As defined by the US Food and Drug Administration, expanded access, sometimes called “compassionate use”, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Met Vital, Inc. is committed to its healthcare providers and patients who are dealing with Glioblastoma multiforme. We are developing promising new therapies to address the unmet medical needs of patients suffering from rare and seriously debilitating diseases such as glioblastoma.
We currently have a Phase 2 clinical trial for patients with newly diagnosed glioblastoma that will start enrolling in the near future. The investigational drug will be added to the standard of care that patients will already be receiving.
Our goal is to provide access to our investigational drug at the appropriate time and in a manner that is most beneficial to the relevant patient population. We believe enrollment in our ongoing clinical trial is the safest and most effective way of achieving this goal, and we encourage all patients and healthcare providers to visit: www.ClinicalTrials.gov; NCT: 04450160 to learn more about this trial.
However, we recognize that some patients who wish to access our investigational drug will not be eligible for our clinical trial and may have no other viable treatment options available to them. In these situations, Met Vital, Inc. will consider providing pre-approval access to our investigational drug, outside of the clinical trial setting, when certain conditions are met. These conditions are as follows:
- The patient to be treated has a serious or immediately life-threatening illness and there is no satisfactory alternative therapy.
- The patient is not eligible for, or cannot access, any ongoing clinical trials.
- The potential benefit of the investigational medicine to the patient, outweighs the potential risk. This should be evaluated by your physician and discussed in detail with the patient.
- There is an adequate supply of the investigational drug, meaning that MetVital, Inc has surplus investigational drug over and above what is required for the ongoing clinical trial.
- Providing the investigational drug will not interfere with the clinical trial that could support a marketing approval.
Requests for our investigational drug must come from a patient’s treating physician. The requesting physician must be willing to work on designing a treatment protocol and obtain the appropriate regulatory and ethics committee approvals from their Institutional Review Board (IRB). MetVital, Inc will not be responsible for the physician gaining IRB approval. The physician must also comply with various regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting.
MetVital, Inc. is committed to providing a fair and equitable evaluation of all the requests we receive. We will review requests on a case by case basis, and the fact that our investigational drug is made available to one patient, does not guarantee it will be made available to future patients. We continually evaluate the benefit-risk profile of our investigational drug, and, based on evolving clinical data, we may require additional information from a treating physician in order to fully evaluate a request. We cannot guarantee that all requests for access will be granted, even when eligibility criteria are met.
Physicians seeking pre-approval access to our investigational drug should submit their requests to email@example.com. When making a request, the treating physician will need to include the following:
- Name and address of the physician
- Name of their Institution/clinic
- Details of how the patient meets all the conditions outlined above
- When the physician would expect to submit to their IRB and the name and contact information for their IRB.
We will acknowledge each submitted written request within 72 hours after receipt. Incomplete requests may delay, or exclude a request for expanded access. When making a request it is important to not include any patient identifiable information such as name, social security number, address. Also, it is advisable when making a request to be as complete as you can so that we may evaluate the request in a timely manner.
MetVital, Inc wants to thank all our healthcare providers and patients for their continued interest in our promising drug development process.