COGENT 1 Trial Scrapped, Sponsor Declares Bankruptcy

Shelley Wood

January 22, 2009

January 22, 2009 (Palo Alto, California) — The sponsor of what was intended to be a 4000-patient trial testing a single-pill combination of clopidogrel and omeprazole to reduce the incidence of GI side effects has pulled the plug on the study and is filing for bankruptcy.

Investigators for the trial say the study has been shut down so abruptly that study sites have been left with no support for patients and staff to close down the study in a safe and timely way.

"We're going to do the best we can for patients, but this has been a pretty big shock for everybody to be left sort of holding the bag," Dr Ian C Gilchrist, a principal investigator for the study at the Heart & Vascular Institute, in Hershey, PA, told heartwire . "I've been doing this for 20 years and some of the companies have not survived, but the question of whether a site was going to be properly reimbursed and the study properly concluded has never been an issue."

The COGENT 1 study, sponsored by Cogentus Pharmaceuticals (Palo Alto, CA), was a phase 3 trial testing its combination product, known as CGT-2168, in patients requiring clopidogrel for at least 12 months, typically following non-ST-segment-elevation ACS, STEMI, or stent implantation. CGT-2168 is a once-daily pill that combines 75-mg clopidogrel with 20 mg of the gastroprotectant omeprazole.

The clinicaltrials.gov description of COGENT 1, which still characterizes the study as "recruiting," lists almost 500 sites in the US, Canada, Mexico, Australia, Chile, and Europe that were to enroll patients; enrollment had begun in North America at the beginning of 2008 and expanded to Europe in June of last year. The randomized, double-blind, double-dummy trial was assessing the safety and efficacy of CGT-21688 compared with clopidogrel alone to reduce the risk of gastrointestinal bleeding and symptomatic ulcer disease.

Enrollment in the study was suspended in December after what the company describes as a "sudden and very substantial loss of capital and an immediate need for a large new financing." Those efforts apparently failed: early last week, investigators were informed in a letter from Parexel International, the clinical research organization running the study, that Cogentus was "no longer able to support" the trial. A letter from the central lab, ACM-Pivotal, stated that "effective immediately, we will no longer process and fulfill kit/supply orders, process and test any incoming specimens, and automatically issue any patient reports."

Parexel further instructed investigators that study patients were to be "promptly scheduled to return study drug" but continued on open-label clopidogrel if warranted. No further payments will be forthcoming from Cogentus, the letter added. According to Gilchrist, some sites may not be paid for work they have already done, depending on what kind of bankruptcy deal is reached, and they're being asked to do more work to close down the study. At his own hospital, he says, nurse coordinators for the study are paid on salary, but their salaries rely directly on incoming funds from study sponsors, like Cogentus.

Calls to Cogentus are answered by a voicemail message saying the number is no longer in service.

A Sign of the Times

Contacted by heartwire , steering committee member Dr Marc Cohen (Beth Israel Deaconess Hospital, Boston, MA) confirmed that the study had been stopped because of the lack of further financial support but said, "I am sure that the closeout will be done in an orderly manner."

Dr Deepak Bhatt (Brigham and Women's Hospital, Boston, MA), another steering committee member, acknowledged to heartwire that the lack of funding to help with closing down the trial might be a "sore point" for investigators but said there was no reason to think there wouldbe any repercussions for patients.

"Sadly, the COGENT 1 trial has fallen victim to the global financial crisis," Bhatt said. "An unfortunate situation for everyone involved with the trial, though the physician leadership of the company is doing what they can to salvage the data that have been accumulated. So, hopefully, the efforts of the patients and investigators will result in at least some meaningful contribution to clinical care."

Gilchrist, however, fears that the fate of Cogentus may signal a new reality and that clinical trialists may need to ask companies up front if they have the funds to see the trial through.

"For most investigators, that's not a question you would normally ask. It's one thing to have Merck or another big company, but I like working with small start-up companies, and you assume that someone else has done their due diligence as far as asking whether the company can actually do this. Even when the FDA approves a protocol for a company to do a trial, you might think that part of the protection would be to have some consideration of whether the company can actually do what they say they want to do. It may be just a sign of the times, but to me it was an eye-opener and I know it was an eye-opener to our grants and contracts office. They are going to approach contracts with smaller companies in a different way."

face="Verdana" size="1">The complete contents of Heartwire , a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

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