A Phase I Study Evaluating the Safety of Cirtuvivint as Monotherapy and in Combination With ASTX727 and ASTX727 + Venetoclax in Patients With Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)

This phase I trial tests the safety, side effects, and best dose of SM08502 (cirtuvivint) alone and in combination with ASTX727 in treating patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Cirtuvivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Giving cirtuvivint alone or in combination with ASTX727 may be safe, tolerable, and/or effective in treating patients with AML and MDS.

开始日期2025-09-16

申办/合作机构

National Cancer Institute

NCT06802523

/ Not yet recruiting临床1期IIT

A Phase I Study of Lintuzumab-Ac-225 in Combination With Venetoclax and ASTX-727 in Adults With Newly Diagnosed AML

This phase I trial tests the safety, side effects, and best dose of lintuzumab-Ac225 in combination with venetoclax and ASTX-727, and how well they work in treating patients with newly diagnosed acute myeloid leukemia (AML). Lintuzumab-Ac225 is a monoclonal antibody, called lintuzumab, linked to a radioactive agent called actinium Ac 225. Lintuzumab attaches to CD33 positive cancer cells in a targeted way and delivers actinium Ac 225 to kill them. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. ASTX-727 is a combination of two drugs, cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Giving lintuzumab-Ac225 in combination with venetoclax and ASTX-727 may be safe and tolerable in treating patients with newly diagnosed AML and may improve the chance of going into remission and staying in remission for a longer period of time.

开始日期2025-04-30

申办/合作机构

National Cancer Institute

NCT06802146

/ Recruiting早期临床1期IIT

A Multi-Site Break Through Cancer Pilot Study Testing the Feasibility and Safety of Therapeutic Intervention for Patients with High-risk Clonal Cytopenia of Undetermined Significance (CCUS)

This research is being done to find out more about the potential risks and benefits of early treatment in participants with high risk Clonal Cytopenia of Unknown Significance (CCUS). This study will give eligible CCUS participants the option of either being observed or taking an oral drug as treatment.
The names of the study drug involved in this study is:
-Decitabine/cedazuridine (DEC/CED) (a nucleoside metabolic inhibitor and cytidine deaminase inhibitor).

开始日期2025-02-07

申办/合作机构

Dana-Farber Cancer Institute, Inc.

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项与地西他滨/西达尿苷相关的文献（医药）

2024-11-01·BRITISH JOURNAL OF HAEMATOLOGY

Oral decitabine/cedazuridine versus intravenous decitabine for acute myeloid leukaemia: A randomised, crossover, registration, pharmacokinetics study

Article

作者: Novák, Jan ; Sano, Yuri ; Illes, Arpad ; Santini, Valeria ; Keating, Mary‐Margaret ; Fracchiolla, Nicola Stefano ; Metzelder, Stephan K. ; Lübbert, Michael ; Lunghi, Monia ; Rodríguez‐Macías, Gabriela ; Platzbecker, Uwe ; Oganesian, Aram ; Arnan, Montserrat ; Mayer, Jiří ; del Castillo, Teresa Bernal ; Krauter, Jürgen ; Koristek, Zdenek ; Geissler, Klaus ; Keer, Harold

Summary:

This study compared decitabine exposure when administered IV (DEC‐IV) at a dose of 20 mg/m2 for 5‐days with orally administered decitabine with cedazuridine (DEC‐C), as well as the clinical efficacy and safety of DEC‐C in patients with acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy. In all, 89 patients were randomised 1:1 to DEC‐IV or oral DEC‐C (days 1–5 in a 28‐day treatment cycle), followed by 5 days of the other formulation in the next treatment cycle. All patients received oral DEC‐C for subsequent treatment cycles until treatment discontinuation. Equivalent systemic decitabine exposures were demonstrated (5‐day area under the curve ratio between the two decitabine formulations of 99.64 [90% confidence interval 91.23%, 108.80%]). Demethylation rates also were similar (≤1.1% difference). Median overall survival (OS), clinical response and safety profile with oral DEC‐C were consistent with those previously observed with DEC‐IV. Next‐generation sequencing was performed to identify molecular abnormalities that impact OS and TP53 mutations were associated with a poor outcome. These findings support the use of oral DEC‐C in patients with AML.

