Despite disappointing Phase III trial results for its lead compound,Integrelin, COR Therapeutics Inc. said Friday it will submit a newdrug application (NDA) to the FDA during the first quarter of 1996for use of the platelet inhibitor with angioplasty.
On June 14, 1995, COR's stock plummeted 45 percent after theSouth San Francisco company released preliminary data from its4,010-patient Impact II study showing Integrelin did not reachstatistical significance compared with placebo in its primarycomposite endpoint _ preventing death, heart attacks and reclosureof arteries following angioplasty.
However, the company's president and CEO, Vaughn Kailian, hassaid the anti-blood clotting drug was successful if the evaluationfocused only on the nearly 3,900 patients treated with eitherIntegrelin or placebo.
About 3 percent of the 4,010 patients enrolled in the study wereexcluded from the treatment protocol, but because the trials at 82medical centers were conducted on an intent-to-treat basis, allpatients were included in the statistical analysis.
Evaluation of the 3,900 patients revealed an 18 percent reduction inadverse cardiac events for those receiving Integrelin. Those findings,company officials said, were statistically significant.
After release of the Phase III data in June 1995, COR said it wouldnot decide whether to file an NDA until meeting with the FDA toassess the Impact II results.
Laura Brege, COR's vice president of finance and chief financialofficer, said Friday those discussions were held.
"We're confident this a good path for the company to take," Bregetold BioWorld Today.
COR's stock (NASDAQ:CORR) has not recovered from the beatinglast June when it fell $8.50 to $10.25. Shares Friday closed at $10.12,up 75 cents.
If Integrelin, a synthetic peptide, is approved by the FDA it willcompete with Malvern, Pa.-based Centocor Inc.'s ReoPro, amonoclonal antibody, which already is on the market. Both drugstarget the IIb/IIIa receptor to inhibit platelet aggregation, whichcauses blood clots.
Some Wall Street analysts had given Integrelin an edge over ReoProbased on concerns about bleeding associated with the latter.However, preliminary results released in December 1995 from twoPhase III trials of ReoPro countered the bleeding concerns andrevealed the drug worked better than previously thought inpreventing adverse cardiac events.
Centocor's stock (NASDAQ:CNTO) soared 125 percent in one weekin late December 1995 to $32.12. Shares Friday were at $30.50, up$1.25.
Centocor won approval of ReoPro in December 1994 in the U.S. andEurope for patients at high risk of artery reclosure followingangioplasty. Based on the December 1995 trial results the company isexpected to seek approval in 1996 to broaden the label to include allangioplasty patients.
More than 700,000 angioplasty procedures are performed each yearin the U.S. and Europe.
ReoPro is marketed by Centocor's partner, Eli Lilly and Co., ofIndianapolis. Schering-Plough Corp., of Madison, N.J., is COR'spartner for Integrelin. n
-- Charles Craig
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