Sangamo is committed to translating groundbreaking science into tomorrow’s genomic cures.
Developing these innovative therapies – from the laboratory to the marketplace – is a thorough process with multiple steps designed to ensure the therapies are safe and effective. It can take years to complete.
We feel an urgent responsibility to advance new therapies as rapidly and efficiently as possible because we know there are patients who need them now – patients who otherwise lack suitable therapies to treat their condition.
Some patients with serious or immediately life-threatening diseases who could potentially be aided by our investigational therapies may not be eligible for or able to participate in our clinical studies. For them, Sangamo is working expeditiously to conduct necessary clinical studies to generate sufficient safety and efficacy data to determine if an early/expanded access program is safe and appropriate. We are committed to having our work make its earliest possible contribution to patient health and well-being.
Typically, investigational therapies need to reach Phase 3 clinical trials before there is sufficient safety and efficacy data to determine if an expanded access program is appropriate. None of the programs for which Sangamo controls the clinical trials has reached Phase 3 yet. When that time comes, we will announce any early/expanded access program involving our therapies well in advance of launch.
Any future expanded access program Sangamo establishes will be consistent with our commitment to patient safety and the safeguards that are in place to protect public health. In addition, these important principles will apply to any Sangamo program:
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