Initial Results From First Patient Dosed With Perspective Therapeutics’ Lead Drug VMT-α-NET Presented at The Treatment of Neuroendocrine Disorders at the 2023 PET/RTRC Annual Workshop Scientific Session

Rhea-AI Summary

Perspective Therapeutics announced positive results from the first patient dosed with 212Pb-VMT-α-NET in India under compassionate use. The treatment showed favorable responses, as monitored by the somatostatin imaging agent 68Ga-DOTANOC, after a single low dose.

Dr. Vikas Prasad presented these findings at the 2023 PET Radiotracer Workshops. Encouraging responses indicate that VMT-α-NET is a promising candidate for treating neuroendocrine tumors (NETs). No adverse reactions were reported, and patients remained stable post-administration. This signifies potential advancements in precision oncology.

Positive

• Favorable responses observed in the first patient dosed with 212Pb-VMT-α-NET.
• Initial response measured by 68Ga-DOTANOC indicating promising results from a single low dose.
• No acute adverse reactions reported, with patients remaining stable.

Negative

• None.

The result from first patient dosed with VMT-α-NET in India on a compassionate use basis showed favorable responses. The initial response was measured by a somatostatin imaging agent 68Ga-DOTANOC and demonstrated surprisingly favorable results after a single low dose of 212Pb-VMT-a-NET.

RICHLAND, Wash. & CORALVILLE, Iowa, Feb. 22, 2023 (GLOBE NEWSWIRE) --  Perspective, Therapeutics, Inc. (formerly known as “Isoray, Inc.”) (NYSE AMERICAN: CATX), a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents and an innovator in seed brachytherapy powering expanding treatment options for multiple cancers, announced the presentation of extremely encouraging results regarding ²¹²Pb-VMT-α-NET, its lead preclinical candidate for neuroendocrine tumors (NET), currently being used therapeutically in India on a compassionate use basis. Dr Vikas Prasad presented the results at the 2023 PET Radiotracer Translation and Resource Center (PET-RTRC) Workshops & Scientific Session hosted by the Mallinckrodt Institute of Radiology (MIR) at Washington University in St. Louis.

Highlights of the presented results include:

• The result from first patient dosed with ²¹²Pb-VMT-α-NET in India on a compassionate use basis showed favorable responses after the first dose.
  
  
• The initial response was measured by a somatostatin imaging agent ⁶⁸Ga-DOTANOC and demonstrated encouraging results after a single low dose of ²¹²Pb-VMT-α-NET.
  
  

Dr. Prasad noted, “The patient data gathered in the clinic under a compassionate use basis is not only remarkable but an extremely encouraging sign for Perspective Therapeutics’ VMT-α-NET program for the treatment of neuroendocrine tumors. Despite advancement in traditional therapies, novel approaches and therapies are required to further increase patients’ overall survival and improve quality of life. There is an urgent need of bringing these kind of therapies in the first line of management of functionally active neuroendocrine tumors.”

Dr. Vikas Prasad, MD, who is an Associate Professor of Radiology, Mallinckrodt Institute of Radiology (MIR), Washington University School of Medicine in St. Louis, presented the ²¹²Pb- VMT-α-NET results. Prior to MIR, Dr. Prasad subsequently performed the first human images of ²⁰³Pb-VMT-α-NET while serving as MD, Vice Chair in the Department of Nuclear Medicine at the University Hospital of Ulm, Ulm, Germany.

"We are grateful that the science and medicine that is in development at Perspective Therapeutics has provided a meaningful intervention in a NET patient’s care journey. The results give us hope that we are standing at the beginning of a new era of precision oncology medicine. We look forward to continuing the progress of our pipeline of targeted radiopharmaceuticals for imaging and therapeutic use,” said Mr. Thijs Spoor, CEO of Perspective Therapeutics.

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 neuroendocrine tumors (NETs). In early December, 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. No acute adverse reactions were observed post administration and patients remained stable and in good condition.

The administration of VMT-α-NET was performed under the supervision of the patients' doctor, Dr. Ishita Sen MBBS, DRM, DNB, Director and Head of Nuclear Medicine at Fortis Hospital, New Delhi, in partnership with BJ Madan, a diagnostic & therapeutic radiopharmaceutical company in New Delhi. Radiopharmaceutical was produced (under the direction of Dr. Sen) by Dr. Parul Thakral Dash PhD and administered following appropriate quality control testing. Patients were imaged immediately prior to their first therapeutic dose and immediately prior to the second therapeutic dose. The results seen between the 1st and 2nd doses implied that the patients had a strongly favorable response which was unexpected at such low doses of the drug. Dr. Sen expressed her pleasure at the patients' progress and said, "Preclinical and clinical data associated with this new radiopharmaceutical demonstrates significant potential to help our NET patients."

