Expanded Access Program

Imaging Biometrics (IB) offers expanded access to gallium maltolate (GaM) for the treatment of high grade brain tumors. Oral GaM is the study under investigation in the Phase 1 Clinical Trial sponsored by IB. Participants in the initial trial experienced no adverse effects and the convenience of taking GaM at home further enhances patient comfort and accessibility. 

Physicians and patients can find more information about this program under clinicaltrials.gov (NCT06404034).

We also encourage physicians to contact us directly at eap@imagingbiometrics.com.

EAP language:  When a clinical trial is not an option and the patient has exhausted all available treatments, regulators or health authorities may allow us to provide a treating physician with pre-approval for an investigational drug.  This individual use of an investigational drug is often referred to as  “expanded access” or “compassionate use,” though it may be known by other names. 

It’s important to note that investigational drugs have not yet been approved by the Food and Drug Administration (FDA), meaning their potential risks and benefits are still unknown.  Therefore, doctors and patients should carefully weigh all possible benefits and risks when considering expanded access to an investigational drug.

JENNIFER CONNELLY, MD (STUDY PI)
CHRISTOPHER R. CHITAMBAR, MD (STUDY CO-PI AND CHAIR)
Imaging Biometrics is currently sponsoring the clinical trial of the oral drug Gallium Maltolate for recurring glioblastoma. In addition, IB provides image analysis for evaluating the response to Gallium Maltolate treatment in patients. 

Dr. Jennifer Connelly, MD, Associate Professor of Neurology at the Medical College of Wisconsin, is the Principal Investigator of the clinical trial with Dr. Christopher Chitambar, MD, serving as co-PI and Chair. Both are long-standing collaborators with Dr. Kathleen Schmainda, PhD, a co-founder of Imaging Biometrics, LLC, and a recognized leader in brain tumor imaging. 

The treatment evolved from research led by Dr. Chitambar and his lab to study iron-dependent processes in cancer biology and the mechanisms by which gallium compounds target iron metabolism and block malignant cell growth. In preclinical studies, Dr. Chitambar and Dr. Schmainda, discovered that when administered intravenously, Gallium Maltolate (GaM) significantly slowed the growth of glioblastoma in a rat brain tumor model. Additional studies showed that GaM, administered orally to glioblastoma-bearing rats, significantly reduced the size of their tumors and prolonged survival.

GaM is an orally available form of the metal gallium, which, in the body, shares many chemical properties with the highly oxidized form of iron, Fe(III). Numerous studies examining the relationship between iron and cancer show that increased levels of iron in the body can be associated with increased cancer risk and severity, due to cancer cells’ dependence on iron to multiply and spread. Cancer cells take up gallium instead of iron, preventing their multiplication, ultimately leading to their death.