Study for Graft vs. Host Disease Dry Eye to Begin Late 2017/Early 2018
ATLANTA, GA – September 29, 2017 – Cambium Medical Technologies (“Cambium”), a clinical stage company, announced today that the U.S. Food & Drug Administration (“FDA”) notified Cambium on September 22 it has completed review of Cambium’s Investigational New Drug Application (IND) submitted late August and that the Study titled A Randomized Multicenter Double-Masked PlaceboControlled Parallel Phase I/II Study to Determine the Safety and Exploratory Efficacy of Topical Fibrinogen-Depleted Human Platelet Lysate in Patients with Dry Eye Secondary to Graft vs. Host Disease–can begin. The Company’s Study will begin at up to five U.S. clinical sites in late 2017 or early 2018, with the support of the Company’s strategic partner AventaCell BioMedical Technology Corporation, Ltd (“AventaCell”).
“We are delighted this Study is about to start,” said Terence Walts, President & CEO of Cambium. “Dry eye is the #1 disease in eye care. There is no cure. We continue to believe the potential for a standardized, commercialized, allogeneic (vs. autologous) and eventually FDA approved growth-factor enriched biologic for dry eye—remains significant. Dry eye is a multifactorial disease of the corneal surface with no single etiology (*). It is possible therapies with not one a.i. but numerous nutritive/regenerative components targeting not one but several dry eye etiologies—will eventually help clinicians better address the often de-habilitating symptoms of dry eye and among a broader patient population.” said Walts.
(*) Dry eye disease was re-defined in the June 2017 Tear Film Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS II) as “a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.”
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 help clinicians improve patients’ quality of life— from within. The Company’s first FDA approved therapy remains on track to be Elate Ocular™ biologic eye drop for dry eye syndrome (keratoconjunctivis sicca or KCS). Elate Ocular™ utilizes Aurarix™, Cambium’s novel processed platelets. Cambium’s patented human platelet lysate technology also plays a key role in UltraGRO™ Advanced and UltraGRO™ PURE, stem cell growth supplements sold worldwide since 2014 by Cambium’s strategic partner AventaCell BioMedical Corporation, a subsidiary of Zheng Yang Biomedical Technology Ltd, Taipei, Taiwan.
For more information about Cambium, contact David Doolittle at +1 404-337-5990 or e-mail David at firstname.lastname@example.org, or go to www.cambiumbio.comFor more information about AventaCell and their line of UltraGRO™ stem cell growth supplements, contact William D. Milligan at +1 604-220- 8428 or email Bill at email@example.com, or go to 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.