Clinical endpoint

BioVentrix Announces Pivotal ALIVE Trial Resumes with First Patients Treated with LIVE Therapy Since COVID-19 Pause

Retrieved on: 
Wednesday, September 2, 2020
Medical devices, Health, Hospitals, Clinical trials, General Health, Cardiology, Health sciences, Health, Articles, Clinical endpoint, Clinical research, Therapy, Destination therapy

COVID-19 has been reported to cause or worsen heart damage, and with the progressive nature of heart failure, delays in treatment can worsen the prognosis for patients.

Key Points: 
  • COVID-19 has been reported to cause or worsen heart damage, and with the progressive nature of heart failure, delays in treatment can worsen the prognosis for patients.
  • We are pleased that our partner centers are able to resume offering LIVE Therapy as an investigational treatment through the ALIVE Trial for these patients in need, said BioVentrix CEO Kenneth Miller.
  • The ALIVE Trial plans to enroll 120 patients at up to 25 sites in the U.S. with a primary endpoint analysis at one year.
  • View a testimonial from one patient who has experienced Less Invasive Ventricular EnhancementTM (LIVETM Therapy) using the Revivent TC System.

Amarin Supports Latest Clinical Research Evaluating VASCEPA® (Icosapent Ethyl) in Patients with Persistent Cardiovascular Risk Presented at ESC Congress 2020, the Annual Meeting of the European Society of Cardiology

Retrieved on: 
Tuesday, September 1, 2020
Clinical research, Health, Medicine, Articles, Fish products, Clinical trials, Biochemistry, Ethyl eicosapentaenoic acid, Polyolefins, Statin, Major adverse cardiovascular events, Clinical endpoint

The prespecified primary endpoint was a comparison of change in LAP volume at 18 months between icosapent ethyl and placebo.

Key Points: 
  • The prespecified primary endpoint was a comparison of change in LAP volume at 18 months between icosapent ethyl and placebo.
  • The only secondary endpoint which did not achieve a significant difference between groups in multivariable modeling was dense calcium (p=0.053).
  • VASCEPA is the first and only agent studied on top of statin therapy reported to exhibit coronary plaque regression in hypertriglyceridemic patients.
  • Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:

Tenax Announces Late-Breaking Results from the HELP Study Accepted for Presentation at the Heart Failure Society of America (HFSA) Annual Scientific Meeting

Retrieved on: 
Monday, August 31, 2020
Health, Clinical trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, Clinical research, Health, Articles, Medicine, Clinical trials, Lactams, Levosimendan, Nitriles, Pyridazines, Placebo, Mayo Clinic, Clinical endpoint, Phase 2 HELP Trial, Levosimendan

Detailed results of the HELP Study will be presented as a late-breaking oral abstract by Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic and a member of the HELP Study Steering Committee.

Key Points: 
  • Detailed results of the HELP Study will be presented as a late-breaking oral abstract by Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic and a member of the HELP Study Steering Committee.
  • Tenax CEO Anthony DiTonno stated We are very excited to have the HELP Study results accepted for presentation as a late-breaking abstract at the HFSA Annual Meeting.
  • The positive results of the HELP Study represent a major milestone for Tenax and our development of levosimendan for the treatment of patients suffering from this debilitating illness.
  • The primary endpoint of the HELP Trial is based on change in PCWP vs baseline compared to placebo.

Dermavant Reports Positive Phase 3 Results for Tapinarof Cream in Adult Patients with Plaque Psoriasis

Retrieved on: 
Wednesday, August 26, 2020
Health, Other Science, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Organ systems, Dermatology, Medical specialties, Psoriasis, RTT, Monoclonal antibodies, Clinical endpoint, Guselkumab, Calcipotriol/betamethasone dipropionate, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant

Key Secondary Endpoint: Proportion of subjects with 75% improvement in Psoriasis Area and Severity Index (PASI) from Baseline at Week 12.

Key Points: 
  • Key Secondary Endpoint: Proportion of subjects with 75% improvement in Psoriasis Area and Severity Index (PASI) from Baseline at Week 12.
  • The discontinuation rate due to AEs for the subset of patients on tapinarof across the studies was
  • Tapinarof previously met the primary endpoints in separate Phase 2b trials for plaque psoriasis and atopic dermatitis.
  • For more information, please visit www.dermavant.com , and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ).

Alzheon Awarded $47 Million Grant from U.S. National Institute on Aging for Phase 3 Clinical Study of ALZ-801, an Oral Treatment for Alzheimer’s Disease

Retrieved on: 
Thursday, August 20, 2020
Health, Genetics, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Alzheimer's disease, Dementia, Apolipoproteins, Health, Apolipoprotein E, Psychiatry, Articles, ADAS-Cog, Clinical endpoint, ALZ-801, Alzheon

The study will enroll Early AD patients, who have two copies of the apolipoprotein 4 allele (APOE4/4), as a cutting-edge precision medicine approach to Alzheimers disease.

Key Points: 
  • The study will enroll Early AD patients, who have two copies of the apolipoprotein 4 allele (APOE4/4), as a cutting-edge precision medicine approach to Alzheimers disease.
  • The Phase 3 study is designed to evaluate ALZ-801 in 300 patients with Early AD and the APOE4/4 genotype.
  • The study will evaluate the cognitive endpoint, Alzheimers Disease Assessment Scalecognitive subscale (ADAS-cog), as the primary clinical outcome, and other functional, behavioral, and global clinical endpoints.
  • Our lead Alzheimers clinical candidate, ALZ-801 , is an oral small molecule that fully blocks formation of neurotoxic amyloid oligomers in the brain.

