Perspective Therapeutics Announces First Patient Dosed in Phase 1/2a Study of [(212)Pb]VMT-α-NET for Treatment of Advanced SSTR2-Positive Neuroendocrine Tumors
- The announcement of dosing the first patient in the Phase 1/2a trial is a positive step towards evaluating the safety and efficacy of [212Pb]VMT-α-NET. The promising clinical data from an investigator-led study in India and the FDA Fast Track Designation indicate potential for significant improvements in clinical outcomes compared to standard of care [177Lu]DOTATATE.
- None.
SEATTLE, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), announced today that the first patient was dosed at Washington University in St Louis in the Company’s Phase 1/2a trial evaluating the safety and efficacy of [212Pb]VMT-α-NET, a targeted alpha-particle therapy (TAT), in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumors (NETs). The trial is a multi-center, open-label dose escalation, dose expansion study of [212Pb]VMT-α-NET in patients who have not received prior peptide receptor radionuclide therapy (PRRT).
“We are proud of our team’s commitment and progress in bringing our radionuclide therapy to patients suffering from these difficult-to-treat neuroendocrine tumors,” said Thijs Spoor, Chief Executive Officer of Perspective Therapeutics. “Based on the promising clinical data observed in the investigator-led study in India that was presented at the recent European Association of Nuclear Medicine meeting, we believe [212Pb]VMT-α-NET has the potential to provide significant improvements in clinical outcomes compared to standard of care [177Lu]DOTATATE. With our FDA Fast Track Designation for first-line treatment in all neuroendocrine tumors, we plan to rapidly advance this product through clinical development.”
“Although [177Lu]DOTATATE is available to a subset of patients with NETs, we know that few develop objective anatomic responses to therapy and ultimately many patients progress on treatment,” commented Richard Wahl, M.D., Professor of Radiology & Radiation Oncology, Mallinckrodt Institute of Radiology, Washington University School of Medicine in St Louis. “The development of Perspective’s [212Pb]VMT-α-NET targeted alpha particle therapy is an important next step in the evolution of treatments for SSTR2-expressing tumors. We are excited to participate in the trial.”
“We are excited about our collaboration with investigators from top-tier research centers who are evaluating [212Pb]VMT-α-NET in patients with intractable SSTR2-expressing neuroendocrine tumors,” said Markus Puhlmann, Chief Medical Officer of Perspective Therapeutics. “Our goal is to demonstrate that systemic delivery of [212Pb]VMT-α-NET is safe and has the potential to selectively target tumor cells while sparing healthy tissues. We expect to present preliminary findings in early 2024.”
About The Study
This is a multi-center open-label study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET, a targeted alpha-particle therapy, for patients with advanced SSTR2-positive neuroendocrine tumors. The first part of this Phase 1/2a trial is a dose-escalation study designed to determine the Maximum Tolerated Dose (“MTD”) or Maximum Feasible Dose (“MFD”) following a single administration of [212Pb]VMT-α-NET. Patients who have not received prior PRRT will be scheduled to receive up to 4 administrations of [212Pb]VMT-α-NET approximately 8 weeks apart. The first patient cohort will receive 111 MBq (3mCi) per dose. The second cohort will receive administered activities of 185 MBq (5mCi), with cohorts 3 and 4 receiving 370 MBq (10 mCi) and 555 MBq (15 mCi), respectively, if the MTD or MFD is not reached during escalation. According to the Modified Toxicity Probability Interval 2 (mTPI-2) study design, intermediate de-escalation doses are also possible to allow selection of the optimal activity dose to take forward into the dose expansion part of the study.
The second part of the study is a dose expansion phase based on the identified MTD/MFD. Patients with positive uptake on FDA-approved SSTR2 PET/CT will receive a fixed dose of [212Pb]VMT-α-NET IV administered at the recommended Phase 2 dose and schedule determined in the Phase I dose escalation.
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 approximately 175,000 people living with this diagnosis.
About VMT-α-NET
VMT-α-NET is a clinical stage targeted alpha particle therapy (TAT) radiopharmaceutical being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, which are a rare and difficult-to-treat type of cancer. VMT-α-NET incorporates Perspective Therapeutics' proprietary lead-specific chelator (PSC) to bind 203Pb for SPECT imaging, and 212Pb for alpha particle therapy.
About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc., is a diversified medical technology and radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body. The Company has a proprietary technology that utilizes the alpha emitting isotope Lead-212 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 associated with many other types of cancer treatments.
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 in the United States. The Company has also developed a proprietary Lead-212 generator to secure key isotopes for clinical trial and commercial operations.
In addition to its targeted alpha therapy programs, Perspective is the sole producer of Cesium-131 brachytherapy seeds which is commercially available in the United States for the treatment of prostate cancer and other solid tumors.
For more information, please visit the Company’s website at www.perspectivetherapeutics.com.
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