Press Releases
Lineage Cell Therapeutics Completes Patient Enrollment in Phase 1/2a Clinical Study of OpRegen® Cell Therapy for the Treatment of Dry Age-related Macular Degeneration
-
OpRegen Data Update to be Featured in Presentation by Principal Investigator
Christopher D. Riemann , M.D., at 2020 AAO Annual Meeting onNovember 15, 2020 -
Therapeutic Expert Call to Discuss Results Scheduled for
November 17, 2020
“Completion of patient enrollment in our OpRegen study is a significant achievement for our team and reflects the focused commitment we have made to advancing our three cell therapy product candidates. We believe the potential for transplanted cells to safely and durably treat serious diseases and conditions, particularly where traditional molecular approaches have failed, will usher in a new treatment paradigm for modern medicine. Demonstrating this potential in clinical trials is a vital step in that process and we are thankful to have reached this important milestone,” stated
About OpRegen
OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled patients with vision as high as 20/64. Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Additionally, for the patients in Cohort 4 that receive subretinal delivery of OpRegen utilizing the Gyroscope Orbit Subretinal Delivery System (Gyroscope Orbit SDS), objectives will include the evaluation of the safety of delivery of OpRegen using the Gyroscope Orbit SDS.
Recently, Lineage reported the first known finding of retinal tissue regeneration in a patient receiving OpRegen for the treatment of atrophic dry AMD. This unprecedented finding supports the view that dry AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable in atrophic end-stage disease patients. These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging. The Company also has observed evidence of benefit in other patients, including increases in Best Corrected Visual Acuity (BCVA), reduction in the growth of GA, and increases in reading speed.
OpRegen is a registered trademark of
About Dry AMD
Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of
About
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential for cell therapy generally and the expected addressable market for OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the
View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005229/en/
(ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
(Gogawa@troutgroup.com)
(646) 378-2949
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242
Source: