Waltham, MA., July 2, 2014—Histogenics Corporation, a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced the appointment of Kathleen Large, R.N., M.S., to Vice President of Clinical Operations. Ms. Large brings over 20 years of leadership and experience in the pharmaceutical and medical industries, including expertise in the strategy, design and execution of large global clinical programs. Ms. Large will be responsible for management of Histogenics’ clinical programs, including the ongoing Phase 3 trial of NeoCart®, studying the treatment of certain knee cartilage injuries.
“We are extremely pleased to welcome Kathleen to Histogenics. Her demonstrated leadership and experience in clinical development and operations will be crucial in supporting our ongoing Phase 3 study of NeoCart®, which is currently enrolling in the U.S.,” said Nancy Lynch, M.D., Chief Medical Officer of Histogenics. “Kathleen has a proven track record of planning, managing and executing complex clinical programs in a variety of therapeutics indications, and we look forward to her contributions as we build the organization for long-term success.”
Prior to joining Histogenics, Ms. Large most recently served as Director, Early Stage Development and Strategic Site Alliances at Millennium Pharmaceuticals, The Takeda Oncology Company. Ms. Large previously served as Director, Clinical Development Operations at Millennium. Prior to Millennium, Ms. Large served in various strategic and leadership positions at Eli Lilly and Company, Quintiles, INC., and University Hospitals of Cleveland. Ms. Large holds a Master of Science in Nursing from the University of California at San Francisco and a Bachelor of Science in Nursing from Boston College.
“Kathleen will be a valuable addition to our team as we continue to advance our ongoing study of NeoCart® for cartilage repair,“ said Adam Gridley, President and CEO of Histogenics. “Her appointment further bolsters our experienced management team at Histogenics and demonstrates our commitment to our investigators and patients in the continued development of NeoCart®.”
Histogenics is a regenerative medicine company focused on developing and commercializing products in the musculoskeletal segment of the marketplace. Our regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions that can be utilized individually or in concert to treat musculoskeletal-related conditions. Our first investigational product candidate, NeoCart®, leverages our platform to provide an innovative treatment in the orthopedic space, specifically cartilage damage in the knee. For more information on Histogenics, please visit the company website at http://www.histogenics.com.
NeoCart®, our Phase 3 investigational product is an implant produced using a patient’s own cartilage cells. A Phase 1 clinical trial conducted in the United States demonstrated favorable preliminary results, which supported proceeding to a Phase 2 clinical trial. A Phase 2 clinical trial conducted in the United States comparing NeoCart® to the standard-of-care microfracture met its endpoints for safety and for improvement in pain and function. These results support the continued clinical development of NeoCart®. The two-year results of our Phase 2 clinical trial are publicly available (Crawford et al. J Bone Joint Surg Am. 2012;94:979-89). A Phase 3 clinical trial conducted in the United States comparing NeoCart® to the standard-of-care microfracture is currently in progress. Information about the study is available on http://www.NeoCartImplant.com and http://www.clinicaltrials.gov.
For additional inquiries, please email us at InvestorRelations@histogenics.com or call us at 781.547.7900.
Forward Looking Statement
This press release contains “forward looking statements” including statements about Histogenics’ future operating results, product development, potential alliances and intellectual property. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements.