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» Cytokinetics, Inc. Q1 2009 Earnings Call Transcript
The following discussion, including our responses to questions contain statements that constitute forward-looking statements for purposes of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 including but not limited to statements relating to our financial guidance, to the initiation, enrolment, design, conduct and result of clinical trial and to other research and development activity. Our actual results might differ materially those projected in these forward-looking statements.Additional information concerning factors that could cause our actual results to differ materially from those in these forward-looking statements is contained in our SEC filings, including our most current quarterly report on Form 10-Q and our current reports on Form 8-K. Copies of these documents may be obtained from the SEC or by visiting the Investor Relations section of our website. These forward-looking statements speak only as of today. You should not rely on them as representing our views in the future and we undertake no obligation to update these statements after this call. Now, I'll turn the call over to Robert. Robert Blum Thank you, Sharon. During the second quarter Cytokinetics took additional steps to execute on the company's business plan directed to the biology of muscle function. In the second quarter, we initiated dosing in two Phase IIa evidence of effect trials of the lead drug candidate from our skeletal muscle activator program, CK-2017357 or CK-357. One in patients with amyotrophic lateral sclerosis or ALS and the other in patients with symptoms of claudication. With these trial initiations, we are demonstrating clear progress towards our goal of advancing a broad and sustainable pipeline of novel mechanism drug candidates. We are especially pleased with the continuation of the Phase IIa trial of CK-357 in patients with ALS. In recent days, we conducted an interim review of the data with results supporting the continuation of this trial under the current protocol. As Andy will elaborate, we are pleased with what we have seen to-date in terms of the apparent safety and tolerability of CK-357 in these patients as well as the dose proportional and predictable pharmacokinetic profile of this drug candidate in the patient studied. We look forward to additional data from this trial by the end of the year.
As Andy and I will both discuss later in the call, Amgen and Cytokinetics continue to work closely together in the development of only omecamtiv mecarbil as a potential treatment for heart failure. We expect to be initiating in the coming months under Amgen's sponsorship a pharmacokinetic trial of two distinct oral formulations of omecamtiv mecarbil in a stable heart failure patients as well as an additional study of an oral form of our drug candidate in renally comprised patients.Moreover, we are together putting the finishing touches on the protocol for our phase IIB trial intended to evaluate the intravenous form of only omecamtiv mecarbil in more acutely ill heart failure patients. Overall, in the second quarter Cytokinetics continued to execute well against clinical development timelines with the goal of progressing our therapeutic pipeline and importantly doing so in a physically responsible way. I now would like to turn the call over to Andy to elaborate on the specific clinical progress achieved during the last quarter in our respective drug development programs and to provide some insights into our plans for the future. Andy Wolff Thank you, Robert. The second quarter was a busy one as our activities starting on advancing our redrug candidate from our skeletal muscle activator program CK-357 into phase IIa evidenced of effect trial designed and conducted by Cytokinetics. In the last quarter, we initiated dosing in our phase IIa evidence of the effect clinical trial of CK-357 and patients with ALS. You may recall that this trial is a double blind randomized placebo controlled treat carrying crossover, pharmacokinetic and pharmacodynamic trail of CK-357 in at least 36 and of the 72 male and female patients with ALS. Read the rest of this transcript for free on seekingalpha.com