Mecasermin rinfabate

Plumbing Industry Has a Role to Play in Contributing to a Responsible and Sustainable Future

Retrieved on: 
Thursday, June 9, 2022

According to the leading plumber Port Stephens wide, The Plumbing Life Saver, the scheme highlights the need to educate and change behaviours across the industry.

Key Points: 
  • According to the leading plumber Port Stephens wide, The Plumbing Life Saver, the scheme highlights the need to educate and change behaviours across the industry.
  • The scheme was developed to help industry understand the volume of available PVC off-cuts and fittings from construction sites.
  • The Plumbing Life Saver offers a one-stop solution for affordable 24/7 plumbing services including installation and maintenance of hot water Port Stephens wide.
  • Providing a convenient, reliable and prompt service, for any plumbing issues including fixing blocked drains Port Stephens wide, contact The Plumbing Life Saver .

MediciNova Receives a Notice of Intention to Grant for a New Patent Covering the Combination of MN-166 (ibudilast) and Riluzole for the Treatment of Amyotrophic Lateral Sclerosis (ALS) in Europe

Retrieved on: 
Thursday, May 6, 2021

Previously, similar patents were granted in the U.S. and Japan based on data from our first clinical trial in ALS patents.

Key Points: 
  • Previously, similar patents were granted in the U.S. and Japan based on data from our first clinical trial in ALS patents.
  • "\nAmyotrophic lateral sclerosis (ALS), also known as\xc2\xa0Lou Gehrig\'s\xc2\xa0disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord.
  • As a result, ALS affects voluntary movement and patients in the later stages of the disease may become completely paralyzed.
  • Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof.

Orphazyme announces topline results from pivotal trial of arimoclomol for Inclusion Body Myositis (IBM)

Retrieved on: 
Monday, March 29, 2021

The primary goal was to evaluate the treatment effect on disease progression as measured by the inclusion body myositis functional rating scale (IBMFRS).

Key Points: 
  • The primary goal was to evaluate the treatment effect on disease progression as measured by the inclusion body myositis functional rating scale (IBMFRS).
  • Participants were randomized (1:1 ratio) to receive either arimoclomol citrate (400 mg three times daily) or placebo for up to 20 months.
  • We recognize these data are disappointing for patients and families who continue to eagerly await a promising option for IBM.
  • Orphazyme expects data from a pivotal Phase 3 trial of arimoclomol in Amyotrophic Lateral Sclerosis (ALS), a neurodegenerative disease, this spring.

BrainStorm to present NurOwn® Phase 3 Clinical Trial Results at 31st International Symposium on ALS/MND

Retrieved on: 
Monday, November 23, 2020

In addition, Brainstorm will present the clinical experience with NurOwn outpatient administration during the phase 3 clinical trial in the poster session.

Key Points: 
  • In addition, Brainstorm will present the clinical experience with NurOwn outpatient administration during the phase 3 clinical trial in the poster session.
  • "We are encouraged by the results of the phase 3 pivotal trial of NurOwn in ALS and are privileged to make these important scientific presentations to the 31st International Symposium on ALS/MND."
  • We believe that there are important insights from our clinical trial and that NurOwn could potentially benefit ALS patients."
  • The Phase 3 NurOwn trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of NurOwn in 189 ALS patients.

BrainStorm Announces Topline Results from NurOwn® Phase 3 ALS Study

Retrieved on: 
Tuesday, November 17, 2020

Results from the trial showed that NurOwn was generally well tolerated in this population of rapidly progressing ALS patients.

Key Points: 
  • Results from the trial showed that NurOwn was generally well tolerated in this population of rapidly progressing ALS patients.
  • Therefore, the trial met the expected 35% NurOwn treatment group efficacy response assumption, however the high placebo response exceeded placebo responses observed in contemporary ALS trials.
  • "This clinical trial included a more severely affected ALS population compared to other recent ALS clinical trials.
  • The Phase 3 NurOwn trial was a multi-center, placebo-controlled, randomized, double-blind trialdesigned to evaluate the safety and efficacy of NurOwn in 189 ALS patients.

Alexion Announces Planned Initiation of Pivotal Phase 3 Study of ULTOMIRIS® (ravulizumab) in ALS

Retrieved on: 
Tuesday, January 14, 2020

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the planned initiation of a pivotal Phase 3 study of ULTOMIRIS (ravulizumab) in amyotrophic lateral sclerosis (ALS).

Key Points: 
  • Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the planned initiation of a pivotal Phase 3 study of ULTOMIRIS (ravulizumab) in amyotrophic lateral sclerosis (ALS).
  • Alexion submitted an investigational new drug application (IND) for ULTOMIRIS in ALS to the FDA in the fourth quarter of 2019 and plans to initiate the Phase 3 study this quarter.
  • The Phase 3 CHAMPION-ALS trial is a randomized, double-blind, placebo-controlled multicenter global study designed to evaluate the efficacy and safety of ULTOMIRIS across a broad ALS population.
  • After 50 weeks, all patients will receive ULTOMIRIS in a 2-year open-label extension phase of the study.

MediciNova Receives Notice of Allowance for New Patent Covering MN-166 (ibudilast) for the Treatment of Amyotrophic Lateral Sclerosis (ALS) in Canada

Retrieved on: 
Monday, October 28, 2019

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than July 2028.

Key Points: 
  • Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than July 2028.
  • Previously, the U.S. FDAgranted both orphan-drug designation and fast-track designation and the European Commission granted Orphan Medicinal Product Designation to MN-166 for the treatment of ALS."
  • Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord.
  • As a result, ALS affects voluntary movement and patients in the later stages of the disease may become completely paralyzed.

Amylyx Pharmaceuticals Announces Last Patient Completes Last Study Visit in CENTAUR Phase 2 Study of AMX0035 in ALS

Retrieved on: 
Friday, October 4, 2019

ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord.

Key Points: 
  • ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord.
  • CENTAUR is a 24-week, randomized, double-blind, placebo-controlled Phase II clinical trial in people with ALS.
  • In 2017, AMX0035 was granted orphan drug status by the U.S. Food and Drug Administration (FDA) as a potential medicine for ALS.
  • Amylyx Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company developing a novel therapeutic for Amyotrophic Lateral Sclerosis (ALS), Alzheimers disease and other neurodegenerative diseases.

Collaborative Medicinal Development, LLC Reports that Lead Drug Modifies ALS Progression

Retrieved on: 
Monday, January 7, 2019

At lower CuATSM dose levels, evaluable patients showed expected decreases in ALSFRS-R score and FVC over 24 weeks, providing a dramatic dose-response effect previously observed in ALS mouse models.

Key Points: 
  • At lower CuATSM dose levels, evaluable patients showed expected decreases in ALSFRS-R score and FVC over 24 weeks, providing a dramatic dose-response effect previously observed in ALS mouse models.
  • CMD plans to initiate a randomized, placebo-controlled study of CuATSM in ALS to confirm the promising results seen in the open-label phase 1 study.
  • The Company's lead drug, CuATSM, was licensed from the University of Melbourne and entered clinical trials in ALS and Parkinson's disease in 2017 at leading clinical centers in Australia.
  • ALS is a progressive and fatal neurodegenerative disease characterized by muscle weakness resulting from degeneration of motor neurons.