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news.Molecular Insight Pharmaceuticals has begun its phase I/II trial for Azedra in malignant pheochromocytoma, a tumor of the adrenal gland.
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According to the company, the clinical trial is designed to determine therapeutic dosing and evaluate the safety and efficacy of Azedra, a targeted radiotherapeutic, which consists of the known I-131-MIBG molecule, radiolabeled using the company’s proprietary Ultratrace technology.
Phase I of the trial will be a dose-ranging study to determine the maximum tolerated dose of Azedra to be administered in phase II of the study. Phase II, meanwhile, is designed to determine the safety and efficacy of Azedra as a monotherapy.
The primary endpoint in phase II will be to assess objective tumor response at nine months following treatment with Azedra. Secondary endpoints will examine objective tumor response rate at three, six and 12 months, biochemical response rate and validated quality of life measurements.
The company said that Azedra has already demonstrated high tumor uptake in preclinical studies and favorable pharmacokinetics in a recently completed phase I dosimetry trial.
“This trial is a key part of our commitment for developing targeted radiotherapeutics for life-threatening disease,” said David Barlow, chairman and CEO of Molecular Insight. “In addition to proving the clinical potential for Azedra, it demonstrates our strategy to leverage our Ultratrace technology platform.”
Azedra has received orphan drug status and a fast track designation by the FDA.