Expanded Access Program

Compassionate Use Program

for Certain Pediatric Cancers

Biomarck has a limited compassionate use program in place that has supported children with difficult to treat cancers such as rhabdomyosarcoma and neuroblastoma, as part of a collaboration with the Live Like Bella Foundation which supports children with cancer, their families, and research into childhood cancer.

Frequently Asked Questions

Who do we contact for more information?

Your physician can email to CompassionateUse@livelikebella.org for more information.

What is BIO-11006?

BIO-11006 is an investigational peptide medication delivered by nebulizer which has shown activity in the laboratory and in animal studies in certain types of cancer. It has been studied in adult lung cancer. BIO-11006 has been given to over 200 patients with COPD (chronic bronchitis and emphysema) and been shown to have a good safety profile at the recommended dose. It has not been given to children or cancer patients in controlled clinical studies.

What types of childhood cancers has BIO-11006 been tested on in the laboratory?

BIO-11006 has shown an effect on isolated rhabdomyosarcoma, neuroblastoma, sarcoma and glioma cells (in vitro).

My child has cancer and has not responded to available treatment – are they a candidate for compassionate use?

Your treating clinical oncologist should determine if the child is a candidate using the above guideline from the FDA.

Where can I find out more about the FDA’s Expanded Access policies?

The FDA has issued updated guidelines to “expanded access” (often known as compassionate use) for patients to gain access to treatment with an investigational product when they have not responded to all currently available approved products and a clinical trial is not available or they do not meet the criteria for any clinical trial. See FDA guidelines 21 CFR part 312 subpart 1.

Are there costs for the patient if the drug is provided?

Biomarck has committed to provide the drug free of charge. However supplies are limited.

Will the drug help extend or save my child’s life?

We do not know the effectiveness of the drug in a child with cancer.