The diagnostic and therapeutic products can be centrally manufactured and shipped as finished product direct to the treatment centres, which removes the need for dedicated radiopharmacy facilities at treatment centres.
Dr Alan Taylor, Clarity's Executive Chairman, commented on the IND approval, "The FDA response suggests not only the importance of developing novel treatments for men with late-stage prostate cancer, whose prognosis is currently very poor, but also validates Clarity's copper pairing paradigm and the centralised manufacturing concept, which differentiates it from the competitor products and enables product supply to the levels suitable for use in large patient indications."
"We are very excited to commence the SECuRE trial in mCRCP patients and have engaged a world class group of key opinion leaders in the prostate cancer space to support the development of 64/67Cu SAR-bisPSMA. Clarity's Global Clinical Development Group has unrivalled experience in the commercialisation of the only currently approved radiotherapeutic for prostate cancer. The FDA response is a crucial milestone in the development of SAR-bisPSMA theranostics and we are looking forward to progressing this trial at some of the leading cancer centres in the U.S. as part of our ultimate goal of developing better treatments for children and adults with cancer," said Dr. Taylor.
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About Clarity
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing targeted therapies based on its SAR Technology Platform for the treatment of cancer and other serious diseases in adults and children.
SOURCE Clarity Pharmaceuticals
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