Decitabine

Aprea Therapeutics to Present Data from U.S. Phase 1b/2 MDS/AML Trial and French Phase 1b/2 MDS/AML Trial at 61st American Society of Hematology Annual Meeting

Retrieved on: 
Wednesday, November 6, 2019
RTT, Acute myeloid leukemia, Chemical compounds, Cancer, Lactams, Nucleosides, Triazines, Branches of biology, Myelodysplastic syndrome, Azacitidine, Tumors of the hematopoietic and lymphoid tissues, Decitabine

Data from the US Phase 1b/2 Trial and interim results from the French Phase 1b/2 Trial for its lead candidate APR-246 in combination with Azacitidine (AZA) in patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) were both chosen for oral presentations.

Key Points: 
  • Data from the US Phase 1b/2 Trial and interim results from the French Phase 1b/2 Trial for its lead candidate APR-246 in combination with Azacitidine (AZA) in patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) were both chosen for oral presentations.
  • The Companys lead product candidate is APR-246, a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).
  • This press release includes forward-looking statements within the meaning of the federal securities laws.
  • Corporate Contacts: Christian S. Schade President and Chief Executive Officer [email protected] Gregory A. Korbel, Ph.D. Vice President of Business Development [email protected]

Novadoz Pharmaceuticals/MSN Labs Receives FDA Clearance for Fosaprepitant and Decitabine the Company's First Generic Specialty Injectable Products

Retrieved on: 
Thursday, September 5, 2019
Chemical compounds, Organic compounds, Prodrugs, Pharmaceuticals policy, Pharmaceutical industry, Generic drug, Public domain, Decitabine, Fosaprepitant

Novadoz expects to begin the shipping of Decitabine, their generic version of DACOGEN from Otsuka, later this month.

Key Points: 
  • Novadoz expects to begin the shipping of Decitabine, their generic version of DACOGEN from Otsuka, later this month.
  • The combined sales of Decitabine brand and generics is trending over $91MIL, while brand sales of Fosaprepitant are approximately $279MIL during the previous twelve months of published sales.
  • Seshu Akula, Novadoz President North America Generics, states "The approval of Fosaprepitant and Decitabine for injection, mark the company's entrance into the specialty injectable market.
  • In addition, the company manufactures finished dosage oral solids, liquids, and injectable products in sixty-five markets throughout the world, doing business in the U.S under the Novadoz label.

Bio-Path Announces Patient Dosing in Amended Phase 2 Prexigebersen Trial in Acute Myeloid Leukemia

Retrieved on: 
Monday, August 26, 2019
Cancer treatments, Nucleosides, Chemical compounds, Lactams, Organic compounds, Decitabine, Janssen Pharmaceutica, Otsuka Pharmaceutical, Triazines, Myelodysplastic syndrome, 7+3, Vadastuximab talirine

The key change in the amended Phase 2 study is the inclusion of patients with high risk myelodysplastic syndrome (MDS) and refractory/relapsed AML patients.

Key Points: 
  • The key change in the amended Phase 2 study is the inclusion of patients with high risk myelodysplastic syndrome (MDS) and refractory/relapsed AML patients.
  • The restructured Phase 2 clinical trial has two cohorts of patients.
  • The amended Phase 2 study will continue evaluating the safety of prexigebersen in combination with decitabine in both cohorts of patients at a dose of 60 mg/m2 in combination with decitabine.
  • The study will include a total of six evaluable patients for a safety assessment of prexigebersen and decitabine.

Tolero Pharmaceuticals Presents Clinical Data from Ongoing Phase 1 Zella 101 Study Evaluating Investigational Agent Alvocidib in Combination with Cytarabine and Daunorubicin in Patients with Newly Diagnosed AML at EHA 2019

Retrieved on: 
Friday, June 14, 2019
Chemical compounds, Organic compounds, Heterocyclic compounds, Lactams, Orphan drugs, Protein kinase inhibitors, RTT, Chromones, Myelodysplastic syndrome, Decitabine, Alvocidib, Sumitomo Dainippon Pharma

Alvocidib is also being evaluated in Zella 101, a Phase I clinical study evaluating the maximum tolerated dose, safety and clinical activity of alvocidib in combination with (7+3) in newly diagnosed patients with AML ( NCT03298984 ), and Zella 102, a Phase 1b/2 study in patients with myelodysplastic syndromes, MDS, in combination with decitabine ( NCT03593915 ).

Key Points: 
  • Alvocidib is also being evaluated in Zella 101, a Phase I clinical study evaluating the maximum tolerated dose, safety and clinical activity of alvocidib in combination with (7+3) in newly diagnosed patients with AML ( NCT03298984 ), and Zella 102, a Phase 1b/2 study in patients with myelodysplastic syndromes, MDS, in combination with decitabine ( NCT03593915 ).
  • In addition, alvocidib is being evaluated in a Phase 1 study in patients with relapsed or refractory AML in combination with venetoclax ( NCT03441555 ).
  • Tolero Pharmaceuticals is based in the United States and is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan.
  • Zella 101: Phase 1 Study of Alvocidib Followed by 7+3 Induction in Newly Diagnosed AML Patients.

