Perspective Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today announced that the U.S. Food and Drug Administration (the "FDA") granted Fast Track Designation for the development of 212Pb VMT01 for the diagnosis and treatment of patients with unresectable or metastatic melanoma and who have demonstrated MC1R tumor expression. Melanocortin 1 receptor, or "MC1R," is a protein that can be overexpressed in metastatic melanoma.
The FDA's Fast Track Designation is one of several approaches utilized by the FDA to expedite development and review of potential medicines for serious conditions and that fulfill unmet medical needs.1 Programs that receive Fast Track Designation are entitled to more frequent interactions with the FDA on the development of a drug development plan, as well as eligibility for accelerated approval, priority review, and rolling review.
"We are pleased with the FDA's recognition of the need for additional treatment options for patients with metastatic melanoma," said Dr. Markus Puhlmann, Perspective Therapeutics' Chief Medical Officer. "We are dedicated to working closely with the agency to accelerate VMT01's clinical development. Having recently completed the observation period for dose limiting toxicity in seven patients enrolled in Cohort 2 of our Phase 1/2a study, we look forward to sharing safety observations with the Safety Monitoring Committee ("SMC") and in a scientific forum later this year. Additionally, pending institutional review board approval, we plan to open a VMT01/anti-PD-1 combination cohort."
About VMT01
Perspective designed VMT01 to target and deliver 212Pb to tumor sites expressing MC1R, a protein that can be overexpressed in metastatic melanoma tumors. The Company is conducting a multi-center, open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05655312) in patients with histologically confirmed melanoma and MC1R-positive imaging scans.
About Melanoma
Melanoma is a cancer of the skin arising from uncontrollable growth of melanocytes, the melanin producing cells of the body. Metastatic melanoma is the result of melanoma that has progressed through the layers of skin, infiltrated the blood stream or lymphatic system, and traveled to other areas of the body to metastasize. In the United States, there are approximately 100,000 new diagnoses of melanoma annually and approximately 8,300 deaths annually from metastatic melanoma.2 Recent advances have led to survival improvement, but there remains a high unmet need for additional treatments, particularly for patients with metastatic disease3 who are refractory to front-line therapy.
About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc. is a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. The Company has proprietary technology that utilizes the alpha-emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting peptides. The Company is also developing complementary imaging diagnostics that incorporate the same targeting peptides, which provide the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity.
The Company's melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs have entered Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions. The Company has also developed a proprietary 212Pb generator to secure key isotopes for clinical trial and commercial operations.
For more information, please visit the Company's website at www.perspectivetherapeutics.com.