CD135

Health Canada Approves Astellas' XOSPATA® (gilteritinib) for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

Retrieved on: 
Tuesday, January 14, 2020

XOSPATA is the first and only targeted treatment approved by Health Canada for patients with relapsed or refractory Acute Myeloid Leukemia with a FLT3 mutation.

Key Points: 
  • XOSPATA is the first and only targeted treatment approved by Health Canada for patients with relapsed or refractory Acute Myeloid Leukemia with a FLT3 mutation.
  • The study enrolled 371 patients with relapsed or refractory AML and FLT3 mutation present in bone marrow or whole blood.
  • FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation.
  • European Commission Approves Astellas' XOSPATA (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation.

61st ASH Congress 2019: Menarini Ricerche Presents the Latest Updates About the First In Human Clinical Trial of SEL24/MEN1703

Retrieved on: 
Monday, December 9, 2019

CLI24-001 (DIAMOND-01) trial is testing SEL24/MEN1703,a first in class, oral dual PIM/FLT3 inhibitor in-licensed from Ryvu Therapeutics.

Key Points: 
  • CLI24-001 (DIAMOND-01) trial is testing SEL24/MEN1703,a first in class, oral dual PIM/FLT3 inhibitor in-licensed from Ryvu Therapeutics.
  • Menarini Group is an Italian pharmaceutical company with a turnover of 3.667 billion Euro and more than 17,000 employees.
  • The Menarini Group has always pursued two strategic objectives: research and internationalization, and has a strong commitment to oncology research and development.
  • The Menarini Group's commitment to precision oncology is also supported by Menarini Silicon Biosystems' technologies and products to study rare cells with single-cell precision.

Actinium Pharmaceuticals Highlights 86% Response Rate and 71% MRD Negative Rate in Actimab-A CLAG-M Combination Trial in Patients with Relapsed or Refractory AML at ASH 2019 Annual Meeting

Retrieved on: 
Monday, December 9, 2019

Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML.

Key Points: 
  • Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML.
  • Efficacy of the combination of venetoclax and hypomethylating agents in relapsed/refractory acute myeloid leukemia.
  • Efficacy and Biological Correlates of Response in a Phase II Study of Venetoclax Monotherapy in Patients with Acute Myelogenous Leukemia.
  • Azacitidine for the treatment of relapsed and refractory AML in older patients.

61st ASH Congress 2019: Menarini Ricerche Presents the Latest Updates About the First In Human Clinical Trial of SEL24/MEN1703

Retrieved on: 
Monday, December 9, 2019

CLI24-001 (DIAMOND-01) trial is testing SEL24/MEN1703,a first in class, oral dual PIM/FLT3 inhibitor in-licensed from Ryvu Therapeutics.

Key Points: 
  • CLI24-001 (DIAMOND-01) trial is testing SEL24/MEN1703,a first in class, oral dual PIM/FLT3 inhibitor in-licensed from Ryvu Therapeutics.
  • Menarini Group is an Italian pharmaceutical company with a turnover of 3.667 billion Euro and more than 17,000 employees.
  • The Menarini Group has always pursued two strategic objectives: research and internationalization, and has a strong commitment to oncology research and development.
  • The Menarini Group's commitment to precision oncology is also supported by Menarini Silicon Biosystems' technologies and products to study rare cells with single-cell precision.

BerGenBio Presents Preliminary Clinical Data From Phase II Combination Trial of Bemcentinib and LDAC in Elderly AML Patients at ASH 2019

Retrieved on: 
Monday, December 9, 2019

The bemcentinib-LDAC combination was safe and well tolerated in elderly AML patients and showed promising efficacy among both newly diagnosed and relapsed/refractory AML patients.

Key Points: 
  • The bemcentinib-LDAC combination was safe and well tolerated in elderly AML patients and showed promising efficacy among both newly diagnosed and relapsed/refractory AML patients.
  • Pretreatment sAXL holds as a predictive biomarker in AML patients treated with the combination, and a new novel blood based predictive biomarker is identified and associated with clinical benefit in AML and Lung cancer patients receiving bemcentinib.
  • The duration of response and successful treatment beyond progression are consistent with the previously reported immunomodulatory activity of bemcentinib.
  • Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme.

BerGenBio Presents Preliminary Clinical Data From Phase II Combination Trial of Bemcentinib and LDAC in Elderly AML Patients at ASH 2019

Retrieved on: 
Monday, December 9, 2019

The bemcentinib-LDAC combination was safe and well tolerated in elderly AML patients and showed promising efficacy among both newly diagnosed and relapsed/refractory AML patients.

Key Points: 
  • The bemcentinib-LDAC combination was safe and well tolerated in elderly AML patients and showed promising efficacy among both newly diagnosed and relapsed/refractory AML patients.
  • The duration of response and successful treatment beyond progression are consistent with the previously reported immunomodulatory activity of bemcentinib.
  • The current data further highlight the novel tumor-immune effects of bemcentinib observed in previous cohorts and in other cancer types.
  • Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme.

Aptose Presents Highlights From Corporate Event At ASH

Retrieved on: 
Saturday, December 7, 2019

SAN DIEGO, TORONTO and ORLANDO, Fla., Dec. 07, 2019 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS) released highlights from a corporate event and clinical update today held at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, FL.

Key Points: 
  • SAN DIEGO, TORONTO and ORLANDO, Fla., Dec. 07, 2019 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS) released highlights from a corporate event and clinical update today held at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, FL.
  • The slides are available and the recording of the presentation will be archived on Aptoses website here shortly after the conclusion of the event.
  • As the first clinical data from CG-806 in patients with chronic lymphocytic leukemia (CLL) have begun to emerge, Drs.
  • William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose also provided a corporate update on the clinical activities of CG-806, Aptoses highly potent pan-FLT3/pan-BTK inhibitor.

The European Commission Approves Astellas’ XOSPATA® for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation Detected by Validated Tests, including the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay

Retrieved on: 
Thursday, December 5, 2019

The LeukoStrat CDx FLT3 Mutation Assay may now be used as an aid in the assessment of AML patients for treatment with XOSPATA (gilteritinib) in Europe.

Key Points: 
  • The LeukoStrat CDx FLT3 Mutation Assay may now be used as an aid in the assessment of AML patients for treatment with XOSPATA (gilteritinib) in Europe.
  • FLT3 mutation must be confirmed with a validated test, such as the LeukoStrat CDx FLT3 Mutation Assay, which served as the companion diagnostic in the Phase 3 ADMIRAL trial resulting in approval of XOSPATA.
  • Companion diagnostics play a key role in the development and approval of targeted drug therapies.
  • Accordingly, the successful approval of a targeted therapy is highly dependent on the performance of the companion diagnostic.

Astellas Presents New Data on XOSPATA® (gilteritinib) in FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia at the 2019 American Society of Hematology Annual Meeting

Retrieved on: 
Tuesday, December 3, 2019

Differentiation Syndrome (See BOXED WARNING)3% of 319 patients treated with XOSPATA in the clinical trials experienced differentiation syndrome.

Key Points: 
  • Differentiation Syndrome (See BOXED WARNING)3% of 319 patients treated with XOSPATA in the clinical trials experienced differentiation syndrome.
  • Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated.
  • FDA Approves Treatment for Adult Patients who Have Relapsed or Refractory Acute Myeloid Leukemia (AML) with a Certain Genetic Mutation.
  • NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Acute Myeloid Leukemia Version 2.2020 (09-03-2019).

Aptose to Present at 31st Annual Piper Jaffray Healthcare Conference

Retrieved on: 
Monday, December 2, 2019

Aptose Biosciences is a clinical-stage biotechnology company committed to developing personalized therapies addressing unmet medical needs in oncology, with an initial focus on hematology.

Key Points: 
  • Aptose Biosciences is a clinical-stage biotechnology company committed to developing personalized therapies addressing unmet medical needs in oncology, with an initial focus on hematology.
  • The Company's small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities.
  • The Company has two clinical-stage investigational products for hematologic malignancies: CG-806, an oral, first-in-class mutation-agnostic FLT3/BTK kinase inhibitor, is in a Phase 1 trial in patients with relapsed or refractory B cell malignancies, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and non-Hodgkin lymphoma (NHL), who have failed or are intolerant to standard therapies; APTO-253, the only clinical stage agent that directly targets the MYC oncogene and inhibits its expression, is in a Phase 1b clinical trial for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS).
  • For further information, please visit www.aptose.com.