Hypomethylating agent

Cellworks Biosimulation Study Reveals Biomarkers That Predict Response to Hypomethylating Agents and Patient Survival in MDS

Retrieved on: 
Monday, December 12, 2022
Software, Research, General Health, Pharmaceutical, Data Management, Oncology, Technology, Genetics, Clinical Trials, Science, Biotechnology, Health, Other Science, Leukemia Research, HOXA9, Lymphatic system, CEBPA, Software, Biosimulation, Society, Research, Methylation, Disease, Patient, DS, SPI1, Pearson, EZH2, Myelodysplastic syndrome, AML, MDS, Drug combination, Prognosis, Decitabine, City, University of Tennessee Health Science Center, University, DNMT3A, Abstract, Survival, NR, R, MD, Leukemia, Diagnosis, CBL, CBM, UnitedHealth Group, Student, TP53, Sequoia Capital, HMA, ASH, Versata Development Group, Inc. v. SAP America, Inc., Master of Science, Exposition, Chair, NF1, ITGAM, Haematopoietic system, Biomarker, RUNX1, Neuro, GATA1, Blood, Hypomethylating agent, NRAS, Medical imaging, Pharmaceutical industry, Hematology

In the study, DS predicted HMA response in MDS patients and showed a strong correlation to the treatment efficacy score (ES).

Key Points: 
  • In the study, DS predicted HMA response in MDS patients and showed a strong correlation to the treatment efficacy score (ES).
  • This study demonstrates the power of using Cellworks personalized therapy biosimulation to gain insight into individual patient mutanome, drug resistance pathways and novel biomarkers that determine their drug response and resistance to better inform treatment decisions for MDS patients.
  • This study shows that Cellworks personalized therapy biosimulation, which was based on each patients genomic aberrations, reveals a high spectrum of DS among patients with MDS.
  • The Cellworks Platform predicts therapy response for individual patients and patient cohorts using a breakthrough Computational Biology Model (CBM) and biosimulation technology.

GlycoMimetics’ Uproleselan in Combination With Venetoclax/HMA Shown to Break Chemoresistance, Reduce Tumor Burden and Increase Survival in AML Model

Retrieved on: 
Saturday, December 5, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Proteins, Clinical medicine, Branches of biology, Selectins, Antineoplastic drugs, Hypomethylating agent, E-selectin, Clinical trial, 7+3, Chemotherapy, Uproleselan (GMI-1271), GlycoMimetics, Inc.

As in previously reported models, uproleselan has shown benefit when added to multiple chemotherapy regimens.

Key Points: 
  • As in previously reported models, uproleselan has shown benefit when added to multiple chemotherapy regimens.
  • The data strongly support conducting a clinical trial with this combination therapy, said Rachel King, GlycoMimetics Chief Executive Officer.
  • Given investigator interest in this data, were actively exploring opportunities for investigator-sponsored clinical trials to study the implications in humans.
  • GlycoMimetics previously presented preclinical data showing that hypomethylating agents up-regulate the expression of E-selectin ligand on AML cells.

Humanigen Australia Proprietary Limited Established to Facilitate Asia-Pacific Growth Plans

Retrieved on: 
Monday, November 23, 2020
Infectious diseases, Health, Oncology, Clinical trials, Clinical medicine, Branches of biology, Medicine, Immune system, EMR1, Hypomethylating agent, Leukemia, Lenzilumab, Chimeric antigen receptor T cell

(NASDAQ: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with its lead drug candidate, lenzilumab, today announced the establishment of Humanigen Australia Proprietary Limited (Humanigen Australia Pty Ltd), through which Humanigen intends to assess potential partnering opportunities, facilitate clinical development programs, and conduct other corporate and business development activities in the Asia-Pacific region.

Key Points: 
  • (NASDAQ: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with its lead drug candidate, lenzilumab, today announced the establishment of Humanigen Australia Proprietary Limited (Humanigen Australia Pty Ltd), through which Humanigen intends to assess potential partnering opportunities, facilitate clinical development programs, and conduct other corporate and business development activities in the Asia-Pacific region.
  • The study is supported by a grant from the Australian Government's Medical Research Future Fund.
  • In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders.
  • Suboptimal response rates to hypomethylating agent therapy in chronic myelomonocytic leukemia; a single institutional study of 121 patients.

GlycoMimetics Program Data to be Highlighted Via Three Oral Presentations and Two Posters at 62nd American Society of Hematology Annual Meeting and Exposition

Retrieved on: 
Wednesday, November 4, 2020
Health, FDA, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Chemical compounds, Proteins, Selectins, Branches of biology, Antineoplastic drugs, Clusters of differentiation, Glycoproteins, Breakthrough therapy, Venetoclax, E-selectin, Hypomethylating agent, American Society of Hematology, Rivipansel, GMI-1687, Uproleselan (GMI-1271), GMI-1359, GlycoMimetics, Inc.

A second presentation includes data from two different preclinical models of VOC using GlycoMimetics highly potent and specific E-selectin antagonist, GMI-1687.

Key Points: 
  • A second presentation includes data from two different preclinical models of VOC using GlycoMimetics highly potent and specific E-selectin antagonist, GMI-1687.
  • A third presentation discloses how targeting E-selectin with uproleselan may help patients with AML overcome resistance to venetoclax combined with hypomethylating agent (HMA) based therapy.
  • GlycoMimetics is honored to have five abstracts from across our product candidate portfolio selected for presentations at this years ASH meeting.
  • At the 2018 Annual Meeting of the American Society of Hematology, data presented in a poster about GMI-1687 pointed to the potential for a life-cycle extension for GlycoMimetics uproleselan.

2020 Disease Analysis on Acute Myeloid Leukemia (AML) - ResearchAndMarkets.com

Retrieved on: 
Monday, September 7, 2020
Pharmaceutical, Health, Oncology, Cancer, Clinical medicine, RTT, Nucleosides, Antineoplastic drugs, Lactams, Triazines, 7+3, Hypomethylating agent, Decitabine, Acute myeloid leukemia, Azacitidine

The "Disease Analysis: Acute Myeloid Leukemia (AML)" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Disease Analysis: Acute Myeloid Leukemia (AML)" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The publisher estimates that in 2018, there were 158,400 incident cases of acute myeloid leukemia (AML) worldwide, and expects that number to increase to 169,000 incident cases by 2027.
  • Approximately 60% of newly diagnosed patients are eligible for intensive chemotherapy, such as the 7+3 regimen of cytarabine and daunorubicin.
  • Gone is the era where all front-line patients received either 7+3 chemotherapy or a hypomethylating agent (decitabine or azacitidine).

Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical Announce FDA and Health Canada Approval of INQOVI® (Decitabine and Cedazuridine) Tablets, Oral Hypomethylating Agent (HMA) Therapy for Intermediate and High-Risk MDS and CMML

Retrieved on: 
Wednesday, July 8, 2020
Oncology, Health, FDA, Clinical trials, Pharmaceutical, Biotechnology, Nucleosides, Chemical compounds, Organic compounds, Decitabine, Janssen Pharmaceutica, Lactams, Triazines, Myelodysplastic syndrome, Hypomethylating agent, Chronic myelomonocytic leukemia, Astex, Clinical medicine, INQOVI (See https://www.inqovi.com), Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML), Astex, Taiho, and Otsuka

Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved INQOVI (decitabine and cedazuridine) tablets.

Key Points: 
  • Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved INQOVI (decitabine and cedazuridine) tablets.
  • INQOVI is the first and only orally administered hypomethylating agent for the treatment for adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML),1 two blood malignancies.
  • Approval was based on data from the ASCERTAIN phase 3 study and supporting phase 1 and 2 clinical studies.
  • The ASCERTAIN phase 3 study evaluated the five-day, decitabine exposure equivalence between oral INQOVI and intravenous decitabine.

