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 +1 404-337-5990 or 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.
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 forward-looking 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.