Cyclopropanes

Nicox’s NCX 470 Receives Approval by Chinese Authorities for Local Start of Mont Blanc Phase 3 Trial

Retrieved on: 
Monday, October 26, 2020
Chemical compounds, Organic compounds, Health, Prostaglandins, Triols, Cyclopropanes, Latanoprost, Glaucoma, Clinical trial, Ocular hypertension, Sodium-calcium exchanger, NicOx

NCX 470 development remains on track, with first results from the Mont Blanc trial expected in Q4 2021.

Key Points: 
  • NCX 470 development remains on track, with first results from the Mont Blanc trial expected in Q4 2021.
  • Initiation of Chinese sites in this trial will be essential in preparing the way for Denali, the second Phase 3 trial with NCX 470, which will include a larger number of Chinese patients.
  • The NCX 470 Mont Blanc Phase 3 clinical trial is a 3-month trial to evaluate the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, versus the current standard of care, latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension.
  • The Mont Blanc trial was initiated in the U.S. in June 2020 and top-line results are currently expected in Q4 2021.

CytoSorbents to Report Q3 2020 Operating and Financial Results

Retrieved on: 
Wednesday, October 21, 2020
Chemical compounds, Chemistry, Physical sciences, Chloroarenes, Surface science, Alcohols, Cyclopropanes, Ticagrelor, Adsorption, Rivaroxaban, Surgery, Cardiothoracic surgery

These are conditions where the risk of death is extremely high, yet no effective treatments exist.

Key Points: 
  • These are conditions where the risk of death is extremely high, yet no effective treatments exist.
  • CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery.
  • CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.
  • CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption.

Iterum Therapeutics to Present Data from Phase 3 Trials in Uncomplicated and Complicated Urinary Tract Infections at IDWeek 2020

Retrieved on: 
Monday, October 19, 2020
Fluoroquinolone antibiotics, Drugs, RTT, Otologicals, Chemical compounds, Health, Ciprofloxacin, Cyclopropanes, Ofloxacin, Urinary tract infection, Infection

The two data presentations will include a poster presentation of the results of SURE-2 in complicated urinary tract infections (cUTI) as well as a late breaker oral abstract presentation of the results from SURE-1 in uncomplicated urinary tract infections (uUTI).

Key Points: 
  • The two data presentations will include a poster presentation of the results of SURE-2 in complicated urinary tract infections (cUTI) as well as a late breaker oral abstract presentation of the results from SURE-1 in uncomplicated urinary tract infections (uUTI).
  • Presentation Title: Efficacy and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Ciprofloxacin in the Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women: Results from the SURE-1 Trial
    Abstracts are accessible via the IDWeek website.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Exelixis to Present the Preclinical Profile and Initial Clinical Pharmacokinetics of XL092, Its Next-Generation Oral Tyrosine Kinase Inhibitor

Retrieved on: 
Friday, October 9, 2020
Pharmaceutical, Health, Oncology, Clinical trials, Tyrosine kinase receptors, Branches of biology, Enzymes, Cell signaling, Tyrosine kinase inhibitors, Exelixis, Cyclopropanes, Quinolines, Protein kinase inhibitor, Cabozantinib, AXL receptor tyrosine kinase, Tyrosine kinase, XL092

XL092 is a next-generation oral tyrosine kinase inhibitor that targets VEGF receptors, MET, AXL, MER, and other kinases implicated in cancers growth and spread.

Key Points: 
  • XL092 is a next-generation oral tyrosine kinase inhibitor that targets VEGF receptors, MET, AXL, MER, and other kinases implicated in cancers growth and spread.
  • In designing XL092, Exelixis sought to build upon the experience and target profile of cabozantinib, the companys flagship medicine, while improving key characteristics, including clinical half-life.
  • Exelixis is a member of the Standard & Poors (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies.
  • For more information about Exelixis, please visit www.exelixis.com , follow @ ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

PhaseBio Doses First Patients in Canada as Part of the REVERSE-IT Global Phase 3 Trial of Bentracimab for Reversal of the Antiplatelet Effects of Ticagrelor

Retrieved on: 
Tuesday, October 6, 2020
Health, Surgery, Clinical trials, Pharmaceutical, Cardiology, Biotechnology, Branches of biology, Blood, Medical specialties, Alcohols, Cyclopropanes, Ticagrelor, Antiplatelet drug, Reversal, Platelet, Antibody, Bentracimab (PB2452), PhaseBio Pharmaceuticals

Bentracimab is a novel, human monoclonal antibody fragment that in earlier trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta (ticagrelor).

Key Points: 
  • Bentracimab is a novel, human monoclonal antibody fragment that in earlier trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta (ticagrelor).
  • We view the expansion of REVERSE-IT enrollment into Canada as an important milestone for the global bentracimab program.
  • Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal will be eligible for enrollment.
  • Additionally, the Phase 2a trial investigated a bentracimab regimen for the reversal of supratherapeutic doses of ticagrelor in healthy younger subjects.

Iterum Therapeutics Announces Positive Pre-NDA Meeting with FDA for Sulopenem for Treatment of Uncomplicated Urinary Tract Infections

Retrieved on: 
Wednesday, September 30, 2020
Drugs, Fluoroquinolone antibiotics, Chemical compounds, RTT, Otologicals, Health, Cyclopropanes, Ciprofloxacin, Ofloxacin, Antibiotic, Infection

We estimate that there are over 6 million quinolone-resistant urinary tract infections annually in the U.S., many of which are also multi-drug resistant, and sulopenem has demonstrated superiority versus ciprofloxacin in treating these infections.

Key Points: 
  • We estimate that there are over 6 million quinolone-resistant urinary tract infections annually in the U.S., many of which are also multi-drug resistant, and sulopenem has demonstrated superiority versus ciprofloxacin in treating these infections.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Nicox Selects 0.1% NCX 470 Dose in Adaptive Stage of Mont Blanc Phase 3 Glaucoma Trial

Retrieved on: 
Wednesday, September 23, 2020
Health, RTT, Chemical compounds, NicOx, Prostaglandins, Triols, Cyclopropanes, Clinical research, Latanoprost, Glaucoma, Adaptive design, Clinical trial

The dose selection also enables the start of Denali, the second NCX 470 Phase 3 trial, before the end of the year

Key Points: 
  • The dose selection also enables the start of Denali, the second NCX 470 Phase 3 trial, before the end of the year
    Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the selection of the 0.1% dose of NCX 470 for Phase 3 following the completion of the adaptive portion of the Mont Blanc Phase 3 clinical trial.
  • As is customary for adaptive design trials, in order to maintain the integrity of the trial, no data from the adaptive portion of the trial will be disclosed until the completion of the trial.
  • Mont Blanc is a Phase 3 clinical trial evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • In the Phase 2 Dolomites trial, NCX 470 ophthalmic solution, 0.065%, demonstrated both statistical non-inferiority and superiority to latanoprost ophthalmic solution, 0.005%.

Aerpio Announces Enrollment Completed in the 28-Day Phase 2 Razuprotafib Glaucoma Trial

Retrieved on: 
Tuesday, September 15, 2020
RTT, Organ systems, Chemical compounds, Organic compounds, Prostaglandins, Blindness, Cyclopropanes, Latanoprost, Triols, Glaucoma, Diabetic nephropathy

The primary endpoint of the study is mean diurnal IOP at 28 days in the razuprotafib treated groups compared to the latanoprost monotherapy group.

Key Points: 
  • The primary endpoint of the study is mean diurnal IOP at 28 days in the razuprotafib treated groups compared to the latanoprost monotherapy group.
  • We remain on track to report top line results from this trial in the fourth quarter, said Kevin Peters, M.D., Chief Scientific Officer and Chief Medical Officer of Aerpio.
  • We believe that razuprotafib will represent an attractive adjunctive therapy for glaucoma patients based on its novel mechanism of action and favorable tolerability profile, and we have worldwide rights to the program.
  • Aerpio is studying a topical ocular formulation of razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy.

Salix Presents Two Methylnaltrexone Scientific Posters At PAINWeek 2020

Retrieved on: 
Friday, September 11, 2020
Chemical compounds, Drugs, Opioid antagonists, Chemistry, Morphinans, Phenols, Ketones, Cyclopropanes, Methylnaltrexone, Opioid, Naltrexone, Salix Pharmaceuticals

BRIDGEWATER, N.J., Sept. 11, 2020 /PRNewswire/ -- Salix Pharmaceuticals ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal (GI) diseases, today announced that two encore methylnaltrexone scientific posters will be presented at PAINWeek Live Virtual Conference , being held Sept. 11-13, 2020.

Key Points: 
  • BRIDGEWATER, N.J., Sept. 11, 2020 /PRNewswire/ -- Salix Pharmaceuticals ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal (GI) diseases, today announced that two encore methylnaltrexone scientific posters will be presented at PAINWeek Live Virtual Conference , being held Sept. 11-13, 2020.
  • "One of Salix's scientific poster presentations at PAINWeek includes analysis examining the effects of methylnaltrexone on patients with advanced illness who were hospitalized with opioid induced constipation (OIC)," said Howard Franklin, MD, chief medical officer, Salix Pharmaceuticals.
  • "Cumulative Laxation Response with Methylnaltrexone: Implications for Hospitalized Patients with Advanced Illness and Opioid-Induced Constipation."
  • "Reductions in All-Cause Mortality Associated with the Use of Methylnaltrexone for Opioid-Induced Bowel Disorders: A Pooled Analysis."

Exelixis and NBE-Therapeutics Enter Into Exclusive Collaboration and License Option Agreement to Discover and Develop Novel Antibody-Drug Conjugates for the Treatment of Cancer

Retrieved on: 
Tuesday, September 8, 2020
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Tyrosine kinase inhibitors, Cyclopropanes, Quinolines, Antineoplastic drugs, Exelixis, Cabozantinib, Tyrosine kinase receptors, C-Met, Chemical substances, Medicine, Chemistry, NBE-Therapeutics, Exelixis

The agreement comes as Exelixis continues to build out its pipeline behind CABOMETYX (cabozantinib), its flagship product that is now a global oncology franchise.

Key Points: 
  • The agreement comes as Exelixis continues to build out its pipeline behind CABOMETYX (cabozantinib), its flagship product that is now a global oncology franchise.
  • Together, the companies will seek to advance multiple ADCs into preclinical development with Exelixis contributing research and development support.
  • NBE advances its products to clinical proof of concept with the goal of improving treatment options for cancer patients.
  • For more information about Exelixis, please visit www.exelixis.com , follow @ ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.