Navigation Links
Cardiome And Astellas Announce Initiation Of Patient Enrolment In ACT 5 Trial


VANCOUVER and DEERFIELD, IL, Oct. 28 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") announced today that patient enrolment has begun for the ACT 5 trial, a confirmatory Phase 3 clinical trial of KYNAPID(TM) (vernakalant hydrochloride) Injection, a drug product candidate under development for the rapid conversion of atrial fibrillation to sinus rhythm. The ACT 5 trial, previously announced in August 2009, is expected to be completed in the first half of 2011.

The ACT 5 Trial

The ACT 5 trial, "A Phase 3b Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Vernakalant Hydrochloride Injection in Patients with Recent Onset Symptomatic Atrial Fibrillation," will enroll approximately 450 patients across approximately 100 centres focused in North America. The study is designed to measure the safety and efficacy of KYNAPID Injection in patients with recent-onset atrial fibrillation (more than 3 hours but less than 7 days). The study excludes patients with evidence or history of congestive heart failure (CHF). Further, the study will evaluate the influence of CYP2D6 genotype status on the pharmacokinetics and pharmacodynamics of vernakalant (and its metabolites), and also allows for an exploratory analysis of safety and healthcare resource utilization between vernakalant and electrocardioversion (ECV).

About Cardiome

Cardiome Pharma Corp. is a product-focused drug development company dedicated to the advancement and commercialization of novel treatments for disorders of the heart and circulatory system. Cardiome is traded on the NASDAQ National Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at

About Astellas

Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In the U.S., Astellas markets products in the areas of Immunology, Urology, Anti-Infectives, Cardiovascular and Dermatology. For more information about Astellas Pharma US, Inc., please visit our website at

Cardiome Forward-Looking Statement Disclaimer

Certain statements in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, our stage of development, lack of product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market our products, the ability to protect our intellectual property, dependence on collaborative partners and the prospects for negotiating additional corporate collaborations or licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties that: we may not be able to successfully develop and obtain regulatory approval for vernakalant (iv) or vernakalant (oral) in the treatment of atrial fibrillation or any other current or future products in our targeted indications; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and sales capabilities and the costs of launching our products may be greater than anticipated; we rely on third parties for the continued supply and manufacture of vernakalant (iv) and vernakalant (oral) and we have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in our filings with the Securities and Exchange Commission available at and the Canadian securities regulatory authorities at Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.

SOURCE Cardiome Pharma Corp.

SOURCE Cardiome Pharma Corp.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Orexigen(R) Therapeutics Presents New Data Showing Weight Loss with Contrave Significantly Improves Important Markers of Cardiometabolic Risk
2. Cardiome Pharma Corp. Announces Final Results of Tender Offer
3. Cardiome Pharma Corp. Announces Commencement of US$27.5 Million Tender Offer
4. Cardiome Announces Upcoming Presentation Of Results Of Phase 2b Clinical Trial Of Vernakalant (Oral) At The European Society Of Cardiology Congress 2009
5. Cardiome Pharma Corp. Announces Tender Offer To Purchase Up To US$27.5 Million Of Its Common Shares
6. Atherotech Adds New Cardiometabolic Tests Amid Strong 2009 Growth
7. Cardiome to Hold Conference Call
8. Cardiome Announces Management Transition
9. Cardiome Achieves Milestone From Collaboration With Merck Co., Inc.
10. Cardiome Announces That Collaboration and License Agreement with Merck & Co., Inc. Now Effective
11. Cardiome Reports First Quarter Results
Post Your Comments:
(Date:11/29/2015)... ... , ... Khanna Vision Institute based in Los Angeles, announced that Dr. Khanna ... Peer Certification by the Board is done so the public knows that the Doctor ... after the completion of three years of training or Residency in Ophthalmology. This is ...
(Date:11/29/2015)... PITTSBURGH, PA (PRWEB) , ... November 29, 2015 , ... ... assistance with kneeling or provide ready access to exercise weights. Fortunately, an inventor from ... prototype for THE TOMMY WALKER to enhance the benefits of a standard walker to ...
(Date:11/29/2015)... ... 29, 2015 , ... Doctors who missed a case of mesothelioma in a ... mesothelioma and push for a diagnosis, especially in people exposed to asbestos. Surviving Mesothelioma ... read it now. , Researchers at Gifu Prefectural Tajimi Hospital in Japan ...
(Date:11/29/2015)... ... November 29, 2015 , ... ProStatic Analog Distortion from ... designed specially for Final Cut Pro X. FCPX users can now ... modification controls. Destoying and creating chaotic distortion is now quick and simple, putting ...
(Date:11/29/2015)... ... ... Effective immediately, every single IguanaMed scrub style will be available at Target via ... “Buy One Scrub Set, Get the 2nd Scrub Set 50% Off” for a limited ... price. , IguanaMed’s mission is to outfit every healer around the world ...
Breaking Medicine News(10 mins):
(Date:11/29/2015)... , Nov. 29, 2015   Royal Philips  ... driven radiology solutions at the 2015 Radiological Society of ... 4 at McCormick Place in Chicago ... will experience the company,s broad portfolio of integrated Diagnostic ... solutions to increase clinical performance, improve workflow and create ...
(Date:11/29/2015)... Germany , Nov. 29, 2015  At this ... attendees to experience the most complete mobile C-arm portfolio ... display is Ziehm Vision RFD 3D, the world,s only ... cm edge length per scan volume. In addition, Ziehm ... fully motorized mobile C-arm in four axes which is ...
(Date:11/29/2015)...  The GE Health Cloud 1 was unveiled today ... North America (RSNA) meeting in ... new cloud ecosystem and its applications will connect radiologists and ... multidisciplinary teams – both inside and outside the hospital setting. ... GE. "As the digital industrial leader, we are betting big ...
Breaking Medicine Technology: