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Clinic roundup

Catalyst Pharmaceutical Partners Inc. , of Coral Gables, Fla., said the independent data monitoring committee recommended that the ongoing pivotal phase III trial of Firdapse for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) continue as p ...

BioWorld Today - Staff - 2014-03-26 00:00 - 0 comments - 0 attachments

Pharma: clinic roundup

Pfizer Inc. , of New York, reported that PROFILE 1014, a phase III study testing anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib) met its primary objective of significantly prolonging progression-free survival in previously untreated p ...

BioWorld Today - Staff - 2014-03-26 00:00 - 0 comments - 0 attachments

Clinic roundup

Ariad Pharmaceuticals Inc. , of Cambridge, Mass., said it started a pivotal phase II study of AP26113 in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) who previously were treated with Xalkori (crizotinib, Pfizer Inc. ...

BioWorld Today - Staff - 2014-03-25 00:00 - 0 comments - 0 attachments

Clinic roundup

Cellceutix Corp. , of Beverly, Mass., said the FDA’s 30-day waiting period pertaining to the investigational new drug application for Prurisol has passed, and the company is moving toward starting clinical trials of the small-molecule drug in psorias ...

BioWorld Today - Staff - 2014-03-24 00:00 - 0 comments - 0 attachments

Clinic Roundup

• TapImmune Inc. , of Seattle, said an interim safety analysis of the first five breast cancer patients treated with HER2/neu Class II antigens did not show any serious adverse events, so treatment of the remaining 17 patients in the Phase I st ...

BioWorld Today - Staff - 2013-01-10 01:00 - 0 comments - 0 attachments

Clinic roundup

Synta Pharmaceuticals Corp. , of Lexington, Mass., said interim results from the ENCHANT-1 trial, a single-arm multicenter phase II proof-of-concept study designed to evaluate ganetespib, administered as a monotherapy for the treatment of metastatic ...

BioWorld Today - Staff - 2014-03-21 00:00 - 0 comments - 0 attachments

Pharma: clinic roundup

Abbvie Inc. , of North Chicago, Ill., said a pivotal phase III trial that will evaluate the use of Humira (adalimumab) as a treatment for fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis, has been initiated. ...

BioWorld Today - Staff - 2014-03-21 00:00 - 0 comments - 0 attachments

Clinic roundup

Cellceutix Corp. , of Beverly, Mass., said the seventh cohort is under way in the phase I trial of anticancer drug candidate, Kevetrin, dosing 165 mg/m2 of Kevetrin compared to 110 mg/m2 in the prior cohort. (BioWorld-Today-2014-03-20) ...

BioWorld Today - Staff - 2014-03-20 00:00 - 0 comments - 0 attachments

Pharma: clinic roundup

Novo Nordisk A/S , of Bagsvaerd, Denmark, reported positive results from pathfinder2, the first phase III trial with long-acting recombinant factor VIII, N8-GP (turoctocog alfa pegol) for hemophilia A patients. (BioWorld-Today-2014-03-20) ...

BioWorld Today - Staff - 2014-03-20 00:00 - 0 comments - 0 attachments

Pharma: clinic roundup

Ipsen SA , of Paris, reported phase IIa results showing that Dysport was associated with a mean reduction from baseline of urinary incontinence episodes greater than 75 percent, 12 weeks after injection, regardless of how the drug was administered in ...

BioWorld Today - Staff - 2014-03-19 00:00 - 0 comments - 0 attachments