Under compassionate use circumstances, VMT-α-NET may be made available to qualified doctors in some countries. In this circumstance, Perspective Therapeutics (formerly Viewpoint Molecular Targeting, Inc.) supplied drug precursors and isotopes for the local production of its proprietary radiotherapeutic, VMT-α-NET. The safety and effectiveness of the treatments will be evaluated by Dr. Sen's team with laboratory testing, observation of NET-associated symptoms, and repeat medical imaging.

In the U.S., VMT-α-NET will soon enter a Phase 1 imaging and therapy study to be conducted at various hospitals and clinics. The administration of VMT-α-NET for compassionate use is completely independent from and not within the scope of the Company's Phase 1 trial.

Under compassionate use circumstances, VMT-α-NET may be made available to qualified doctors in some countries. In this circumstance, Viewpoint supplied drug precursors and isotopes for the local production of its proprietary radiotherapeutic, VMT-α-NET. The safety and effectiveness of the treatments will be evaluated by Dr. Sen's team with laboratory testing, observation of NET-associated symptoms, and repeat medical imaging.

In the U.S., VMT-α-NET will soon enter a Phase 1 imaging and therapy study to be conducted at various hospitals and clinics. The administration of VMT-α-NET for compassionate use is completely independent from and not within the scope of the Company's Phase 1 trial.

About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc., formerly known as Isoray, Inc., is a medical technology and radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body. The Company is the sole producer of Cesium-131 brachytherapy seeds and has a proprietary technology that utilizes the isotope lead-212 to deliver powerful alpha 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 are entering 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 lead-212 generator to secure isotope supply for clinical trial and commercial operations. For more information, please visit the Company’s website at www.perspectivetherapeutics.com.

Safe Harbor Statement
Statements in this news release about Perspective Therapeutics, Inc.’s (“Perspective”) future expectations, including: whether ongoing favorable results of the compassionate use basis trials on the patient will continue and whether those results can be commercialized for wider use; whether the Phase I trial is successful; expectations about the Company’s addressable markets; the functionality and capabilities of the Company’s therapies including its targeted alpha-particle radiotherapy; the potential size of the commercial market for the Company’s treatment programs; the Company’s expectations, beliefs, intentions, and strategies regarding the future; and all other statements in this news release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing the Company of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as whether and to what extent the anticipated benefits of the merger are realized; the ability to raise ongoing capital to fund added costs of research and development related to the Company’s business; the ability of the Company to manage growth and successfully integrate its businesses; whether the Company can maintain its key employees; whether additional studies are released that reinforce the results of the studies discussed in this presentation; whether the anticipated benefits of the Company’s therapies are realized; training and use of the Company’s products; market acceptance and recognition of the Company’s products; the Company’s ability to enforce its intellectual property rights; whether ongoing patient results are favorable and in line with the conclusions of clinical studies and initial patient results; successful completion of future research and development activities; whether we, our distributors, and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell, and use our products in their various forms; the procedures and regulatory requirements mandated by the FDA for animal trials, human trials, clinical studies, Phase I and II approvals and 510(k) approval and reimbursement codes; changes in applicable laws and regulations; and other risks detailed from time to time in the Company’s reports filed with the SEC.

Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. For more information regarding risks and uncertainties that could affect the Company’s results of operations or financial condition, please review the definitive Proxy Statement filed on November 7, 2022, and our Form 10-K filed on September 28, 2022, with the SEC.

FAQ

What were the results of the first patient dosed with ISR's 212Pb-VMT-α-NET?

The first patient dosed with 212Pb-VMT-α-NET showed favorable responses after treatment, as indicated by the somatostatin imaging agent 68Ga-DOTANOC.

When was the first patient dosed with ISR's VMT-α-NET?

The first patient was dosed in early December 2022 under compassionate use in India.

Where was the presentation about ISR's VMT-α-NET results made?

The results were presented at the 2023 PET Radiotracer Workshops hosted by the Mallinckrodt Institute of Radiology.

What is the significance of the results for ISR's VMT-α-NET therapy?

The results indicate the potential of VMT-α-NET as a new treatment option for patients with neuroendocrine tumors, highlighting its role in precision oncology.