Cytarabine

Moleculin Announces Final Topline Data from Successful European Phase 1 Trial Evaluating Annamycin as Single Agent Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)

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Monday, February 13, 2023
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HOUSTON, Feb. 13, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the following topline results from its MB-105 European Phase 1 clinical trial assessing the safety and efficacy of Annamycin as a single agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML). The final MB-105 results align with the overall safety profile of Annamycin and observations made in previously completed and ongoing clinical studies evaluating Annamycin. Additionally in the last cohort where all subjects were at least 60 years of age, Annamycin demonstrated an overall response rate (ORR) of 80%.

Key Points: 
  • The final MB-105 results align with the overall safety profile of Annamycin and observations made in previously completed and ongoing clinical studies evaluating Annamycin.
  • "We also are encouraged by the absence of cardiotoxicity with Annamycin to date," Mr. Klemp added.
  • 20 subjects were enrolled in the trial with the age range of 24-76 years with a median age of 64.5.
  • As announced in February 2022, upon safely reaching the RP2D of 240 mg/m2 in the MB-105 trial, the Company concluded recruitment for the trial.

Biosight Launches a Phase 1/2 Clinical Trial of Aspacytarabine in Combination with Venetoclax for First-Line AML Induction Therapy, Followed by Aspacytarabine Consolidation

Retrieved on: 
Tuesday, November 22, 2022
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The trial, conducted in leading clinical centers in the United States, enrolls newly-diagnosed AML patients who are unfit for standard induction chemotherapy due to age or comorbidities.

Key Points: 
  • The trial, conducted in leading clinical centers in the United States, enrolls newly-diagnosed AML patients who are unfit for standard induction chemotherapy due to age or comorbidities.
  • We are therefore very excited to be launching this first combination therapy trial".
  • Results from a recently completed Phase 2b study evaluating aspacytarabine as a single-agent first-line AML therapy demonstrate safety and impressive single-agent activity.
  • Additional studies are ongoing to evaluate aspacytarabine as a second line treatment for patients with relapsed or refractory MDS or AML.

Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia

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Monday, October 24, 2022
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The Priority Review follows receipt of Fast Track Designation, granted by the FDA in March 2022 for quizartinib in newly diagnosed FLT3-ITD positive AML.

Key Points: 
  • The Priority Review follows receipt of Fast Track Designation, granted by the FDA in March 2022 for quizartinib in newly diagnosed FLT3-ITD positive AML.
  • The FDAs prioritization of this application reflects the importance of the data, and we will continue to work with the FDA and other global regulatory authorities to support the review of quizartinib for the treatment of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia.
  • Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo combined with anthracycline- and cytarabine-based regimens.
  • Eligible patients, including those who underwent hematopoietic stem cell transplant (HSCT), continued with quizartinib or placebo for up to 36 cycles.

Moleculin Biotech to Present at the Virtual Investor Innovations in Acute Myeloid Leukemia (AML) Spotlight Event

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Friday, September 23, 2022
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HOUSTON, Sept. 23, 2022 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that Walter V. Kemp, Founder, President, CEO and Chairman, and Wolfram C. M. Dempke, MD, PhD, MBA, European Chief Medical Officer of Moleculin will participate in the Virtual Investor Innovations in Acute Myeloid Leukemia Spotlight Event on Wednesday, September 28, 2022 at 11:00 AM ET.

Key Points: 
  • In addition to the moderated portion of the event, investors and interested parties will have the opportunity to submit questions.
  • A live video webcast of the Event will be available on the Events page of the Investors section of the Company's website ( moleculin.com ).
  • The Company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity.
  • Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

Quizartinib Marketing Authorization Application Validated by EMA for Treatment of Adult Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia

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Tuesday, August 23, 2022
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We look forward to working with the EMA to support their review of quizartinib as a potential option for patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia.

Key Points: 
  • We look forward to working with the EMA to support their review of quizartinib as a potential option for patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia.
  • The application is based on data from the QuANTUM-First phase 3 trial recently presented at the European Hematology Association (#EHA2022) Congress.
  • Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo combined with anthracycline- and cytarabine-based regimens.
  • Quizartinib is currently approved for use in Japan for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an approved test.

Kronos Bio Reports Recent Business Progress and Second-Quarter 2022 Financial Results

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Thursday, August 4, 2022
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SAN MATEO, Calif. and CAMBRIDGE, Mass., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer and other serious diseases, today reported recent business progress and second-quarter 2022 financial results.

Key Points: 
  • Data are anticipated in the second half of 2023 with a primary endpoint of measurable residual disease negative complete response.
  • Kronos Bio opened additional sites for its planned Phase 1b/2 clinical trial of lanraplenib, the companys next generation SYK inhibitor, in combination with gilteritinib in patients with FLT3-mutated AML.
  • Kronos Bio is continuing to enroll patients in the dose escalation stage of the Phase 1/2 study of KB-0742 in solid tumors.
  • Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass.

Biosight Granted Orphan Drug Designation from the FDA for Aspacytarabine for the Treatment of Myelodysplastic Syndromes

Retrieved on: 
Monday, August 1, 2022
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AIRPORT CITY, Israel, Aug. 1, 2022 /PRNewswire/ -- Biosight Ltd ., a pharmaceutical development company focused on the development of innovative therapeutics for hematological malignancies and disorder, announced today that theUnited States Food & Drug Administration(FDA) has granted Orphan Drug Designation to aspacytarabine (BST-236), an investigational novel antimetabolite, for the treatment of myelodysplastic syndromes, in addition to the Orphan Drug Designation granted in 2019 for aspacytarabine for the treatment of acute myeloid leukemia (AML).

Key Points: 
  • AIRPORT CITY, Israel, Aug. 1, 2022 /PRNewswire/ -- Biosight Ltd ., a pharmaceutical development company focused on the development of innovative therapeutics for hematological malignancies and disorder, announced today that theUnited States Food & Drug Administration(FDA) has granted Orphan Drug Designation to aspacytarabine (BST-236), an investigational novel antimetabolite, for the treatment of myelodysplastic syndromes, in addition to the Orphan Drug Designation granted in 2019 for aspacytarabine for the treatment of acute myeloid leukemia (AML).
  • "We are very pleased to have received from theFDA the Orphan Drug Designation for aspacytarabine for the treatment of MDS, which adds to the designation granted already for the treatment of AML" saidDr.
  • Orphan Drug Designation by the FDA entitles Biosight to seven years of market exclusivity for the use of aspacytarabine for the treatment of MDS, if approved, plus significant development incentives, including tax credits related to clinical trial expenses, an exemption from the FDA-user fee, and FDA assistance in clinical trial design.
  • Biosight is a private Phase 2 clinical stage biotech company developing innovative therapeutics for hematological malignancies and disorders.

ClearPoint Neuro Congratulates Partner PTC Therapeutics on Being Granted Marketing Authorization by the European Commission for Upstaza™ - First Disease-Modifying Treatment for AADC Deficiency

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Thursday, July 21, 2022
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SOLANA BEACH, Calif., July 21, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the Company), a global therapy-enabling platform company providing navigation and delivery to the brain, congratulates partner PTC Therapeutics for being granted marketing authorization for Upstaza (eladocagene exuparvovec) by the European Commission.

Key Points: 
  • SOLANA BEACH, Calif., July 21, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the Company), a global therapy-enabling platform company providing navigation and delivery to the brain, congratulates partner PTC Therapeutics for being granted marketing authorization for Upstaza (eladocagene exuparvovec) by the European Commission.
  • The use of ClearPoint Neuros proprietary CE Marked SmartFlow Neuro Cannula for minimally invasive infusion of the gene therapy is included in the Upstaza SmPC (Summary of Product Characteristics).
  • The marketing authorization, approved for patients 18 months and older, is applicable to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein.
  • The approval of Upstaza by the European Commission will have an immense impact on patients, their families, and the global gene therapy research community.

Roswell Park Expert to Present on Effectiveness of New Combination for Acute Myeloid Leukemia

Retrieved on: 
Monday, June 6, 2022
National Cancer Institute, Society, Upstate New York, Nausea, American Society of Clinical Oncology, FLT3, ASCO, AML, Hope, Annual general meeting, Daunorubicin, Patient, Acute myeloid leukemia, Roswell Park Comprehensive Cancer Center, ITD, CDT, Idarubicin, Cytarabine, MD, Clinical trial, Diarrhea, Hematology, TKD, Febrile neutropenia, Crenolanib, Pharmaceutical industry, Leukemia, Allotransplantation, Myelodysplastic syndrome

CHICAGO, June 6, 2022 /PRNewswire-PRWeb/ -- On Tuesday, June 7, Eunice Wang, MD, Chief of Leukemia at Roswell Park Comprehensive Cancer Center, will present the long-term results of a phase 2 clinical trial combining crenolanib, a second-generation FLT3 inhibitor, with standard intensive chemotherapy for treatment of adults with newly diagnosed FLT3-mutant acute myeloid leukemia (AML). Dr. Wang will discuss the findings at the American Society of Clinical Oncology (ASCO) annual meeting 2022, at 11:57 a.m. CDT, in Hall S, room 100a, during the Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant oral abstract session (abstract 7007).

Key Points: 
  • CHICAGO, June 6, 2022 /PRNewswire-PRWeb/ -- On Tuesday, June 7, Eunice Wang, MD , Chief of Leukemia at Roswell Park Comprehensive Cancer Center, will present the long-term results of a phase 2 clinical trial combining crenolanib, a second-generation FLT3 inhibitor, with standard intensive chemotherapy for treatment of adults with newly diagnosed FLT3-mutant acute myeloid leukemia (AML).
  • After one treatment cycle, 73% of patients experienced clinical responses, and 86% of patients responded to treatment after two cycles.
  • Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York.
  • Rebecca Vogt, Roswell Park Comprehensive Cancer Center, 716-548-0482, [email protected]
    Annie Deck-Miller, Roswell Park Comprehensive Cancer Center, 716-845-8593, [email protected]

Global Cytidine (Cytarabine, Azacitidine, Decitabine) Markets, 2021-2022 & 2027 - ResearchAndMarkets.com

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Friday, May 27, 2022
Health, Pharmaceutical, Death, Disease, Acute leukemia, Incidence, Degenerative disease, Government, Cytarabine, Research, WHO, Cancer, Cerebrovascular disease, CAGR, Prevalence, Growth, Pharmaceutical industry, Agriculture, Marketing, Decitabine, Azacitidine

Global Cytidine Market Size, Share & Trends Analysis Report, By Product Types (Cytarabine, Azacitidine, Decitabine), By Application (Cancer Therapy, Acute Leukemia Therapy, Cerebrovascular Disease), Forecast (2021 - 2027)

Key Points: 
  • Global Cytidine Market Size, Share & Trends Analysis Report, By Product Types (Cytarabine, Azacitidine, Decitabine), By Application (Cancer Therapy, Acute Leukemia Therapy, Cerebrovascular Disease), Forecast (2021 - 2027)
    The global cytidine market is anticipated to grow at a considerable CAGR during the forecast period.
  • The rising incidence and prevalence of chronic disorders such as cancer, acute leukaemia, and cerebrovascular diseases is creating demand for cytidine market.
  • Analysis of regional regulations and other government policies impacting the global cytidine market.
  • Insights about market determinants that are stimulating the global cytidine market.