Expanded Access Policy
Molecular Templates is developing novel therapies in oncology and other serious diseases through its proprietary biologic engineered toxin body (ETB) drug platform. We are committed to developing safe and effective therapies, obtaining regulatory approval expeditiously, and providing our therapies as quickly as possible to patients who are most likely to benefit. We recognize, however, that patients and physicians may have interest in accessing our investigational therapies through pre-regulatory approval access programs.
We believe that participation in a clinical trial is the best way for patients to access our investigational therapies prior to regulatory approval. Expanded Access, also known as Compassionate Use, provides for an alternative process for the clinical use of an investigational drug or biologic product that has not yet been approved by the U.S. Food and Drug Administration (FDA) to treat, diagnose, or prevent a serious disease or condition. Providing an investigational therapeutic product as part of an Expanded Access Program is a complex matter and is different from studying the unapproved product as part of a clinical trial, where more comprehensive safety and efficacy data are collected.
We understand the need for Expanded Access Programs under certain circumstances, and we recognize the importance of thoughtfully considering all the criteria to have an appropriate policy in place for responding to requests for this kind of pre-approval access to certain investigational therapeutic products. The following criteria, among others, must be considered by clinical trial sponsors when determining whether to accept or grant requests for expanded access to investigational therapeutic products:
- Substantial scientific evidence that the benefit to the patient would likely outweigh the potential risks, based on all available safety and efficacy information;
- Providing the investigational therapy will not interfere with or delay clinical trials that could support further development or marketing approval, and will not adversely impact supply of the investigational therapy that is needed for ongoing or planned clinical trials; and
- The company is able to provide the investigational therapy in a fair and equitable manner and in a manner that is not unduly burdensome.
We always keep patient safety foremost in our research and development efforts, and our main priority is to obtain regulatory approval from the FDA so that each of our therapies can be made available to the largest number of patients as quickly as possible. To date, we have collected limited clinical data on our investigational therapies such that we are currently unable to assess adequately the overall benefits and risks of each. Accordingly, our unapproved product candidates are only available for physician use in clinical trials and we are not accepting expanded access use requests.
We encourage all eligible patients to speak to their physicians about the possibility of enrolling in a clinical trial in order to gain access to our investigational therapies and also to support the development of promising new therapies. Treating physicians, patients, and/or caregivers who are interested in learning more about our investigational therapies and our ongoing clinical trials can find more information by visiting www.clinicaltrials.gov and searching for “Molecular Templates, Inc.” in the Other Terms search field.
We will re-evaluate this policy periodically and upon emerging clinical trial data for our investigational therapies, may revise it at any time. If you have any questions about the Molecular Templates Expanded Access Policy, please contact us at eap@mtem. We kindly ask that you do not send any personal or private health information to this email address.