2024-09-01·Clinical Lymphoma Myeloma & Leukemia

Oral Decitabine/Cedazuridine Is an Effective Ambulatory Therapy for Patients With Myelofibrosis Refractory to JAK2 Inhibitor Therapy

Article

作者: Dueck, Amylou ; Ginzburg, Yelena ; Handa, Shivani ; Mascarenhas, John O ; Sivakumar, Ganesh ; Tremblay, Douglas ; Hoffman, Ronald ; Kremyanskaya, Marina ; Srisuwananukorn, Andrew

BACKGROUND:

Outcomes are dismal for patients with myelofibrosis (MF) who are no longer responsive to JAK2 inhibitors (JAKi) and/or have increasing blast cell numbers. Although prior reports have suggested the benefits of intravenous decitabine (DAC) combined with ruxolitinib for patients with Myeloproliferative Neoplasm (MPN) accelerated/blast phase (AP/BP), decitabine-cedazuridine (DEC-C), an oral fixed-dose combination providing equivalent pharmacokinetic exposure, has not been evaluated in MF.

METHODS:

We conducted a retrospective analysis of 14 patients with high-risk MF refractory to ruxolitinib or MPN-AP (10-19% blasts) treated with DEC-C +/- JAKi at Mount Sinai Hospital from 2021 to 2024.

RESULTS:

The cohort was elderly (median age,76 years) and almost uniformly possessed high risk mutations with 13 of the 14 patients progressing on JAKi therapy. With a median follow-up of 9.4 months, the median overall survival (OS) was 29 months for the entire cohort. Median OS was 10.8 months for MPN-AP and was not reached for ruxolitinib refractory MF patients. All patients (n = 9) receiving > 4 cycles of DEC-C had clinical benefit exemplified by a reduction in blast cell numbers, spleen size, and lack of progression to MPN-BP (78%). Furthermore, 3/14 patients proceeded to allogeneic stem cell transplant. Myelosuppression was a common adverse event which was managed by reducing the number of days of administration of DEC-C from 5 to 3 per cycle.

CONCLUSIONS:

This report demonstrates the feasibility, tolerability, and clinical benefit of an exclusively ambulatory regimen for high-risk, elderly patients with advanced MF which warrants further evaluation in a prospective clinical trial.

2024-04-01·The Lancet. Haematology

Oral decitabine and cedazuridine plus venetoclax for older or unfit patients with acute myeloid leukaemia: a phase 2 study

Article

作者: Garcia-Manero, Guillermo ; Kadia, Tapan ; Short, Nicholas ; Pierce, Sherry ; Alvarado, Yesid ; Bataller, Alex ; Jain, Nitin ; Masarova, Lucia ; Islam, Rabiul ; Konopleva, Marina ; Kornblau, Steven ; Ravandi, Farhad ; Bazinet, Alexandre ; Montalban-Bravo, Guillermo ; Maiti, Abhishek ; Issa, Ghayas ; Abuasab, Tareq ; Daver, Naval ; DiNardo, Courtney D ; Kantarjian, Hagop ; Yilmaz, Musa ; Huang, Xuelin ; Jabbour, Elias ; Montalbano, Kathryn ; Rausch, Caitlin R

BACKGROUND:

Hypomethylating agents combined with venetoclax are effective regimens in patients with acute myeloid leukaemia who are ineligible for intensive chemotherapy. Decitabine and cedazuridine (ASTX727) is an oral formulation of decitabine that achieves equivalent area-under-curve exposure to intravenous decitabine. We performed a single centre phase 2 study to evaluate the efficacy and safety of ASTX727 plus venetoclax.

METHODS:

This study enrolled patients with newly diagnosed (frontline treatment group) acute myeloid leukaemia who were ineligible for intensive chemotherapy (aged ≥75 years, an Eastern Cooperative Oncology Group [ECOG] performance status of 2-3, or major comorbidities) or relapsed or refractory acute myeloid leukaemia. Being aged 18 years or older and having an ECOG performance status of 2 or less were requirements for the relapsed or refractory disease treatment cohort, without any limits in the number of previous lines of therapy. Treatment consisted of ASTX727 (cedazuridine 100 mg and decitabine 35 mg) orally for 5 days and venetoclax 400 mg orally for 21-28 days in 28-day cycles. The primary outcome was overall response rate of ASTX727 plus venetoclax. Living patients who have not completed cycle one were not evaluable for response. Safety was analysed in all patients who started treatment. This study was registered on ClinicalTrials.gov (NCT04746235) and is ongoing. The data cutoff date for this analysis was Sept 22, 2023.

