Press Releases
Lineage Cell Therapeutics Reports Regeneration of Retinal Tissue in Patient Treated With OpRegen RPE Cells for Dry AMD With Geographic Atrophy
- First Known Clinical Report of Retinal Tissue Regeneration Following RPE Transplant
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Call Scheduled for
June 8, 2020 with Therapeutic Area Experts to Discuss Findings
The loss of retina pigmented epithelium (RPE) cells over time creates progressively larger areas of atrophy in the adult retina, leading to impaired vision or complete blindness, a condition known as dry AMD. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which has led to a presumption that progression of geographic atrophy (GA) may someday be slowed or halted but cannot be reversed. The unique finding from the ongoing OpRegen clinical trial supports a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. We report evidence from a patient with atrophic end-stage disease who received a transplant of allogeneic RPE cells and showed substantial restoration of retinal tissue within the area of GA. Specifically, the area of GA assessed at 9 months was approximately 25% smaller than the patient’s pre-treatment baseline and it grew approximately 50% slower than its historical rate during the subsequent six months. These unprecedented 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.
“Any therapy which can save photoreceptors and RPE cells in areas of geographic atrophy would be very important to these patients. It is hypothesized that cells in the transition areas at the boundary of the GA are dysfunctional and dying, but not completely lost,” stated Jordi Monés, M.D., Ph.D. “The addition of new RPE cells may restore the microenvironment in surrounding tissue and contribute to the possibility of restoring function to existing cells that otherwise, if left untreated, would inevitably progress to further expansion of the atrophic region.”
“Our team has independently reviewed these data as part of our ongoing collaborative efforts with Lineage and I think it is evidence of a partially restorative effect in this patient. We have observed apparent RPE regeneration on detailed review of imaging and will look forward to reviewing additional patient data from the OpRegen clinical trial to determine the reproducibility and durability of this unexpected finding,” added
“We have evidence at multiple time points which demonstrate a thickening of the outer nuclear layer and restoration of retinal structure. These changes penetrated into the area of GA where those cells are thought to be destroyed and the improvement has persisted over time. The patient also exhibited a consistent seven to ten letter improvement in their visual acuity for the past year. These findings are extremely encouraging and it is important that we investigate why this particular individual experienced a restoration of tissue in the boundary areas of their GA,” stated
“To our knowledge, this is the first time any experimental treatment for dry AMD has demonstrated a reduction, rather than expansion, of an area of atrophy over a clinically meaningful time period. If this finding is confirmed in additional patients, I believe it will create a new paradigm for how we and others approach the treatment of dry AMD and will help advance the incredibly promising area of cell therapy in which we enjoy a leadership position, the directed differentiation and transplant of specific cell types to treat severe diseases and conditions,” stated
OpRegen is currently being evaluated in a Phase 1/2a clinical study in patients with dry AMD with GA. Seventeen of twenty-one expected patients have been enrolled to date. The Company has observed evidence of benefit in some patients, including increases in Best Corrected Visual Acuity (BCVA), reduction in the growth of geographic atrophy and increases in reading speed. The addition of signs of retinal tissue regeneration provides further support that OpRegen may be a viable treatment for the millions of individuals living with dry AMD, one of the leading causes of vision loss in the world.
OpRegen was originally developed by Drs.
KOL Call Information and Webcast
Lineage will host a conference call with Drs. Monés and Ip, on
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 benefits of OpRegen and Lineage’s objectives. 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
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Solebury Trout IR
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