ATLANTA, GA – June 15, 2018 – Cambium Medical Technologies (“Cambium”), a clinical stage company, announced today first patient enrollment for its Elate Ocular® topical fibrinogen-depleted human platelet lysate biologic in a randomized, multicenter, double-masked placebo-controlled parallel Phase I/II study. The study is designed to determine safety and exploratory efficacy in patients with dry eye secondary to graft-versus-host disease. The core study involves a minimum of 60 patients at up to five U.S. eye centers. Including two sub-studies, a maximum of 108 patients may be enrolled in the overall study.
“To our knowledge, our study is the first to evaluate a standardized, cGMP processed, allogeneic (donor sourced) versus autologous (patient sourced), enriched platelet-rich-plasma lysate serum drop in a U.S. IND sanctioned dry eye clinical trial,” said Terence Walts, President & CEO of Cambium. “The industry already recognizes autologous and PRP serum as generally proven therapies to treat the symptoms of not only dry eye but numerous additional corneal diseases and conditions. To date, however, their use has been largely relegated to end stage, failed meds status for inherent reasons unrelated to efficacy. Cambium believes, following approvals–its Elate Ocular® product has potential as a main stage, first line therapy for many corneal diseases and conditions including GvHD dry eye,” said Walts.
About Cambium Medical Technologies LLC:
Founded in 2013 by four distinguished physician/scientists at Emory University, Atlanta, Georgia (USA)— Cambium is focused on the development of regenerative therapies through the use of novel processed human platelets. Cambium’s Mission: To improve patients’ quality of life—from within. The Company’s first FDA-approved therapy is targeted to be Elate Ocular®, a topical eye drop for dry eye syndrome (keratoconjunctivis sicca or KCS). Elate Ocular® utilizes Aurarix®, Cambium’s novel processed enriched platelets depleted of fibrinogen, the clotting agent in platelets. Cambium’s Aurarix® technology is currently sold worldwide as UltraGRO™-Advanced and UltraGRO™ -PURE in the stem cell growth supplement market by Cambium’s strategic partner AventaCell Biomedical Corp., Ltd, a subsidiary of Zheng Yang Biomedical Technology Co., Ltd—both headquartered in Taipei, Taiwan with manufacturing facilities in Atlanta, GA.
For more information about Cambium, contact David Doolittle at email@example.com, or go to www.cambiumbio.com. To learn more about AventaCell and their line of UltraGRO™ stem cell growth supplements, contact William D. Milligan at firstname.lastname@example.org or visit www.atcbiomed.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, and within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Act”) and are intended to be covered by the safe harbors created thereby. These forward-looking statements include, but are not limited to, statements regarding the expected benefits of the Company’s technologies, investment in product development, possible future financings or other activities and/or statements preceded by, followed by or that include the words “believes,” “could,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “projects,” “seeks,” “potential,” “targets” or similar expressions. Investors are cautioned that all forwardlooking statements involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements for any reason. All forward-looking statements speak only as of the date of this press release and the Company undertakes no obligation to update such forward-looking statements.