Ureas | Jotup

Blueprint Medicines Announces Top-line Results from Phase 3 VOYAGER Trial of Avapritinib versus Regorafenib in Patients with Advanced Gastrointestinal Stromal Tumor

Retrieved on:

Tuesday, April 28, 2020

Creative works, Chemical compounds, Organic compounds, Chloroarenes, Pyridines, Regorafenib, Ureas, Clinical endpoint, Progression-free survival, Star Trek: Voyager

The VOYAGER trial did not meet the primary endpoint of an improvement in progression-free survival (PFS) for avapritinib versus regorafenib.

Key Points:

The VOYAGER trial did not meet the primary endpoint of an improvement in progression-free survival (PFS) for avapritinib versus regorafenib.
The VOYAGER trial evaluated the efficacy and safety of avapritinib (N=240) versus regorafenib (N=236) in patients with third- or fourth-line GIST.
Additional analyses of the VOYAGER trial results are ongoing, and Blueprint Medicines plans to present the data at a future medical meeting.
VOYAGER was a global, open-label, randomized, Phase 3 trial designed to evaluate the efficacy and safety of avapritinib versus regorafenib in patients with third- or fourth-line GIST.

Yiviva Announces Dosing of First Patient in Phase 2b Study of First-Line YIV-906 Plus Sorafenib Combination Therapy in the Treatment of Hepatocellular Carcinoma

Retrieved on:

Monday, April 6, 2020

Health, Clinical research, Medicine, Chemical compounds, Design of experiments, Chloroarenes, Pyridines, Sorafenib, Ureas, Clinical trial, Placebo-controlled study, Placebo

YIV-906 is a novel, proprietary therapeutic candidate based on molecular profiling of extracts identified from use in traditional botanical medicine.

Key Points:

YIV-906 is a novel, proprietary therapeutic candidate based on molecular profiling of extracts identified from use in traditional botanical medicine.
Observations of the effects of YIV-906 in proof of concept clinical studies provide a compelling rationale for conducting this large global study in the first-line treatment setting.
The randomized, placebo-controlled Phase 2b study of YIV-906 is evaluating efficacy, safety, and quality of life in patients with hepatitis B-positive HCC.
Patients will be randomized 2:1 to either the study arm (YIV-906 plus sorafenib) or control arm (placebo plus sorafenib).

AVEO Oncology Announces Submission of New Drug Application to U.S. FDA for Tivozanib in Patients with Relapsed or Refractory Renal Cell Carcinoma

Retrieved on:

Tuesday, March 31, 2020

AVEO Oncology (NASDAQ: AVEO) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tivozanib, the Companys vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma (RCC).

Key Points:

AVEO Oncology (NASDAQ: AVEO) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tivozanib, the Companys vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma (RCC).
All of us at AVEO offer our continued gratitude to the patients, caregivers, and investigators who participated in our clinical trials.
The NDA submission is based on the pivotal active comparator-controlled Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in 3rd and 4th line RCC patients.
AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma, hepatocellular carcinoma and other cancers.

Results from First Clinical Study Using Danoprevir to Treat Naive and Experienced COVID-19 Patients

Retrieved on:

Wednesday, March 25, 2020

Health, RTT, Chemistry, Medicine, Hepatotoxins, HIV protease inhibitors, Carbamates, Ureas, Ritonavir, Hepatitis C, Clinical trial

HANGZHOUand SHAOXING,China, March 24, 2020 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) announces today the first clinical study using Ganovo(danoprevir) to treat naive and experienced COVID-19 patients was published in medRxiv.

Key Points:

HANGZHOUand SHAOXING,China, March 24, 2020 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) announces today the first clinical study using Ganovo(danoprevir) to treat naive and experienced COVID-19 patients was published in medRxiv.
The data from this small-sample clinical study showed that danoprevir combined with ritonavir is safe and well tolerated in all patients.
Clinical findings suggest that danoprevir combined with ritonavir is a promising therapeutic option for COVID-19.
Ganovo (Danoprevir) is the first direct-acting anti-viral agent for hepatitis C, developed by a domestic firm in China.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib

Retrieved on:

Wednesday, March 11, 2020

Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Clinical medicine, Medicine, Drugs, Bristol-Myers Squibb, Antineoplastic drugs, Breakthrough therapy, Monoclonal antibodies, Ipilimumab, Ureas, Nivolumab, Sorafenib, Melanoma

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Key Points:

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients.
In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients.
In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

Myovant Sciences Provides Recent Corporate Updates and Reports Financial Results for Third Fiscal Quarter Ended December 31, 2019

Retrieved on:

Monday, February 10, 2020

Chemical compounds, Organic compounds, Chemistry, Ethers, Pyrimidines, Relugolix, Triketones, Ureas, Maa

Myovant also anticipates submitting a Marketing Authorization Application (MAA) to the European Medicines Agency in the first quarter of calendar year 2020.

