Key Developments For Cytokinetics, Incorporated
Cytokinetics, Incorporated (CYTK.O) (Consolidated Issue listed on NASDAQ Global Market)
Cytokinetics, Inc. And GlaxoSmithKline plc Announces Non-Clinical Data Relating To GSK-923295
Cytokinetics, Inc. announced the abstracts summarizing non-clinical data relating to GSK-923295, an inhibitor of centromere-associated protein E (CENP-E). GSK-923295 is currently being studied in a Phase I, first time in humans clinical trial sponsored by GlaxoSmithKline plc and designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetic profile of this drug candidate in patients with solid tumors. This study identified multiple genes along the MAPK pathway as hits in a synthetic lethal siRNA library screen for GSK-923295, suggesting that inhibiting the MAPK pathway may enhance sensitivity of cells to GSK-923295. The combination of these two drug candidates was tested by fixed-ratio dosing in 5 colon cell lines, 15 lung cell lines and 8 pancreas lines. Synergy between these two drug candidates was observed in most of the cell lines using one or more judging criteria; there was no association with genetic background (RAS/PIK3CA). Finally, as measured by caspase assay, more apoptosis was induced in the presence of both drugs than either alone.
Cytokinetics, Inc. Announces Advancement Of CK-2017357 In Phase I Clinical Trials
Cytokinetics, Inc. announced the initiation of a double-blind, randomized, placebo-controlled, multiple-dose Phase I clinical trial to investigate the pharmacokinetic profile of CK-2017357. The Company also announced that it has initiated the second part, or 'Part B', of a previously initiated first-time-in-humans, Phase I clinical trial of CK-2017357 in healthy male volunteers. In the Multi-Dose Phase I Clinical Trial, two cohorts of at least 12 healthy male volunteers per cohort will be randomized to receive either CK-2017357 or placebo once daily for seven days. The primary objective of this clinical trial is to determine the safety and tolerability of CK-2017357 after multiple oral doses to steady state in healthy male volunteers. The secondary objective is to evaluate the pharmacokinetic profile of CK-2017357 after multiple oral doses to steady state. The second part, or Part B, of this Phase I clinical trial is a double-blind, randomized, placebo-controlled study of single doses that were tolerated in Part A of this trial. In order to assess the pharmacodynamic effect of CK-2017357 when administered orally to healthy male volunteers, the force-frequency relationship of an externally stimulated nerve-muscle pair and its relationship to CK-2017357 plasma concentration will be determined. A single cohort of volunteers will receive each of three single oral doses of CK-2017357 and oral placebo treatment in a four period crossover design.
Cytokinetics, Inc. Presents Phase IIa Clinical Trials Data On Omecamtiv Mecarbil
Cytokinetics, Inc. announced data relating to two Phase IIa clinical trials evaluating omecamtiv mecarbil (formerly CK-1827452), one in stable heart failure patients and one in patients with ischemic cardiomyopathy and angina. The primary objective of clinical trial was to evaluate the safety and tolerability of omecamtiv mecarbil administered as an intravenous infusion to stable heart failure patients. The primary safety endpoint of this clinical trial was stopping an exercise treadmill test, performed during double-blind therapy with either omecamtiv mecarbil or placebo, due to angina at a stage earlier than the shorter of two baseline exercise treadmill tests. This endpoint occurred in one patient receiving placebo and in no patients receiving either the lower or higher of two dose levels of omecamtiv mecarbil. The authors concluded that in heart failure patients with ischemic cardiomyopathy and angina, who theoretically could be most vulnerable to the possible deleterious consequences of systolic ejection time prolongation, treatment with omecamtiv mecarbil, at doses producing plasma concentrations previously demonstrated in other trials to increase cardiac function, did not deleteriously affect a broad range of safety assessments in the setting of exercise.
Cytokinetics, Inc. Issues FY 2009 Revenue Guidance Below Analysts' Estimates-Conference Call
Cytokinetics, Inc. announced that it is updating its fiscal 2009 guidance and expects revenues in the range of $54 million to $58 million. The financial revenue guidance includes the $50 million which was received during the quarter associated with the option exercised by Amgen and also includes anticipated revenues associated with the reimbursement of our R&D expenses related to the clinical development program for omecamtiv. This financial guidance is on a cash basis and does not include an estimated $24.5 million in GAAP revenues primarily related to Amgen's initial payment for its nonexclusive license and technology access fee under the parties' collaboration and option agreement and $7.3 million in non-cash-related operating expenses primarily related to FAS 123R stock compensation expense. According to Reuters Estimates, analysts are expecting the Company to report revenues of $64 million for the same period.
Cytokinetics, Inc. Announces Initiation Of a First-Time-in-Humans, Phase I Clinical Trial of CK-2017357
Cytokinetics, Inc. announced that it has initiated a first-time-in-humans, Phase I clinical trial of CK-2017357 in healthy male volunteers. CK-2017357 is a fast skeletal muscle troponin activator and is the lead drug candidate that has emerged from the Company's skeletal sarcomere activator program. CK-2017357 selectively activates the troponin complex and increases its sensitivity to calcium, subsequently to an increase in skeletal muscle force. This mechanism of action has demonstrated encouraging pharmacological activity in preclinical models that may relate to the potential treatment of diseases associated with aging, muscle wasting, and neuromuscular dysfunction. This Phase I clinical trial is a double-blind, randomized, placebo-controlled, single ascending dose study designed to evaluate CK-2017357 in healthy male volunteers. Each volunteer will participate in two dosing sessions separated by an adequate washout period. Subjects will be randomized (3:1) at the start of each dosing period to receive active study drug or placebo. The primary objective of this clinical trial is to determine the safety, tolerability and maximum tolerated dose (MTD) of CK-2017357 administered orally. The secondary objective is to evaluate the pharmacokinetic profile of CK-2017357.
