- First U.S. patient with refractory or relapsed SSTR2-positive neuroendocrine tumors treated with [212Pb]VMT-α-NET
- Preliminary data readout expected in second half of 2024
SEATTLE, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), announced today that the first patient was dosed at the University of Iowa in an investigator-initiated Phase 1 trial evaluating the safety 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 patients being enrolled in the study have either progressed or relapsed after previous therapies, including currently approved peptide receptor radionuclide therapies ("PRRT").
The trial is a single-center, open-label study of [212Pb]VMT-α-NET that is designed to explore safety and efficacy when pre-treatment dose planning is aided by imaging with [203Pb]VMT-α-NET using quantitative SPECT/CT imaging. Participants are assigned a radiation dose to the kidneys that may not be exceeded and is tailored to each person's unique tumor uptake of [203Pb]VMT-α-NET and how long it lasts in the body.
"We are delighted that this innovative investigator-initiated study has commenced in refractory and relapsed neuroendocrine tumor patients," said Thijs Spoor, Chief Executive Officer at Perspective Therapeutics. "Along with our company-sponsored first-line trial that is well underway, we expect that the data gathered during this investigator initiated trial from this previously treated population will increase the number of patients who might be available to receive [212Pb]VMT-α-NET in the future. The first-line PRRT setting has been commercially validated by [177Lu]DOTATATE, and there has also recently been a great deal of value ascribed to development in the PRRT-relapsed setting, so we look forward to seeing the results of these investigations."
"Although [177Lu]DOTATATE is effective at delaying tumor progression in patients with NETs, we know that many become refractory to treatment," said Markus Puhlmann, Chief Medical Officer of Perspective Therapeutics. "The preliminary data from the clinical investigation program underway in India has shown that responses are possible in PRRT-refractory and relapsed settings, as presented at the European Association of Nuclear Medicine meeting in September 2023. Although we believe [212Pb]VMT-α-NET has the potential to provide significant improvements in clinical outcomes compared to standard of care [177Lu]DOTATATE, there is also a large number of patients who have exhausted these treatment options. We are excited by this collaboration, and we look forward to the Iowa team presenting preliminary findings in 2024."
About The Study
This is a single site safety study (clinicaltrials.gov identifier NCT06148636) of [212Pb]VMT-α-NET targeted alpha-particle therapy for patients with refractory or relapsed somatostatin receptor type 2 (SSTR2)-positive neuroendocrine tumors. The first part of this Phase 1 trial is imaging with a surrogate tracer, [203Pb]VMT-α-NET, using SPECT/CT imaging. Each participant is assigned a radiation dose to the kidneys that cannot be exceeded.
The second part of the study is a sequential 3 + 3 dose escalation phase of 4 cohorts based on the maximum allowed injected dose for an individual while keeping kidney exposure to less than a predetermined threshold. The study involves 2 treatments, about 8 to 10 weeks apart. The drug will be given by infusion once per treatment. Participants will also receive an infusion of amino acids to help protect the kidneys as well as medications to help protect against nausea. A participant administered [212Pb]VMT-α-NET, will be monitored for at least 6 months for safety assessments. Participants will also have imaging at 6 months post-treatment to measure how their tumors responded to therapy and will have lifelong follow-up for this study.
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 Pb-203 for SPECT imaging, and Pb-212 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. The Company has also developed a proprietary Lead-212 generator to secure key isotopes for clinical trial and commercial operations.
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 .
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 expectation that the data gathered will increase the number of patients who might be able to receive [212Pb]VMT-α-NET in the future; the Company's belief that [212Pb]VMT-α-NET has the potential to provide significant improvements in clinical outcomes compared to standard of care [177Lu]DOTATATE; the Company's expectation that the Iowa team will present preliminary findings in 2024; the Company's prediction that complementary imaging diagnostics that incorporate certain targeting peptides provide the opportunity to personalize treatment and optimize patient outcomes; the Company's expectation that its "theranostic" approach enables the ability to see specific tumors and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments; the Company's clinical development plans and the expected timing thereof; 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; 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; the Company's ability to continue as a going concern; 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; whether there is 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, FDA 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.
CONTACT: Media and Investor Relations Contacts: Russo Partners, LLC Nic Johnson or Harrison Seidner, Ph.D. E: Nic.johnson@russopartnersllc.com E: Harrison.seidner@russopartnersllc.com
- 美國首位患有 SSTR2 陽性難治性或複發性神經內分泌腫瘤的患者使用 [212Pb] VMT-α-Net
- 預計將在2024年下半年公佈初步數據
西雅圖，2023年12月7日（GLOBE NEWSWIRE）——Perspective Therapeutics, Inc.（“Perspective” 或 “公司”）（紐約證券交易所美國股票代碼：CATX）今天宣佈，愛荷華大學在一項由研究人員發起的評估安全性的1期試驗中給藥了第一位患者。212Pb] VMT-α-NET，一種靶向α粒子療法（TAT），適用於表達神經內分泌腫瘤（NET）的不可切除或轉移性生長抑素受體 2 型（SSTR2）患者。參與該研究的患者在接受先前的治療（包括目前批准的肽受體放射性核素療法（“PRRT”）後已經取得進展或復發。
該試驗是一項單中心、開放標籤的研究，針對 [212Pb] VMT-α-Net，旨在通過成像輔助治療前劑量計劃來探索安全性和有效性 [203Pb] VMT-α-Net 使用定量 SPECT/CT 成像。爲參與者分配的腎臟輻射劑量不得超過該劑量，該劑量是根據每個人對腫瘤的獨特吸收量量身定製的 [203Pb] VMT-α-Net 以及它在體內的持續時間。
Perspective Therapeutics首席執行官Thijs Spoor表示：“我們很高興這項由研究人員發起的創新研究已經在難治性和復發的神經內分泌腫瘤患者中開始。”“除了我們公司贊助的一線試驗正在進行中，我們預計，在這項研究者發起的試驗中，從這些先前接受過治療的人群中收集的數據將增加可能可以接受治療的患者人數。[212Pb] 未來的 VMT-α-Net。第一線 PRRT 設置已通過商業驗證 [177Lu] DOTATATE，而且最近在PRRT復發環境中的開發也具有很大的價值，因此我們期待看到這些調查的結果。”
“雖然 [177Lu] DOTATATE可以有效延緩神經內分泌瘤患者的腫瘤進展，我們知道許多神經內分泌瘤的治療難治性。” Perspective Therapeutics首席醫學官馬庫斯·普爾曼說。“正如在2023年9月的歐洲核醫學協會會議上所介紹的那樣，印度正在進行的臨床研究計劃的初步數據表明，在PRRT難治和復發環境中可能出現反應。儘管我們相信 [212Pb] 與標準護理相比，VMT-α-Net有可能顯著改善臨床結果 [177Lu] DOTATATE，也有大量患者已經用盡了這些治療方案。我們對這種合作感到興奮，我們期待愛荷華州團隊在2024年公佈初步調查結果。”
關於這項研究
這是一項針對 [的單點安全研究（clinicaltrials.gov 標識符 NCT06148636）212Pb] VMT-α-Net 靶向 α-粒子療法，用於難治性或複發性生長抑素受體 2 型 (SSTR2) 陽性神經內分泌腫瘤患者。這項 1 期試驗的第一部分是使用替代示蹤劑進行成像，[203Pb] VMT-α-Net，使用 SPECT/CT 成像。爲每位參與者分配的腎臟輻射劑量不能超過該劑量。
該研究的第二部分是4個隊列的連續3+3劑量遞增階段，該階段基於個人的最大允許注射劑量，同時保持腎臟暴露量低於預定閾值。該研究涉及2次治療，間隔約8至10周。每次治療將通過輸液給藥一次。參與者還將接受氨基酸輸注以幫助保護腎臟，並獲得有助於防止噁心的藥物。參與者管理 [212Pb] VMT-α-Net，將接受至少6個月的監控，以進行安全評估。參與者還將在治療後6個月接受影像學檢查，以測量其腫瘤對治療的反應，並將對這項研究進行終身隨訪。
關於神經內分泌腫瘤
神經內分泌腫瘤在與神經系統相互作用的細胞或產生激素的腺體中形成。它們可能起源於身體的各個部位，最常見於腸道或肺部，可以是良性的，也可以是惡性的。神經內分泌腫瘤通常被歸類爲胰腺神經內分泌腫瘤或非胰腺神經內分泌腫瘤。根據cancer.net的數據，據估計，美國每年有超過12,000人被診斷出患有神經內分泌瘤。重要的是，與其他腫瘤相比，神經內分泌腫瘤的存活時間相對較長，因此，大約有17.5萬人患有這種診斷。
關於 vmt-α-net
vmt-α-net是一種臨床階段靶向α粒子療法（TAT）放射性藥物，用於治療和診斷表達神經內分泌腫瘤的生長抑素受體亞型2（SSTR2），神經內分泌腫瘤是一種罕見且難以治療的癌症。VMT-α-net 採用了 Perspective Therapeutics 專有的鉛特異性螯合劑 (PSC)，可結合Pb-203進行SPECT成像，結合Pb-212進行α粒子治療。
關於 Perspective Therapeut
Perspective Therapeutics, Inc. 是一家多元化的醫療技術和放射性藥物公司，正在開創全身癌症的先進治療應用。該公司擁有一項專有技術，該技術利用發射α的同位素Lead-212，通過專門的靶向肽專門向癌細胞提供強大的輻射。該公司還在開發補充成像診斷，其中包含相同的靶向肽，這爲個性化治療和優化患者療效提供了機會。這種 “治療學” 方法使人們能夠看到特定的腫瘤，然後對其進行治療，從而有可能提高療效並最大限度地減少與許多其他類型的癌症治療相關的毒性。
該公司的黑色素瘤（VMT01）和神經內分泌腫瘤（VMT-α-net）項目已進入多家領先學術機構治療轉移性黑色素瘤和神經內分泌腫瘤的1/2a期成像和治療試驗。該公司還開發了一種專有的Lead-212發生器，用於保護臨床試驗和商業運營的關鍵同位素。
Perspective是Cesium-131近距離放射治療種子的唯一生產商，這些種子在美國上市，用於治療前列腺癌和其他實體瘤。
欲了解更多信息，請訪問公司的網站。
安全港聲明
本新聞稿包含1995年《美國私人證券訴訟改革法》所指的前瞻性陳述。本新聞稿中不是歷史事實陳述的陳述是前瞻性陳述。諸如 “可能”、“將”、“應該”、“預期”、“預期”、“可能”、“打算”、“目標”、“項目”、“估計”、“相信”、“預測”、“潛力” 或 “繼續” 之類的詞語或這些術語的否定或其他類似表達方式旨在識別前瞻性陳述，儘管並非所有前瞻性陳述都包含這些識別性詞語。本新聞稿中的前瞻性陳述包括有關以下內容的聲明：公司預計收集的數據將增加可能能夠接受治療的患者人數 [212Pb] 未來的VMT-α-Net；該公司相信 [212Pb] 與標準護理相比，VMT-α-Net有可能顯著改善臨床結果 [177Lu] DOTATATE；該公司預計愛荷華州團隊將在2024年公佈初步調查結果；該公司預測含有某些靶向肽的補充成像診斷將爲個性化治療和優化患者預後提供機會；該公司期望其 “療法” 方法能夠看到特定的腫瘤然後進行治療，從而有可能提高療效並最大限度地減少與許多其他類型癌症治療相關的毒性；該公司的臨床開發計劃和預期的時機；公司候選產品的潛在功能、能力和優勢以及這些候選產品在其他疾病適應症中的潛在應用；公司對未來的期望、信念、意圖和戰略；以及其他非歷史事實的陳述。
公司實際上可能無法實現前瞻性陳述中披露的計劃、意圖或預期，您不應過分依賴前瞻性陳述。這些前瞻性陳述涉及風險和不確定性，可能導致公司的實際業績與前瞻性陳述中描述或暗示的結果存在重大差異，包括但不限於：監管機構可能不批准或可能推遲對公司候選產品的批准；與臨床試驗的設計、註冊、完成和結果有關的不確定性和延遲；意想不到的成本和支出；公司繼續經營的能力；早期臨床試驗可能不代表以後的臨床試驗的結果；臨床試驗結果可能不支持監管部門的批准或特定適應症的進一步開發或根本不支持；監管機構的行動或建議可能會影響臨床試驗的設計、啓動、時間、持續和/或進展，或導致需要進行額外的臨床試驗；公司獲得和維持監管部門對公司候選產品的批准的能力；公司產品的生產和供應延遲、中斷或失敗候選人；公司候選產品的市場規模和增長潛力，以及公司爲這些市場服務的能力；公司的現金和現金等價物可能不足以在預期的時間內支持其運營計劃；公司對支出、未來收入、資本要求以及額外融資可用性和需求的預期、預測和估計；公司獲得額外資金以支持其臨床開發計劃的能力；可用性或潛力針對可能影響候選產品可用性或商業潛力的公司目標疾病的替代產品或治療方法的可用性；公司管理增長和成功整合業務的能力；公司留住關鍵員工的能力；對公司產品和候選產品的培訓和使用是否充分；市場對公司產品和候選產品的接受和認可；公司維護和執行其知識產權的能力權利；公司維持與能源部簽訂的治療性同位素供應協議的能力；公司繼續遵守美國食品藥品管理局規定的額外試驗、第一和第二階段批准、FDA快速通道批准以及510（k）批准和報銷代碼的程序和監管要求的能力；以及適用法律和法規的任何變更。可能導致公司實際業績與本新聞稿中前瞻性陳述中表達或暗示的業績存在重大差異的其他因素在公司向美國證券交易委員會（“SEC”）提交的最新10-KT表過渡報告和公司最新的10-Q表季度報告、公司向美國證券交易委員會提交的其他文件以及公司未來向美國證券交易委員會提交的報告中，在 “風險因素” 標題下進行了描述向美國證券交易委員會提交，可在www.sec.gov上查閱。
本新聞稿中包含的前瞻性陳述自該日起作出，除非適用法律要求，否則公司沒有義務更新此類信息，無論是由於新信息、未來事件還是其他原因。
聯繫人：媒體和投資者關係聯繫人： 魯索合夥人有限責任公司 Nic Johnson 或 Harrison Seidner，博士 E: Nic.johnson@russopartnersllc.com E: Harrison.seidner@russopartnersllc.com
