Technology-Amplified dCRO Model Accelerating Personalized Approach to Targeted Therapies, Including Greater Collaboration, Higher Data Quality, and Reduced Development Costs
MORRISVILLE, N.C. (Business Wire) April 9, 2014 – Clinipace Worldwide, a global digital clinical research organization (dCRO), announced today that Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, has entered into a preferred provider agreement with Clinipace to manage several clinical programs, including oncology, wound healing, and other diseases.
As part of a long-term strategic partnership, Clinipace expects to manage numerous study starts on behalf of Karyopharm in 2014.
“It is our mission to foster scientific creativity with pioneering technologies and developmental approaches within an innovative culture,” noted Sharon Shacham, Ph.D., MBA, Karyopharm’s Founder, President and Chief Scientific Officer. “By partnering with a like-minded technology-driven company like Clinipace, we believe we can help accelerate our first-in-class small molecule modulators into effective targeted therapeutics for life threatening conditions.”
“As tailored therapies such as those Karyopharm have under development become more prominent, drug developers must find increasingly innovative ways to help bring their products to market in the most effective and efficient manner,” said Jeff Williams, CEO and co-founder, Clinipace Worldwide. “Working with a technology-enabled digital CRO (dCRO) provides our clients with a significant level of information sharing that helps increase collaboration, improves data quality, and reduces their overall development costs.”
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases. Karyopharm’s Selective Inhibitors of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). The inhibition of XPO1 by Karyopharm’s lead drug candidate, Selinexor (KPT-330), a first-in-class, oral SINE compound, leads to the accumulation of tumor suppressor proteins in the cell nucleus, which subsequently reinitiates and amplifies their tumor suppressor function. This is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. SINE compounds have shown biological activity in models of cancer, autoimmune disease, certain viruses, and wound-healing. Karyopharm was founded by Dr. Sharon Shacham and is located in Natick, Massachusetts.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the therapeutic potential of and potential clinical development plans for Karyopharm’s drug candidates, including the timing of initiation of certain trials and of the reporting of data from such trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that any of Karyopharm’s SINE compounds, including Selinexor (KPT-330), or any other drug candidate, including PAK4 inhibitors, that Karyopharm is developing will successfully complete necessary preclinical and clinical development phases or that development of any of Karyopharm’s drug candidates will continue. Further, there can be no guarantee that any positive developments in Karyopharm’s drug candidate portfolio will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Karyopharm’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Karyopharm’s ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm’s competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm’s ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption “Risk Factors” in Karyopharm’s Annual Report on Form 10-K for the year ended December 31, 2013, which is on file with the Securities and Exchange Commission (SEC), and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
About Clinipace Worldwide
As a global full-service digital contract research organization (dCRO), we have pioneered an innovative technology-amplified CRO service model to serve the unique needs of venture-backed, mid-tier, and strategic pharmaceutical, biotechnology, and medical device firms. Powered by TEMPO™, our proprietary eClinical platform, our team of experts brings extensive therapeutic knowledge and insight into assisting life science firms in developing and executing regulatory strategies, clinical development, and post-approval research to ensure a successful drug and medical device development program. We have managed over 1,800 global clinical research, strategic product development, regulatory, and GxP/CMC/QA projects in therapeutic areas such as cardiovascular & metabolic diseases, central nervous system, dermatology, gastroenterology, immunology, infectious diseases, nephrology, oncology, respiratory, rheumatology, and vaccines (and other cell and tissue based therapies). Clinipace Worldwide has its global headquarters in Research Triangle Park, NC with additional domestic operations in Irvine, CA, Overland Park, KS, and Boulder, CO; European operations in Zurich, Switzerland, Munich, Germany, and London, United Kingdom; Asian operations in Taipei, Taiwan, China offices in Beijing, Shanghai, Guangzhou, Seoul, South Korea, Hong Kong, Hanoi, Vietnam, Singapore, Kuala Lumpur, Malaysia; South American operations based in Sao Paulo, Brazil, Buenos Aires, Argentina, and Lima, Peru; Middle Eastern operations in Tel-Aviv, Israel and Indian operations in Trivandrum and New Delhi, India. For more information, visit our website at www.clinipace.com.