Expanded Access Policy

Gradalis is committed to developing safe and effective therapies that have a positive impact on patient health.  We are a biotechnology company focused on the development and commercialization of novel personalized therapeutics to treat cancer.

Consistent with Gradalis’ mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make medicines broadly available  to patients. Working with clinical investigators and enrolling patients  in our clinical trials to develop new, safe and effective therapies under review of regulatory authorities is our approach to serve patients by developing our therapies.

At the same time, we understand that there are  patients with serious or life-threatening diseases who will not be eligible for any of our clinical trials and may not have other options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. Under specific circumstances and in compliance with regulatory authorities, Gradalis may consider, on a case by case basis, providing patients a pre-approval access to unapproved or investigational therapies, such as Vigil®, for the treatment of an individual patient outside of our clinical trials. Gradalis may consider granting pre-approval access, only when all of the following criteria are met, including but not limited to:

• The patient has a serious or life-threatening illness or condition.
• The patient must have exhausted all therapies available and is no longer responsive to or no longer able to tolerate these treatments;

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 a biological rationale making the investigational drug available to the patient;

• The patient is not eligible for ongoing or pending clinical trials of the investigative drug;
• The request of the investigational drug must come from the patient’s qualified physician or the country’s health authority;
• The requesting physician must agree to comply with all applicable laws and contractual conditions, including safety reporting, and must also be responsible for obtaining all regulatory approvals for their patients’ access to an expanded access investigational drug.
• The investigational drug requested must be in active clinical trial development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
• Making the investigational drug available will not negatively impact or delay the conduct of any ongoing or planned clinical trials or regulatory review or approval of the investigational drug for broader patient access;
• There must be sufficient supply of the investigational medicine to support the expanded access. Supplying the medicine through expanded access must not compromise the supply of medicine available for active or soon-opening clinical trials; and

It is important to remember that investigational medicines have not yet received regulatory approval and therefore their potential risks and benefits are not yet established (safety and efficacy have not been established). Thus, physicians and patients should consider all possible benefits and risks when seeking expanded access to an investigational medicine. For this reason, a patient should seek the advice of his or her treating physician before a request for expanded access is submitted to Gradalis.

Gradalis is committed to a fair and impartial clinical evaluation of each request by a patient’s qualified physician for expanded access to our investigational medicines. Expanded access, however, is not guaranteed.

We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each compound under development is different and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests for patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. As noted, all requests for expanded access will be considered on a case-by-case basis.

Physicians seeking expanded access for patients with no alternative treatment options should submit their requests to info@gradalisinc.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 3-5 business days after receipt. A company representative will contact the applying physician if any additional information if needed to fully evaluate the request.   Each request will be given careful consideration by Gradalis whose decisions are final.