Key Developments For Cubist Pharmaceuticals, Inc.
Cubist Pharmaceuticals, Inc. (CBST.O) (Nasdaq)
Alnylam Pharmaceuticals, Inc. And Cubist Pharmaceuticals, Inc. Announce Complete Data From Phase II Study Of ALN-RSV01 In Lung Transplant Patients
Alnylam Pharmaceuticals, Inc. and Cubist Pharmaceuticals, Inc. announced the complete data from their Phase II study of ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV) infection. Data were presented at the BIT Life Science`s 2nd Annual Summit of Antivirals held in Beijing, China from July 18 - 25, 2009. The Phase II study was a randomized, double-blind study of inhaled ALN-RSV01 or placebo in adult lung transplant patients naturally infected with RSV. Clinical evaluations at 90 days confirmed that the primary objective of safety and tolerability was achieved. In the Phase II study, conducted at 11 sites in 4 countries, 24 lung transplant patients with confirmed RSV infection were randomized to receive inhaled ALN-RSV01 (N=16) or placebo (N=8) once daily for three consecutive days. Overall, the study achieved its primary objective of demonstrating safety and tolerability of ALN-RSV01. In particular, there were no drug-related serious adverse events or discontinuations, and there were no clinically significant differences in the overall adverse event profile between ALN-RSV01 and placebo. Importantly, there was no evidence of disease exacerbation related to ALN-RSV01 treatment. At the 90 day endpoint, all patients survived and the incidence of intubation, new respiratory infection, or acute rejection was comparable across ALN-RSV01 and placebo groups.
Evotec AG Enters into Research Agreement with Cubist Pharmaceuticals Inc.
Evotec AG announced that on July 14, 2009, it has entered into a research agreement with Cubist Pharmaceuticals, Inc., a biopharmaceutical company based in the United States.
Cubist Pharmaceuticals, Inc. Initiates Phase 2 Trial In Europe For Therapy To Reduce Blood Loss During Surgery In High Risk Patients
Cubist Pharmaceuticals, Inc. announced that it has begun dosing in the CONSERV-2 clinical trial with ecallantide. CONSERV-2, being conducted in Europe, is a Phase 2 trial that will investigate effect on surgical blood loss volume in cardiac surgery patients who are on cardiopulmonary bypass and are at a high risk of bleeding. The trial is expected to enroll 300 subjects.
Alnylam Pharmaceuticals, Inc. and Cubist Pharmaceuticals, Inc., Report Preliminary Data from Phase II Study of ALN-RSV01 in Lung Transplant Patients Naturally Infected With Respiratory Syncytial Virus
Alnylam Pharmaceuticals, Inc. and Cubist Pharmaceuticals, Inc., reported preliminary data from their Phase II study of ALN-RSV01, an RNAi therapeutic in development for the treatment of respiratory syncytial virus (RSV) infection. The Phase II study was a randomized, double blind study of inhaled ALN-RSV01 or placebo in adult lung transplant patients infected with RSV. The primary objective of the study was safety and tolerability. Secondary objectives of the study included measurements of viral dynamics and clinical symptoms. In the Phase II study, conducted at 11 sites in 4 countries, 24 lung transplant patients with confirmed RSV infection were randomized to receive inhaled ALN-RSV01 (N=16) or placebo (N=8) once daily for three consecutive days. Overall, the study achieved its primary objective of demonstrating safety and tolerability of ALN-RSV01 over 30 days post treatment. In particular, there were no drug-related serious adverse events or discontinuations, and there were no clinically significant differences in the overall adverse event profile between ALN-RSV01 and placebo. Further, patients treated with ALN-RSV01 showed no significant increases in plasma cytokine levels and showed no changes in lung function post-dosing as determined by spirometry. Importantly, there was no evidence of disease exacerbation related to ALN-RSV01 treatment.
Cubist Pharmaceuticals, Inc. Initiates Phase 2 Trial For Therapy To Reduce Blood Loss During Surgery
Cubist Pharmaceuticals, Inc. announced that it has begun dosing in the CONSERV-1 clinical trial with ecallantide. CONSERV-1 is a Phase 2 trial evaluating the safety, efficacy, and clinical outcomes of various doses of ecallantide for the reduction of blood loss volume during on-pump cardiothoracic surgery. The trial is expected to enroll more than 300 patients undergoing on-pump cardiothoracic surgery.
