Expanded Access Policy for Investigational Medicines

Argo Biopharma is committed to advancing innovative therapies for patients with serious diseases, including those with urgent and unmet medical needs. 

New medicines undergoing clinical development are often referred to as "investigational medicines" before approval by health authorities. 

We encourage patients to discuss with their licensed healthcare professional whether participating in a clinical trial could be a potential option for them. Clinical trials remain the most appropriate and controlled setting for the use of investigational medicines, ensuring patient safety while contributing to the scientific understanding of  therapy.

Expanded Access

Expanded access (also known as "compassionate use") is a potential pathway that may allow patients with serious or immediately life-threatening diseases to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials, provided that no comparable or satisfactory alternative therapy options are available.

We understand that the FDA encourages companies developing investigational therapies for serious or life-threatening diseases to make them available through expanded access to patients who will not be eligible for clinical trials and who may have no other alternative therapy options. Argo Biopharma appreciates the intent and importance of expanded access programs.

At this time, Argo Biopharma does not provide access to our investigational therapies outside of clinical trials. We believe that participation in well-controlled clinical studies is the most appropriate method for evaluating the safety and efficacy of our investigational medicines and for ensuring the highest standards of patient protection.

Future Considerations

As our clinical development programs advance, we will continue to evaluate the possibility of providing expanded access to our investigational medicines. If and when we have confirmed the safety and efficacy of a medicine through robust clinical data and can ensure an adequate supply of the product, we may consider implementing an expanded access program.

We will update this policy and provide further information on our website as our programs evolve and if our position on expanded access changes.

Contact Information

For questions regarding participation in our clinical trials, please visit clinicaltrials.gov or discuss with your healthcare provider.