Trial of BMX-001 or Placebo in Head and Neck Cancer Patients
Status:
Withdrawn
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
Summary
There are an estimated 65,000 newly diagnosed cases of head and neck cancer each year in the
United States. The most common treatment for head and neck cancers is radiotherapy in
combination with cisplatin chemotherapy. This treatment regimen is effective in killing the
tumor; however, the normal tissues that line the mouth and throat can sustain severe injury
from the radiation. Side-effects incurred during irradiation include: mucositis, xerostomia,
swelling, trouble swallowing, pain, infections, cavities, hair loss and reddening of the
skin. Some of these side effects can be so severe that patients require feeding tubes and
management of severe pain can lead to the premature halt of radiotherapy. There are currently
no effective radio-protectors used to ameliorate these severe side-effects.
BioMimetix has developed small molecular weight superoxide dismutase (SOD) mimetic, BMX-001,
that is a very potent radio-protector of head and neck tissues. In our first clinical trial
in a head and neck cancer patient cohort using this drug, we have early evidence that BMX-001
may protect against radiation-induced mucositis and xerostomia.
This will be a randomized, placebo-controlled Phase 2 clinical trial to study the effects of
BMX-001 (14 mg/subject biw) + radiation therapy + cisplatin against placebo + radiation
therapy + cisplatin in prevention of acute and chronic mucositis and xerostomia.
Phase:
Phase 2
Details
Lead Sponsor:
BioMimetix JV, LLC
Collaborators:
Duke University University of California, San Francisco