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Aprea Therapeutics Announces Positive Results from Phase 2 Trial of Eprenetapopt + Azacitidine for Post-Transplant Maintenance Therapy in TP53 Mutant MDS and AML

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Wednesday, July 21, 2021

Chemical compounds, Organic compounds, Heterocyclic compounds, Orphan drugs, Lactams, Nucleosides, Triazines, Antineoplastic drugs, Azacitidine, Venetoclax, H. Lee Moffitt Cancer Center & Research Institute, 7+3

In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial.

Key Points:

In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial.
The post-transplant RFS and OS data with eprenetapopt and azacitidine maintenance therapy in these very difficult-to-treat TP53 mutant MDS and AML patients are incredibly exciting, said trial principal investigator Asmita Mishra, M.D., of the H. Lee Moffitt Cancer Center and Research Institute.
Post-transplant maintenance therapy with eprenetapopt and azacitidine could, if approved, represent a new treatment paradigm that meaningfully improves outcomes for these patients with limited treatment options.
A Phase 1/2 clinical trial of eprenetapopt with venetoclax and azacitidine for the frontline treatment of TP53 mutant AML met the primary efficacy endpoint of complete remission.

FDA Grants Breakthrough Therapy Designation for Venclexta in Combination With Azacitidine for the Treatment of Patients With Myelodysplastic Syndromes

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Wednesday, July 21, 2021

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Venclexta® (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the revised International Prognostic Scoring System (IPSS-R). MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells. This can lead to weakness, frequent infections, anemia and debilitating fatigue that can profoundly affect a person’s quality of life. In some cases, MDS can also progress into acute myeloid leukemia (AML). Every year in the United States, approximately 10,000 people are diagnosed with MDS, and the median survival for those with higher-risk MDS is approximately 18 months.

Key Points:

We are pleased that the FDA has granted Venclexta its sixth Breakthrough Therapy Designation in recognition of its potential to improve outcomes for people with MDS in combination with azacitidine.
The patients doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta.
Patients should not receive a live vaccine before, during, or after treatment with Venclexta, until the patients doctor tells them it is okay.
The patients doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing.

Bristol Myers Squibb Receives European Commission Approval for Onureg® (azacitidine tablets) as Frontline Oral Maintenance Therapy for Adults with Acute Myeloid Leukemia

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Friday, June 18, 2021

Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Lactams, Nucleosides, Triazines, Azacitidine, Acute myeloid leukemia, 7+3, Leukemia, Chemical substances, Branches of biology, Cancer, Vadastuximab talirine, Acute eosinophilic leukemia

The approval of Onureg by the European Commission has the potential to clinically benefit and change the treatment paradigm of patients with acute myeloid leukemia, across a range of subtypes.

Key Points:

The approval of Onureg by the European Commission has the potential to clinically benefit and change the treatment paradigm of patients with acute myeloid leukemia, across a range of subtypes.
The EC approval of Onureg was based on results from the QUAZAR AML-001 study, a Phase 3, international, randomized, double-blind trial.
Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission (QUAZAR AML-001).
New England Journal of Medicine 2020; 383:2526-2537; Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission.

Aprea Therapeutics Announces Phase 1/2 Trial of Eprenetapopt + Venetoclax + Azacitidine in TP53 Mutant AML Meets Complete Remission Primary Efficacy Endpoint

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Wednesday, June 16, 2021

Chemical compounds, Organic compounds, Branches of biology, Orphan drugs, Antineoplastic drugs, Lactams, Nucleosides, Triazines, Venetoclax, Azacitidine, P53

The trial met the primary efficacy endpoint of CR, which is based on a Simon 2-stage design.

Key Points:

The trial met the primary efficacy endpoint of CR, which is based on a Simon 2-stage design.
As of the data cut, 11 patients remain on study treatment and continue to be followed for safety and efficacy.
We are pleased with these results from the combination of eprenetapopt with venetoclax and azacitidine in this very difficult-to-treat TP53 mutant AML population, a patient group with significant unmet medical need, said Eyal Attar, M.D., Chief Medical Officer of Aprea Therapeutics.
A pivotal Phase 3 clinical trial of eprenetapopt and azacitidine for frontline treatment of TP53 mutant MDS has been completed and failed to meet the primary statistical endpoint of complete remission.

