- Ten patients received therapy, with an initial response seen in 7 out of 9 evaluable patients to date.
- Responses observed in both peptide receptor radionuclide therapy-naïve and peptide receptor radionuclide therapy-refractory disease.
SEATTLE, Wash., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), today announced the presentation of encouraging early clinical results from an open-label, single-arm, investigator-initiated study investigating the safety and efficacy of [212Pb]VMT-α-NET, a targeted alpha therapy (TAT), in patients with metastatic neuroendocrine tumors (NETs) and medullary thyroid carcinomas. The results were presented at the 36th Annual Congress of the European Association of Nuclear Medicine (EANM), held in Vienna, Austria, from September 9-13, 2023.
Highlights of the presented results include:
- Ten patients who failed at least 1 prior line of standard of care therapy have received [212Pb]VMT-α-NET therapy to date, with initial responses observed in 7 of 9 evaluable patients. Responses were observed across both peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-refractory disease. Of the 10 patients enrolled in the study, 3 presented with gastrointestinal NETs, 5 presented with pancreatic NETs, and 2 presented with medullary thyroid carcinoma. Four patients (1 with gastro-intestinal NETs; 3 with pancreatic NETs) were previously treated with [177Lu]DOTATATE PRRT, one of which also received 3 prior administrations of [225Ac]DOTATATE.
- Improvements in patients’ symptoms and quality of life trended strongly positive with consecutive [212Pb]VMT-α-NET doses.
- No significant renal or hepatic function adverse events have been observed to date. Most adverse events were mild and included Grade 1 anemias, alopecia, and fatigue, which usually resolved within 1 week of [212Pb]VMT-α-NET administration. Two patients experienced serious adverse events (SAEs) that were deemed unrelated to [212Pb]VMT-α-NET treatment. One patient who developed myelodysplastic syndromes (MDS) discontinued treatment and the other patient, who was heavily pre-treated, died (patient was deemed not evaluable).
“We have safely administered a total of 25 doses of [212Pb]VMT-α-NET across the 10 patients enrolled in the trial, with two of these patients having received all 4 doses to date,” commented Dr. Dharmender Malik, Consultant Nuclear Medicine and PET-CT, MBBS, DNB, FANMB & RSO-II, at the Fortis Memorial research institute (FMRI), Gurugram India. “[212Pb]VMT-α-NET shows encouraging initial efficacy and safety across different neuroendocrine and medullary thyroid tumor types in patients who failed prior lines of therapy, including standard of care [177Lu]DOTATATE, and [225Ac]DOTATATE.”
"While still early, these initial high objective response rates are promising in light of the 13% response rate for LUTATHERA® (www.novartis.com/us-en/sites/novartis_us/files/lutathera.pdf, Table 8). We are especially encouraged by the responses at low [212Pb]VMT-α-NET activity doses as these are in the starting range of our IND-enabled dose escalation study which is currently screening patients in the US,” said Thijs Spoor, Chief Executive Officer at Perspective. “Additionally, these early responses among multiple tumor types suggest the potential to expand into other indications including small cell lung cancers, meningiomas, pheochromocytomas, paragangliomas, and neuroblastomas – especially given the compelling preclinical neuroblastoma [212Pb]VMT-α-NET therapy data presented at EANM on Sunday. We will continue to monitor patients’ progress, and we look forward to providing a more extensive data readout in the upcoming quarters.”
About the study
Ten adult subjects with histologically confirmed NETs and metastatic medullary thyroid carcinomas who failed at least one prior line of treatment were treated as part of a compassionate use program. All patients were planned to receive [212Pb]VMT-α-NET peptide at intervals of 8 weeks up to 4 doses or until evidence of radiographic progression, unacceptable toxicity or the patient’s decision to discontinue. All patients were to be co-infused with an amino acid solution for renal protection. The primary objective of the study is to evaluate the safety of low doses of [212Pb]VMT-α-NET in this patient population. Secondary assessments will include objective response rate measured by RECIST 1.1 criteria, and the number of patients with treatment-related adverse events as assessed by CTCAE v.4.0. Both will be measured at 24 months after the last administered dose of [212Pb]VMT-α-NET. Isotope was provided using Perspective’s proprietary VMT-α-GEN generator.
About VMT-α-NET
VMT-α-NET is 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. The dosed patients were diagnosed with confirmed-advanced somatostatin expressing NETs. In early December 2022, VMT-α-NET, the Company’s lead drug for the treatment of neuroendocrine tumors was administered to patients in India on a compassionate use basis, independent of a planned U.S. trial.
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 enable isotope supply 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 are 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.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements concerning, among other things, the Company’s clinical development plans and the expected timing thereof; the expected timing for availability and release of data; expectations regarding the potential market opportunities for the Company’s product candidates; the potential functionality, capabilities, and benefits of the Company’s product candidates and the potential application of these product candidates for other disease indications; the Company’s expectations, beliefs, intentions, and strategies regarding the future; the Company’s intentions to improve important aspects of care in cancer treatment; and other statements that are not historical fact.
The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the Company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, the potential that regulatory authorities may not grant or may delay approval for the Company’s product candidates; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; early clinical trials may not be indicative of the results in later clinical trials; clinical trial results may not support regulatory approval or further development in a specified indication or at all; actions or advice of regulatory authorities may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Company’s ability to obtain and maintain regulatory approval for the Company’s product candidates; delays, interruptions or failures in the manufacture and supply of the Company’s product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its clinical development programs; the availability or potential availability of alternative products or treatments for conditions targeted by the Company that could affect the availability or commercial potential of its product candidates; the ability of the Company to manage growth and successfully integrate its businesses; the Company’s ability to maintain its key employees; sufficient training and use of the Company’s products and product candidates; the market acceptance and recognition of the Company’s products and product candidates; the Company’s ability to maintain and enforce its intellectual property rights; the Company’s ability to maintain its therapeutic isotope supply agreement with the Department of Energy; the Company’s ability to continue to comply with the procedures and regulatory requirements mandated by the FDA for additional trials, Phase 1 and 2 approvals, Fast Track approvals, and 510(k) approval and reimbursement codes; and any changes in applicable laws and regulations. Other factors that may cause the Company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the Company’s most recent Transition Report on Form 10-KT and the Company’s most recent Quarterly Report on Form 10-Q, each filed with the Securities and Exchange Commission (the “SEC”), in the Company’s other filings with the SEC, and in the Company’s future reports to be filed with the SEC and available at www.sec.gov.
Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.
Investor Relations Contact: LifeSci Advisors Chuck Padala E: chuck@lifesciadvisors.com
