Crossbow is committed to helping patients who have failed available therapies and may benefit from treatment access to the investigational therapies that we are developing in a manner that is both scientifically and ethically responsible. This Policy for Access to Investigational Agents describes the principles, criteria and government regulations that we will follow when considering a request for access to an investigational agent outside of a clinical trial.

 

1. The investigational therapy must be in active clinical development. Crossbow must be actively studying the investigational therapy in human subjects in the geography where drug is being requested. Restricting access to investigational therapies with active clinical programs ensures that there are personnel trained and responsible for the safe release of the investigational therapy.

2. The patient has exhausted all appropriate standard of care treatments without success and no comparable or satisfactory alternative treatment/prophylaxis is available or exists to treat the disease or condition.

3. The patient is ineligible for participation in any ongoing clinical study of the Crossbow investigational product, which includes lack of access due to geographic limitations.

4. The patient must have a serious disease or condition.

5. There is biological rationale for the disease or condition to be treated, coupled with adequate data to support an assessment that the potential patient benefit justifies the potential risks of the treatment use, and those potential risks are not unreasonable in the context of the disease or condition to be treated.

6. The physician who requests access must be qualified, agree to directly supervise treatment, be willing to obtain relevant health authority approval/clearance, otherwise comply with relevant local and/or country regulations, and agree to follow Crossbows policies applicable to expanded use in general. The physician may be asked to comply with special monitoring procedures and to provide ongoing clinical information, as requested by Crossbow. Such requests would be made in the interest of patient safety and ensuring that a positive benefit-risk ratio persists for the patient.

7. Adequate supply of the investigational drug exists to perform necessary clinical studies in addition to providing access to patients who do not have alternative treatment options.

 

All requests should be submitted by a medically qualified physician. Please initiate the request by completing the web form here and emailing it to clinical@crossbowtx.com. Do not include any patient identifiers in the request. Crossbow is committed to providing a fair and equitable evaluation of all the requests we receive; therefore, all decisions are based on clinical circumstances. Whenever possible, patients will be referred to ongoing clinical studies as the primary way to access investigational drugs. We will review requests on a case-by-case basis, and the fact that our treatment is made available to one patient does not guarantee it will be made available to future patients. We continually evaluate the benefit-risk profile of our investigational drugs and, based on evolving clinical data, we may require additional information from a treating physician to fully evaluate a request. We cannot guarantee that all requests for access will be granted, even when eligibility criteria are met. We regularly monitor the email box that these requests may be submitted to and we will acknowledge each submitted request within one (1) business day after receipt.

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You can find further contact details on the Contact Us page of our website.

 

The publication of this policy by Crossbow is not a guarantee of access to any specific investigational drug by any individual patient.  Crossbow may revise this Expanded Access Policy at any time.