On October 3, 2019 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported that it has received a response on its Investigational New Drug (IND) application that the study may proceed from the U.S. Food and Drug Administration (FDA) for a Phase 1-2a theranostic (i.e. diagnostic and therapy) trial with 64Cu-SARTATE and 67Cu-SARTATE in paediatric patients (Press release, Clarity Pharmaceuticals, OCT 3, 2019, View Source [SID1234540032]).
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This trial will be using Clarity’s lead product, SARTATE, administered to paediatric patients with somatostatin receptor-2 positive, relapsed or refractory, high-risk neuroblastomas. It is a multi-centre, dose escalation, open-label, non-randomised, Phase 1-2a theranostic clinical trial planned for up to 34 patients using 64Cu-SARTATE for PET imaging and 67Cu-SARTATE for therapy.
The FDA response suggests not only the importance of the study in the treatment of neuroblastoma, but also validates the manufacturing of 64Cu-SARTATE and 67Cu-SARTATE to levels suitable for diagnostic and therapeutic use, as well as the suitability of the centralised manufacturing concept of this theranostic pairing.
Neuroblastoma is a disease that occurs most often in infants and young children, usually in children younger than 5 years old. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 13% of paediatric cancer mortality. High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.
This study is supported by a human imaging study in 10 adults with neuroendocrine tumours and preliminary results of a first-in-human study of adult patients with meningioma, who were administered a diagnostic dose of 64Cu-SARTATE followed by up to four doses of the therapeutic product,67Cu-SARTATE.
Dr Alan Taylor, Clarity’s Executive Chairman, commented on the IND approval "The acceptance of Clarity’s first IND application in a relatively short time indicates the quality and importance of work conducted by our preclinical, clinical and manufacturing teams in the field of theranostics and reflects the support for the development of novel treatments for children with cancer. We are very pleased to have achieved this significant milestone. Our Team is looking forward to progressing this trial at some of the leading cancer centres in the U.S. and we are hoping to commence recruitment shortly which will get us one step closer to our goal of better treating children and adults with cancer."
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Dr Alan Taylor
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