Astex and Otsuka Announce Results of the Phase 3 ASCERTAIN Study of the Novel Oral Cedazuridine/Decitabine Fixed-Dose Combination (ASTX727) in Patients with Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)

Retrieved on: 
Thursday, June 6, 2019
Stem cells, Health, Clinical trials, Oncology, Pharmaceutical, FDA, Chemical compounds, Nucleosides, Heterocyclic compounds, Organic compounds, Lactams, Triazines, Myelodysplastic syndrome, RTT, Decitabine, Evofosfamide

Safety and clinical activity were similar to that observed in a previous phase 1/2 study.

Key Points: 
  • Safety and clinical activity were similar to that observed in a previous phase 1/2 study.
  • Subject to regulatory review and approvals, ASTX727 could bring a new treatment option to patients with these deadly diseases.
  • ASTX727 may also have potential in all-oral combination regimes for the treatment of a range of different tumor types.
  • An oral fixed-dose combination of decitabine and cedazuridine in myelodysplastic syndromes: a multicentre, open-label, dose-escalation, phase 1 study.

Tolero Pharmaceuticals to Highlight Clinical Data Evaluating Investigational Agent Alvocidib in Patients with Newly Diagnosed AML at EHA 2019

Retrieved on: 
Thursday, May 16, 2019
Drugs, Chemical compounds, Organic compounds, Lactams, RTT, Orphan drugs, Protein kinase inhibitors, Chromones, Myelodysplastic syndrome, Decitabine, 7+3, Daunorubicin/cytarabine

Alvocidib is also being evaluated in Zella 101, a Phase I clinical study evaluating the maximum tolerated dose, safety and clinical activity of alvocidib in combination with cytarabine/daunorubicin(7+3) in newly diagnosed patients with AML ( NCT03298984 ), and Zella 102, a Phase 1b/2 study in patients with myelodysplastic syndromes (MDS) in combination with decitabine ( NCT03593915 ).

Key Points: 
  • Alvocidib is also being evaluated in Zella 101, a Phase I clinical study evaluating the maximum tolerated dose, safety and clinical activity of alvocidib in combination with cytarabine/daunorubicin(7+3) in newly diagnosed patients with AML ( NCT03298984 ), and Zella 102, a Phase 1b/2 study in patients with myelodysplastic syndromes (MDS) in combination with decitabine ( NCT03593915 ).
  • In addition, alvocidib is being evaluated in a Phase 1 study in patients with relapsed or refractory AML in combination with venetoclax ( NCT03441555 ).
  • Tolero Pharmaceuticals is based in the United States and is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan.
  • Any forward-looking statements set forth in this press release speak only as of the date of this press release.

Menarini Ricerche Announces New Positive Results in Acute Myeloid Leukemia Cell Lines for MEN1112/OBT357 at the 60th Annual SIC Meeting

Retrieved on: 
Wednesday, September 19, 2018
RTT, Lactams, Cancer, Acute myeloid leukemia, Nucleosides, Triazines, Chemistry, Clinical medicine, Decitabine, Azacitidine, Leukemia, Vadastuximab talirine

Menarini Ricerche will present tomorrow, September 20th, at the 60th Annual Meeting of the Italian Cancer Society (SIC), new preclinical data showing that pre-treatment with 5-Azacytidine and Decitabine enhances the Antibody-dependent cellular cytotoxicity (ADCC) of the clinical candidate MEN1112/OBT357 on several Acute Myeloid Leukemia (AML) cell lines.

Key Points: 
  • Menarini Ricerche will present tomorrow, September 20th, at the 60th Annual Meeting of the Italian Cancer Society (SIC), new preclinical data showing that pre-treatment with 5-Azacytidine and Decitabine enhances the Antibody-dependent cellular cytotoxicity (ADCC) of the clinical candidate MEN1112/OBT357 on several Acute Myeloid Leukemia (AML) cell lines.
  • MEN1112/OBT357 is a monoclonal antibody targeting CD157, a myeloid marker present on leukemia cells.
  • A comprehensive work of preclinical characterization has been already fulfilled and MEN1112/OBT357 is currently in phase I clinical trial for the treatment of patients with relapsed/refractory (R/R) Acute Myeloid Leukemia (AML).
  • The experimental results that will be presented strongly suggest that pre-treatment with 5-Azacytidine and Decitabine enhances the cell killing activity of MEN1112/OBT357 on SKNO-1, HL60 and K052 cell lines.