Hepatotoxins

CytoDyn’s Leronlimab Decreased Mortality at 14 Days by 82% With Statistically Significant P-Value of 0.0233 Amongst Critically Ill COVID-19 Patients

Retrieved on: 
Tuesday, March 30, 2021

Length in hospital stay decreased by 5.5 days in the critically ill population (N=62, p=.005).

Key Points: 
  • Length in hospital stay decreased by 5.5 days in the critically ill population (N=62, p=.005).
  • The FDA has granted a FastTrack designation to CytoDyn for two potential indications of leronlimab for critical illnesses.
  • The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

Medsenic Announces Positive Results of its Phase II Clinical Study with Arscimed® for the Treatment of Chronic Graft Versus Host Disease (cGvHD)

Retrieved on: 
Monday, March 29, 2021

The study data validate the therapeutic potential of our product Arscimed, as a new selective immunosuppressive/anti-inflammatory drug for cGvHD.

Key Points: 
  • The study data validate the therapeutic potential of our product Arscimed, as a new selective immunosuppressive/anti-inflammatory drug for cGvHD.
  • The primary endpoint of this prospective Phase II multicentre, non-randomised study was the improvement of treatment response, i.e., complete or partial disease remission 6 months after GvHD diagnosis, with Arscimed in combination with prednisone with or without cyclosporine.
  • Over a 4-week period, 21 patients with moderate to severe chronic GvHD received as first-line treatment daily intravenous infusions of Medsenics arsenic trioxide drug.
  • This ability to eliminate the use of corticosteroids is a major advantage of arsenic trioxide treatment.

Antibe Therapeutics Receives FDA Clearance of IND Application for Otenaproxesul for Osteoarthritis Pain

Retrieved on: 
Monday, March 29, 2021

This enables Antibe to undertake human clinical trials in the U.S.; as previously announced, Antibe anticipates initiating its Phase III program later this year.

Key Points: 
  • This enables Antibe to undertake human clinical trials in the U.S.; as previously announced, Antibe anticipates initiating its Phase III program later this year.
  • We are pleased to have been authorized to proceed with our clinical program for otenaproxesul, commented Dr. Joseph Stauffer, Antibes Chief Medical Officer.
  • Antibes lead drug, otenaproxesul, is entering Phase III for the treatment of osteoarthritis pain.
  • Additional assets under development include a safer alternative to opioids for peri-operative pain, and a GI-protective alternative to low-dose aspirin.

Global Menopausal Hot Flashes Market Growth, Trends, and Forecasts 2021-2026 - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 25, 2021

The "Menopausal Hot Flashes Market - Growth, Trends, COVID-19 Impact, And Forecasts (2021 - 2026)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Menopausal Hot Flashes Market - Growth, Trends, COVID-19 Impact, And Forecasts (2021 - 2026)" report has been added to ResearchAndMarkets.com's offering.
  • The menopausal hot flashes market is projected to register a CAGR of 3.4% during the forecast period.
  • The increasing incidence of menopausal hot flashes, increasing number of new drug approvals for the treatment and rising awareness regarding menopause health are the key driving factors in menopausal hot flashes market.
  • The estrogen-segment hold a significant market share in the menopausal hot flashes market and is anticipated to show a similar trend over the forecast period.

Polymyalgia Rheumatica Treatment Market to Record a Robust Growth at a CAGR of 13.60% for the Study Period (2018-2030), states DelveInsight

Retrieved on: 
Monday, March 22, 2021

The Polymyalgia Rheumatica market report also proffers an analysis of recent Polymyalgia Rheumatica treatment algorithm/practice, market drivers, market barriers, and unmet medical needs.

Key Points: 
  • The Polymyalgia Rheumatica market report also proffers an analysis of recent Polymyalgia Rheumatica treatment algorithm/practice, market drivers, market barriers, and unmet medical needs.
  • Clinicians often use the rapid resolution of symptoms to low prednisone doses (20 mg) to confirm Polymyalgia Rheumatica diagnosis.
  • Other alternatives to Glucocorticoids have been evaluated for Polymyalgia Rheumatica treatment, but results have been disappointing to date.
  • The corticosteroid drug deflazacort is being studied for the treatment of Polymyalgia Rheumatica.

Polymyalgia Rheumatica Treatment Market to Record a Robust Growth at a CAGR of 13.60% for the Study Period (2018-2030), states DelveInsight

Retrieved on: 
Monday, March 22, 2021

The Polymyalgia Rheumatica market report also proffers an analysis of recent Polymyalgia Rheumatica treatment algorithm/practice, market drivers, market barriers, and unmet medical needs.

Key Points: 
  • The Polymyalgia Rheumatica market report also proffers an analysis of recent Polymyalgia Rheumatica treatment algorithm/practice, market drivers, market barriers, and unmet medical needs.
  • Clinicians often use the rapid resolution of symptoms to low prednisone doses (20 mg) to confirm Polymyalgia Rheumatica diagnosis.
  • Other alternatives to Glucocorticoids have been evaluated for Polymyalgia Rheumatica treatment, but results have been disappointing to date.
  • The corticosteroid drug deflazacort is being studied for the treatment of Polymyalgia Rheumatica.

Family Physician Recounts His Personal COVID Experience, in the Journal of American Physicians and Surgeons

Retrieved on: 
Monday, March 22, 2021

He describes his experience and his early home treatment regimen, in the spring issue of the Journal of American Physicians and Surgeons .

Key Points: 
  • He describes his experience and his early home treatment regimen, in the spring issue of the Journal of American Physicians and Surgeons .
  • When symptoms continued to worsen, he consulted colleagues who recommended adding a tapering dose of prednisone starting with 30 mg a day and aspirin 325 mg daily.
  • This is likely due to yet unconfirmed risk factors like blood type, A, B, or AB vs O.
  • The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS) , a national organization representing physicians in all specialties since 1943.

Daré Bioscience Completes Recruitment in Phase 1 Clinical Trial of DARE-HRT1, a Novel Intravaginal Ring Designed to Deliver Non-Oral, Bio-identical Hormone Therapy for the Treatment of Vasomotor Symptoms and Genitourinary Syndrome Associated with Menopau

Retrieved on: 
Monday, March 22, 2021

DARE-HRT1 is a novel intravaginal ring (IVR) designed to deliver bio-identical 17-estradiol and bio-identical progesterone continuously over a 28-day period.

Key Points: 
  • DARE-HRT1 is a novel intravaginal ring (IVR) designed to deliver bio-identical 17-estradiol and bio-identical progesterone continuously over a 28-day period.
  • It is being developed for the treatment of vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause as part of a hormone therapy regimen.
  • The randomized Phase 1 study is designed to evaluate the pharmacokinetics (PK) of DARE-HRT1 in approximately 30 healthy, post-menopausal women.
  • The primary objective of the study is to describe the PK parameters of two different dose combinations over 28 days.

NEXLETOL® (bempedoic acid) Tablet, ezetimibe and atorvastatin combination lowered bad cholesterol by 60.5% vs. placebo in Phase 2 study

Retrieved on: 
Wednesday, March 17, 2021

The aim of this Phase 2 study was to evaluate LDL-C lowering when NEXLETOL was initiated together with ezetimibe (10 mg) and atorvastatin (20 mg), as compared with placebo.

Key Points: 
  • The aim of this Phase 2 study was to evaluate LDL-C lowering when NEXLETOL was initiated together with ezetimibe (10 mg) and atorvastatin (20 mg), as compared with placebo.
  • The mean age of patients in this randomized, double-blind, placebo-controlled study was 61.2, and mean baseline LDL-C was 154.8 mg/dL.
  • In these studies, NEXLETOL provided an average of 18% placebo-corrected LDL-C lowering at week 12 when used with moderate or high-intensity statins.
  • Sterling, et al., Combination of bempedoic acid, ezetimibe, and atorvastatin in patients with hypercholesterolemia: A randomized clinical trial, Atherosclerosis.

CytoDyn Appoints Christopher Recknor, M.D., as Chief Operating Officer

Retrieved on: 
Tuesday, March 16, 2021

to the executive position of Chief Operating Officer.

Key Points: 
  • to the executive position of Chief Operating Officer.
  • Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, "We are very pleased Dr. Recknor is joining our executive team.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients.