Cytokinetics Announces the Initiation of Phase I Clinical Trial for SB-743921 in Cancer Patients with Solid Tumors
Second Drug Candidate to Enter Clinical Trials under Strategic Alliance with GlaxoSmithKline
South San Francisco, CA - May 13, 2004
Cytokinetics, Inc. (Nasdaq: CYTK) today announced that GlaxoSmithKline (GSK) has initiated a Phase I clinical trial of SB-743921, the second small molecule inhibitor of kinesin spindle protein (KSP) to be advanced into the clinic under Cytokinetics’ collaboration with GSK. The companies established the collaboration in June 2001 to discover, develop and commercialize small molecule therapeutics for the treatment of cancer and other diseases.
This Phase I study is an open-label, non-randomized, dose-finding trial to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of SB-743921 in patients with advanced cancers. SB-743921 is structurally distinct from SB-715992, Cytokinetics’ most advanced drug candidate under the strategic alliance with GSK, for which GSK recently initiated a broad Phase II clinical trials program designed to evaluate its effectiveness in the treatment of many different types of cancer.
“We are excited about the progression of this second KSP inhibitor into the clinic, close on the heels of initiating Phase II studies for our initial KSP inhibitor in December 2003,” stated Dr. James Sabry, Cytokinetics’ President and Chief Executive Officer. “Advancing SB-743921 is consistent with our view that the concurrent development of both drug candidates is key to maximizing the potential for the development of a commercially viable cancer drug.”
“The initiation of this Phase I study is further evidence of the strong commitment of Cytokinetics and GSK to building a solid scientific and clinical foundation for next-generation approaches to anti-cancer therapies,” stated Dr. George Wilding, Director of the University of Wisconsin Comprehensive Cancer Center. “I am eager to work with SB-743921 in patients and to expand the clinical profile associated with this novel anti-mitotic mechanism.”
Background
Since their introduction over 30 years ago, anti-mitotic drugs (taxanes and vinca alkaloids) have advanced the treatment of cancer and are commonly used for the treatment of several tumor types. However, these drugs have demonstrated no treatment benefit against certain tumor types. In addition, these drugs target tubulin, a cytoskeletal protein involved not only in mitosis and cell proliferation, but also in other important cellular functions. The inhibition of these other cellular functions produces dose-limiting toxicities such as peripheral neuropathy, an impairment of the peripheral nervous system. Neuropathies result when these drugs interfere with the dynamics of microtubule filaments that are responsible for the long-distance transport of important cellular components within nerve cells.
Cytokinetics’ cancer drug candidates, SB-715992 and SB-743921, are structurally distinct small molecule compounds that modulate cell proliferation and promote cancer cell death by specifically inhibiting KSP. KSP is a mitotic kinesin that is essential for cell proliferation, a process which when unregulated, results in tumor growth. Mitotic kinesins are essential to mitosis, and, unlike tubulin, appear to have no role in unrelated cellular functions. Drugs that inhibit KSP and other mitotic kinesins may represent the next generation of anti-mitotic cancer drugs by arresting mitosis and cell proliferation without impacting unrelated, normal cellular functions, avoiding many of the toxicities commonly experienced by patients treated with existing anti-mitotic drugs.
About Cytokinetics
Cytokinetics is a leading biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs that specifically target 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, cardiovascular disease, fungal diseases and other diseases. Cytokinetics has developed a cell biology driven approach and proprietary technologies to evaluate the function of many interacting proteins in the complex environment of the intact human cell. Cytokinetics employs the PUMA™ system and Cytometrix™ technologies to enable early identification and automated prioritization of compounds that are highly selective for their intended protein targets without other cellular effects, and are thereby less likely to give rise to clinical side effects. Cytokinetics and GlaxoSmithKline have entered into a strategic alliance to discover, develop and commercialize small molecule therapeutics targeting human mitotic kinesins for applications in the treatment of cancer and other diseases. GlaxoSmithKline is conducting Phase II clinical trials with SB-715992 and Phase I clinical trials with SB-743921, each a drug candidate that has emerged from the strategic alliance. Additional information about Cytokinetics can be obtained at www.cytokinetics.com.
On April 29, 2004, Cytokinetics announced the pricing of its initial public offering of 6,900,000 shares of its common stock at a price of $13.00 per share. A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on April 29, 2004. On May 4, 2004, Cytokinetics announced that it had closed its initial public offering of 7,935,000 shares of its common stock, which included shares issued upon exercise in full of the underwriters' option to purchase an additional 1,035,000 shares of its common stock. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 and it is the Company’s intent that such statements be protected by the safe harbor created thereby. Examples of such statements include, but are not limited to, statements relating to the potential benefits of the Company’s drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company’s drug candidates that could slow or prevent product approval or market acceptance (including the risk that uncertainty of patent protection for the Company’s intellectual property or trade secrets, the Company’s ability to obtain additional financing if necessary and unanticipated research and development and other costs). For further information regarding these and other risks related to the Company’s business, investors should consult the Company’s filings with the Securities and Exchange Commission. Cytokinetics does not undertake any obligation to update forward-looking statements.
