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Biotech / Medical : Cardiome -- CRME -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (75)	9/13/2006 7:43:19 AM
From: dr.praveen	Read Replies (1) \| Respond to of 285

Cardiome Announces Positive Phase 2a Results For Oral RSD1235 Wednesday September 13, 7:30 am ET < Hardly any difference in the efficacy between the 300mg dose and the 600mg dose in this low no study. Thing to note is the very good safety profile and no tdp. Cardiome might go with the 300mg dosing in P3. Key is to have a large P3. C/C at 8:00 AM should be interesting > VANCOUVER, Sept. 13 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced top-line results from both the 300mg and 600mg dosing groups for its recently-completed Phase 2a pilot study of RSD1235 (oral). The study was initiated in December 2005, and an interim analysis of the 300mg dosing group relative to the initial placebo group was announced on July 24, 2006. For the 300mg dosing group, 61% (33 of 54) of patients receiving RSD1235 (oral) completed the study in normal heart rhythm, as compared to 43% (24 of 56) of all patients receiving placebo. For the 600mg dosing group, 61% (30 of 49) of patients receiving RSD1235 (oral) completed the study in normal heart rhythm, as compared to 43% of all patients receiving placebo. A Kaplan-Meier analysis of the results demonstrated a statistically significant efficacy difference between the 300mg dosing group and the placebo group (p=0.048). The difference between the 600mg dosing group and the placebo group trended toward but did not reach statistical significance (p=0.060). A combined analysis of all drug group patients relative to the placebo group also demonstrated a statistically significant difference (p=0.028). For the entire study, a total of 171 patients were successfully cardioverted after the initial 3 days of dosing and continued in the study, of which 159 reached an endpoint of the study (completion of dosing or relapse to atrial fibrillation). The remainder of the patients were discontinued from the study for reasons unrelated to atrial fibrillation. The safety data for both dosing groups suggests that RSD1235 (oral) appears well-tolerated within the target population. During the 28 days of oral dosing, serious adverse events occurred in 8% of all placebo patients, 10% of patients in the 300mg dosing group, and 11% of patients in the 600mg dosing group. Potentially drug-related serious adverse events occurred in 1% of all placebo patients, 4% of patients in the 300mg dosing group and 5% of patients in the 600mg dosing group. There were no cases of drug-related "Torsades de Pointes", a well-characterized arrhythmia which is an occasional side effect of some current anti-arrhythmic drugs. "This clinical trial has exceeded our expectations, reinforcing the signal we saw in the 300mg interim results and giving us an even greater degree of confidence in the potential for RSD1235 (oral) as a therapy for the prevention of recurrence of atrial fibrillation," said Bob Rieder, Chief Executive Officer of Cardiome. "In particular, we are encouraged by the strong safety data we've seen in a target patient population which includes a high proportion of older patients and patients with congestive heart failure." "This Phase 2a study was designed to test safety and tolerability, and we are very pleased with the clear early efficacy trends demonstrated," said Dr. Charles Fisher, Executive Vice President and Chief Medical Officer of Cardiome. "The consistency in safety, tolerability and efficacy across the two dosing groups indicates the potential to realize efficacy in the broad atrial fibrillation population within the context of the doses explored." The double-blind, placebo-controlled, randomized, dose-ranging study was designed to explore safety and tolerability, pharmacokinetics and preliminary efficacy of RSD1235 (oral) over 28 days of dosing in patients at risk of recurrent atrial fibrillation. The majority of patients enrolled had experienced atrial fibrillation for greater than 30 days and less than 180 days in duration. Patients received a 300mg dose of RSD1235 (oral), a 600mg dose of RSD1235 (oral) or placebo twice per day. After the first 3 days, patients still in atrial fibrillation were electrically cardioverted. Successfully cardioverted patients continued to receive RSD1235 (oral) or placebo for the remaining 25 days and were monitored throughout the dosing period. Cardiome initiated the Phase 2a pilot study of RSD1235 (oral) in December 2005. The study was conducted across 72 centres in Canada, U.S. and Europe. Cardiome will hold a teleconference and webcast on Wednesday, September 13, 2006 at 8:00am EST (5:00am PST) to discuss these results. Please dial 800-814-4853 or 416-644-3416 to access the call. There will be a separate dial-in line for analysts on which we will respond to questions at the end of the presentation. The webcast can be accessed through Cardiome's website at www.cardiome.com. About Cardiome Pharma Corp. Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with two clinical drug programs focused on atrial arrhythmia (intravenous and oral dosing), and a pre-clinical program directed at improving cardiovascular function. RSD1235 (iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation (AF). Positive top-line results from two pivotal Phase 3 trials for RSD1235 (iv), called ACT 1 and ACT 3, were released in December 2004 and September 2005. An additional Phase 3 study evaluating patients with post-operative atrial arrhythmia, called ACT 2, and an open-label safety study evaluating recent-onset AF patients, called ACT 4, are ongoing. Cardiome and its co-development partner Astellas are working toward re-submitting a New Drug Application for RSD1235 (iv) following receipt of a Refusal to File letter from the FDA in May 2006. RSD1235 (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Cardiome announced positive results from a Phase 2a pilot study for RSD1235 (oral) in July 2006 and September 2006. Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME). Further information about Cardiome can be found at www.cardiome.com.