Boston, MA 10/22/2013 (wallstreetpr) – After the Data Monitoring Committee (DMC) approval, Catalyst Pharmaceutical Partners, Inc. (NASDAQ:CPRX) will now continue with the pivotal phase III clinical trial of Firdapse in the U.S. and Europe. This drug is geared towards the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS). This follows DMC’s clinical data and safety reviews on the drug.
The approval of DMC comes as positive news for CPRX as the body is mandated with independent review touching on clinical safety and efficacy obtained from clinical trials. This is done to safeguard the interest of future patients and participants in the clinical trials. It therefore means that this approval also bears a lot of morale boost for CPRX.
According to the biopharmaceutical company, the phase III clinical trial of Firdapse is a randomized placebo-controlled, double-blind, discontinuation trial. It’s enrolling some 36 patients diagnosed with LEMS in sites in the U.S. and Europe. Additional sites are expected shortly.
This trial enrollment is expected to come to a close by end of Q4.13, after which top line data will be announced from the trials in the course of the Q2.14.
LEMS, is an autoimmune disorder featuring muscle weakness of the limbs. The disease is caused by formation of antibodies on the connection between nerves and muscles supplied.
It is important to remember that Firdapse enjoys orphan drug status in EU, U.S. and Switzerland. The Firdapse’s marketing rights were acquired by CPRX in October 2012 from BioMarin Pharma Inc. In 2012, BioMarin Pharma realized increase of 7.6% in Firdapse sales hitting $14.2 million compared to 2011.
In what can be seen as efforts to support the development of Firdapse, CPRX in September 2013 made direct offering of its 8.8 million common shares, thus raising $15.1 million on $1.72 per share. The company is expected to use the proceeds for further development of Firdapse and also to begin new studies on its CCP-115 candidate.
During the previous session’s trading, the bio-pharm company slipped 27.20% to close down $1.90. It now has $100.50 million in market cap.