FINDINGS:

Between March 16, 2021, and Sept 18, 2023, 62 patients were enrolled (49 frontline and 13 relapsed or refractory) with a median age of 78 years (IQR 73-82). 36 (58%) were male; 53 (85%) were White, 4 (6%) Black, 2 (3%) Asian and 3 (5%) other or did not answer. 48 (77%) of 62 patients were European LeukemiaNet 2022 adverse risk, 24 (39%) had antecedent myelodysplastic syndromes, 12 (19%) had previously failed a hypomethylating agent, ten (16%) had therapy-related acute myeloid leukaemia, and 11 (18%) had TP53 mutations. The median follow-up time was 18·3 months (IQR 8·8-23·3). The overall response rate was 30 (64%) of 47 patients (95% CI 49-77) in frontline cohort and six (46%) of 13 patients (19-75) in relapsed or refractory cohort. The most common grade 3 or worse treatment-emergent adverse events were febrile neutropenia in 11 (18%) of 62 patients, pneumonia in eight (13%), respiratory failure in five (8%), bacteraemia in four (6%), and sepsis in four (6%). Three deaths occurred in patients in remission (one sepsis, one gastrointestinal haemorrhage, and one respiratory failure) and were potentially treatment related.

INTERPRETATION:

ASTX727 plus venetoclax is an active fully oral regimen and safe in most older or unfit patients with acute myeloid leukaemia. Our findings should be confirmed in larger multicentric studies.

FUNDING:

MD Anderson Cancer Center Support Grant, Myelodysplastic Syndrome/Acute Myeloid Leukaemia Moon Shot, Leukemia SPORE, Taiho Oncology, and Astex Pharmaceuticals.

项与地西他滨/西达尿苷相关的新闻（医药）

2025-03-27

·PipelineReview

Actinium Pharmaceuticals Announces ATNM-400 a Novel Non-PSMA Targeting First in Class Prostate Cancer Radiotherapy Leveraging Actinium-225

– 99.8% tumor growth inhibition achieved with a single dose of ATNM-400 in preclinical prostate cancer models – ATNM-400 accumulated in tumors for up to 144 hours and showed minimal uptake in healthy tissues in prostate cancer xenograft model – Initial ATNM-400 preclinical data to be presented at AACR including results in Pluvicto resistant prostate cancer models NEW YORK, NY, USA I March 27, 2025 I Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, today announced ATNM-400, a novel, non-PSMA targeting, first in class radiotherapy for prostate cancer utilizing the Actinium-225 (Ac-225) radioisotope. Initial preclinical data from ATNM-400 will be presented at the American Association for Cancer Research (AACR) Annual Meeting being held on April 25 – 30, 2025, in Chicago, IL. The ATNM-400 AACR abstract will include the results from in vitro and in vivo studies including biodistribution imaging and efficacy analyses with various dose levels of ATNM-400. Actinium continues to advance ATNM-400 with additional data expected from Pluvicto-resistant prostate cancer models at AACR. Pluvicto (Lu-177-PSMA-617) is a prostate-specific membrane antigen (PSMA) directed targeted radiotherapy that uses the beta-particle emitting radioisotope Lutetitium-177 (Lu-177) that is approved for patients with metastatic prostate cancer. Pluvicto is marketed and sold by Novartis and generated sales of $1.39 billion in 2024. ATNM-400 is differentiated from Pluvicto as it targets a different marker than PSMA that has been shown to be overexpressed in patients with prostate cancer and uses the alpha-particle emitter Ac-225, which is more potent than Lu-177 but has a shorter path length, which could result in fewer off-target effects. Sandesh Seth, Actinium’s Chairman and CEO, said, “The current era of radiotherapy is built on the clinical and commercial success of Pluvicto in prostate cancer. The field is now looking to address patients that do not respond or progress after Pluvicto therapy. We believe ATNM-400 can address this high unmet need and we are incredibly excited by our data to date. As anticipated, we have seen robust tumor control and ATNM-400 has shown to be well tolerated in preclinical studies, which we believe is due to the precise and potent cell-killing of Ac-225. We are also highly excited by the results of our biodistribution studies that showed selective tumor uptake with minimal uptake in normal tissues. By focusing on a non-PSMA target, we also believe ATNM-400 has the potential to address some of the toxicities reported with Pluvicto and other PSMA targeting radiotherapies such as xerostomia. We are eager to present our ATNM-400 data at AACR and to continue to advance this highly novel prostate cancer candidate.” Highlights from the abstract include: ATNM-400 AACR Presentation Details Title: ATNM-400 is a novel Actinium-225 antibody radioconjugate with strong efficacy in preclinical models of prostate cancer Abstract Number: 578 Session: PO.ET08.01 – Theranostics and Radiotheranostics Date & Time: April 27, 2025 – 2:00 pm – 5:00 pm About Actinium Pharmaceuticals, Inc. Actinium is a pioneer in the development of targeted radiotherapies intended to meaningfully improve patient outcomes. Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic, as potential backbone therapy in acute myeloid leukemia (AML) and other myeloid malignancies leveraging the mutation agnostic alpha-emitter radioisotope payload Actinium-225 (Ac-225). Actimab-A has demonstrated potential activity in relapsed and refractory acute myeloid leukemia (r/r AML) patients in combination with the chemotherapy CLAG-M including high rates of Complete Remissions (CR) and measurable residual disease (MRD) negativity leading to improved survival outcomes and is being advanced to a pivotal Phase 2/3 trial. In addition, Actinium is engaged with the National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA ® and OPDIVO ® by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. Iomab-ACT, Actinium’s next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium is seeking a potential strategic partner for the U.S. ATNM-400 is Actinium’s novel non-PSMA targeting Ac-225 radiotherapy for prostate cancer, which is supported by preclinical data and is being advanced to clinical trials. In addition, the company’s R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. For more information, please visit: https://www.actiniumpharma.com/ SOURCE: Actinium Pharmaceuticals

