Radiopharm Theranostics, a developer of a platform of radiopharmaceutical and nuclear medicine products for both diagnostic and therapeutic uses, has announced that its RAD201 breast cancer imaging asset has been the subject of an article published in the peer-reviewed journal Molecular Pharmaceutics.
The journal article, ‘Development of a 99mTc-Labeled Single-Domain Antibody for SPECT/CT Assessment of HER2 Expression in Breast Cancer’, analysed RAD201 as a molecular imaging tracer for the non-invasive detection of HER2 expression, investigating the safety, radiation dosimetry, biodistribution and tumour targeting potential in ten breast cancer patients.
The company said the article confirmed the logistical feasibility of RAD201 while also showing it to be safe and well-tolerated.
The patients were injected with an amount of the drug that produces an effective dose of only 3 millisievert (mSv), slightly less than the average radiation exposure from natural sources that a US resident can expect each year.
"Favourable biodistribution and imaging characteristics were observed, with a clear tumour signal obtained in the primary and metastatic lesions within two hours after injection," said the company.
"The drug was almost entirely eliminated from each patient after 24 hours. Balanced excretion between the renal and hepatobiliary systems also bodes well for use of RAD201 and its therapeutic pair RAD202 as a new potential theranostic approach."
Radiopharm Theranostics managing director and CEO Riccardo Canevari said, “The paper found that using RAD201 can provide an accurate and non-invasive method of identifying HER2 status in breast cancer patients. With additional studies across larger cohorts of patients we can examine this further and compare imaging and pathologic HER2 expression results.”