EXPANDING PATIENT ACCESS TO ONCOSEC’S INVESTIGATIONAL THERAPIES
Section A: Introduction
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. 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 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.
Section B: Decision Criteria for Considering an EAP
The following criteria must be met before OncoSec will consider establishing an EAP for an OncoSec investigational therapy:
There is an unmet medical need that cannot be met by existing products
The benefit-risk profile of the drug in the indication and the patient population is positive
There is a good understanding of the likely indication to be approved
There are definite plans to file and commercialize the drug in the region
The program will be fairly and equitably available to the population of the region in question
The program is compliant with local rules and laws
There are adequate supplies of investigational product to meet the needs of the EAP without impairing the clinical trials program
The program must be discontinued as soon as feasible when approval of the drug is achieved in the country
Section C: Process for Seeking Access
Patients should consult with their healthcare provider about their eligibility to enroll in any of OncoSec’s clinical trials and expanded access programs. To get more information about available OncoSec clinical trials, visit http://oncosec.com/clinical-pipeline/current-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:
A scientifically justified rationale for the theoretical benefit that the investigational therapy could provide
A statement that approved therapies typically used to treat the disease have been exhausted and the patient is no longer responsive to, or able to tolerate, these therapies
A statement that there are no other viable therapy options, including participation in ongoing relevant clinical trials
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.