Key Points:

Myovant also anticipates submitting a Marketing Authorization Application (MAA) to the European Medicines Agency in the first quarter of calendar year 2020.
Myovant completed patient recruitment in SPIRIT 2 in August 2019 and in SPIRIT 1 in October 2019, enrolling 623 women and 638 women, respectively.
In December 2019, Myovant successfully completed one-year stability studies for the relugolix combination tablet in support of potential commercialization.
Interest expense for the quarter ended December31, 2019, was $3.6 million compared to $1.6 million in the comparable prior year period.

NantHealth’s Eviti Connect Data Shows Recycling of Chemotherapy and Biologics for Advanced CRC Patients More Common Than Switching to Drug Regimens with Alternative Mechanism of Action

Retrieved on:

Saturday, January 25, 2020

NantHealths presentation examined therapeutic preferences and treatment patterns among advanced CRC patients using data from NantHealths Eviti Connect , an evidence-based treatment intelligence and web-based oncology decision support platform.

Key Points:

NantHealths presentation examined therapeutic preferences and treatment patterns among advanced CRC patients using data from NantHealths Eviti Connect , an evidence-based treatment intelligence and web-based oncology decision support platform.
Detailed information from 6,325 treatment plans was analyzed to identify treatment patterns using regorafenib and trifluridine + tipiracil for advanced CRC patients as third-line of therapy.
National Comprehensive Cancer Network (NCCN) guidelines state that regorafenib and trifluridine+tipiracil are both treatment options for patients who have progressed through all available regimens.
Our analysis shows that recycling of chemotherapy and biologics in the late line setting is common and occurs more frequently than switching to a drug regimen with an alternative mechanism of action, said William A.

Eisai to Present Latest Data on LENVIMA® (lenvatinib) at the 2020 Gastrointestinal Cancers Symposium

Retrieved on:

Tuesday, January 21, 2020

Organic compounds, Medicine, Chemical compounds, Chloroarenes, Orphan drugs, Ureas, Cyclopropanes, Lenvatinib, Eisai, Everolimus, Fistula

WOODCLIFF LAKE, N.J., Jan. 21, 2020 /PRNewswire/ --Eisai announced today the presentation of three abstracts at the 2020 Gastrointestinal Cancers Symposium (#GI20) in San Francisco from January 23-25.

Key Points:

WOODCLIFF LAKE, N.J., Jan. 21, 2020 /PRNewswire/ --Eisai announced today the presentation of three abstracts at the 2020 Gastrointestinal Cancers Symposium (#GI20) in San Francisco from January 23-25.
Across clinical trials in 799 patients with DTC, RCC, and HCC, grade 3 or higher cardiac dysfunction occurred in 3% of LENVIMA treated patients.
Fistula Formation and Gastrointestinal Perforation.Of the 799 patients treated with LENVIMA or LENVIMA + everolimus in DTC, RCC, and HCC, fistula or gastrointestinal perforation occurred in 2%.
LENVIMA is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
View original content to download multimedia: http://www.prnewswire.com/news-releases/eisai-to-present-latest-data-on-...

Bayer to showcase new data including research in immuno-oncology at ASCO GI Cancers Symposium 2020

Retrieved on:

Tuesday, January 21, 2020

Bayer will present new research from the Companys oncology portfolio, including Stivarga (regorafenib) and Vitrakvi (larotrectinib), at the 2020 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium, taking place January 23-25 in San Francisco, California.

Key Points:

Bayer will present new research from the Companys oncology portfolio, including Stivarga (regorafenib) and Vitrakvi (larotrectinib), at the 2020 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium, taking place January 23-25 in San Francisco, California.
The presentations will feature data on Stivarga in hepatocellular carcinoma (HCC) and gastric and colorectal cancers, as well as Vitrakvi in gastrointestinal cancer.
Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world.
For more information, go to www.bayer.com
BAYER, the Bayer Cross, Vitrakvi, and Stivarga are registered trademarks of Bayer.

Hoth Therapeutics Exercises Patent Licensing Option with the George Washington University to Further Develop a Therapeutic for Cancer Patients Suffering Cutaneous Changes Like Rash and Hair Loss, as Well as Other Neurogenic Inflammation Side Effects

Retrieved on:

Wednesday, January 15, 2020

Chemical compounds, Organic compounds, Chemistry, Antiemetics, Aprepitant, Lactams, Morpholines, Triazoles, Ureas, Hoth, Patent

The option agreement included pre-negotiated business terms for the exclusive patent license, so Hoth anticipates finalizing the license this month.

Key Points:

The option agreement included pre-negotiated business terms for the exclusive patent license, so Hoth anticipates finalizing the license this month.
In June of 2019, Hoth entered into a sponsored research agreement with GWto explore the potential use of Aprepitant in different forms.
Mr.Robb Knie, Chief Executive Officer of Hoth, commented, "Our research collaboration with GW has yielded positive preliminary results.
Management looks forward to sharing the preclinical results of our unique formulation of this topical therapeutic upon its completion later this year."