Aprea Therapeutics Presents Results From French Phase Ib/II Clinical Trial of APR-246 (Eprenetapopt) and Azacitidine in Patients with TP53 Mutant Myelodysplastic Syndromes and Acute Myeloid Leukemia at the 25th European Hematology Association Annual Meeti

Retrieved on: 
Friday, June 12, 2020
RTT, Lactams, Cancer, Nucleosides, Triazines, Clinical medicine, Drugs, Hypomethylating agent, Acute myeloid leukemia, Myelodysplastic syndrome, Azacitidine, Tumors of the hematopoietic and lymphoid tissues

The trial is evaluating the safety and efficacy of APR-246 (eprenetapopt) in combination with azacitidine (AZA) for the treatment of TP53 mutant myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

Key Points: 
  • The trial is evaluating the safety and efficacy of APR-246 (eprenetapopt) in combination with azacitidine (AZA) for the treatment of TP53 mutant myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).
  • Details of the on-demand oral presentation are as follows:
    Title: APR-246 Combined with Azacitidine in TP53 Mutated Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia.
  • A Phase 2 Study by the Groupe Francophone des Mylodysplasies (GFM)
    Eligible patients in the Phase Ib/II clinical trial include hypomethylating agent (HMA) nave, TP53 mutated MDS and AML.
  • The Companys lead product candidate is APR-246 (eprenetapopt), a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

Genentech Announces Venclexta Combination Improved Overall Survival in People With Previously Untreated Acute Myeloid Leukemia

Retrieved on: 
Monday, March 23, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Organic compounds, RTT, Cancer, Acute myeloid leukemia, Lactams, Nucleosides, Triazines, Hypomethylating agent, Leukemia, Chronic lymphocytic leukemia, Venetoclax, the VIALE-A Study, AML, Venclexta, Genentech in Hematology, Genentech

Venclexta (venetoclax) in combination with azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukemia (AML) who were ineligible for intensive induction chemotherapy, compared to azacitidine alone.

Key Points: 
  • Venclexta (venetoclax) in combination with azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukemia (AML) who were ineligible for intensive induction chemotherapy, compared to azacitidine alone.
  • Two-thirds of patients received 400 mg Venclexta daily, in combination with azacitidine, and the remaining patients received placebo tablets in combination with azacitidine.
  • Acute myeloid leukemia (AML) is the most common type of aggressive leukemia in adults, which has the lowest survival rate for all types of leukemia.
  • In the United States, Venclexta has been granted five Breakthrough Therapy Designations by the U.S. Food and Drug Administration: one for previously untreated chronic lymphocytic leukemia (CLL), two for relapsed or refractory CLL and two for previously untreated acute myeloid leukemia.

Astex Pharmaceuticals Presents Topline Data from the ASCERTAIN Phase 3 Study of its Novel, Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727) in MDS and CMML at the American Society of Hematology Meeting in Orlando, FL.

Retrieved on: 
Monday, December 9, 2019
Oncology, Health, FDA, Stem cells, Clinical trials, Pharmaceutical, Biotechnology, Nucleosides, Chemical compounds, Organic compounds, Lactams, Triazines, Hypomethylating agent, Decitabine, Myelodysplastic syndrome, Clinical medicine, Area under the curve, Cedazuridine and Decitabine Fixed-Dose Combination (ASTX727), Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML), Astex Pharmaceuticals, Inc.

The data presented demonstrated that the ASCERTAIN study met the primary endpoint of total 5-Day decitabine Area-Under-The-Curve (AUC) equivalence of oral ASTX727 and IV decitabine.

Key Points: 
  • The data presented demonstrated that the ASCERTAIN study met the primary endpoint of total 5-Day decitabine Area-Under-The-Curve (AUC) equivalence of oral ASTX727 and IV decitabine.
  • Preliminary clinical activity as of the data cutoff was also consistent with published data for IV decitabine.
  • The data support that ASTX727 could become an oral hypomethylating agent alternative to IV decitabine.
  • An oral fixed-dose combination of decitabine and cedazuridine in myelodysplastic syndromes: a multicentre, open-label, dose-escalation, phase 1 study.

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
Chemical compounds, Organic compounds, Heterocyclic compounds, RTT, Piperazines, Orphan drugs, Lactams, CD135, Gilteritinib, Acute myeloid leukemia, Hypomethylating agent, 7+3

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.