Cytarabine

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

Retrieved on: 
Friday, September 23, 2022

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

Retrieved on: 
Tuesday, August 23, 2022

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

Retrieved on: 
Thursday, August 4, 2022

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

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

Retrieved on: 
Thursday, July 21, 2022

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

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

Retrieved on: 
Friday, May 27, 2022

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.

ClearPoint Neuro Congratulates Partner PTC Therapeutics on Receiving Positive CHMP Opinion for Gene Therapy to Treat AADC Deficiency

Retrieved on: 
Friday, May 20, 2022

The use of ClearPoint Neuros proprietary CE Marked SmartFlow Neuro Ventricular Cannula for minimally invasive infusion of the gene therapy is included in the submission for administration of Upstaza.

Key Points: 
  • The use of ClearPoint Neuros proprietary CE Marked SmartFlow Neuro Ventricular Cannula for minimally invasive infusion of the gene therapy is included in the submission for administration of Upstaza.
  • This is a significant milestone for PTC Therapeutics, for ClearPoint and for biologics researchers everywhere as it marks the very first positive CHMP recommendation for direct injection to the brain of a gene therapy to treat a severe, highly morbid and fatal neurological disorder, commented Joe Burnett, President and CEO of ClearPoint Neuro.
  • First, it provides a potential path for other therapies to follow and sets an important precedent for regulatory approval of direct administered gene therapies to the brain.
  • And second, we see this as a validation of ClearPoints biologics partnership strategy and our rigorous bench, preclinical and clinical experience.

Kronos Bio’s Investigational SYK Inhibitors Entospletinib and Lanraplenib to be Featured in Four Poster Presentations at EHA2022 Congress

Retrieved on: 
Thursday, May 12, 2022

SAN MATEO, Calif. and CAMBRIDGE, Mass., May 12, 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 announced that its two novel investigational spleen tyrosine kinase (SYK) inhibitors, entospletinib and lanraplenib, will be featured in poster presentations at the European Hematology Association (EHA) 2022 Congress, being held June 9-12 in Vienna.

Key Points: 
  • Data are anticipated in the second half of 2023 with a primary endpoint of measurable residual disease (MRD) negative complete response.
  • The company is also advancing lanraplenib, a next generation SYK inhibitor, as a potential treatment for patients with relapsed/refractory AML in combination with gilteritinib in a Phase 1b/2 study.
  • Kronos Bio has begun to open trial sites and plans to initiate dosing of the first patient in the second quarter.
  • Additional experiments demonstrated that entospletinib and lanraplenib could restore T-cell proliferation in a subset of AML samples from patients with dysfunctional T-cell responses.

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

Retrieved on: 
Wednesday, May 4, 2022

SAN MATEO, Calif. and CAMBRIDGE, Mass., May 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 first quarter 2022 financial results.

Key Points: 
  • Data are anticipated in the second half of 2023 with a primary endpoint of measurable residual disease (MRD) negative complete response.
  • Kronos Bio has implemented fiscal prudence measures, which provide expected cash runway into the second half of 2024, as announced earlier this year.
  • Kronos Bio announced the appointment of Dr. Elizabeth Olek, DO, MPH, as senior vice president, Clinical Development.
  • Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass.