Expanded Access Policy

ITB-MED is a biopharmaceutical company developing immunomodulatory biologics for patients with life-threatening diseases.  Clinical trials are an essential part of the development and registration of innovative products. They enable the collection of robust safety and efficacy data on investigational products to support regulatory approval.  At ITB-MED, we are focused on conducting the clinical trials necessary to achieve regulatory approval and commercialization of our innovative products.  Clinical trials follow strict scientific standards designed to produce reliable data and results. Where possible, use of an investigational drug within a clinical trial is preferable because clinical trials follow protocols designed to monitor and safeguard patient experiences with a product, and because trials generate data that may lead to the approval of therapies allowing for wider use. We believe that participation in our clinical trials represents the most efficient manner to obtain access to our investigational products.  Information about our clinical trials can be accessed at https://clinicaltrials.gov/.

We recognize that not every patient with a serious or life-threatening disease can participate in a clinical trial.  These patients may be willing to try an experimental drug for which robust clinical information about efficacy is not yet available. These programs can be referred to by different names; two common ones are “expanded access” and “compassionate use.” In such circumstances, the use of investigational products is allowed by both the U.S. Food and Drug Administration and the U.S. government under Expanded Access regulations.

Consistent with such regulations, ITB-MED supports efforts to provide rapid access to investigational drugs for patients diagnosed with a serious or life-threatening disease or condition, who have exhausted approved treatment options, and who are not eligible for clinical trials.  In such instances, where the following criteria are met, we will consider providing a requesting physician with access to one or more of our investigational drugs:

• An independent request has been made by a qualified healthcare provider with expertise appropriate for the administration of the drug and for managing the patient;
• The patient has a serious or immediately life-threatening disease or condition with no satisfactory alternative therapy (such as approved products or clinical trials);
• The patient is unable to participate in a clinical study of the investigational drug, which includes lack of access to clinical trial sites due to geographic limitations;
• Sufficient information exists to reasonably believe the potential benefit of treatment outweighs the potential risk in the context of the disease or condition to be treated;
• There is an adequate supply of the investigational medicine and providing the product to the requesting physician will not interfere with ongoing clinical studies; and
• The patient meets any other important medical criteria established by the medical experts working on the product development program

All requests for expanded use must be submitted by a licensed physician at expanded.access[at]itb-med.com. The physician’s request will be reviewed by ITB-MED’s medical and regulatory experts, and we aim to respond within 5 business days. We may request additional information to assist with our analysis.  All information submitted as part of a request will be maintained in the strictest of confidence and used solely for evaluating eligibility.