Perspective Therapeutics Selected by FDA to Participate in the CDRP Program to Expedite Chemistry, Manufacturing, and Controls Development Readiness for VMT-α-NET in NETs

SEATTLE, April 30, 2024 (GLOBE NEWSWIRE) --  Perspective Therapeutics, Inc. (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today announces the selection of investigational product [²¹²Pb]VMT‐α‐NET for the treatment of certain patients with neuroendocrine tumors (“NETs”) by the U.S. Food and Drug Administration (“FDA”) to participate in the Chemistry, Manufacturing, and Controls (“CMC”) Development and Readiness Pilot (“CDRP”) program.

FDA's CDRP Program was initiated in 2022 to facilitate alignment of CMC development of novel products under investigational new drug (IND) applications with expedited clinical development timeframes based upon the anticipated clinical benefits of earlier patient access.

The [²¹²Pb]VMT‐α‐NET IND is for the treatment of Peptide Receptor Radionuclide Therapy (“PRRT”)-naïve patients with somatostatin receptor subtype 2 (“SSTR2”)-positive unresectable or metastatic NETs (including gastroenteropancreatic [“GEP]-NETs” or bronchial NETs and pheochromocytomas and paragangliomas) who have experienced tumor progression on, lack of symptom relief on, or intolerance to, approved therapies. This program was granted Fast Track Designation (FTD) based on preclinical data by the FDA.

Applicants for inclusion in the CDRD Program are required to submit planned CMC tasks and activities intended to yield complete CMC data and information to be included in a marketing application, such as plans for ensuring product availability for commercial launch.

“Our priority is to expeditiously investigate whether [²¹²Pb]VMT‐α‐NET can benefit patients beyond current standard of care in NETs, and if so, be ready to supply patients,” said Thijs Spoor, Perspective Therapeutics' CEO.   “We are grateful to be able to partner with the FDA to that end, and look forward to increased interactions with the FDA on manufacturing readiness.”

“We look forward to collaborating with the FDA while we are establishing a network of our own and partnered facilities strategically placed locally to major metropolitan areas that are within reach for delivery of Perspective’s radiopharmaceuticals for trials and ultimately for commercialization,” said Shane Cobb, Executive Vice President of Operations.

About Neuroendocrine Tumors

Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. According to cancer.net, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors and as a result, there are over 170,000 people living with this diagnosis.