Biodexa Pharma’s Expanded Access Policy
Biodexa Pharma is committed to improving the lives of both adult and paediatric patients with malignant gliomas. We are developing innovative treatment options for patients with Glioblastoma Multiforme. We conduct clinical trials in these indications at various hospitals across the USA and Europe and believe that participating in clinical trials is an important and very valuable way for the patients to get access to investigational treatment options before these get approved by regulatory authorities.
However, Biodexa Pharma recognises that not every patient may meet pre-defined eligibility criteria for participation in clinical trials. Under very specific circumstances, these patients may become eligible for receiving investigational treatment outside of a controlled clinical trial through a compassionate use programme, also known as ‘expanded access’.
Eligibility criteria for access to investigational treatment through the expanded access policy
The following criteria should all be typically met before the patient is considered for access to the investigational treatment through the expanded access policy:
- The disease is serious or life-threatening;
- The patient is ineligible or unable to participate in any ongoing clinical study of the investigational product;
- All other available alternative therapies have been exhausted, but the patient may still benefit from further treatment with a Biodexa investigational product;
- The investigational therapy must be part of an active clinical development program, typically in Phase 2 or later and not yet approved or placed on clinical hold;
- Granting access to an investigational, unapproved drug through the expanded access policy should not delay, interfere with, or compromise the completion of clinical trials that are run to support approval by regulatory authorities;
- The use of the investigational product in an expanded access protocol is compliant with local rules and regulations;
- There must be a sufficient supply of the investigational medicinal product to reasonably accommodate the likely delivery method and duration of treatment;
- There must be adequate access to a device or a set of devices used for delivery of the investigational product at the proposed location of treatment and a treating physician(s) must have adequate demonstratable experience in using such device(s);
- The treating physician must be qualified, agree to directly supervise treatment, be willing to provide relevant data to support regulatory submissions, and must otherwise comply with relevant regulations, including those relating to safety reporting;
- There must be sufficient clinical data to identify an appropriate dose and treatment regimen;
Any such programme will be discontinued as soon as either of the criteria below are met:
- Commercial availability of the medicine for a particular need or condition, at which point it would be more broadly available to these patients in need;
- A negative regulatory decision, or Biodexa’s decision not to proceed with and/or the discontinuation of clinical trials, or commercialization for a particular disease or condition. In this instance, patients on expanded access treatment at the time of such a decision may be allowed to continue to access therapy until disease progression;
- New information becomes available about the activity or safety of a medicine that could substantially change its benefit/risk profile;
- Limited product supply or other manufacturing issues.
If you are a patient:
- Start by reviewing the criteria mentioned above;
- You may also wish to login to www.clinicaltrials.gov and read more about clinical trials we are conducting and whether you might be eligible to participate in one of them;
- If you’d still like us to consider your eligibility for the expanded access to our investigational product, please speak with your treating physician as any requests for the access may only be made by them.
If you are a treating physician:
- Start by reviewing the expanded access policy eligibility criteria mentioned above;
- In the U.S., physicians may find additional information regarding expanded access to investigational therapies by visiting the U.S. Food and Drug Administration website: Expanded Access: Information for Physicians. For non-US physicians, please refer to your own country relevant regulations;
- If you believe your patient meets the criteria and would like to submit questions or a request for access, please send an enquiry to firstname.lastname@example.org We would usually acknowledge receipt of such request within 5 business days.
Posting of this policy by Biodexa Pharma shall not serve as a guarantee of access to any investigational drug of the company for any patient.
Reports & Presentations