COR Therapeutics Inc. submitted a new drug application (NDA) withthe FDA to market the company's lead compound, Integrelin, forprevention of acute cardiac complications in patients undergoingangioplasty.
The NDA for the platelet inhibitor was filed this week 10 monthsafter COR released disappointing data from its Phase III trial ofIntegrelin. The preliminary results in June 1995 sent the South SanFrancisco company's stock (NASDAQ:CORR) plummeting 45percent in one day from $18.75 to $10.25. COR ended Wednesday at$11.62, up 25 cents.
The findings from the 4,010-patient Phase III study showed Integrelindid not achieve statistical significance compared with placebo in itsprimary composite endpoint _ preventing death, heart attacks andartery reclosure following angioplasty.
However, COR officials said the anti-blood clotting drug wassuccessful if the evaluation focused on the 3,900 patients treated witheither Integrelin or placebo. About 3 percent of the patents enrolledin the trial were excluded from the treatment protocol, but wereincluded in the statistical analysis because the study was conductedon an intent-to-treat basis.
Evaluation of the 3,900 patients revealed an 18 percent reduction inadverse cardiac events for those receiving Integrelin.
Vaughn Kailian, COR's president and CEO, said Wednesday theNDA includes data from the Phase III study along with results fromnine other Phase I and Phase II trials. The application also containsfindings from the six-month follow-up of patients in the Phase IIItrial, demonstrating the beneficial effects seen in the preliminaryanalysis after 30 days extended to 180 days.
After meeting with the FDA about the Phase III study results, CORofficials said in early January 1996 they intended to file an NDA inthe first quarter of 1996.
In April 1995, COR signed a potential $120 million collaborationwith Schering-Plough Corp., of Madison, N.J., for development andmarketing of Integrelin. The synthetic peptide also is underevaluation in a Phase III trial for unstable angina and a Phase II studyfor acute heart attacks.
If approved by the FDA, Integrelin likely will compete with Malvern,Pa.-based Centocor Inc.'s ReoPro. n
-- Charles Craig
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