AACR会议临床研究放射疗法

2025-03-27

·PRNewswire

Actinium Pharmaceuticals Provides Business Update After Presentation at Trump Mar-A-Lago Club Announcing Novel Non-PSMA Prostate Cancer Radiotherapy ATNM-400 and Outlining Revitalized Clinical Pipeline with 2025 Corporate Objectives

- ATNM-400 is a novel, non-PSMA targeting, first-in-class Actinium-225 radiotherapy for prostate cancer with initial preclinical results to be presented at the AACR Annual Meeting - Actinium is establishing radiopharmaceutical manufacturing infrastructure in 2025 to support expanding clinical trials and to leverage its proprietary Actinium-225 cyclotron manufacturing technology - Data from several clinical trials expected in 2H:2025 across myeloid malignancies, solid tumors and cell and gene therapy conditioning - Actinium's targeted radiotherapy programs expanded to four multi-billion-dollar market opportunities NEW YORK, March 27, 2025 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, today provided a business update detailing recent achievements and anticipated milestones from its revitalized and expanding clinical pipeline. The update featured the unveiling of ATNM-400, Actinium's new Actinium-225 (Ac-225) solid tumor program, which is a novel, non-PSMA targeting, first-in-class radiotherapy for prostate cancer. Initial preclinical data from ATNM-400 will be presented at AACR on April 27, 2025. In addition, Actinium highlighted its 2025 manufacturing infrastructure activity, including its Actinium-225 cyclotron manufacturing technology, to support its expanding clinical pipeline. Finally, Actinium highlighted several clinical trials that are expected to generate clinical data in the second half of 2025 including its Actimab-A frontline AML trial under its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), data from trials in the Actimab-A solid tumor program which combines Actimab-A with PD-1 checkpoint inhibitors KEYTRUDA® and OPDIVO® in head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) and Iomab-ACT commercial CAR-T and sickle cell disease (SCD) trials. This update follows Actinium's company presentation at Trump Mar-a-Lago Club on March 26th and an Actimab-A KOL investor call on March 25th, which can be accessed for replay here. Sandesh Seth, Actinium's Chairman and CEO, said, "We are resurgent and expect 2025 will be an impactful year for Actinium as we execute to demonstrate the inherent value of our truly innovative and first of their kind clinical programs that focus on patients with high unmet needs. We are thrilled to introduce ATNM-400 and we look forward to presenting our promising preclinical results at AACR in April. We believe a significant opportunity exists in prostate cancer for ATNM-400, particularly for patients progressing or not well served by the PSMA targeting radiotherapy Pluvicto given its novel target and the potent cell killing ability of the Ac-225 isotope payload. In conjunction with advancing our clinical programs, several of which are expected to generate clinical data this year, we are building out manufacturing infrastructure in 2025 to support these programs which are expected to enter advanced development in 2026. Our strong balance sheet with cash runway expected to last into mid-2027 allows us to focus on unlocking the value inherent in our pipeline which has four distinct blockbuster opportunities with Actimab-A in hematology and solid tumors, Iomab-ACT in cell and gene therapy conditioning and now ATNM-400 in prostate cancer." Actinium's 2025 achievements to date including the following: Unveiled ATNM-400, a first-in-class, novel non-PSMA targeting Actinium-225 radiotherapy for prostate cancer with initial preclinical data to be presented at AACR on April 27, 2025 Initiated Actimab-A frontline AML triplet trial under NCI CRADA that will study Actimab-A as a backbone in combination with Venetoclax and ASTX-727, an oral hypomethylating agent developed by Taiho oncology, Inc., an Otsuka Holdings company Results of Actimab-A + CLAG-M combination trial published in the peer-reviewed journal Leukemia highlighting high rates of MRD- and