Followers | 120 |
Posts | 10004 |
Boards Moderated | 1 |
Alias Born | 04/28/2007 |
Tuesday, November 01, 2011 9:43:01 AM
SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- 11/01/11 -- Cytokinetics, Incorporated (NASDAQ: CYTK) announced today the initiation of a second cohort, or Part B, of an ongoing Phase II clinical trial of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS). CK-2017357, a fast skeletal muscle troponin activator, selectively activates the fast skeletal muscle troponin complex by increasing its sensitivity to calcium, which increases skeletal muscle force in response to neuronal input and delays the onset and reduces the degree of muscle fatigue. CK-2017357 is the lead drug candidate that has emerged from the company's skeletal muscle contractility program.
Part B of this clinical trial, a double-blind, randomized, placebo-controlled evaluation of the safety and tolerability of multiple doses of CK-2017357 in patients with ALS, is designed to enroll patients who are also receiving riluzole. In Part B, an estimated 24 patients are planned to be enrolled at eight to ten study centers in the United States . Patients in the trial will be randomized to one of four different treatment groups, to receive daily oral doses of placebo, 125 mg, 250 mg, or 375 mg of CK-2017357, respectively, in addition to 50 mg of riluzole for two weeks; clinical assessments will take place at pre-determined times during the course of treatment. Patients will also participate in follow-up evaluations one week after their final dose.
The primary objective of this clinical trial is to assess the safety and tolerability of CK-2017357, after multiple oral doses to steady state plasma concentrations, in patients with ALS who are also receiving riluzole. A secondary objective of this clinical trial is to evaluate the ALS Functional Rating Scale-revised (ALSFRS-R), other measures of pulmonary function, muscle strength and fatigue, and physician and patient global assessments in these patients while receiving two weeks of treatment with CK-2017357 at the indicated doses or placebo. Additional information about this trial can be found at www.clinicaltrials.gov.
Cytokinetics recently concluded enrollment of the first cohort, or Part A, of this trial which was designed to evaluate the safety and tolerability, pharmacokinetic and pharmacodynamics of multiple fixed daily doses of CK-2017357 in ALS patients who are not receiving riluzole. The company anticipates that data from Part A of this trial will be presented at the 22nd International Symposium on ALS and Motor Neurone Diseases Meeting in Sydney, Australia to be held November 30-December 2, 2011 .
Development Status of CK-2017357 in ALS
Cytokinetics is developing CK-2017357, a skeletal muscle activator, as a potential treatment for diseases and conditions associated with aging, muscle wasting or neuromuscular dysfunction. CK-2017357 is currently the subject of a Phase II clinical trials program and has been granted orphan-drug designation by the U.S. Food and Drug Administration for the potential treatment of ALS, a debilitating disease of neuromuscular impairment in which CK-2017357 demonstrated potentially clinically relevant pharmacodynamic effects in a Phase IIa Evidence of Effect clinical trial. In that trial, the single doses of CK-2017357 evaluated appeared safe and generally well-tolerated. In addition, both patients and investigators perceived a positive change in the patients' overall status, in a dose-dependent fashion, at 6 hours after dosing with CK-2017357, based on a Global Assessment in which the patient and the investigator each independently assessed patients' status compared to prior to dosing. Furthermore, there was a clear relationship between improvements in Global Assessments and the CK-2017357 plasma concentration. Also at this 6-hour time point, there was a trend towards decreased muscle fatigability, as evidenced by data from a test of sub-maximal hand-grip endurance. Data from this clinical trial also demonstrated a statistically significant, dose-related increase in the maximum volume of air patients could inhale and exhale in ten seconds (Maximum Voluntary Ventilation) at both 6 and 24 hours after 500 mg of CK-2017357, as well as small but statistically significant increases in maximum strength of certain muscle groups tested.
