Cytarabine

Kronos Bio Announces First Patient Dosed in AGILITY Phase 3 Clinical Trial of Entospletinib in Patients With Newly Diagnosed NPM1-mutated Acute Myeloid Leukemia

Retrieved on: 
Monday, December 6, 2021

SAN MATEO, Calif. and CAMBRIDGE, Mass., Dec. 06, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that the first patient has been dosed in the registrational Phase 3 AGILITY clinical trial of entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK), in combination with standard of care anthracycline and cytarabine (7+3) chemotherapy. This trial is the first in acute myeloid leukemia (AML) to use measurable residual disease (MRD) as the primary endpoint and has the potential to support accelerated approval of entospletinib by the U.S. Food and Drug Administration (FDA) as a treatment for patients newly diagnosed with NPM1-mutated AML who are fit for intensive induction.

Key Points: 
  • Entospletinib is Kronos Bios lead product candidate, and the company expects to share data from the trial in the second half of 2023.
  • This trial will test the hypothesis, based on robust preclinical and Phase 2 clinical data, that NPM1 mutation leads to dependency on SYK signaling.
  • In the trial, patients will be randomized 1:1 to receive either entospletinib or placebo in combination with standard induction and consolidation chemotherapy.
  • Kronos Bio is developing entospletinib for the frontline treatment of NPM1-mutated acute myeloid leukemia (AML).

Global Acute Myeloid Leukemia (AML) Therapeutics Market Research Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, December 6, 2021

The "Acute Myeloid Leukemia (AML) Therapeutics - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Acute Myeloid Leukemia (AML) Therapeutics - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.
  • This segment currently accounts for a 18.2% share of the global Acute Myeloid Leukemia (AML) Therapeutics market.
  • These R&D endeavors are also attributed to limitations associated with existing therapies available on the market for acute myeloid leukemia.
  • The U.S. Market is Estimated at $194.4 Million in 2021, While China is Forecast to Reach $85.7 Million by 2026
    The Acute Myeloid Leukemia (AML) Therapeutics market in the U.S. is estimated at US$194.4 Million in the year 2021.

Notable and CicloMed Initiate Phase 1B/2A Clinical Trial of Fosciclopirox in Acute Myelogenous Leukemia Under Co-Development Agreement

Retrieved on: 
Wednesday, December 1, 2021

Notable Labs, Inc. (Notable), a clinical-stage predictive precision therapeutics company and CicloMed LLC (CicloMed), a developmental-stage pharmaceutical company have initiated a Phase 1B/2A clinical trial of fosciclopirox in patients with refractory acute myelogenous leukemia (AML) under the terms of a co-development agreement.

Key Points: 
  • Notable Labs, Inc. (Notable), a clinical-stage predictive precision therapeutics company and CicloMed LLC (CicloMed), a developmental-stage pharmaceutical company have initiated a Phase 1B/2A clinical trial of fosciclopirox in patients with refractory acute myelogenous leukemia (AML) under the terms of a co-development agreement.
  • Fosciclopirox is a strategically and deliberately selected program, as it has already performed well on our predictive precision medicines platform.
  • The encouraging results from this work led to our co-development agreement and the initiation of our on-going clinical trial.
  • Under the terms of the co-development agreement, CicloMed holds the primary responsibility for executing clinical trial operations while Notable is primarily focused on optimizing Notables predictive precision medicine platform.

AB Science received FDA authorization to initiate Phase 1/II trial of AB8939 in the treatment of acute myeloid leukemia

Retrieved on: 
Monday, November 22, 2021

Study AB18001 is titled A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous of AB8939 in patients with Relapsed/Refractory Acute Myeloid Leukemia.

Key Points: 
  • Study AB18001 is titled A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous of AB8939 in patients with Relapsed/Refractory Acute Myeloid Leukemia.
  • This dose expansion study aims to determine the schedule for a Phase 2 trial in patients with relapsed/refractory AML and to also provide an early efficacy (response rate) assessment of AB8939.
  • The first indication AB8939 is being developed for is acute myeloid leukemia (AML).
  • Moreover, while azacytidine was associated with strong treatment related hematotoxicity, AB8939 did not induce hematotoxicity throughout its 4-week treatment period.

Biosight Announces Initiation of Phase 2 Clinical Trial of Aspacytarabine for MDS and AML

Retrieved on: 
Friday, November 12, 2021

AIRPORT CITY, Israel, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced the initiation of a Phase 2 trial to evaluate aspacytarabine (BST-236), Biosight’s proprietary antimetabolite, as a second line treatment for patients with relapsed or refractory myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The multi-center study will be conducted across 18 leading U.S. and Israeli sites including Memorial Sloan Kettering Cancer Center and The University of Texas MD Anderson Cancer Center.

Key Points: 
  • The initiation of this multi-center, U.S. based, Phase 2 study is an important step forward in the development of aspacytarabine, seeking to address unmet needs in the treatment of patients with relapsed or refractory AML and MDS.
  • Patients with relapsed or refractory AML and MDS have limited treatment options and poor prognoses, with many patients unable to tolerate intensive chemotherapy.
  • Biosight is a private Phase 2 clinical stage biotech company developing innovative therapeutics for hematological malignancies and disorders.
  • Aspacytarabine is currently being investigated as a single agent in a Phase 2b clinical trial, which recently completed enrollment, for the first-line treatment of AML.

Biosight Encourages Advaxis Stockholders to Vote “FOR” Proposed Merger

Retrieved on: 
Thursday, November 11, 2021

AIRPORT CITY, Israel, Nov. 11, 2021 (GLOBE NEWSWIRE) -- Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today issued the following statement from its Chairman, Pini Orbach, PhD.

Key Points: 
  • Therefore, we did not enter into a merger agreement lightly and we negotiated what we believe is a fair apportionment of relative value between Biosight and Advaxis.
  • Advaxis stockholders have experienced this over the recent period of pipeline rejuvenation that has led to the HOT programs.
  • The relative valuations of the proposed merger reflect the significant value Biosight is contributing.
  • In our view, it is clear that the proposed merger of Advaxis and Biosight is preferable for all parties involved, as we believe it represents a superior outcome compared to both a stand-alone Advaxis and stand-alone Biosight.

Biosight Announces Upcoming Presentation at the 63rd American Society of Hematology Annual Meeting

Retrieved on: 
Thursday, November 4, 2021

It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine.

Key Points: 
  • It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine.
  • Due to its unique pharmacokinetics and metabolism, aspacytarabine enables high-dose therapy with lower systemic exposure to free cytarabine and relative sparing of normal tissues.
  • Biosight is a private Phase 2 clinical stage biotech company developing innovative therapeutics for hematological malignancies and disorders.
  • Interim results demonstrate tolerability with promising efficacy in the challenging population of AML patients unfit for intensive standard-of-care chemotherapy.

Rafael Holdings Provides Update on Rafael Pharmaceuticals’ Two Phase 3 Trials of CPI-613® (Devimistat), AVENGER 500 in Metastatic Pancreatic Cancer and ARMADA 2000 in Relapsed or Refractory Acute Myeloid Leukemia

Retrieved on: 
Thursday, October 28, 2021

NEWARK, N.J., Oct. 28, 2021 (GLOBE NEWSWIRE) -- Rafael Holdings, Inc., (NYSE: RFL), a holding company focused on developing novel cancer metabolism therapeutics through its Barer Institute, investment in Rafael Pharmaceuticals, Inc. (“Rafael Pharmaceuticals”) as well as other investments in early-stage ventures, today announced that the AVENGER 500 Phase 3 clinical trial for CPI-613® (devimistat), Rafael Pharmaceuticals’ lead product candidate, did not meet its primary endpoint of significant improvement in overall survival in patients with metastatic adenocarcinoma of the pancreas.

Key Points: 
  • The median overall survival in the treatment arm was 11.1 months, compared to 11.7 months in the control arm.
  • Devimistat is also being evaluated in a multi-national Phase 3 randomized clinical trial, ARMADA 2000, in patients with relapsed or refractory acute myeloid leukemia (AML).
  • Following a pre-specified interim analysis, the independent data monitoring committee has recommended the trial be stopped due to lack of efficacy.
  • The European Medicines Agency (EMA) has granted orphan drug designation to devimistat for pancreatic cancer, acute myeloid leukemia and Burkitts lymphoma.

AB Science today reports its revenues for the first half of 2021 and provides an update on its activities

Retrieved on: 
Thursday, September 30, 2021

In addition, the amount of off-balance sheet commitments received as of 30 June 2021 was 90 million.

Key Points: 
  • In addition, the amount of off-balance sheet commitments received as of 30 June 2021 was 90 million.
  • AB Science announced publication of a peer-reviewed article titled Masitinib is a broad coronavirus 3CL inhibitor that effectively blocks replication of SARS-CoV-2 in the journal Science.
  • AB Science announced it has received approval to commence a second Phase 2 study in Covid-19.
  • The following table summarizes the consolidated financial statements for the first half of 2021 prepared in accordance with IFRS, and comparative information with the first half of 2020:

Efficacy and Safety Data for GlycoMimetics’ Lead Investigational Drug Uproleselan Published in BLOOD

Retrieved on: 
Thursday, September 23, 2021

Efficacy and safety data from a Phase 1/2 clinical study of uproleselan, GlycoMimetics lead investigational drug, were published online September 16, 2021 in the journal BLOOD.

Key Points: 
  • Efficacy and safety data from a Phase 1/2 clinical study of uproleselan, GlycoMimetics lead investigational drug, were published online September 16, 2021 in the journal BLOOD.
  • The results of this Phase 1/2 study demonstrate the safety and tolerability of uproleselan in combination with an intensive salvage chemotherapeutic regimen.
  • Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin.
  • In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML.