Medregen is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness.
Consistent with Medregen’s mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on conducting the clinical trials with MRG-001 necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. In these circumstances, Medregen will consider providing a requesting physician with access to the investigational drug MRG-001, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following but are not limited to:
- The patient has a serious or potentially life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option;
- A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available;
- Making the investigational drug available will not negatively impact or significantly delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and
- Adequate supply of the investigational drug is available.
We continually evaluate the benefit-risk profile of each request based on evolving clinical data. Furthermore, the fact that an investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to requests for other patients whose circumstances and medical histories may be different. Requests will be considered on a case-by-case basis.
Medregen is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician and Medregen may require more detailed medical information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by Medregen whose decisions are final.
Medregen may revise this expanded access policy at any time, including termination of this Expanded Access Policy. Additionally, the posting of this policy does not serve as a guarantee of access to any specific investigational new drug by any individual patient and their physician.
Physicians seeking access to Medregen’s investigational drug MRG-001 for patients with no alternative treatment options should submit their requests to expandedaccess@medregenco.com. Medregen regularly monitors this mailbox and will use our best efforts to acknowledge each submitted request within 3 business days after receipt.
Email Address: Expandedaccess@medregenco.com
