CV Therapeutics Inc. said its Phase III trial of tecadenoson in patients with an abnormally rapid heart rhythm met its primary endpoint of converting the abnormal rate to a normal or sinus rhythm. Also, the company said it is continuing to evaluate tecadenoson in a broad Phase IIb program of patients with atrial fibrillation.
Company officials would not speculate as to when they would file a new drug application for either use of tecadenoson, formerly referred to as CVT-510. However, Eric Schmidt, of SG Cowen in New York, estimated in a research report that filing will occur in 2004-05 for both indications.
Tecadenoson selectively stimulates the A1 adenosine receptor, which slows the conduction of electrical impulses in the AV node of the heart, a region that controls the transmission of electrical impulses from the atria to the ventricles.
The 181-patient Phase III trial achieved its primary endpoint, which was the conversion of paroxysmal supraventricular tachycardia (PSVT) to normal, or sinus, heart rhythm without second- or third-degree atrio-ventricular block. The study was a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate five doses of tecadenoson, the company said.
"We're very pleased with this data. However, this trial alone would not be enough to support a filing. Typically you need at least two pivotal Phase III studies for an indication such as PSVT," John Bluth, director of corporate communications for Palo Alto, Calif.-based CV Therapeutics, told BioWorld Today. "But we haven't decided what the next steps are going to be. We are still evaluating the information."
CV Therapeutics plans to release a full analysis of the trial at the American Heart Association meeting in Chicago in November.
Meanwhile, the company intends to continue conducting additional studies to identify the appropriate commercial dosing regimen for tecadenoson in patients with atrial fibrillation or atrial flutter.
Research notes released by Mark Monane, principal, biotechnology and life sciences, at Needham & Co. Inc. in New York, said further Phase II testing likely would be necessary for the development of tecadenoson in the atrial fibrillation indication.
Finally, both Monane and Schmidt said they expect that CV Therapeutics will submit an NDA for Ranexa (ranolazine) for the treatment of stable angina in the fourth quarter.
"We further believe that Ranexa, the first new drug class for angina therapy in the past 20 years, represents an exciting addition to the medication armamentarium," Monane's note said.
Monane believes Ranexa sales could reach $417 million by 2007.
CV Therapeutics and Innovex, a subsidiary of Quintiles Transnational, of Research Triangle Park, N.C., have a sales and marketing agreement for Ranexa, but the company has entered no such deal for tecadenoson.
CV Therapeutics' stock (NASDAQ:CVTX) closed Tuesday at $23.74, down 89 cents.