. Patient Eligibility Criteria To be eligible for access to an investigational product, patients must meet the following criteria: • Suffer from a serious or immediately life-threatening disease or condition.
Xynomic Pharmaceuticals, Inc.
• Have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition. • Are ineligible for participation in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations. • The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational product and the benefit outweighs the known or anticipated risks. • There is adequate information to support appropriate dosing for a special population patients such as pediatric, elderly, renal or hepatic disease, etc. • Any other pertinent medical criteria for access to the investigational product, as established by the Xynomic clinically or medically responsible individual.
3.2. Investigational Product Criteria In addition to the patient eligibility requirements, the investigational product must meet the following criteria: • The product is under investigation in one or more clinical studies. • There is sufficient evidence to expect that the investigational product will have an acceptable safety profile for the intended patient population. • The provision of the investigational product will not interfere with or compromise the clinical development of the product.
3.3. Treating Physician Criteria and Responsibilities The physician(s) attending to the patient(s) who is/are receiving an investigational product through compassionate use access is (are) properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with: • Any applicable country-specific legal and regulatory requirements related to providing an investigational product under Expanded Access. • Any Xynomic requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property. A treating physician may submit questions or requests regarding expanded access to EA@xynomicpharma.com
We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each compound under development is different and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. Requests will be considered on a case-by-case basis.
Xynomic Pharmaceuticals, Inc.
Xynomic is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Xynomic may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by Xynomic, whose decisions are final. Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to EA@xynomicpharma.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 5 business days after receipt.