Expanded Access Policy
SynOx Therapeutics is a clinical stage biopharmaceutical company developing emactuzumab for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other macrophage-mediated diseases. Our mission is to establish emactuzumab as a best-in-class drug of choice to address the unmet medical needs, and improve the quality of life, of as many patients as possible.
We are a science-driven company committed to putting patients first. Our goal is to provide access to emactuzumab at the appropriate time and in the correct manner for patients.
Clinical trials are an essential part of the development and registration of new medicines as they enable the collection of robust safety and efficacy data to support regulatory approval.
Expanded access, sometimes called “Compassionate Use”, “Named Patient Supply”, or “Special Access Schemes/Programs”, refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. We understand the importance of expanded access programmes, and we recognize the need to have an appropriate policy.
Synox Therapeutics will consider the following criteria when considering making emactuzumab available to patients under an expanded access programme:
- The patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrolment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
At this time, SynOx Therapeutics believes that participation in our clinical trial is the most appropriate way to access emactuzumab. SynOx Therapeutics continues to assess the eligibility requirements and criteria for Early Access to the investigational drug emactuzumab will re-evaluate this policy from time to time.
If you are a patient who is interested in accessing emactuzumab, please speak with your physician. If you have additional questions, please contact:
Information about SynOx Therapeutics’ clinical trial may be found here:
https://www.clinicaltrials.gov and search for Synox.
If you are a physician who is interested in learning more about our investigational drugs, or participating in our clinical trials, please submit a request to
We anticipate acknowledging receipt of requests sent to this email within five business days.
SynOx Therapeutics Limited
3 Dublin Landings, North Wall Quay
Dublin 1
D01 C4E0
Ireland
SynOx Therapeutics UK Limited
John Eccles House
Robert Robinson Avenue
Oxford Science Park
Oxford
OX4 4GP
UK
