Cor Therapeutics Announces Preliminary Results of Phase III Clinical Trial of Integrelin(TM).SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif.--(BUSINESS WIRE)--June 14, 1995-- COR Therapeutics, Inc. (Nasdaq: CORR CORR Used on the consolidated tape to indicate a correction in a reported transaction : CORR.LAST.GY 50 WAS 51. ) today announced preliminary results from IMPACT II, a 4,010 patient, 82 center trial of Integrelin(TM), a novel cardiovascular agent, in the setting of coronary angioplasty. In the trial, Integrelin was tested in two different treatment arms. All Integrelin-treated patients received a bolus bolus /bo·lus/ (bo´lus) 1. a rounded mass of food or pharmaceutical preparation ready to swallow, or such a mass passing through the gastrointestinal tract. 2. a concentrated mass of pharmaceutical preparation, e. injection of 135 ug/kg. Thereafter, patients in one treatment arm received infusions at the rate of 0.5 ug/kg-min (Group 1) and patients in the other treatment arm received infusions at the rate of 0.75 ug/kg-min (Group 2). The trial also included a placebo, or control arm. The primary efficacy endpoint of the trial was a composite of death, myocardial infarction myocardial infarction: see under infarction. and the need for urgent intervention within 30 days following enrollment. Preliminary analysis of the occurrence of the composite endpoint for all patients who were enrolled in the trial showed that the differences between Integrelin-treated patients and control patients, while exhibiting a favorable trend, did not achieve conventional statistical significance. However, an analysis of the same data with respect to all patients who actually received the drug or a placebo (approximately 97% of the total patients enrolled in the trial) showed a reduction in the occurrence of composite endpoint events for the patients in Group 1 with a p value equal to 0.035. In addition, when all patients who actually received drug (either dose) were compared to all patients who received placebo, the trial showed a reduction in the occurrence of the composite endpoint events with a p value equal to 0.046. Below are the preliminary data concerning the composite endpoint, both for all patients enrolled in the trial (whether or not they received the drug or a placebo) and all patients actually treated with the drug or a placebo. -0-
Composite Efficacy Combined
Endpoint Group 1 Group 2 Integrelin Placebo
1. All patients enrolled 9.2% 9.9% 9.5% 11.4%
p value vs. placebo 0.06 0.22 0.07
% reduction 19 13 16
2. All patients treated 9.1% 10.0% 9.5% 11.6%
p value vs. placebo 0.035 0.18 0.046
% reduction 22 14 18
The trial showed a favorable trend for reductions in the incidence of death and Q-wave myocardial infarction at both rates of infusion. In the comparison of patients who received Integrelin treatment to those who received placebo, the event rate of death and Q-wave myocardial infarction was 2.5% in the placebo group, 1.3% in Group 1 and 2.0% in Group 2. The safety data related to Integrelin were very favorable. The rate of major bleeding (as defined in the study) was 4.8% for the placebo group, 5.1% for Group 1, and 5.2% for Group 2. Minor bleeding was experienced by 9.6% of the placebo group, 11.8% of Group 1, and 14.0% of Group 2. There was no increase in the incidence of stroke, including hemorrhagic stroke hemorrhagic stroke Neurology An ischemic stroke in which blood enters necrotic brain tissue, which may not be accompanied by a worsening clinical status Risks for HS Hemophilia, thrombocytopenia, sickle cell anemia, DIC, anticoagulants, HTN. See Stroke. . The Company emphasized that the trial data are very complex and the analysis of the data remains very preliminary. The implications of the trial in terms of preparation of an application for regulatory approval cannot be readily determined because the trial did not achieve the level of statistical significance specified in the protocol. The Company is reviewing the data and looks forward to further analysis by the investigators who conducted the trial. Data from IMPACT II will be presented by the clinical investigators at the European Congress of Cardiology cardiology Medical specialty dealing with heart diseases and disorders. It began with the 1749 publication by Jean Baptiste de Sénac of contemporary knowledge of the heart. Diagnostic methods improved in the 19th century, and in 1905 the electrocardiograph was invented. in Amsterdam. The presentations are scheduled for Thursday, August 24, 1995. In addition to the IMPACT II trial, COR Therapeutics and its partner Schering-Plough are pursuing a 10,000 patient multicenter clinical trial of Integrelin in the setting of unstable angina un·sta·ble angina n. Angina pectoris characterized by pain of coronary origin that occurs in response to less exercise or other stimuli than usually required to produce pain. . COR Therapeutics, Inc. is dedicated to the discovery, development and commercialization of novel pharmaceutical products for the treatment and prevention of severe cardiovascular diseases. COR has complementary product development programs that address critical needs in severe cardiovascular care, including unstable angina, acute myocardial infarction acute myocardial infarction ( CONTACT: COR Therapeutics, Inc. Laura A. Brege Vice President, Finance and CFO See Chief Financial Officer. (415) 244-6889 or Burns McClellan, Inc. Lilian S. Stern (investors) Lisa Burns (media) (212) 505-1919 REPEATS: New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of 212-575-8822 or 800-221-2462; Boston 617-330-5311 or 80 |
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