MORRISVILLE, N.C.--(BUSINESS WIRE)--Clinipace Worldwide, a global digital clinical research organization (dCRO), announced today that Plexxikon Inc., a leader in the structure-guided discovery and development of novel small molecule pharmaceuticals to treat human disease, has selected Clinipace to manage all aspects of four clinical trials comprising a Phase 1 healthy volunteer study, a Phase 1b rheumatoid arthritis (RA) study, and two phase 2 oncology studies.
Plexxikon announced in January that enrollment started for the first of two Phase 1 clinical trials with PLX5622, a novel, oral, targeted and highly selective Fms kinase inhibitor for the treatment of autoimmune diseases such as RA. The initial Phase 1 trial is a single-ascending dose (SAD) study in up to 48 healthy volunteers. The second trial is a multiple-ascending dose (MAD) study in approximately 32 RA patients that will begin once the first SAD healthy volunteer cohort has been cleared for safety, with continued enrollment in a staggered fashion following each SAD dose level. Both studies are being managed by Clinipace Worldwide.
Additionally, Plexxikon has awarded Clinipace Worldwide two phase 2 trials with PLX3397, an orally available compound that selectively co-inhibits three key kinase targets—Fms, Kit and FIt3-ITD—resulting in down-modulation of a number of cell types including macrophages, microglia, osteoclasts and mast cells, as well as cells harboring the Flt3-ITD mutation, a driver in as many as 30% of acute myeloid leukemia (AML) cases. These clinical trials are targeted for initiation in 2011 and focus on recurrent glioblastoma multiforme and relapsed or refractory Flt3-ITD+ AML.
“We chose Clinipace Worldwide to manage these important clinical trials for both PLX5622 and PLX3397 based on Clinipace’s commitment to customer service. Plexxikon’s programs are highly differentiated from its competition, and we needed a highly differentiated CRO to get the job done. The Clinipace team values each working opportunity as a true, strategic partnership,” said Paul Lin, MD, MBA, Director of Business Development, Plexxikon. “We believe in Clinipace’s dCRO model and the Clinipace team. As our portfolio grows in value, we have confidence that Clinipace has the experience and expertise to handle additional, mission-critical trials with high visibility and efficiency.”
“As a digital CRO, we know that successful trials hinge on the transparent exchange of trial and project data among all constituents,” said Jeff Williams, CEO, Clinipace Worldwide. “This platform enables our clients to substantially improve their ability to avoid problems and mitigate risk. As a result we look forward to a long-lasting and successful partnership with Plexxikon as they continue to bring innovative and effective drugs to market.”
About Plexxikon
Plexxikon is a leader in the structure-guided discovery and development of novel small molecule pharmaceuticals to treat human disease. The company’s lead compound, PLX4032, recently met overall survival and progression-free survival endpoints in a Phase 3 trial of melanoma patients. The company is developing a portfolio of clinical and preclinical stage compounds to address significant unmet medical needs in cardio-renal disease, CNS disorders, autoimmune and neuro-inflammatory diseases, and oncology. Plexxikon’s proprietary Scaffold-Based Drug Discovery™ platform integrates multiple state-of-the-art technologies, including structural screening as a key component that provides a significant competitive advantage over other drug discovery approaches. For more information, please visit www.plexxikon.com.
About Clinipace Worldwide
Clinipace Worldwide, a global digital clinical research organization (dCRO), specializes in fully-integrated clinical research services for biopharmaceutical and medical device firms. Optimized by TEMPO™, its proprietary eClinical platform, the Clinipace team of experts brings extensive knowledge and insight into site selection, patient recruitment, clinical operations, data management, medical monitoring, biostatistics, regulatory affairs, strategic development, and quality assurance to ensure a successful clinical development program through proactive clinical trial management. With specific expertise in oncology, among other therapeutic areas, Clinipace Worldwide has managed over 200 contract research and regulatory projects. Clinipace Worldwide is headquartered in Research Triangle Park, NC with additional domestic operations in Overland Park, KS, and Boulder, CO, and South American operations based in Brazil, Argentina, and Peru. For more information visit our website at www.clinipace.com.