Healthcare Review: GW Pharmaceuticals, Galena Biopharma, Isis Pharmaceuticals, Novartis, Alexion Pharmaceuticals Print E-mail
By Staff and Wire Reports   
Tuesday, 17 June 2014 11:10
U.S. stocks traded little changed in choppy trading Tuesday, as investors weighed disappointing housing-market data against easing jitters over Iraq. The Dow Jones Industrial Average slipped nine points, or 0.1%, to 16772. The Dow was down as much as 48 points and up 29 points earlier in the session. That follows a similar back-and-forth session on Monday, when the Dow closed up five points, after being down 53 points and up 26 points. The S&P 500 index eased one point, or 0.1%, to 1937. The index was 0.7% below its June 9 record high close of 1951.27.

GW Pharmaceuticals ($GWPH) reports preliminary data on 27 children and young adults with treatment-resistant epilepsy who have been treated with its investigational cannabidiol product candidate Epidiolex for a period of 12 weeks. Of the 27 patients, nine have Dravet syndrome and the remaining 18 have treatment-resistant epilepsies with convulsive and/or non-convulsive siezures.The mean overall reduction in seizure frequency compared to baseline was 44%. The median overall reduction was 42%.At the end of 12 weeks, 48% of the patients achieved at least a 50% reduction in seizure frequency compared to baseline. 41% of the patients achieved at least a 70% reduction. 22% of the patients achieved at least a 90% reduction and 15% of the patients were seizure-free.

Galena Biopharma ($GALE) completes enrollment of the full 45-patient cohort for the Phase 2a clinical trial for GALE-301 (Folate Binding Protein (FBP) peptide immunotherapy). The two arms of the trial consist of HLA-A2-positive patients treated with the FBP peptide plus granulocyte macrophage-colony stimulating factor (GM-CSF) and an observational control group of HLA-A2-negative patients. After an initial induction series of six vaccinations given once per month, patients will receive booster inoculations at two subsequent six-month intervals. The primary objectives are to measure the immune response, time to recurrence and overall survival between treatment arms.

Isis Pharmaceuticals ($ISIS) earns its first milestone payment from its neurological disorder collaboration with Biogen (BIIB). The $10M payment was triggered by the validation of an undisclosed target.

The FDA designates Alexion Pharmaceuticals' ($ALXN) Soliris (eculizumab) an Orphan Drug for the neurologic disorder Myasthenia Gravis (MG). The company is currently enrolling patients in a multinational placebo-controlled registration trial of eculizumab in patients with refractory generalized MG.

Novartis ($NVS) submits its BLA to the FDA for its Breakthrough Therapy-designated meningitis B vaccine Bexsero (Multicomponent Meningococcal Group B Vaccine [recombinant, absorbed]). The vaccine helps protect adolescents and young adults from ages 10 - 25 against invasive meningococcal disease caused by serogroup B (meningitis B).

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