When results from clinical trials suggest that our investigational therapies may offer benefits for patients facing life-threatening conditions, OncoSec is committed to bringing that therapy to those patients as quickly and equitably as possible. OncoSec believes participation in clinical trials should be the primary route by which patients get access to investigational therapies and contribute to the collection of safety and efficacy data needed to support regulatory approval worldwide.
These clinical studies are needed to demonstrate that the therapy meets the standards for safety and efficacy that government regulatory agencies have established for granting approval. Gaining regulatory approval for a therapy is the best way to bring rapid access to the greatest number of patients who may benefit.
For patients with a serious or immediately life-threatening disease who are ineligible or unable to participate in a clinical trial, use of an expanded access program may be an option. Depending on country regulations and the program criteria, access to investigational therapies may be provided through Expanded Access Programs (EAP) (known as compassionate use programs in certain jurisdictions), or Country-Specific Authorization to Use Cohorts.
The following criteria must be met before OncoSec will consider establishing an EAP for an OncoSec investigational therapy:
Patients should consult with their healthcare provider about their eligibility to enroll in any of OncoSec’s clinical trials and expanded access programs. Click here for more information about available OncoSec clinical trials.
If the physician feels that the patient is not able to participate in an available clinical trial and that an expanded access program may be suitable for the patient, the physician should contact OncoSec to make the request on behalf of the patient.
The physician’s request should contain the following:
This will enable the physician to work with experts within the company to determine the appropriate course of action. Physicians seeking help on behalf of their patients in the U.S. may contact firstname.lastname@example.org. All emails will be acknowledged within two business days of receipt. Further information and/or a decision on the request will be sent to the requestor as soon as possible.
Making a request does not guarantee access to the investigational therapy.