Viracta Therapeutics, Inc. is a clinical-stage drug development company focused on advancing new therapies to address a broad range of virus associated cancers and diseases. Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug. The following is Viracta’s policy for evaluating and responding to requests for individual patient access to investigational drugs that are intended to treat serious diseases.
Viracta believes that investigational drugs should be studied in patients as part of clinical trials designed to obtain data on safety and efficacy that may be used to support approval of the product and subsequent wider accessibility to patients. We encourage patients to speak with their physicians and to participate in clinical trials. In rare cases when patients with serious diseases are unable to participate in clinical trials and have exhausted all available therapies, Viracta may consider providing an investigational drug outside of a clinical trial. As a general policy, Viracta will not provide investigational drug until sufficient preliminary safety and efficacy information has been obtained in clinical trials, typically following Phase 2 investigation.
If you are a patient who is interested in accessing our investigational drugs, please speak with your physician, after reviewing the general criteria below. You may also learn more about our ongoing clinical trials by going to www.clinicaltrials.gov and searching for Viracta.
If you are a physician who is interested in learning more about our investigational drugs, or participating in our clinical trials, please submit a request to ClinicalTrials@Viracta.com.
If you are a treating physician, who believes your patient meets the criteria detailed below, and would like to submit questions or requests regarding expanded access, please submit your query to ExpandedAccess@Viracta.com. Please note that requests for expanded access must be made by the physician responsible for treating the patient, and each request needs to relate to a single patient, including sufficient supporting detail to enable Viracta to evaluate the expanded access request. We anticipate acknowledging receipt of requests sent to this email within five business days.
At this time, Viracta believes that participation in one of our clinical trials is the most appropriate way to access our investigational drugs. Several factors, consistent with regulatory agencies’ guidelines, should be taken into account when considering expanded access. These include:
- The investigational therapy must be part of an active clinical development program and not yet approved.
- The patient must have a serious and life-threatening disease with no alternative therapeutic options, including participation in ongoing relevant clinical trials.
- The patient must be ineligible for current clinical trials of the investigational therapy.
- Access to the investigational therapy must not interfere with completion of clinical investigations to support regulatory approval of the investigational therapy, which would make the therapy available to many more patients.
- There must be a sufficient supply of the investigational medicinal product to reasonably accommodate the likely method and duration of treatment.
- The potential benefit must be considered to outweigh the collective potential risks to the patient.
- There must be sufficient clinical data to identify an appropriate dose and treatment regimen.
- There is a good understanding of the actions of the investigational drug in the indication for which use is requested.
- The treating physician must be qualified, agree to directly supervise treatment, be willing to provide relevant data to support regulatory submissions, and must otherwise comply with relevant regulations, including those relating to safety reporting.
- The program must be compliant with local rules and laws.
- The program will be discontinued as soon as feasible when the drug is approved for the relevant use.
In line with the 21st Century Cures Act, Viracta may revise this expanded access policy at any time. Additionally, the posting of the policy by Viracta shall not serve as a guarantee of access to any specific investigational drug for any patient.