Cyclopentanes

ENYO Pharma Announces 16 Weeks Vonafexor (EYP001) Top-Line Interim Results from Two on-going Phase 2a Studies in Chronic Hepatitis B Patients

Retrieved on: 
Friday, July 30, 2021
Infectious diseases, Biotechnology, Pharmaceutical, Health, Medical specialties, Clinical medicine, Medicine, Hepatitis B virus, Viral structural proteins, Bristol-Myers Squibb, Cyclopentanes, Entecavir, Hepatotoxins, HBsAg, Hepatitis, HBeAg, Chronic Hepatitis B (CHB), Vonafexor (EYP001), ENYO Pharma, CHRONIC HEPATITIS B (CHB), VONAFEXOR (EYP001), ENYO PHARMA

Vonafexor met the primary endpoint of lowering HBsAg by an average of 1 log10, a key biomarker of viral activity in the liver, after 16 weeks of treatment.

Key Points: 
  • Vonafexor met the primary endpoint of lowering HBsAg by an average of 1 log10, a key biomarker of viral activity in the liver, after 16 weeks of treatment.
  • These results in CHB patients are further positive news for Vonafexor, after the recent disclosure of strong positive clinical results in Non-Alcoholic Steato-Hepatitis (NASH) patients on July 28, 2021.
  • The subjects were thereafter maintained for the next 24 weeks on oral, once-daily 0.5 mg Entecavir only.
  • Established data on CHB patients confirm that more and more patients are HBeAg negative (>80% currently) as a consequence of the chronic evolution of their disease.

Xenikos Announces T-Guard® Phase 3 Clinical Update and Outlines 2021-2022 Corporate Objectives

Retrieved on: 
Monday, July 19, 2021
Chemical compounds, Medical specialties, Clinical medicine, Cyclopentanes, Nitriles, Pyrazoles, Ruxolitinib, Hematopoietic stem cell transplantation

Xenikos expects to commence this Phase 3 study in the second half of 2021.

Key Points: 
  • Xenikos expects to commence this Phase 3 study in the second half of 2021.
  • Initiate new Phase 3 study evaluating T-Guard versus ruxolitinib in patients with SR-aGVHD following allo-HSCT in the second half of 2021.
  • Complete safety run-in phase of Phase 3 study mid 2022.
  • Mehdi Hamadani, Protocol Officer, Scientific Director of CIBMTR, Medical College of Wisconsin; John Levine, Protocol Co-chair, Director of BMT Clinical Research, Mt.

TRIO Completes Enrolment for Phase 2 Giredestrant Early Breast Cancer Trial Ahead of Schedule

Retrieved on: 
Tuesday, July 6, 2021
Chemical compounds, Organic compounds, Drugs, Protein kinase inhibitors, Breakthrough therapy, Piperazines, Cyclopentanes, Lactams, Palbociclib, Breast cancer, Conjugated estrogens, Cancer research

The trial is investigating the ability to expand the safety and efficacy of giredestrant as monotherapy and in combination with palbociclib into the early breast cancer setting.

Key Points: 
  • The trial is investigating the ability to expand the safety and efficacy of giredestrant as monotherapy and in combination with palbociclib into the early breast cancer setting.
  • The trial design evaluates the efficacy, safety, and pharmacokinetics of presurgical treatment with giredestrant plus palbociclib compared with anastrozole plus palbociclib for postmenopausal women with ER+ and HER2-negative untreated early breast cancer.
  • The scale of interest from patients further underlines the urgency to bring forward new treatment options to treat early stage breast cancer.
  • TRIO advances translational cancer research by introducing innovative and novel targeted therapeutic concepts into the clinical trial setting.

China Ruxolitinib Market Report 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 17, 2021
Health, Pharmaceutical, Chemical compounds, Countries, Pyrazoles, Organic compounds, Cyclopentanes, Nitriles, Ruxolitinib, China

The "Investigation Report on China's Ruxolitinib Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Investigation Report on China's Ruxolitinib Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.
  • According to the market research, the sales value of Ruxolitinib in China has increased year by year from 2017 to 2020, with the highest growth rate of Ruxolitinib in 2020 (4030%).
  • Due to the growth of indications in Ruxolitinib in China, the market will also expand and sales will continue to rise.
  • 2 Sales of Ruxolitinib in China, 2017-2020
    2.3 Sales of Ruxolitinib by Dosage Form in China, 2017-2020
    3 Analysis of Major Ruxolitinib Manufacturers in China, 2017-2020
    4 Prices of Ruxolitinib for Different Manufacturers in China, 2020-2021
    5 Prospect of Chinese Ruxolitinib drug Market, 2021-2025
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210617005469/en/

Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis

Retrieved on: 
Friday, June 11, 2021
FDA, Health, Sports, Other Health, Pharmaceutical, Biking, Cycling, Chemical compounds, Organic compounds, Pyrazoles, Autoimmune diseases, Cyclopentanes, Nitriles, Ruxolitinib, Incyte, Atopic dermatitis, Prescription Drug User Fee Act, Dermatitis, Janus kinase inhibitor

Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD).

Key Points: 
  • Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD).
  • The FDA extended the PDUFA action date to allow time to review additional analyses of previously submitted data provided by Incyte in response to the FDAs information request.
  • Ruxolitinib cream is a proprietary formulation of Incytes selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application.
  • Ruxolitinib cream is currently in Phase 3 development for the treatment of adolescents and adults with atopic dermatitis (TRuE-AD) and vitiligo (TRuE-V).

Insights on the Cyclopentane Global Market to 2027 - Featuring Dymatic Chemicals, HCS Group & Ineos Among Others - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 3, 2021
Chemicals, Plastics, Manufacturing, Cycloalkanes, Cyclopentane, Cyclopentanes, Compound annual growth rate

The "Cyclopentane - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Cyclopentane - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.
  • Blowing Agent & Refrigerant, one of the segments analyzed in the report, is projected to record a 5.3% CAGR and reach US$152.4 Million by the end of the analysis period.
  • The U.S. Market is Estimated at $68.2 Million, While China is Forecast to Grow at 8.3% CAGR
    The Cyclopentane market in the U.S. is estimated at US$68.2 Million in the year 2020.
  • In the global Other Functions segment, USA, Canada, Japan, China and Europe will drive the 4.9% CAGR estimated for this segment.

Early amcenestrant data featured at ASCO support its potential to become a new endocrine backbone therapy for ER+/HER2- breast cancer

Retrieved on: 
Wednesday, May 19, 2021
Chemical compounds, Organic compounds, Aminopyridines, Cyclopentanes, Palbociclib, Piperazines

\xe2\x80\x9cThe analysis also demonstrated no clinically significant cardiac or ocular findings and an overall safety profile in line with what we saw in the monotherapy setting.

Key Points: 
  • \xe2\x80\x9cThe analysis also demonstrated no clinically significant cardiac or ocular findings and an overall safety profile in line with what we saw in the monotherapy setting.
  • Amcenestrant 200mg daily in combination with palbociclib demonstrated a favorable overall safety profile (n=39), with treatment related adverse events (TRAEs) attributable to amcenestrant similar to those observed with monotherapy.
  • For all grade events, amcenestrant TRAEs occurred in 72% and to palbociclib in 90% of patients, and for grade \xe2\x89\xa53 in 15% and 46% of patients, respectively.
  • The most frequent non-hematological amcenestrant TRAEs included fatigue (18%) and nausea (18%), all grade \xe2\x89\xa42.

Incyte Announces Positive Results from Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream in Patients with Vitiligo

Retrieved on: 
Monday, May 17, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Chemical compounds, Organic compounds, Pyrazoles, Cyclopentanes, Nitriles, Ruxolitinib, Atopic dermatitis

The overall efficacy and safety profile of ruxolitinib cream is consistent with previously reported Phase 2 data , and no new safety signals were observed.

Key Points: 
  • The overall efficacy and safety profile of ruxolitinib cream is consistent with previously reported Phase 2 data , and no new safety signals were observed.
  • \xe2\x80\x9cWe look forward to working with regulators to bring this much needed treatment option to patients.
  • Participants were randomized into two arms: 1.5% ruxolitinib cream twice daily (BID) and vehicle control for the 24-week double-blind period.
  • Ruxolitinib cream is currently in Phase 3 development for the treatment of atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V).

Incyte Announces New Findings from a Randomized Phase 2 Study of Ruxolitinib Cream in Patients with Vitiligo

Retrieved on: 
Friday, April 23, 2021
Biotechnology, Pharmaceutical, Health, Clinical trials, Chemical compounds, Autoimmune diseases, Type I hypersensitivity, Organic compounds, Medical specialties, Cyclopentanes, Nitriles, Ruxolitinib, Atopic dermatitis, Vitiligo, Atopy, Dermatitis

\xe2\x80\x9cThese findings continue to point to the potential of ruxolitinib cream to provide meaningful facial and total body repigmentation that continues to improve over time for patients who seek treatment for vitiligo.

Key Points: 
  • \xe2\x80\x9cThese findings continue to point to the potential of ruxolitinib cream to provide meaningful facial and total body repigmentation that continues to improve over time for patients who seek treatment for vitiligo.
  • The findings suggest that the repigmentation seen with ruxolitinib cream may be maintained after treatment discontinuation.
  • Over-activity of the JAK signaling pathway has been shown to drive inflammation involved in the pathogenesis and progression of vitiligo.
  • Ruxolitinib cream is currently in Phase 3 development for the treatment of atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V).

Real-World Evidence Supports Effectiveness of First-line IBRANCE® (palbociclib) Combination Therapy in HR+, HER2- Metastatic Breast Cancer

Retrieved on: 
Thursday, March 25, 2021
Biotechnology, Pharmaceutical, Medical Supplies, Oncology, Health, Infectious diseases, Hospitals, Clinical trials, Chemical compounds, Protein kinase inhibitors, Organic compounds, Piperazines, Aminopyridines, Breakthrough therapy, Cyclopentanes, Palbociclib, Breast cancer, Letrozole, HER2/neu, Metastatic breast cancer, the IBRANCE Real-World Evidence Program, IBRANCE® (palbociclib) 125 mg tablets and capsules, Pfizer Oncology, Pfizer: Breakthroughs That Change Patients’ Lives

These findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research .

Key Points: 
  • These findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research .
  • With more than six years of patient experience, a positive benefit-risk profile, strong clinical data and robust real-world data, the totality of evidence solidifies the role of IBRANCE plus endocrine therapy as a treatment for patients with HR+, HER2- metastatic breast cancer.
  • The analysis also showed the two-year OS rate was 78.3% in the IBRANCE group and 68.0% with letrozole.
  • The findings from this landmark real-world study align with the positive impact that I have seen in my own patients treated with IBRANCE combination therapy.