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GENSIA ANNOUNCES ARASINE CLINICAL RESULTS AND PLANS FOR REGULATORY SUBMISSIONS

 GENSIA ANNOUNCES ARASINE CLINICAL RESULTS
 AND PLANS FOR REGULATORY SUBMISSIONS
 SAN DIEGO, Sept. 22 /PRNewswire/ -- Gensia Pharmaceuticals, Inc. (NASDAQ: GNSA) today announced that based on the company's preliminary analysis of clinical evidence of safety and efficacy in its clinical program with Arasine(TM) in patients undergoing coronary artery bypass surgery, Gensia plans to file regulatory submissions, as previously announced. Based on the company's analysis of the U.S. Phase 3 multicenter clinical trial, Gensia believes that Arasine appears to provide clinically important and statistically significant benefits in reducing the incidence of myocardial infarctions and other adverse cardiovascular outcomes associated with coronary artery bypass surgery in the high-dose group versus placebo. The final analysis of the U.S. data is in progress by the clinical investigators who participated in the U.S. study and Gensia. A preliminary analysis of data from an international study conducted in Canada and certain European countries indicates that the results of the international study, when all patients were evaluated, were not statisticaly significant, although clinically and statistically significant reductions in a primary endpoint were obtained in two important subgroup analyses. The company is continuing to analyze aspects of the international study which may have affected certain results of this study. In both of the Phase 3 clinical trials, there were no differences in the overall incidence of side effects between the placebo and drug treated groups.
 The Phase 3 program consisted of two multicenter trials conducted with Arasine in a total of approximately 1,450 patients undergoing coronary artery bypass surgery. In addition, the company plans to continue to evaluate Arasine in a new multicenter clinical trial with patients undergoing coronary bypass surgery as additional support for the use of the drug in this indication. The company expects to complete this clinical trial by the end of 1993.
 "Based on the safety and efficacy of Arasine in Phase 2 and 3 clinical trials, we plan to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) under the procedure established by the Committee for Proprietary Medicinal Products (CPMP) in the European Community (EC) by the end of 1992," said Hale. "A Canadian filing and regulatory submissions to the members of the European Free Trade Association (EFTA) are planned for the first quarter of 1993. We plan to meet with regulatory authorities to discuss the results of the clinical program prior to filing regulatory submissions." There can be no assurance that Gensia will be able to obtain the necessary regulatory approvals for the manufacturing or marketing of Arasine.
 Following the filing of the hard copy of the NDA, Gensia plans to file a computer assisted NDA, called a CANDA, in the first quarter of 1993. A CANDA provides the FDA with a sophisticated database which affords direct access to the clinical data by FDA reviewers, allowing them to conduct their own statistical analyses.
 Gensia was recently notified by the CPMP in Europe that Arasine would be reviewed under the "High Tech" procedure as a Group "B" product. Group "B" products are pharmaceutical products representing significant innovation, such as the first of a new class of drugs, drugs which treat diseases in which no adequate therapy exists, or drugs prepared in unique dosage forms. The "High Tech" procedure coordinates the review of pharmaceutical products in countries which are members of the EC through the CPMP.
 Gensia is also conducting a Phase 2 clinical trial with Arasine to investigate dosing regiments in patients undergoing major non-cardiac surgery. Due to the initiation of an additional clinical trial in coronary artery bypass surgery, the company estimates a delay of up to six months in the start of a multicenter Phase 3 clinical trial with Arasine in patients undergoing non-cardiac surgery who are at high risk of developing cardiovascular complications.
 "We expect data from the Phase 3 clinical trials with Arasine to be presented at a major medical meeting in the first quarter of 1993," Hale said. "We anticipate that several papers will be written by the clinical investigators who participated in these studies and that these papers will be published in medical journals in mid-to-late-1993."
 Gensia's second cardiovascular product, the GenESA(TM) System, is in Phase 3 clinical trials in the U.S. and certain European counties. The company expects to begin Phase 3 clinical trials in Canada shortly. The GenESA System is being developed to enhance the diagnosis and evaluation of coronary artery disease when used in conjunction with electrocardiography, echocardiography and radionuclide imaging. The company expects to complete enrollment in the Phase 3 clinical trials with the GenESA System by the end of 1992.
 Gensia is also using its novel adenosine regulating agent (ARA) technology in conjunction with Aramed, Inc. (NASDAQ: ARAMZ) to develop second generation ARA compounds for the treatment of cardiovascular, cerebrovascular and neurological diseases. Gensia also has basic research programs in diabetes and inflammatory diseases.
 Gensia Pharmaceuticals is a San Diego-based biopharmaceutical company formed to discover, develop, manufacture and market novel pharmaceutical products for the treatment and diagnosis of human diseases. Aramed is a special purpose corporation formed in 1991 to accelerate the discovery, research and development of new therapeutic drugs utilizing Gensia's ARA technology.
 1. When were the blinds broken on the two clinical trials?
 Answer: The blinds were broken on Sept. 15, 1992 for the international study and on July 9, 1992 for the U.S. study.
 2. What were the primary endpoints in the Phase 3 clinical trials?
 Answer: The two primary endpoints were a reduction in the incidence of: a) myocardial infarction and b) adverse cardiovascular outcomes.
 3. How do you define adverse cardiovascular outcomes?
 Answer: Adverse cardiovascular outcomes measured as part of a composite primary endpoint in these clinical trials were cardiac death, acute myocardial infarctions, stroke, severe arrhythmias and congestive heat failure.
 4. What was the incidence of myocardial infarction observed in the placebo treated groups in the Phase 3 clinical trials?
 Answer: The incidence of myocardial infarctions observed in the clinical trials was consistent with the range of approximately 3 - 15 percent in the clinical literature depending on the criteria used to diagnose myocardial infarction.
 5. What were the side effects observed with Arasine?
 Answer: There were no differences in the overall incidence of side effects between the placebo and drug treated groups in the U.S. and international studies. Based on our investigations, Arasine appears to be safe and well tolerated in patients undergoing coronary artery bypass surgery.
 6. How many patients have you tested in coronary artery bypass surgery?
 Answer: In total, we enrolled approximately 1,580 patients: approximately 118 patients in our Phase 2 multicenter clinical trial, approximately 630 in our U.S. multicenter Phase 3 clinical trial and approximately 830 in our international Phase 3 clinical trial.
 7. When will the data from these Phase 3 clinical trials be made public?
 Answer: We expect data from the Phase 3 clinical trials with Arasine to be presented at a major medical meeting in the first quarter of 1993. We anticipate that several papers will be written by the clinical investigators who participated in these studies and that these papers will be submitted in the next several months for publication in medical journals in mid- to late-1993.
 -0- 9/22/92
 /CONTACT: Martha L. Hough or Elizabeth A. Gard of Gensia Pharmaceuticals, Inc., 619-546-8300/
 (GNSA ARAMZ) CO: Gensia Pharmaceuticals, Inc.; Aramed, Inc. ST: California IN: MTC SU:


TS -- NY012 -- 2012 09/22/92 09:01 EDT
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