EP0031 Expanded Access Policy

Ellipses Pharma Ltd | EP0031 Expanded Access Policy  | Last updated: February 2024

Ellipses Pharma Limited is a clinical-stage precision drug development biotechnology company focused on developing novel therapies for cancers. We conduct clinical trials to evaluate the safety and efficacy of investigational product candidates.
Ellipses encourages awareness of, and participation in, our clinical trials. For information regarding these trials, please visit clinicaltrials.gov and search for Ellipses Pharma.

Our current focus is to complete our ongoing clinical trial for EP0031 to demonstrate safety and efficacy and to obtain regulatory approval and provide widespread availability of EP0031.

Prior to regulatory approval by global regulatory authorities, patients gain access to investigational treatments, including Ellipses’ development candidates, by participating in clinical trials. In certain cases, when it is not possible for a patient to participate in a clinical trial, and where all other available medical options have been exhausted, a patient’s doctor may attempt to seek special access to an investigational product candidate for that patient outside of a clinical trial. This is known, among other terms, as expanded access or compassionate use.

For a patient to obtain access to an investigational product candidate through expanded access, the patient’s doctor, the drug’s sponsor and the regulatory authority in the doctor’s country of practice (e.g., FDA in the US or the MHRA in the UK etc) must all approve the use. Unlike the use of an investigational new drug in a clinical trial setting, the primary purpose of expanded access is to use the investigational drug for patient treatment purposes, rather than to gather data on safety, tolerability and effectiveness.

Currently, Ellipses Pharma does not offer an expanded access program. We believe that access to our investigational product candidates should be limited to controlled clinical trials until such time as their safety, tolerability and effectiveness have been determined and confirmed by regulatory authorities.

Additionally access to our development candidates before dose and dosing regimen have been optimized and safety and tolerability have been confirmed may not be in the best interest of patients.

Accordingly, while clinical trials are ongoing, we believe participation in our clinical trials are the only safe and appropriate way to access our investigational product candidates.

In accordance with the 21st Century Cures Act this policy may be revised at any time and will be shared with the public on the Company website (ellipses.life) and the Reagan-Udall Foundation Expanded Access Navigator (navigator.reaganudall.org)

Should Ellipses Pharma decide to make its investigational medicinal products available on an expanded access basis, this policy will be updated with a hyperlink to the expanded access record on clinicaltrials.gov after that record becomes active.

If you have questions about Ellipses Pharma’s expanded access policy, please contact us at expanded.access@ellipses.life

Ellipses Pharma Limited may revise this policy at any time.