SAN DIEGO -- Gensia Pharmaceuticals Inc. on Mondayconfirmed its long-stated hopes to file by the end of the year anew drug application (NDA) for its Arasine drug to treatpatients undergoing coronary bypass surgery.
It will take the company about six months to compile data insupport of the NDA from multicenter Phase III clinical studiesof Arasine completed in April in the United States, said David F.Hale, Gensia's chairman, president and chief executive officer.
Soon after its expected FDA filing for an NDA this fall, Gensiaintends to file for European marketing approval with theEuropean Community, Hale said. A Canadian filing for Arasineis expected during the first quarter of 1993.
Purine-based Arasine is administered to coronary bypasspatients during a seven-hour regimen starting just prior tosurgery and continuing through the patient's stay in therecovery room to promote delivery of oxygen to heart tissue,according to the company.
Arasine appears to promote the release of adenosine in heartmuscle tissue, which dilates the blood vessels, said WalterSingleton, head of Gensia's clinical development program.Arasine also prevents the stickiness of white blood cells thatare associated with blockages in the microcirculation systemsduring heart attacks.
Patient enrollment has been completed for the planned PhaseIII clinical trials in Western Europe and Canada. About 1,400bypass patients worldwide have been treated with Arasine inthe past 12 months, the company said. Arasine first enteredclinical trials in July 1991.
Gensia stock (NASDAQ:GNSA) closed Monday down 38 cents at$33.25 a share. Last February, the company's stock jumped$12.50 a share to $62 following an announcement of Phase IIdata showing that Arasine significantly reduced heart muscledamage during bypass surgery.
Data from the U.S. Phase III studies will likely be presented toa major medical conference in early 1993, while EuropeanPhase III data should be announced by mid-1993, thecompany said.
The Phase III trials are to demonstrate that Arasine reducesthe incidence of heart attacks and the overall incidence ofadverse outcomes in patients undergoing coronary arterybypass surgery, Gensia said.
A secondary purpose of the Phase III trials is to investigateArasine's potential ability to improve cardiac function, reducelocal ischemia (angina) and improve patient recovery aftersurgery.
In addition, Gensia last March started another Phase II trial toinvestigate the appropriate dosing regimens for patientsundergoing non-cardiac surgery who are at high risk ofdeveloping cardiovascular complications, such as abdominalsurgery or hip replacements.
-- Ray Potter Senior Editor
(c) 1997 American Health Consultants. All rights reserved.