Cytokinetics Inc announced the initiation of a Phase I clinical trial of a small-molecule inhibitor of kinesin spindle protein (KSP). Initiation of this trial triggers an undisclosed milestone payment from GlaxoSmithKline plc to Cytokinetics under the terms of the collaboration established in June 2001 between the two companies to discover, develop and commercialize novel small-molecule therapeutics for the treatment of cancer and other diseases.
This first Phase I study is an open-label, non-randomized, dose-finding trial being conducted to investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of the KSP inhibitor. The study is being conducted at two clinical centers in the United States (CTRC Institute for Drug Development, affiliated with the University of Texas Health Science Center in San Antonio, Texas and the University of Wisconsin Comprehensive Cancer Center in Madison, Wisconsin) in patients with advanced cancers.
"Cytokinetics has achieved uncommonly rapid success in translating our expertise and focus on the cytoskeleton into our first anti-cancer drug candidate," stated Dr. James Sabry, Cytokinetics' President and Chief Executive Officer. "Initiation of human clinical trials of our first KSP inhibitor with GlaxoSmithKline represents a significant milestone under the broad strategic alliance initiated just one year ago. We are now entering the next phase of our collaboration as we embark on investigating the potential of this biology to generate a new class of therapeutics in cancer."
"Cytotoxic anti-mitotic compounds currently serve as the foundation for a majority of existing anti-cancer regimens and, looking forward, will likely continue to occupy a prominent role in the oncology armamentarium," stated Dr. Eric Rowinsky, Director of Clinical Research at the CTRC Institute for Drug Development. "We are excited to be beginning the clinical evaluation of this promising compound in the setting of various human cancers. A novel small-molecule anti-mitotic that offers the potential of a broader therapeutic index would have clinical impact."
Under the terms of the collaboration, GlaxoSmithKline has committed funding of approximately $50 million over the minimum 5-year research term, including a $14 million upfront cash payment and a $14 million purchase of Cytokinetics preferred stock. In addition, GlaxoSmithKline could make milestone payments to Cytokinetics ranging from $30-50 million per target for products directed to each of over 10 mitotic kinesins that will be the subject of collaborative activities. GlaxoSmithKline is responsible for worldwide development and commercialization of products arising from the collaboration. Cytokinetics will receive royalties from the sale of any resulting products.
In addition, Cytokinetics retains a product-by-product option to co-fund certain development activities, thereby increasing its royalty and affording co-promotion rights in North America. During the collaboration, targets may revert to Cytokinetics for independent research and development, with GlaxoSmithKline retaining an option to resume joint activities.