FDA Approves Neuralstem To Treat Final Cohort In NSI-189 Phase Ib Trial In Major Depressive Disorder

Neuralstem, Inc. (NYSE MKT: CUR) announced that it has received approval from the Food and Drug Administration (FDA) to begin dosing the third and final cohort of patients in its ongoing Phase Ib to test the safety of NSI-189 in the treatment of major depressive disorder (MDD). NSI-189, the lead compound in Neuralstem's neurogenic small molecule platform, is a proprietary new chemical entity that stimulates new neuron growth in the hippocampus, a region of the brain believed to be implicated in MDD, as well as other diseases and conditions such as: traumatic brain injury (TBI), Alzheimer's disease, and post-traumatic stress disorder (PTSD).

ARCA biopharma and Medtronic to Collaborate on Atrial Fibrillation Clinical Trial for GencaroTM

Patients in Novel Clinical Trial Will Have Cardiac Rhythms Continuously Monitored with Implanted Medtronic Devices

ARCA biopharma, Inc. (ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that it has entered into an agreement with Medtronic, Inc. (MDT), a leader in medical technologies to improve the treatment of chronic diseases, including cardiac rhythm disorders, to collaborate on ARCA’s proposed clinical trial, known as GENETIC-AF, of its lead developmental drug Gencaro (bucindolol hydrochloride).

Treatment with VX-661 and Ivacaftor in a Phase 2 Study Resulted in Statistically Significant Improvements in Lung Function in People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation

-Treatment with combination of VX-661 and ivacaftor for 28 days in two highest dose groups resulted in mean relative increases in lung function (percent predicted FEV1) of 9.0% (p=0.01) and 7.5% (p=0.02) versus placebo -

-VX-661 was generally well-tolerated alone and in combination with ivacaftor-

Vertex Pharmaceuticals Incorporated (VRTX) today announced data from a Phase 2 study of VX-661 and ivacaftor that showed statistically significant improvements in lung function among adults with cystic fibrosis (CF) who have two copies (homozygous) of the most common mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, known as F508del.

Neuralstem Receives FDA Approval To Commence Phase II Stem Cell Trial In Amytrophic Lateral Sclerosis

Trial Expands to Two Centers; Approval Includes Significant Increase in Dosing

 Neuralstem, Inc. (NYSE MKT: CUR) announced that it has received approval from the Food and Drug Administration (FDA) to commence a Phase II trial using NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). This Phase II dose escalation and safety trial will expand to two centers, Emory University Hospital in Atlanta, Georgia, where Phase I was recently completed, and ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, subject to approval by the Institutional Review Board at each institution. The trial is designed to treat up to 15 patients, in five different dosing cohorts.