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Cytokinetics Inc. (CYTK)
Business Update Call
March 31, 2008 8:00 am ET
Dr. John R. Teerlink - Associate Professor of Medicine
Dr. Andrew A. Wolff - Senior Vice President of Clinical Research and Development and Chief Medical Officer
Dr. John Cleland - Professor of Cardiology
Andrew A. Wolff
Previous Statements by CYTK
» Cytokinetics, Inc. Q1 2009 Earnings Call Transcript
» Cytokinetics, Inc. Q4 2008 Earnings Call Transcript
» Cytokinetics Q3 2007 Earnings Call Transcript
As you can see from our agenda, we have a lot to cover in the next hour. Before we start, I’d like to emphasize that we’re both pleased and encouraged by the positive interim results from this our first phase IIa clinical trial of CK-1827452 in heart failure patients. As Andy will outline for you in a moment, we believe that the growing body of clinical data supports the ongoing development of CK-452, its novel mechanism, and [inaudible] well for what we may observe going forward as we continue the promising program. I’d like to take the opportunity to introduce our speakers.
To my right is our first speaker, Dr. John Teerlink. He is Associate Professor of Medicine at the School of Medicine and Director of the Heart Failure Clinic and Clinical Echocardiography at the San Francisco Veteran Affairs Medical Center, University of California, San Francisco. John was awarded a fellowship in the American College of Cardiology in 1999, and the American Heart Association in 2002, and the European Society of Cardiology in 2003. He serves on the AHA National Committee on Heart Failure and Transplantation, is a member of the US Food and Drug Administration’s Cardiovascular and Renal Drug Advisory Committee, and is on multiple committees with the Heart Failure Society of America.
John received his postgraduate clinical cardiology and internal medicine training at UCSF after obtaining his medical degree from Harvard. Next to John is Andy Wolff, Cytokinetics Senior Vice President, Clinical Research and Development, and the company’s chief medical officer. Andy has been a member of our executive team since September 2004 and has made a tremendous impact especially in leading and overseeing the implementation of both our cardiovascular and oncology clinical trials programs. Prior to joining the company, Andy was Chief Medical Officer at CV Therapeutics, and prior to that held various clinical positions at Syntex, now Roche. In addition, he holds an employment in the Cardiology Division of the University of California, San Francisco, where he is currently an associate clinical professor. Andy received his MD from Washoe St. Louis.
Next to Andy is Dr. John Cleland, Professor of Cardiology at University of Hull in the UK where he has been and continues to be responsible for an impressive portfolio of international clinical trials in the field of cardiovascular care. He has published over 400 papers and participated in numerous clinical trials. He is a consultant to the World Health Organization, and is the current Chairman of the British Society of Heart Failure. Dr. Cleland is also a member of the editorial board of the Journal of the American College of Cardiology. He received his MD from Glasgow in the UK. I should also mention that John Teerlink was the co-PI for our phase I study, first-time-in-human study of CK-452, and John is the investigator in the phase IIa trial for which you will be hearing the interim results here in a moment.
With that I’d like to remind everyone that we’ll be making forward-looking statements during the presentation and Q&A session, and as a result, I refer you to our publicly filed SEC documents for a complete discussion of our risks and uncertainties.
With that I’d like to turn the program over to Dr. John Teerlink.
Dr. John R. Teerlink
Thanks very much. Good morning. It’s my pleasure to actually have an opportunity to speak on CK-1827452 and put it into the context – a bit on how one evaluates cardiac performance in a contemporary drug development. For centuries it has been recognized that the fundamental or one of the fundamental defects in heart failure is the reduced ability of the heart to pump blood. In that context, much of the drug development in heart failure has been geared toward developing new agents that can improve cardiac performance or attempt to improve cardiac performance. However, unfortunately the currently available drugs that we have do so at considerable costs, and these, I am specifically referring to the beta adrenergic agonists such as dobutamine and the phosphodiesterase inhibitors such as milrinone. While these agents do increase cardiac output, they do so at the expense of increasing myocardial oxygen demand and having the clinical adverse effects of increasing ischemia, increasing arrhythmogenicity, and also contributing to increased mortality. These adverse effects are actually directly related to their mechanism of action such that the whipping of the heart, the increase of intracellular calcium, can directly result in these adverse effects. In addition, these agents work by increasing vasodilation – they open up the blood vessels peripherally. So, up until now we’ve never had an agent that directly affected cardiac performance solely and independently, and it is in that context that this truly novel mechanism of action of CK-1827452, which I from now on will just call CK-452, this novel mechanism of action where one can specifically activate cardiac myosin without all of these other potential adverse effects has been potentially a tremendous advancement in the field.