Expanded Access Policy

At Oncoinvent, we are committed to developing new innovative products to provide better treatment options for cancer patients. Currently, our lead candidate Radspherin® is in clinical trials to evaluate its safety and efficacy in patients with metastatic colorectal or ovarian cancer in the peritoneal cavity.

An Expanded Access Policy – sometimes called “compassionate use”, refers to the use of an investigational medicinal product outside of clinical trials. It is a potential pathway for patients to obtain access to investigational therapies under some extraordinary circumstances, in compliance with guidelines on eligibility criteria set out by the US Food and Drug Administration (FDA) and other regulatory agencies. For example, if a patient has a serious or immediately life-threatening disease, and/or the potential benefit to the patient clearly outweighs the collective potential risks, expanded access to a therapy may be considered.

We strive to establish efficacy and safety in controlled clinical trials as early as possible. The scientific evidence generated in these clinical trials is essential to obtain market approvals to make Radspherin® available to as many patients as possible.

At Oncoinvent, we believe that participation in one of our clinical trials is the best way to access Radspherin® in a controlled setting. Our current policy is that Radspherin® will not be available on an expanded access basis. This may change in the future when sufficient safety and efficacy information has been demonstrated in randomized, controlled clinical trials.