Patient Access to T-Guard®

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At Xenikos, we are committed to making our investigational drug, T-Guard, available to patients as early as possible.

Until marketing authorization is obtained, enrolling in an ongoing clinical trial is the primary way that patients can gain access T-Guard.

These clinical trials are designed and executed in accordance with the latest standards in order to ensure the highest data quality and integrity, thus providing regulatory authorities with a reliable risk-benefit assessment.

To learn more about our ongoing and upcoming clinical trials, please visit clinicaltrials.gov and clinicaltrialsregister.eu and search for the terms “Xenikos” or “T-Guard”. Patients should enroll in a T-Guard clinical trial where eligibility allows. If this is not possible then T-Guard may also be made available to patients outside of a clinical trial (e.g expanded access, named patient programs, compassionate use), provided that:

• There is an unmet medical need, defined as follows:
• The patient has a serious, life-threatening disease or condition;
• No comparable or satisfactory therapy is currently available; and
• The patient is not eligible and/or able to participate in an ongoing clinical trial involving T-Guard.
• The patient’s physician has determined that sufficient safety and efficacy data (including dosing information) is available to support the use of T-guard.
• The patient is not at greater risk from taking the investigational medicine than when the disease is left untreated.
• The request is made by the patient’s physician and not by Xenikos or any other individual or organization.
• The drug is administered in compliance with all applicable local, regional, and/or national laws and regulations (e.g., in the United States, Xenikos can only deliver T-Guard after both the FDA and the IRB at the patient’s hospital or clinic have reviewed and approved its use in this patient).
• Xenikos has sufficient documented evidence that T-Guard will likely have a net positive risk-benefit profile in this particular case.
• Xenikos has an adequate supply of T-Guard available to complete all ongoing clinical trials.

Xenikos is committed to providing a fair and impartial evaluation of each request for access to our investigational medicines. Therefore, all decisions are based on clinical circumstances and availability of the investigational product.

How to request T-Guard outside a clinical trial setting (Expanded Access)
Patients are encouraged to first speak with their physician to determine whether they are eligible to enroll in a clinical trial. If the physician determines that T-Guard treatment may be the only option available for the patient, but the patient is not eligible for a clinical trial, the physician should contact Xenikos by email (info[at]xenikos.com) in order to make a formal request for access to T-Guard on the patient’s behalf. If applicable, the physician must agree to obtain any required regulatory and/or ethics committee approval. Furthermore, the physician must agree to comply with all safety, monitoring, and patient consent requirements in accordance with Xenikos’ policy and local regulations.

Each request must include the following information:

• Date of the request.
• The requesting physician’s full name, professional title and qualifications, contact information, and full address (including country, state, and postal code, if applicable).
• The name of the requested investigational product (i.e. T-Guard) and the therapeutic indication.
• The medical rationale for the request, including an explanation of why alternative therapies cannot be used and/or why the patient does not qualify for any ongoing or upcoming clinical trials.

At Xenikos, we strive to evaluate each request for expanded access to T-Guard in a manner that is both fair and objective. In addition, we will acknowledge receipt of each request as quickly as possible, typically within 7 working days.

In the event that the request for T-Guard is granted, the physician—who must be properly licensed and fully qualified to administer T-Guard to patients—must agree to comply with all applicable legal and regulatory requirements with the relevant jurisdiction, as well as any additional requirements established by Xenikos, which may include reporting of safety data and protection of intellectual property.

As needed, this web page will be updated to include direct hyperlinks to the relevant expanded access records at www.clinicaltrials.gov as soon as possible after such records become available.

Xenikos reserves the right to revise this policy at any time. In addition, posting this policy does not guarantee that Xenikos can provide expanded access of T-Guard to all patients who request it.