Cytokinetics Announces the Selection of CK-2017357 to Windhover's
"Top 10 HOT SPACE Projects to Watch" List
"Top 10 HOT SPACE Projects to Watch" List
SOUTH SAN FRANCISCO, CA, Oct 27, 2010 (MARKETWIRE via COMTEX) --
Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that CK-2017357, its novel fast skeletal muscle troponin activator, has been named one of Windhover Therapeutic Area Partnership's "Top 10 HOT SPACE Projects to Watch." This list, which was handpicked by Windhover and independent consultants, represents the top 10 product candidates that are available for partnering in orphan diseases, women's health, dermatology, bone and muscle diseases, ophthalmology and other high value categories.
In connection with its inclusion in the "Top 10 HOT SPACE Projects to Watch" list, Cytokinetics has been selected to present at Windhover's Therapeutic Area Partnerships Conference, on Wednesday, November 3, 2010, in the Essex North East Room at the Westin Copley Place Hotel in Boston, Massachusetts. More information on the meeting can be found at www.tapartnerships.com.
"We are pleased that CK-2017357 has been selected for this prestigious list by respected industry experts," stated Elisabeth Schnieders, PhD, Cytokinetics' Vice President of Business Development. "Cytokinetics is currently conducting Phase IIa clinical trials designed to evaluate the potential effects of our novel drug candidate on muscle power and force in patients with amyotrophic lateral sclerosis and to possibly delay the onset of muscle fatigue in patients with symptoms of claudication due to peripheral artery disease. These trials may inform therapeutic roles for this novel mechanism of action in treating conditions associated with aging, muscle wasting and neuromuscular dysfunction and the potential future development strategy being contemplated as part of Cytokinetics' partnering discussions related to our skeletal muscle contractility program."
Development Status of CK-2017357
CK-2017357 is the subject of a Phase IIa clinical trials program and has been granted orphan-drug designation by the United States Food and Drug Administration for the potential treatment of ALS (amyotrophic lateral sclerosis.) Cytokinetics is currently conducting two Phase IIa Evidence of Effect clinical trials: one in patients with ALS and one in patients with claudication associated with peripheral artery disease. In addition, the National Institute of Neurological Disorders and Stroke has awarded the company a grant to support research and development of CK-2017357 directed to the potential treatment of myasthenia gravis.
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 Peripheral Artery Disease and Claudication
Claudication is a symptomatic complication associated with peripheral artery disease (PAD). Claudication associated with PAD results primarily from atherosclerosis of arteries in the lower extremities. During walking or other exercise, patients suffering from claudication experience fatigue, aching, cramping, and burning pain in the legs due to impaired blood circulation and chronic changes in muscle metabolism. As many as 3 million people in the United States, including 5% of the population over age 70, are estimated to be affected by claudication due to PAD.
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. 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.
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 IIa 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. Cytokinetics is also conducting 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 systemic hypertension or bronchoconstriction. 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 the initiation, conduct, design and results of clinical trials for CK-2017357 and the significance and utility of clinical trial results, and the properties and potential benefits of Cytokinetics' drug candidates and potential drug candidates, such as CK-2017357. 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 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 market exclusivity 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; Cytokinetics may be unable to enter into future collaboration agreements for its drug candidates and programs on acceptable terms, if at all; the availability of funds under the National Institute of Neurological Disorders and Stroke grant is not assured; 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
SOURCE: Cytokinetics, Inc.