Cytokinetics will elaborate on the clinical trial design and include enrollment and baseline demographics data from BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS), which is evaluating tirasemtiv, a novel mechanism skeletal muscle activator, as a potential treatment for patients with amyotrophic lateral sclerosis (ALS).
Posts belonging to Category Clinical Trials
AB Science SA, a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors (PKIs), announces, following the press release from November 4, that the acceleration of the clinical development program in ALS is in line with proof of efficacy experiments conducted in two different models that generated positive results of increased survival.
Researchers at Houston Methodist Neurological Institute and elsewhere will soon begin phase IIa clinical trials of TDI-132, a drug that in animal models has shown promise in reducing the inflammation associated with Amyotrophic Lateral Sclerosis, also known as ALS or Lou Gehrig’s Disease.
Richard Casey, Neuraltus’ newly appointed CEO, said Wednesday at the Biotechnology Industry Organization’s investor forum that a Phase IIb trial of 300 patients with the muscle-wasting disease will start enrolling patients in the first quarter of 2014. The final patient will be dosed in second-quarter 2015, and early data is expected in third-quarter 2015.
This Phase II Neuralstem study is designed to determine the safety of the maximum tolerated dose of human spinal cord-derived neural stem cell transplantation for the treatment of amyotrophic lateral sclerosis (ALS).
Neuralstem ALS Trial Data Presented at the American Association of Neurological Surgeons Annual Meeting
“That our cells and method of delivery are safe in ALS patients bodes very well for expanding to other indications. We expect to commence our FDA-approved Phase I trial in chronic spinal cord injury later this year using the same methodology. We want to thank the surgeons at Emory, who developed these techniques, as well as the patients and their families who have taken part in the trial.”
Antisense Oligonucleotides May be Feasible ALS Therapeutic Strategy
BOSTON, Massachusetts, March 29, 2013 — Published online today in Lancet Neurology, an SOD1-related familial ALS trial under the direction of NEALS researchers Timothy Miller, MD, PhD (Washington University School of Medicine) and Merit Cudkowicz (Massachusetts General Hospital) indicates that antisense oligonucleotide delivery to the central nervous system may [...]
Cytokinetics Inc. Announces Initiation of First-Time-in-Humans, Phase I Clinical Trial of CK-2127107
Cytokinetics, Incorporated announced today the initiation of a first-time-in-humans, Phase I clinical trial of CK-2127107 in healthy male volunteers. Cytokinetics is developing CK-2127107, a novel small molecule activator of the fast skeletal muscle troponin complex, for the potential improvement of skeletal muscle function in diseases and medical conditions associated with neuromuscular dysfunction, muscular weakness, and/or muscle fatigue. Like tirasemtiv, the lead drug candidate from the company’s skeletal muscle activator program, CK-2127107 slows the rate of calcium release from the regulatory troponin complex of fast skeletal muscle fibers, which sensitizes the sarcomere to calcium.
Data Indicate Initial Clinical Benefit in Overall Clinical and Respiratory Function
NEW YORK, NY and PETACH TIKVAH, ISRAEL, March 21, 2013 — BrainStorm Cell Therapeutics, a leading developer of adult stem cell technologies for neurodegenerative diseases, today reported some of the final results from a clinical study evaluating the company’s NurOwn™ technology in 12 ALS patients. NurOwn [...]
Lithium in patients with amyotrophic lateral sclerosis (LiCALS): a phase 3 multicentre, randomised, double-blind, placebo-controlled trial
From the UKMND-LiCALS Study Group
Summary article posted online in The Lancet Neurology, February 27, 2013 •
Lithium has neuroprotective effects in cell and animal models of amyotrophic lateral sclerosis (ALS), and a small pilot study in patients with ALS showed a [...]