improved overall survival in patients with r/r AML Initiated Actimab-A solid tumor program to combine Actimab-A with PD-1 checkpoint inhibitors KEYTRUDA and OPDIVO in head-to-head trials in head and neck squamous cell carcinoma and non-small cell lung cancer Entered into sponsored research agreements with Memorial Sloan Kettering Cancer Center to further elucidate Actimab-A's mutation agnostic mechanism of action and potential as a backbone therapy in myeloid malignancies Executed a supply agreement with Exckert & Ziegler for Actinium-225 Radioisotope to support comprehensive development activities for both U.S. and international clinical trials Abstracts accepted for presentation at the American Association for Cancer Research Annual Meeting highlighting Actimab-A's mutation agnostic profile in AML Actinium's pipeline revitalization has resulted in expanded market opportunities for its first-in-class targeted radiotherapies in myeloid malignancies, solid tumors and cell and gene therapy conditioning. Actinium seeks to address four distinct blockbuster opportunities with ATNM-400, Actimab-A and Iomab-ACT. Actinium outlined its 2025 business objectives for its revitalized and expanding clinical pipeline as follows: Pipeline Expansion into Prostate Cancer with ATNM-400, a first-in-class, non-PSMA targeting Ac-225 radiotherapy Present abstract at AACR highlighting Actinium-225 targeted radiotherapy for novel radiotherapy cancer target Establish In-house Radiopharmaceutical Manufacturing & Production Advance build-out of manufacturing facility Explore strategic partnerships leveraging proprietary Actinium-225 cyclotron manufacturing technology Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) across multiple treatment settings Initiate Phase 2/3 trial in combination with CLAG-M in relapsed or refractory AML and seek potential partners or collaborators Generate initial clinical data in frontline AML in first trial under CRADA with NCI Initiate additional clinical trials in myeloid malignancies Actimab-A as a pan solid tumor therapy in combination with PD-1 inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs) Generate clinical proof of concept data in head and neck squamous cell carcinoma and non-small cell lung cancer Explore additional solid tumor indications for future trials Iomab-ACT as a universal targeted conditioning agent to increase patients access to cell & gene therapies and improve patient outcomes Present initial data from commercial CAR-T trial at University of Texas Southwestern Generate clinical data in first non-malignant indication from sickle cell disease allogeneic stem cell transplant trial at Columbia University About Actinium Pharmaceuticals, Inc. Actinium is a pioneer in the development of targeted radiotherapies intended to meaningfully improve patient outcomes. Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic, as potential backbone therapy in acute myeloid leukemia (AML) and other myeloid malignancies leveraging the mutation agnostic alpha-emitter radioisotope payload Actinium-225 (Ac-225). Actimab-A has demonstrated potential activity in relapsed and refractory acute myeloid leukemia (r/r AML) patients in combination with the chemotherapy CLAG-M including high rates of Complete Remissions (CR) and measurable residual disease (MRD) negativity leading to improved survival outcomes and is being advanced to a pivotal Phase 2/3 trial. In addition, Actinium is engaged with the National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA® and OPDIVO® by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium is seeking a potential strategic partner for the U.S. ATNM-400 is Actinium's novel non-PSMA targeting Ac-225 radiotherapy for prostate cancer, which is supported by preclinical data and is being advanced to clinical trials. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. For more information, please visit: Forward-Looking Statements This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. Investors: [email protected] SOURCE Actinium Pharmaceuticals, Inc. 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临床研究

2025-03-26

·PRNewswire

Actinium Pharmaceuticals to Present Business Update at Trump Mar-A-Lago Club Today

- Company to highlight recent significant progress made with its Actimab-A and Iomab-ACT clinical programs, leading-edge R&D and radiopharmaceutical manufacturing infrastructure - Revitalized clinical programs focused on 3 separate multi-billion-dollar market opportunities in myeloid malignancies, solid tumors and cell & gene therapy conditioning with clinical data expected in 2025 supporting each addressable market - Presentation follows Investor KOL Event and Company Update on March 25th NEW YORK, March 26, 2025 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, announced it will be presenting a business update today at Trump Mar-a-Lago Club, Florida. This presentation follows an Investor KOL Call and Company Update hosted by Actinium on Tuesday, March 25th highlighting its revitalized clinical programs and expanded market opportunities. Actinium's Investor KOL Call and Company Update can be accessed for replay here. Sandesh Seth, Actinium's Chairman and CEO, said, "We are honored to have this opportunity to present Actinium Pharmaceuticals and highlight the significant progress we have made in the last several months at the Mar-a-Lago Club. We have great enthusiasm for our revamped clinical programs and expect to achieve significant milestones in 2025. If successful, we will have the opportunity to address multiple potential blockbuster market opportunities with Actimab-A in myeloid malignancies and solid tumors and with Iomab-ACT for cell and gene therapy conditioning." Actinium has outlined its expanded market opportunities and expected 2025 milestones for each of its clinical programs as well as its R&D and radiopharmaceutical manufacturing capabilities as follows: Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) across multiple treatment settings Initiate Phase 2/3 trial in combination with CLAG-M in relapsed or refractory AML and seek potential partners or collaborators Generate initial clinical data in frontline AML in first trial under CRADA with NCI Initiate additional clinical trials in myeloid malignancies Actimab-A as a pan solid tumor therapy in combination with PD-1 inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs) Generate clinical proof of concept data in head and neck squamous cell carcinoma and non-small cell lung cancer Explore additional solid tumor indications for future trials Iomab-ACT as a universal targeted conditioning agent to increase patients access to cell & gene therapies and improve patient outcomes Present initial data from commercial CAR-T trial at University of Texas Southwestern Generate clinical data in first non-malignant indication from sickle cell disease allogeneic stem cell transplant trial at Columbia University Pipeline Expansion Leveraging Targeted Radiotherapy R&D Capabilities Present abstract at AACR highlighting Actinium-225 targeted radiotherapy for novel radiotherapy cancer target Establish In-house Radiopharmaceutical Manufacturing & Production Advance build-out of manufacturing facility Explore strategic partnerships leveraging proprietary Actinium-225 cyclotron manufacturing technology Mr. Seth continued, "In addition to the multitude of milestones that lie ahead for our clinical programs, we are excited to highlight our expanding capabilities. As a pioneer in targeted radiotherapy, we are leveraging our robust know-how and intellectual property to develop new pipeline programs to address indications with high unmet needs. In addition, we are investing in our infrastructure and are thrilled to be moving ahead with the build-out of our manufacturing facility starting next quarter in anticipation of future clinical success. Finally, we look forward to fully leveraging our proprietary Actinium-225 cyclotron manufacturing technology to meet our projected demand given our expanding Actinium-225 programs as well as facilitate strategic partnerships. With our strong balance sheet providing runway into mid-2027, our team is focused and committed on execution and value creation." About Actinium Pharmaceuticals, Inc. Actinium is a pioneer in the development of targeted radiotherapies intended to meaningfully improve patient outcomes. Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic, as potential backbone therapy in acute myeloid leukemia (AML) and other myeloid malignancies leveraging the mutation agnostic alpha-emitter radioisotope payload Actinium-225 (Ac-225). Actimab-A has demonstrated potential activity in relapsed and refractory acute myeloid leukemia (r/r AML) patients in combination with the chemotherapy CLAG-M including high rates of Complete Remissions (CR) and measurable residual disease (MRD) negativity leading to improved survival outcomes and is being advanced to a pivotal Phase 2/3 trial. In addition, Actinium is engaged with the National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA® and OPDIVO® by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium is seeking a potential strategic partner for the U.S. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. For more information, please visit: Forward-Looking Statements This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. Investors: [email protected] SOURCE Actinium Pharmaceuticals, Inc. 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临床研究

100 项与地西他滨/西达尿苷相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	地西他滨/西达尿苷	L01XY	DB15694

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
急性髓性白血病	欧盟	Otsuka Pharmaceutical Netherlands B.V.	2023-09-15
急性髓性白血病	冰岛	Otsuka Pharmaceutical Netherlands B.V.	2023-09-15
急性髓性白血病	列支敦士登	Otsuka Pharmaceutical Netherlands B.V.	2023-09-15
急性髓性白血病	挪威	Otsuka Pharmaceutical Netherlands B.V.	2023-09-15
慢性粒单核细胞白血病	澳大利亚	Otsuka Australia Pharmaceutical Pty Ltd.	2020-10-29
骨髓增生异常综合征	美国	Taiho Oncology, Inc.	2020-07-07

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
骨髓增生异常/骨髓增生性疾病	临床2期	美国	The University of Texas MD Anderson Cancer Center	2025-01-31
骨髓增生性疾病	临床2期	美国	The University of Texas MD Anderson Cancer Center	2025-01-31
急性淋巴细胞白血病	临床2期	美国	Astex Pharmaceuticals, Inc.	2024-07-01
急性淋巴细胞白血病	临床2期	美国	The University of Texas MD Anderson Cancer Center	2024-07-01
血液肿瘤	临床2期	美国	The University of Texas MD Anderson Cancer Center	2024-07-01
血液肿瘤	临床2期	美国	Astex Pharmaceuticals, Inc.	2024-07-01
造血干细胞移植	临床2期	美国	The University of Texas MD Anderson Cancer Center	2024-07-01
造血干细胞移植	临床2期	美国	Astex Pharmaceuticals, Inc.	2024-07-01
白血病	临床2期	美国	The University of Texas MD Anderson Cancer Center	2024-07-01
白血病	临床2期	美国	Astex Pharmaceuticals, Inc.	2024-07-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05010772 (4277, ASH2024)	临床1期	急性髓性白血病 complex cytogenetics \| antecedent MDS/MPN \| therapy-related AML ... 更多	31	ASTX727 alone	鑰艱鏇積艱衊簾鬱觸構(糧鑰構繭憲夢遞窪鏇鬱) = 鏇憲築窪構淵積觸壓糧膚蓋糧構鹽襯夢鬱網積 (願壓餘醖網齋顧淵遞廠 ) 更多	积极	2024-12-09
				ASTX727 plus venetoclax	鑰艱鏇積艱衊簾鬱觸構(糧鑰構繭憲夢遞窪鏇鬱) = 顧膚遞顧鹽顧鹹廠夢窪膚蓋糧構鹽襯夢鬱網積 (願壓餘醖網齋顧淵遞廠 ) 更多
NCT04746235 (2896, ASH2024)	临床2期	急性髓性白血病 TP53mutation \| FLT3-ITD \| N/KRASmutation	60	ASTX727 35/100 mg + Venetoclax 400 mg	願積簾廠顧蓋觸糧憲鹹(鑰蓋淵積蓋獵壓鬱憲餘) = 鹽蓋襯鹹築鹽觸餘醖蓋廠顧鹽鬱鏇衊艱糧糧壓 (獵選選觸鬱襯網鹹鬱鏇 ) 更多	积极	2024-12-08
NCT05360160 (ASH2024) 人工标引	临床1/2期	急性髓性白血病 NPM1 Mutation \| KMT2A Rearrangement \| NUP98 Rearrangement	26	Revumenib (SNDX-5613) with Decitabine/Cedazuridine (ASTX727) and Venetoclax (SAVE)	獵鹹壓獵蓋艱衊蓋願網(齋醖鏇選鬱襯獵憲網憲) = 艱窪構製鬱蓋願選醖鑰顧廠襯衊淵廠構觸蓋獵 (壓範顧築鏇遞廠製鹽衊 ) 更多	积极	2024-12-07
NCT05835011 (CTgov)	临床2期	骨髓增生异常综合征	2	Decitabine/Cedazuridine+Magrolimab	選艱範鏇顧窪鑰艱範願 = 鏇鑰鬱鑰醖簾醖糧鹹範鬱窪簾構艱製齋製襯鑰 (鏇願選鹹願醖廠襯蓋繭, 鑰齋糧糧遞廠蓋鏇範蓋 ~ 願願顧鏇鑰衊遞繭窪築) 更多	-	2024-10-02
NCT02103478 \| NCT03306264 (ASCERTAIN, EHA2024) 人工标引	临床2/3期	骨髓增生异常综合征	180	DEC-CDEC-C (ASTX727)	選觸獵齋淵繭襯選餘艱(膚餘獵觸襯膚鹹廠艱壓) = 鏇憲築簾憲窪製願構顧壓鏇鑰鏇鏇網簾餘積壓 (鹽糧窪齋遞鑰壓壓餘選 ) 更多	积极	2024-05-14
				DEC-Ccitabine	選觸獵齋淵繭襯選餘艱(膚餘獵觸襯膚鹹廠艱壓) = 艱壓鑰醖壓築衊鬱遞夢壓鏇鑰鏇鏇網簾餘積壓 (鹽糧窪齋遞鑰壓壓餘選 )
MYDAS-T MDS05 \| ES-3000 (EHA2024)	临床1/2期	骨髓增生异常综合征	8	ES-3000 60mg TID	鹽齋醖簾壓顧願廠淵網(築築選網簾範網衊鏇鹽) = One patient progressed and subsequently died of infective complications (colitis) attributable to progressive disease in cycle 2 壓齋鹹鬱齋廠獵遞衊淵 (餘蓋壓餘鬱範遞夢蓋齋 ) 更多	-	2024-05-14
EHA2024	N/A	慢性粒单核细胞白血病	50	Azacitidine	鬱製醖築糧積簾願鹽構(憲鏇廠構鬱淵願襯製構) = 衊鹹淵衊繭觸選壓齋醖夢鏇膚鹹醖積積壓願顧 (網選獵憲壓蓋獵衊鹽願 ) 更多	-	2024-05-14
				Decitabine-cedazuridine	鬱製醖築糧積簾願鹽構(憲鏇廠構鬱淵願襯製構) = 鹽網夢衊壓襯鹹膚鹽觸夢鏇膚鹹醖積積壓願顧 (網選獵憲壓蓋獵衊鹽願 ) 更多
NCT04746235 (Pubmed) 人工标引	临床2期	急性髓性白血病	62	ASTX727 (cevenetoclax 100 mg and decitabine 35 mg) plus venetoclax 400 mg	壓遞艱齋簾鏇鹹繭鹽願(衊遞構窪壓齋壓鑰鬱構) = 鏇壓衊選齋積窪糧艱鏇憲遞製齋膚簾網廠選廠 (糧憲鹽構醖顧觸網鬱鹹 ) 更多	积极	2024-04-01
				ASTX727 + venetoclax 400 mgvenetoclax 400 mg (newly diagnosed acute myeloid leukaemia)	壓遞艱齋簾鏇鹹繭鹽願(衊遞構窪壓齋壓鑰鬱構) = 簾觸顧網繭鹹膚築鹹膚憲遞製齋膚簾網廠選廠 (糧憲鹽構醖顧觸網鬱鹹, 49 ~ 77)
NCT03306264 (ASCERTAIN, Pubmed 1 \| Pubmed 2 \| Lancet Haematol) 人工标引	临床3期	慢性粒单核细胞白血病 \| 骨髓增生异常综合征	133	ASTX727	繭選鬱簾願衊鹹願醖膚(築繭餘簾願壓齋壓鹹築) = 鹽襯艱鬱範繭餘鏇築繭齋鑰願淵願觸窪淵網醖 (獵範衊糧夢製獵獵餘積, 92·66 ~ 105·60) 更多	积极	2024-01-01
				decitabine	願糧醖鏇廠構構憲築淵(醖糧築淵網遞窪蓋鬱衊) = 襯觸簾繭窪積遞簾艱衊鬱醖願衊醖餘範繭鬱繭 (醖糧齋襯艱製鹹築網積 )
NCT04746235 (ASH2023)	临床2期	急性髓性白血病	52	ASTX727 (Decitabine/Cedazuridine) plus Venetoclax	築憲鹹襯衊廠選鬱壓廠(憲膚夢壓構壓餘鏇夢醖) = 廠窪構餘夢齋鹹繭齋構廠艱獵蓋憲夢簾範獵鬱 (襯衊鬱襯築壓選構鏇醖 ) 更多	-	2023-12-11