Cardiome Announces Interim Phase 2a Results for Oral RSD1235
Monday July 24, 7:45 am ET
<Very Positive results without safety issues...Up by 3$ by 35% premarket>
NASDAQ: CRME TSX: COM
VANCOUVER, July 24 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced interim clinical results from the 300mg dosing group for its Phase 2a pilot study of RSD1235 (oral). The safety data for this first of two dosing groups suggests that RSD1235 (oral) appears well-tolerated within the target population. The interim analysis further demonstrated a clear positive trend toward efficacy, with 61% (33 of 54) of patients receiving RSD1235 (oral) completing the study in normal heart rhythm, as compared to 37% (10 of 27) of patients receiving placebo.
A total of 83 patients were successfully cardioverted after the initial 3 days of dosing and continued in the study, of which 81 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.
During the 28 days of oral dosing, serious adverse events occurred in 9% of placebo patients and 10% of patients receiving RSD1235 (oral). Potentially drug-related serious adverse events occurred in 3% of placebo patients and 4% of patients receiving RSD1235 (oral). 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.
"We are very pleased with these results and are enthusiastic about the prospects of RSD1235 (oral) as a therapy for the prevention of recurrence of atrial fibrillation," said Dr. Charles Fisher, Executive Vice President and Chief Medical Officer of Cardiome. "The 300mg dose is well below the maximum tolerated dose indicated by our Phase 1 studies, and to see a positive safety profile coupled with a clear trend toward efficacy at these levels is very encouraging. We await the outcome for the 600mg dosing group and remaining placebo patients for final determination of the statistical significance of both active doses utilized in this trial."
The double-blind, placebo-controlled, randomized, dose-ranging study is 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 in the first stage of the study received a 300mg 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 is being conducted across 72 centres in Canada, U.S. and Europe.
"This patient population suffers significant disease burden including substantial risk of stroke, impaired cardiac function and decreased quality of life," said Bob Rieder, Chief Executive Officer of Cardiome. "Worldwide, more than 4 million patients could benefit from a safe and effective oral drug to prevent atrial fibrillation. These interim trial results move RSD1235 (oral) an important step closer to meeting this critical unmet medical need."
Enrollment and dosing for the second stage of this study, evaluating patients receiving a 600mg dose of RSD1235 (oral) or placebo twice per day, has now been completed. Results from this dosing group, and the complete study, are expected later in the 3rd quarter of this year. Initiation of a larger Phase 2b clinical study will follow analysis of these final results.
Cardiome will hold a teleconference and webcast on Monday, July 24, 2006 at 9:00am EST (6:00am PST) to discuss these results. Please dial 800-814-4941 or 416-644-3432 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 also 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. A Phase 2a pilot study for RSD1235 (oral) was initiated in December 2005.
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. |
