Study Evaluating Standardized, Novel, Enriched, Allogeneic Serum Drop for Ocular Graft-vs.-Host Disease
ATLANTA, GA – Feb. 20, 2020 – Cambium Medical Technologies (“Cambium”), a clinical stage company developing novel processed platelets for various therapeutic applications, announced the final patient was enrolled in Dec. 2019 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 (oGvHD). The study enrolled a total of 66 patients at nine U.S. eye centers. A placebo and two study biologic cohorts were involved. Allowing time at study end for placebo patients to “roll over” into a repeat study to receive study biologic, final outcomes are expected in 2Q 2020.
“Cambium remains on track for Elate Ocular® to be the first standardized, cGMP processed, allogeneic, enriched platelet-rich-plasma lysate serum drop approved for any dry eye indication,” said Terry Walts, President & CEO of Cambium. “We selected oGvHD because of its need, because there is no approved therapeutic for oGvHD to date, and to intentionally assess Elate Ocular® among one of the severest of patient populations as a statement of the biologic’s potential. We believe a complex, multi-component therapeutic like Elate Ocular® may be required to better address the complex, multifactorial nature of dry eye.”
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 biologic eye drop for dry eye syndrome (keratoconjunctivis sicca or KCS). Elate Ocular® utilizes Aurarix®, Cambium’s novel processed enriched platelet-rich-plasma (PRP) lysate. Cambium’s Aurarix® contains over 30 key nutritive/regenerative components documented important to corneal health. Most of these same components are also present in healthy tear film. Cambium’s Aurarix® technology is currently sold worldwide as UltraGRO™-Advanced and UltraGRO™ -PURE, processed for use 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, Taipei, Taiwan.
For more information about Cambium, contact David Doolittle at firstname.lastname@example.org, or visit www.cambiumbio.com. To learn more about AventaCell and their line of UltraGRO™ stem cell growth supplements, contact William D. Milligan at email@example.com or visit www.atcbiomed.com.
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