Positive results from a Phase II study of RSD1235 in atrial fibrillation patients has prompted Cardiome Pharma Corp. to publicly state it is looking for partners to help further develop and market the product.
The Vancouver, British Columbia-based company said data from its 56-patient study demonstrated that RSD1235 appeared to be effective in terminating atrial fibrillation and in converting atrial fibrillation to normal heart rhythm.
"We look at this as a major landmark for patients with atrial fibrillation and a major landmark for our small company in Vancouver," Alan Ezrin, Cardiome's chief scientific officer, told BioWorld Today. "We're a small company working in a big space and very rarely do you get it right, and this one we got right. The news today supports the fact that we have developed a team in cardiovascular medicine that we think is unparalleled."
Indeed, Cardiome, which has been in business for about eight years and employs 33 people, developed RSD1235 in-house. "The uniqueness of this molecule is that it influences the function only of the atrial - or upper chambers of the heart - and as such, it will have a wider safety range than the other drugs that lack selectivity," Ezrin said. "These other drugs have some very serious cardiac side effects."
There were no significant drug-related adverse events in the data released on RSD1235, the company said.
The next step for the company is to prepare for three Phase III studies, each one including 300 patients. Ezrin expects to enter Phase III sometime next year, and if all goes well, Cardiome should file its first application for regulatory approval (possibly in the U.S.) in 2006.
In the meantime, the company will continue seeking a partner for RSD1235. "We've had a number of discussions around regional partnerships, that is, U.S. only or Europe only," Bob Rieder, Cardiome's president and CEO, told BioWorld Today. "We expect that this data will now transform those discussions into negotiations."
Also, he hopes the data will attract sophisticated investors who will see the value of the company.
The Phase II trial of RSD1235 was a placebo-controlled, double-blind, step-dose study in patients with recent-onset atrial fibrillation. Patients were randomized to receive placebo or RSD1235 at a low or high dose. The primary endpoint was the ability of RSD1235 to terminate atrial fibrillation within 30 minutes of infusion, and the secondary endpoints included observation of heart rhythm at 30 minutes, one hour and 24 hours post-infusion.
According to the company, during the 30-minute post-dosing observation interval, 11 percent of the low-dose group and 61 percent of the high-dose group experienced termination of atrial fibrillation, against a placebo rate of 5 percent. At the end of the 24-hour post-dosing interval, 100 percent of the high-dose patients whose arrhythmia was terminated remained in normal sinus rhythm.
The value of the pharmaceuticals used to treat atrial fibrillation exceeds US$1 billion annually in the developed world, a prepared statement from Cardiome said.
In a stock deal completed in March and valued then at US$12 million to US$15 million, Cardiome merged with New York-based Paralex Inc. Through that deal, Cardiome gained intellectual property related to cardiovascular applications of xanthine oxidase inhibitors, as well as the congestive heart failure drug oxypurinol. (See BioWorld Today, March 12, 2002.)
Oxypurinol is expected to enter Phase II trials in congestive heart failure this year.
Cardiome shares (TSE:COM) gained C36 cents, or 25.7 percent, Tuesday on the Toronto Stock Exchange to close at C$1.76.