Cytokinetics, Incorporated Provides Development Program Update for Tirasemtiv
Oct 20 14
Cytokinetics, Incorporated provided a program update relating to tirasemtiv, the company's lead drug candidate from its skeletal muscle contractility program. The company announced that it has completed its review of results from BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS) and has concluded that effects observed on Slow Vital Capacity (SVC) in patients treated with tirasemtiv are robust and potentially clinically meaningful. In addition, following consultation with clinical and statistical experts, the company believes that data from BENEFIT-ALS support progression of tirasemtiv to a potential Phase III clinical trial in patients with amyotrophic lateral sclerosis (ALS). The company also announced that it has begun regulatory interactions with the U.S. Food and Drug Administration (FDA) regarding results from BENEFIT-ALS and has received initial feedback from the FDA. The company believes that effects on SVC could be a Phase III clinical trial endpoint and could support registration of tirasemtiv as a potential treatment for patients with ALS. As a result, Cytokinetics has initiated planning for a potential Phase III clinical trial of tirasemtiv that could begin in 2015.
Cytokinetics, Incorporated Announces the Completion of Five Phase I Clinical Trials Evaluating CK-2127107
Oct 13 14
Cytokinetics, Incorporated announced the completion of five Phase I clinical trials evaluating CK-2127107 in healthy volunteers, and certain other Phase II readiness activities, all in connection with the agreed development plan under the collaboration between Cytokinetics and Astellas Pharma Inc. The Phase I clinical trials demonstrated that CK-2127107 appeared safe and well-tolerated in healthy volunteers and that exposures generally increased across dose ranges studied. CK-2127107 increased the response of muscle to neuromuscular input in a dose and plasma concentration related fashion in healthy volunteers consistent with preclinical observations. In addition, an oral tablet formulation of CK-2127107 appears appropriate for use in Phase II clinical trials. These activities were conducted by Cytokinetics in collaboration with Astellas. Cytokinetics conducted five Phase I clinical trials for CK-2127107 under sponsorship by Astellas. The first Phase I clinical trial, known as CY 5011, was a double-blind, randomized, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of single ascending oral doses of CK-2127107 administered to healthy adult males in a three period, escalating dose, crossover design. The primary objective of this trial was to evaluate the safety and tolerability of single doses of CK-2127107 administered orally to healthy male volunteers. The secondary objective was to evaluate the pharmacokinetic profile of single doses of CK-2127107. Planned single doses of CK-2127107 up to 4000 mg, the dose administered in this trial, were well-tolerated without an emerging pattern of adverse events; therefore, a maximum tolerated dose could not be defined. The pharmacokinetic profile of CK-2127107 was linear and dose-proportional across the dose range studied with a mean terminal half-life compatible with once or twice daily dosing. A second Phase I clinical trial, known as CY 5012, was a double-blind, randomized, placebo-controlled, multiple ascending dose, parallel group study. The primary objective of this clinical trial was to assess the safety, tolerability, and pharmacokinetics of CK-2127107 in healthy young and elderly volunteers. This clinical trial consisted of three ascending dose cohorts of 12 young volunteers (ages 18-55), and two ascending dose cohorts of 12 elderly volunteers (ages 65-85); split evenly between men and women. In each cohort, volunteers received CK-2127107 or placebo in accordance with 2:1 randomization over a 10-day period. This clinical trial demonstrated that a 10-day course of CK-2127107, either 300 mg or 500 mg twice daily, was well tolerated by both younger (18-55 years) and older (65-85 years) subjects. Plasma concentrations of CK-2127107 achieved steady state and no differences in pharmacokinetics between younger and older subjects were observed. A third Phase I clinical trial, known as CY 5013, was a randomized, placebo-controlled, single dose, 4-period crossover study of CK-2127107 in healthy male volunteers. The primary objective of this clinical trial was to evaluate the change in the force-frequency profile of the tibialis anterior muscle during transcutaneous stimulation of the deep fibular nerve and its relationship to dose and plasma concentrations of CK-2127107. This clinical trial consisted of 16 healthy volunteers who completed four dosing periods administered one week apart. A fourth Phase I clinical trial, known as CY 5014, was a randomized, open-label, 2-period crossover study designed to assess the relative oral bioavailability, pharmacokinetics, safety and tolerability of two oral formulations of CK-2127107 in healthy volunteers. The primary objective of this clinical trial was to assess the relative oral bioavailability and pharmacokinetic profiles of two formulations of CK-2127107 following a single dose. This clinical trial enrolled 24 healthy male volunteers divided in two cohorts. Each volunteer completed two dosing periods administered one week apart. A fifth Phase I clinical trial, known as CY 5015, was an open-label, randomized, single dose study designed to evaluate the pharmacokinetics, in a fed and fasted state, of an oral tablet formulation of CK-2127107 in healthy male volunteers. The primary objective of this Phase I clinical trial was to assess the relative oral bioavailability and pharmacokinetic profile of CK-2127107 following a single dose and a secondary objective was to evaluate the pharmacokinetic effect of a single dose of CK-2127107 following fed and fasted states. The clinical trial evaluated 24 male volunteers, split evenly into three cohorts, who in a cross-over fashion received two single doses of CK-2127107 administered orally a week apart. In addition to these five Phase I clinical trials, Cytokinetics has conducted other Phase II readiness activities for CK-2127107 in accordance with an agreed development plan under the joint oversight of Cytokinetics and Astellas. These activities included process improvement and optimization activities for the manufacturing of CK-2127107, pre-clinical and toxicology studies, and Phase II indication prioritization analyses.
Cytokinetics, Incorporated Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2014
Jul 31 14
Cytokinetics, Incorporated reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2014. Revenues for the second quarter of 2014 were $7.8 million, compared to $1.0 million during the same period in 2013. The net loss for the second quarter was $8.4 million, or $0.23 per basic and diluted share. This is compared to a net loss for the same period in 2013, of $15.0 million, or $0.58 per basic and diluted share. Operating loss was $8,407,000 against $15,068,000 a year ago.
Revenues for the six months ended June 30, 2014 were $15.8 million, compared to $1.8 million for the same period in 2013. The net loss for the six months ended June 30, 2014, was $17.1 million, or $0.49 per basic and diluted share, compared to a net of $27.7 million, or $1.11 per basic and diluted share, for the same period in 2013. Operating loss was $17,177,000 against $27,715,000 a year ago.