ORYZON Presents Iadademstat ALICE 30-Month Data at EHA-2021, Confirming Positive and Robust Efficacy in Combination with Azacitidine in AML

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Friday, June 11, 2021

Lactams, Nucleosides, Triazines, Azacitidine, Chemical substances, Chemistry

The data were presented at the virtual EHA-2021 Conference, in an e-poster entitled ALICE MAINTAINS HIGH CLINICAL RESPONSE RATES SUPPORTING THE EFFICACY OF IADADEMSTAT COMBINATION WITH AZACITIDINE IN AML MANAGEMENT.

Key Points:

The data were presented at the virtual EHA-2021 Conference, in an e-poster entitled ALICE MAINTAINS HIGH CLINICAL RESPONSE RATES SUPPORTING THE EFFICACY OF IADADEMSTAT COMBINATION WITH AZACITIDINE IN AML MANAGEMENT.
With historical response rates of 28% in this population when treated with azacitidine alone (19% CR/CRi and 9% PRs), these results support a strong synergy between iadademstat and azacitidine when used in combination.
The duration of the observed responses is also encouraging, with 60% of the CR/CRi lasting more than 6 months.
The combination of iadademstat with azacitidine continues to show a good safety profile with only two serious adverse events reported as probably related to treatment.

Forma Therapeutics to Present Data from Pivotal Phase 2 Trial of Olutasidenib at ASCO 2021

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Thursday, May 20, 2021

The data indicate the duration of CR/CRh for people on treatment was 13.8 months.

Key Points:

The data indicate the duration of CR/CRh for people on treatment was 13.8 months.
\xe2\x80\x9cThe safety data from the treatment cohort are consistent with the findings from our Phase 1 evaluation in this high-risk AML patient population.
Phase 1 of the trial, 2102-HEM-101, was an open-label, dose-escalation and expansion study of olutasidenib alone and in combination with azacitidine (AZA).
The Phase 2 portion was an open-label, fixed-dose study of olutasidenib as a monotherapy and in combination with AZA in multiple IDH1m AML/MDS populations.

ORYZON Reports Results and Corporate Update for Quarter Ended March 31, 2021

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Friday, May 7, 2021

Triazines, Azacitidine, Lactams, Nucleosides, Acute myeloid leukemia, Chemical substances, Chemistry

Carlos Buesa, Oryzon\xe2\x80\x99s Chief Executive Officer, said: \xe2\x80\x9cOryzon continued to make strong progress in our pioneering work in personalized medicine in epigenetics during the first quarter.

Key Points:

Carlos Buesa, Oryzon\xe2\x80\x99s Chief Executive Officer, said: \xe2\x80\x9cOryzon continued to make strong progress in our pioneering work in personalized medicine in epigenetics during the first quarter.
The Phase II trial ALICE, investigating iadademstat in combination with azacitidine in acute myeloid leukemia, continues recruitment and is progressing as planned.
Long responses are maturing, with 4 patients in response already for > 1 year, and the longest remission > 2 years (still ongoing).
This is due to a higher investment in research and non-capitalized development of the ESCAPE clinical trial and non-recurring expenses.

Global Research Department Explosive (RDX) Market Report 2021-2027: Growing Demand for RDX in Europe & Innovations in Developing Energetic Materials

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Friday, April 30, 2021

Nitroamines, Explosives, RDX, Triazines, Explosive, Chemistry, Science and technology

b'DUBLIN, April 30, 2021 /PRNewswire/ -- The "Research Department Explosive Market Forecast to 2027 - COVID-19 Impact and Global Analysis by Type and Application" report has been added to ResearchAndMarkets.com\'s offering.\nResearch Department Explosive (RDX) Market was valued at US$ 8,061.38 million in 2019 and is projected to reach US$ 10,363.27 million by 2027; it is expected to grow at a CAGR of 3.3% from 2020 to 2027.\nResearch department explosive (RDX) is hard, dissolvable in different solvents such as ethanol and ether, and insoluble in water.

Key Points:

b'DUBLIN, April 30, 2021 /PRNewswire/ -- The "Research Department Explosive Market Forecast to 2027 - COVID-19 Impact and Global Analysis by Type and Application" report has been added to ResearchAndMarkets.com\'s offering.\nResearch Department Explosive (RDX) Market was valued at US$ 8,061.38 million in 2019 and is projected to reach US$ 10,363.27 million by 2027; it is expected to grow at a CAGR of 3.3% from 2020 to 2027.\nResearch department explosive (RDX) is hard, dissolvable in different solvents such as ethanol and ether, and insoluble in water.
The manufacturing process of RDX comprises multiple stages, such as nitration, raw materials storing and feeding, filtration, disintegration, and transport.\nVarious manufacturers are investing comprehensively in research & development activities to build up pioneering products to support the defense forces and fulfill ever-escalating product demand.
RDX is used in various military and typical applications such as fireworks and cast PBX charges.\nThe growing safety concerns and increasing need to protect the national borders and boundaries are inclining the government of different nations to spend more on their respective military, defense arms, and ammunition.
RDX is used in a wide range of military applications such as bombs, munition of all calibers, plastic explosives, and missile warheads.

Global Research Department Explosive (RDX) Market Report 2021 - ResearchAndMarkets.com

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Tuesday, April 27, 2021

Chemicals, Plastics, Manufacturing, Nitroamines, RDX, Triazines, Explosives, Explosive, Chemistry, Science and technology

b'The "Research Department Explosive Market Forecast to 2027 - COVID-19 Impact and Global Analysis by Type and Application" report has been added to ResearchAndMarkets.com\'s offering.\nResearch Department Explosive (RDX) Market was valued at US$ 8,061.38 million in 2019 and is projected to reach US$ 10,363.27 million by 2027; it is expected to grow at a CAGR of 3.3% from 2020 to 2027.\nResearch department explosive (RDX) is hard, dissolvable in different solvents such as ethanol and ether, and insoluble in water.

Key Points:

b'The "Research Department Explosive Market Forecast to 2027 - COVID-19 Impact and Global Analysis by Type and Application" report has been added to ResearchAndMarkets.com\'s offering.\nResearch Department Explosive (RDX) Market was valued at US$ 8,061.38 million in 2019 and is projected to reach US$ 10,363.27 million by 2027; it is expected to grow at a CAGR of 3.3% from 2020 to 2027.\nResearch department explosive (RDX) is hard, dissolvable in different solvents such as ethanol and ether, and insoluble in water.
The manufacturing process of RDX comprises multiple stages, such as nitration, raw materials storing and feeding, filtration, disintegration, and transport.\nVarious manufacturers are investing comprehensively in research & development activities to build up pioneering products to support the defense forces and fulfill ever-escalating product demand.
In 2021, the Stockholm International Peace Research Institute mentioned that the global spending on military and defense is US$1,917 billion, which mostly accounts for 2.2% of the global gross domestic product (GDP).\nThe US, India, China, Russia, and Saudi Arabia are the top five spenders on defense and military applications and contribute to more than 60% of the global military spending.
RDX is used in a wide range of military applications such as bombs, munition of all calibers, plastic explosives, and missile warheads.

Bristol Myers Squibb Receives Positive CHMP Opinion for Onureg® (azacitidine tablets; CC-486) as Frontline Oral Maintenance Therapy for Adults with Acute Myeloid Leukemia in First Remission

Retrieved on:

Friday, April 23, 2021

A subgroup analysis showed consistency in the OS benefit for patients in either CR or CRi.

Key Points:

A subgroup analysis showed consistency in the OS benefit for patients in either CR or CRi.
Serious adverse reactions in \xe2\x89\xa52% of patients who received Onureg included pneumonia (8%) and febrile neutropenia (7%).
One fatal adverse reaction (sepsis) occurred in a patient who received Onureg.
Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission (QUAZAR AML-001).