SOURCE: Cytokinetics, Inc.

May 16, 2008 07:30 ET

Cytokinetics Announces Clinical Trials Data to be Presented at the 2008 Annual Meeting of the American Society of Clinical Oncology

SOUTH SAN FRANCISCO, CA--(Marketwire - May 16, 2008) - Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that three abstracts summarizing data from clinical trials relating to its oncology programs are planned to be presented at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, May 30-June 3, 2008. Two of these abstracts relate to clinical trials evaluating ispinesib that are sponsored by Cytokinetics or the National Cancer Institute (NCI). The third abstract relates to a clinical trial evaluating SB-743921 that is sponsored by Cytokinetics.

Ispinesib and SB-743921 are novel, chemically distinct, small molecule inhibitors of kinesin spindle protein (KSP), a mitotic kinesin essential for proper cell division. Both drug candidates have arisen from a broad strategic collaboration between Cytokinetics and GlaxoSmithKline (GSK) to discover, develop and commercialize novel small molecule therapeutics targeting human mitotic kinesins for applications in the treatment of cancer and other diseases.

Presentations at ASCO

The following abstracts are planned to be presented at ASCO. These abstracts are available through the ASCO website (www.asco.org):

Oral Presentation:

Abstract #10014: Pediatric Phase I Trial and Pharmacokinetic (PK) study of ispinesib (SB-715992): A Children's Oncology Group Phase I Consortium Study. (Oral presentation by Abdul-Kader Souid, MD, PhD, SUNY Upstate Medical University, Syracuse, NY, on Sunday, June 1, 2008, Pediatric Cancer II; S100b, 8:00 AM - 11:00 AM).

Poster Presentations:

Abstract #1143: A Phase I-II Open-Label Trial of Ispinesib on an Alternate Dosing Schedule in Chemotherapy-Naive Patients with Locally Advanced or Metastatic Breast Cancer (MBC). (Poster presentation by Manuel Philco, MD, Hospital Nacional Alberto Sabogal Sologúren, Lima, Peru on Monday, June 2, 2008, Breast Cancer - Metastatic, General Poster Session, S Hall A1, Poster #48D, 2:00 PM - 6:00 PM).

Abstract #8539: A Phase I-II trial of the Kinesin Spindle Protein (KSP) Inhibitor SB-743921 on Days 1 and 15 Every 28 Days in Non-Hodgkin or Hodgkin Lymphoma. (Poster discussion by Owen O'Connor, MD, PhD., Columbia Medical Center, New York, N.Y. on Tuesday, June 3, 2008, Lymphoma and Plasma Cell Disorders, Poster Discussion, E450a, Poster #14, 8:00 AM - 12:00 PM).

About Cytokinetics

Cytokinetics is a biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs that may address areas of significant unmet clinical needs. Cytokinetics' development activities are primarily directed to advancing multiple drug candidates through clinical trials with the objective of determining the intended pharmacodynamic effect or effects in two principal diseases: heart failure and cancer. Cytokinetics' cardiovascular disease program is focused to cardiac myosin, a motor protein essential to cardiac muscle contraction. Cytokinetics' lead compound from this program, CK-1827452, a novel small molecule cardiac myosin activator, entered Phase II clinical trials for the treatment of heart failure in 2007. Under a strategic alliance established in 2006, Cytokinetics and Amgen Inc. are performing joint research focused on identifying and characterizing activators of cardiac myosin as back-up and follow-on potential drug candidates to CK-1827452. Amgen has obtained an option for an exclusive license to develop and commercialize CK-1827452, subject to Cytokinetics' development and commercial participation rights. Cytokinetics' cancer program is focused on mitotic kinesins, a family of motor proteins essential to cell division. Under a strategic alliance established in 2001, Cytokinetics and GlaxoSmithKline (GSK) are conducting research and development activities focused on the potential treatment of cancer. Cytokinetics is developing two novel drug candidates that have arisen from this program, ispinesib and SB-743921, each a novel inhibitor of kinesin spindle protein (KSP), a mitotic kinesin. Cytokinetics believes that ispinesib has demonstrated clinical activity in Phase II monotherapy clinical trials in breast cancer, ovarian cancer and non-small cell lung cancer and recently initiated an additional Phase I/II clinical trial of ispinesib as monotherapy as a first-line treatment in chemotherapy-naïve patients with locally advanced or metastatic breast cancer on a more dose-dense schedule than previously studied. Cytokinetics is also conducting a Phase I/II trial of SB-743921 on a similar more dose-dense schedule in non-Hodgkin and Hodgkin lymphomas. GSK has obtained an option for the joint development and commercialization of ispinesib and SB-743921. Cytokinetics and GSK are conducting collaborative research activities directed to the mitotic kinesin centromere-associated protein E (CENP-E). GSK-923295, a CENP-E inhibitor, is being developed under the strategic alliance by GSK, subject to Cytokinetics' option to co-fund certain later-stage development activities and to co-promote any resulting approved drug in North America. GSK began a Phase I clinical trial with GSK-923295 in 2007. In April 2008, Cytokinetics announced the selection of a potential drug candidate directed towards skeletal muscle contractility which may be developed as a potential treatment for skeletal muscle weakness associated with neuromuscular diseases or other conditions. 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. Cytokinetics' focus on the cytoskeleton enables it to develop novel and potentially safer and more effective classes of drugs directed at treatments for cancer and cardiovascular and other diseases. 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 Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' and its partners' research and development activities, including the presentation of data from clinical trials, the potential benefits of Cytokinetics' drug candidates and potential drug candidates and the enabling capabilities of Cytokinetics' cytoskeletal focus. 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 approval or production of Cytokinetics' drug candidates that could slow or prevent clinical development, 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 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, and Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; GSK may decide to postpone or discontinue development activities for GSK-923295, Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing necessary to conduct development of its products, standards of care may change, others may introduce products or alternative therapies 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 our 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 Information

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    Director, Corporate Development
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    Director, Investor Relations
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