Expanded Access Program to Investigational Therapies
Ayala Pharmaceuticals Inc. (Ayala) is committed to developing safe and effective therapies for patients with cancer, and we believe in collaborating with patients, families, patient advocacy organizations, physicians, researchers, and regulatory authorities to accomplish this goal.
We believe that wherever possible participation in a clinical trial is desirable and important as these trials are designed to generate comprehensive safety and efficacy data necessary to enable regulatory authority review of our investigational therapies and provide appropriate guidance to treating physicians.
In cases when a patient may not qualify for a clinical trial, or there may be no trials available, or all available and appropriate treatment possibilities have been exhausted, Ayala may consider providing access to eligible patients through our Expanded Access Program (EAP). This refers to the use of an Ayala investigational drug outside of clinical trials and prior to its commercial availability.
Criteria for Considering a Request for Expanded Access
Ayala is committed to reviewing all requests for Expanded Access (EA) in compliance with international and local regulatory requirements. A number of factors are taken into account by Ayala when considering requests for EA. They include:
- The patient’s illness must be serious or life-threatening
- There must be no other satisfactory treatment options available to the patient
- Patient enrollment in a clinical trial is not possible
- There is sufficient evidence, based on available safety and efficacy data, that the potential benefit to the patient justifies the potential risks of treatment
- Granting access to the investigational therapy must not interfere with Ayala’s ability to supply investigational therapies to patients participating in ongoing clinical trials or otherwise compromise the overall clinical development program
- Granting access to the investigational therapy will not delay ongoing clinical trials or interfere with or delay regulatory submissions intended to make the therapy more broadly accessible
Making a Request for Expanded Access
We encourage patients to speak first with their physician about their eligibility to enroll in a clinical trial.
If a treating physician believes expanded access may be the only option for a patient, the physician should contact Ayala to make a formal request on behalf of the patient.
Formal requests should provide the physician’s contact information, relevant qualifications, medical rationale for the request, including an explanation of why no comparable or satisfactory therapy is available; i.e alternative therapies cannot be used, why the patient does not qualify for an ongoing or planned clinical trial, why the potential benefit from the use of the investigational product outweighs the potential risks and why those risks are not unreasonable in the context of the disease or condition being treated.
The request should be sent to EAP@ayalapharma.com.
The request for access to an investigational therapy can only be considered if the patient’s treating physician is committed to, and supportive of, the requested treatment.
In addition, Ayala will only consider access to its EAP in countries where Ayala has sites open for its ongoing clinical trial(s).
Treating physicians, patients, and/or caregivers interested in learning more about Ayala’s investigational therapies currently undergoing clinical trials can find more information on clinicaltrials.gov. If you have additional questions, please speak with your physician or contact EAP@ayalapharma.com.
We anticipate acknowledging receipt of requests sent to this email within three weeks.
Ayala may revise or discontinue this policy at any time.