Cytokinetics recently met with the U.S. Food and Drug Administration Center for Drug Evaluation and Research's Division of Neurology Products to discuss the progress in the development of CK-2017357 as a potential treatment for patients with ALS and the company's strategy for its further development, including potential registration strategies. Based on this discussion, Cytokinetics is assessing options that may enable the initiation of a clinical trial of CK-2017357 in ALS patients that could potentially serve as a pivotal trial for global registration purposes.
Background on Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that afflicts 20,000 to 30,000 people in the United States . Approximately 5,600 new cases of ALS are diagnosed each year. The average life expectancy of an ALS patient is approximately three to five years and only 10% of patients survive for more than 10 years. Death is usually due to respiratory failure because of diminished strength in the skeletal muscles responsible for breathing. Few treatment options exist for these patients, resulting in a high unmet need for new therapeutic options to address the symptoms and modify the disease progression of this grievous illness.
Background on Cytokinetics Skeletal Muscle Contractility Program
CK-2017357, a fast skeletal muscle troponin activator, is the lead drug candidate from the company's skeletal muscle contractility program. CK-2017357 selectively activates the fast skeletal muscle troponin complex by increasing its sensitivity to calcium, leading 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 or neuromuscular dysfunction. Skeletal muscle contractility is driven by the sarcomere, the fundamental unit of skeletal muscle contraction. The sarcomere is a highly ordered cytoskeletal structure composed of skeletal muscle myosin, the cytoskeletal motor that is directly responsible for converting chemical energy into mechanical force, as well as actin, and a set of regulatory proteins, troponins and tropomyosin, which make the actin-myosin interaction dependent on changes in intracellular calcium levels. Cytokinetics' skeletal muscle contractility program is focused to the discovery and development of small molecule skeletal sarcomere activators and leverages Cytokinetics' expertise developed in its ongoing discovery and development of cardiac sarcomere activators, including the cardiac myosin activator omecamtiv mecarbil, now in clinical development as a potential treatment for heart failure. Skeletal sarcomere activators have demonstrated pharmacological activity in preclinical models that may lead to new therapeutic options for diseases associated with aging, muscle wasting and neuromuscular dysfunction. The clinical effects of muscle wasting, fatigue and loss of mobility can range from decreased quality of life to, in some instances, life-threatening complications. By directly improving skeletal muscle function, a small molecule activator of the skeletal sarcomere may potentially enhance physical performance and quality of life in aging patients.
About Cytokinetics
Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Cytokinetics' lead drug candidate from its cardiac muscle contractility program, omecamtiv mecarbil (formerly CK-1827452), is in clinical development for the potential treatment of heart failure. Amgen Inc. holds an exclusive license worldwide (excluding Japan ) to develop and commercialize omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization participation rights. Cytokinetics is independently developing CK-2017357, a skeletal muscle activator, as a potential treatment for diseases and conditions associated with aging, muscle wasting or neuromuscular dysfunction. CK-2017357 is currently the subject of a Phase II clinical trials program and has been granted orphan-drug designation by the U.S. Food and Drug Administration for the potential treatment of amyotrophic lateral sclerosis, a debilitating disease of neuromuscular impairment in which CK-2017357 demonstrated potentially clinically relevant pharmacodynamic effects in a Phase IIa trial. Cytokinetics is also conducting research and non-clinical development of compounds that inhibit smooth muscle contractility and which may be useful as potential treatments for diseases and conditions associated with excessive smooth muscle contraction, such as bronchoconstriction associated with asthma and chronic obstructive pulmonary disorder (COPD). In addition, prior Cytokinetics' research generated three anti-cancer drug candidates that have progressed into clinical development: ispinesib, SB-743921 and GSK-923295. All of these drug candidates and potential drug candidates have arisen from Cytokinetics' research activities and are directed towards the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Additional information about Cytokinetics can be obtained at www.cytokinetics.com.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' and its partners' research and development activities, including plans for and the initiation, conduct, scope, design and results of clinical trials for CK-2017357, the significance and utility of clinical trial results for CK-2017357 and the anticipated timing for the availability of clinical trial data; the potential size of markets for CK-2017357; the properties and potential benefits of CK-2017357 and Cytokinetics' other drug candidates and potential drug candidates, including CK-2017357's potential utility in the treatment of patients with ALS; and planned presentations by Cytokinetics . Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results, patient enrollment for or conduct of clinical trials may be difficult or delayed, Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy, the U.S. Food and Drug Administration (FDA) or foreign regulatory agencies may delay or limit Cytokinetics' or its partners' ability to conduct clinical trials, the FDA may not grant CK-2017357 orphan drug exclusivity in ALS even if it is approved for marketing, and Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; Amgen's decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing necessary to conduct development of its products on acceptable terms, if at all; funding from the National Institute of Neurological Disorders and Stroke may not be available in future periods; Cytokinetics may be unable to enter into future collaboration agreements for its drug candidates and programs on acceptable terms, if at all; standards of care may change, rendering Cytokinetics' drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics' collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission .
Contact: Christopher S. Keenan Director, Investor & Media Relations (650) 624-3000
Visit the BREAKOUT BOARD!
All statements and annotations should not be used as buy/sell advice
Recent CYTK News
- Cytokinetics to Host Investor Event and Conference Call to Discuss the Primary Results From SEQUOIA-HCM at the European Society of Cardiology Heart Failure 2024 Congress • GlobeNewswire Inc. • 04/29/2024 08:00:00 PM
- Cytokinetics to Announce First Quarter Results on May 8, 2024 • GlobeNewswire Inc. • 04/24/2024 08:00:00 PM
- Cytokinetics Announces Three Late Breaking Clinical Trial Presentations Relating to SEQUOIA-HCM at the European Society of Cardiology Heart Failure 2024 Congress • GlobeNewswire Inc. • 04/10/2024 11:30:00 AM
- Cytokinetics Presents Additional 48-Week Data From FOREST-HCM, the Open Label Extension Clinical Study of Aficamten, at The American College of Cardiology 73ʳᵈ Annual Scientific Session • GlobeNewswire Inc. • 04/05/2024 11:30:00 AM
- Cytokinetics Presents Additional 48-Week Data From FOREST-HCM, the Open Label Extension Clinical Study of Aficamten, at The American College of Cardiology 73ʳᵈ Annual Scientific Session • GlobeNewswire Inc. • 04/05/2024 11:30:00 AM
- Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 04/02/2024 08:00:00 PM
- Cytokinetics to Participate in the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 04/01/2024 08:00:00 PM
- Cytokinetics Announces Four Upcoming Presentations at the American College of Cardiology 73rd Annual Scientific Session • GlobeNewswire Inc. • 03/25/2024 12:15:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/07/2024 09:26:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/07/2024 09:24:18 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/07/2024 09:22:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/07/2024 09:18:49 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/05/2024 09:21:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/05/2024 09:05:52 PM
- Cytokinetics to Participate in March Investor Conferences • GlobeNewswire Inc. • 03/04/2024 09:00:00 PM
- Super Micro Computer and Deckers Outdoor Set to Join S&P 500; Others to Join S&P 100, S&P MidCap 400 and S&P SmallCap 600 • PR Newswire (US) • 03/01/2024 11:47:00 PM
- Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 03/01/2024 09:00:00 PM
- Cytokinetics Joins Global Initiative to Recognize International Rare Disease Day • GlobeNewswire Inc. • 02/29/2024 12:30:00 PM
- Cytokinetics, The Mended Hearts, Inc. and WomenHeart Announce Launch of New Initiative to Increase Engagement in Cardiovascular Clinical Trials • GlobeNewswire Inc. • 02/28/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/27/2024 09:05:22 PM
- Cytokinetics Reports Fourth Quarter 2023 Financial Results • GlobeNewswire Inc. • 02/27/2024 09:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/14/2024 09:04:11 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 02/14/2024 09:03:41 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 02/13/2024 09:11:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/13/2024 09:01:39 PM
FEATURED NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM