Expanded Access Policy
Wugen is a clinical-stage biopharmaceutical company focused on discovering and developing safe and effective next-generation cellular immunotherapies for the treatment of cancer.
The best way for Wugen to achieve these goals is to complete the clinical studies necessary to demonstrate safety and effectiveness of our investigational products. Patient enrollment in such clinical trials is essential for drug approval.
What is Expanded Access?
“Expanded access” programs are a means by which biopharmaceutical manufacturers may, in limited circumstances, provide investigational products to physicians to treat seriously ill patients. Under an expanded access program, a company may provide an investigational product to physicians for administration to patients with limited to no therapeutic alternatives, who are ineligible or unable to participate in a clinical trial, and who may nonetheless desire access to an investigational product.
Does Wugen Consider Expanded Access Requests?
Wugen designs its clinical studies for development of new potential therapies to determine the safety and efficacy for medical use consistent with approval requirements of the US Food and Drug Administration (FDA) and similar regulatory authorities in other countries. Treating physicians should consider approved therapies for a patient’s disease as well as on-going clinical studies before seeking expanded access use with an investigational agent.
At this time, based on these factors, Wugen believes that participation in one of our clinical trials is the only appropriate way to access our investigational cell therapies. We do not currently provide our investigational cell therapies for use through expanded access.
What Does the Company Consider in Evaluating Requests?
The decision to establish an expanded access program is dependent on a few key factors consistent with the FDA and other regulatory agencies’ guidelines. These include, but are not limited, to the following:
- The illness for which the investigational cell therapy is being considered must be serious or life-threating, with no other satisfactory treatment options (such as approved products or enrolling clinical trials);
- There is sufficient evidence that the potential benefit of the investigational cell therapy to the patient would likely outweigh the potential risks, based on all available safety and efficacy information; and
- Providing the investigational cell therapy as part of an expanded access program will not interfere with clinical trials that could support the investigational cell therapy’s development or marketing approval for the treatment indication.
In the future, Wugen may, on a case-by-case basis, consider requests by treating physicians to file an investigational new drug application for expanded access to Wugen investigational products in Phase 2 or Phase 3 of development and for Wugen to supply such investigational product. There is no guarantee of expanded access to an investigational product. For information about Wugen’s current investigational products in development, please visit ClinicalTrials.gov.
If you are a patient who is interested in accessing our investigational cell therapies, please speak with your physician. You may also learn more about ongoing clinical trials by going to www.clinicaltrials.gov and searching for Wugen, Inc.
If you are a physician who is interested in learning more about our investigational cell therapies, or participating in our clinical trials, please submit a request to email@example.com.
Wugen cannot guarantee access to any Wugen investigational agent and reserves the right to grant or deny a request in its full discretion.
Wugen reserves the right to revise these policy statements in whole or in part at any time, without notice.