BioLineRx Achieves Enrollment Target in Phase 3 GENESIS Trial for Planned Interim Analysis

Retrieved on: 
Wednesday, August 19, 2020
Clinical trials, Clinical research, Medical statistics, Health, Articles, Clinical endpoint, BioLineRx, Interim

If the primary endpoint is not reached in the interim analysis, the Company expects recruitment will continue until the originally planned sample size is met.

Key Points: 
  • If the primary endpoint is not reached in the interim analysis, the Company expects recruitment will continue until the originally planned sample size is met.
  • "A significantly lower than anticipated patient dropout rate in the GENESIS trial triggered our decision to conduct an interim efficacy analysis, for which we have now enrolled a sufficient number of patients," said Philip Serlin, Chief Executive Officer of BioLineRx.
  • "Once this analysis is complete, we will have enough information to decide whether to cease further enrollment or continue until completion of the original target enrollment of 177 patients.
  • We expect the interim analysis to be completed within the next few months."

Fulcrum Therapeutics Announces Interim Analysis Data from its ReDUX4 Trial in Facioscapulohumeral Muscular Dystrophy (FSHD)

Retrieved on: 
Tuesday, August 11, 2020
Branches of biology, Anatomy, Muscular system, Medicine, Biopsy, Interventional radiology, Rare diseases, DUX4, Skeletal muscle, Muscle biopsy, Clinical endpoint, Facioscapulohumeral muscular dystrophy

The interim analysis was not powered for statistical significance and did not include individual patient level data.

Key Points: 
  • The interim analysis was not powered for statistical significance and did not include individual patient level data.
  • Were excited about the study progress and look forward to the final analysis.
  • The primary endpoint is to evaluate the reduction of DUX4-driven gene expression in affected skeletal muscle biopsies.
  • The original design of ReDUX4 included a muscle biopsy at week 16 during the 24-week treatment period followed by an open label extension.

Axsome Therapeutics Announces Further Progress in AXS-05 Depression Clinical Program

Retrieved on: 
Monday, August 10, 2020
Clinical research, Health, Medical research, Articles, Clinical trials, Antidepressants, Medical statistics, Bupropion/dextromethorphan, Management of depression, Placebo, Montgomery–Åsberg Depression Rating Scale, Clinical endpoint

Enrollment has been completed in the COMET (Clinical Outcomes with NMDA-based Depression Treatment) Phase 3open-label, long-term safety trial to support the planned NDA filing of AXS-05 in MDD.

Key Points: 
  • Enrollment has been completed in the COMET (Clinical Outcomes with NMDA-based Depression Treatment) Phase 3open-label, long-term safety trial to support the planned NDA filing of AXS-05 in MDD.
  • Axsome remains on track to achieve the required number of patients treated for one year in the fourth quarter.
  • The trial endpoints will include the change from baseline in the Montgomery-sberg Depression Rating Scale (MADRS) total score, clinical response, and remission.
  • MERIT Trial Axsome is conducting the MERIT trial, a Phase 2, double-blind, placebo-controlled, randomized withdrawal study of AXS-05 in patients with TRD.

Celsion Corporation to Continue Following Patients in Phase III OPTIMA Study for Overall Survival

Retrieved on: 
Tuesday, August 4, 2020
Clinical research, Health, Articles, Clinical trials, Medical statistics, Medicine, Epidemiology, Clinical endpoint, Medical terminology, Survival rate, Data monitoring committee, Progression-free survival

Celsion further noted that OPTIMA Study investigators in China and Vietnam, who enrolled 37% of the subjects, joined the study approximately 12 and 18 months, respectively, after the trial was initiated.

Key Points: 
  • Celsion further noted that OPTIMA Study investigators in China and Vietnam, who enrolled 37% of the subjects, joined the study approximately 12 and 18 months, respectively, after the trial was initiated.
  • Depending on the trends noted during the OS follow-up period, Celsion may choose to discontinue the Study at any time.
  • On July 13, 2020 Celsion announced that the independent Data Monitoring Committee (DMC) recommended that Celsion should consider stopping the OPTIMA Study.
  • In addition to the primary overall survival endpoint, progression-free survival, time to disease progression and safety are key secondary endpoints.

TAGRISSO Granted Breakthrough Therapy Designation in the US for the Adjuvant Treatment of Patients With Stage IB-IIIA EGFR-mutated Lung Cancer

Retrieved on: 
Thursday, July 30, 2020
Research, FDA, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Oncology, Health, Organic compounds, Chemical compounds, Lung cancer, Aging-associated diseases, Clinical endpoint, Clinical research, Heart failure, Osimertinib, lung cancer, ADAURA, TAGRISSO, AstraZeneca

Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors.

Key Points: 
  • Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors.
  • For symptomatic congestive heart failure, permanently discontinue TAGRISSO
    Keratitis was reported in 0.7% of 1142 patients treated with TAGRISSO in clinical trials.
  • Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose.
  • The primary endpoint is DFS in Stage II and IIIA patients and a key secondary endpoint is DFS in Stage IB, II and IIIA patients.