At CytomX Therapeutics, we are committed to developing ProbodyTM therapeutics to potentially extend the lives of people with cancer and minimize harmful side effects. At present, our therapies are considered investigational, which means that they have not been approved as safe and effective by regulatory health authorities, such as the United States Food and Drug Administration (FDA).
Expanded access, also called compassionate use, refers to a pathway in which patients with serious or immediately life-threatening diseases may gain access to an investigational therapy outside the context of participation in clinical trials designed to evaluate safety and efficacy.
Providing access to our investigational therapies through an expanded access program is a complex matter to which we have given much thought. We believe it is important not to provide our investigational therapies to patients who are not participating in our clinical trials unless we can offer reasonable assurance that we will not, in doing so, inadvertently cause harm to those patients, nor potentially compromise the broader development program that is being conducted to support product registration.
We believe it is only through diligent adherence to the regulatory development process leading to product registration that we can have the greatest, most positive impact on the patients whom our therapies are designed to benefit.
For these reasons, CytomX is not providing access to any investigational therapies under an expanded access program. We encourage any person with cancer interested in gaining access to our investigational therapies to consult their physician regarding the possibility of participating in one of our clinical trials.