00:11 , Aug 18, 2018 |  BioCentury  |  Product Development

Doing more with less

In rare diseases where natural history data are scarce, Phase II studies may have to perform dual duty to both seek efficacy signals and test out new endpoints. Ovid Therapeutics Inc. and Clementia Pharmaceuticals Inc....
08:00 , Jan 4, 2016 |  BC Week In Review  |  Clinical News

CPP-115: Phase Ib data

Top-line data from a 2-part, U.S. Phase Ib trial in healthy volunteers showed that CPP-115 for 14 days increased GABA levels by 150-200% from baseline in both the parietal-occipital cortex and the supplementary motor area...
07:00 , Aug 17, 2015 |  BC Week In Review  |  Clinical News

Vigabatrin: Phase I/II data

Top-line data from an open-label, U.S. Phase I/II trial in 4 Tourrette’s disorder patients who were refractory to all other previous treatments showed that 1 patient receiving twice-daily oral vigabatrin for 8 weeks achieved a...
07:00 , Sep 8, 2014 |  BC Week In Review  |  Clinical News

CPP-115: Phase I started

Catalyst began a 2-part, U.S. Phase Ib trial to evaluate single and multiple doses of CPP-115 in up to 38 healthy, male volunteers. The trial will evaluate increases in brain GABA levels, which Catalyst believes...
07:00 , Apr 8, 2013 |  BC Week In Review  |  Company News

Catalyst Pharma neurology news

Catalyst disclosed in its 4Q12 earnings that it will require a strategic partner or grant funding for the "near-term advancement" of GABA transaminase inhibitor CPP-115 to treat West syndrome (infantile spasms). Last year, Catalyst reported...
08:00 , Dec 17, 2012 |  BC Week In Review  |  Clinical News

Sabril vigabatrin neurology data

Lundbeck reported 3-year data from its registry of 4,292 patients with refractory complex partial seizures and infantile spasms receiving Sabril. Specifically, 2,339 (55%) patients discontinued Sabril treatment, of which 14 (0.6%) discontinued due to visual...
08:00 , Nov 12, 2012 |  BC Week In Review  |  Clinical News

Vigabatrin: Phase IIb data

Top-line data from the double-blind, U.S. Phase IIb CPP-01005 trial in 207 cocaine addicts showed that CPP-109 missed the primary endpoint of a greater proportion of cocaine-free patients during the last 2 weeks of treatment...
01:41 , Nov 9, 2012 |  BC Extra  |  Clinical News

Catalyst falls on CPP-109 Phase IIb miss

Catalyst Pharmaceutical Partners Inc. (NASDAQ:CPRX) fell $0.95 (66%) to $0.50 on Thursday after the company reported that CPP-109 missed the primary endpoint of a greater proportion of cocaine-free patients during the last two weeks of...
07:00 , Oct 1, 2012 |  BC Week In Review  |  Clinical News

Vigabatrin: Phase II started

Catalyst said investigators at the Mount Sinai School of Medicine began an open-label, U.S. Phase I/II trial to evaluate oral CPP-109 twice daily for 8 weeks in about 10 young adults with treatment-refractory Tourette's disorder....
07:00 , Jul 23, 2012 |  BC Week In Review  |  Clinical News

Vigabatrin: Additional Phase II data

Additional data from the double-blind, U.S. Phase II CPP-01004 trial in 186 cocaine addicts showed that twice-daily 1.5 g vigabatrin for 12 weeks did not lead to visual acuity reductions or significant peripheral visual constriction...