Why the price jumped today

  • Lineage Cell Therapeutics Inc’s (NYSEAMERICAN: LCTX) share price rose 13% during today’s intraday trading. That’s why it happened.

Lineage Cell Therapeutics Inc (NYSEAMERICAN: LCTX) – a clinical-stage biotechnology company that develops allogeneic cell therapies for unmet medical needs – has risen 13% in today’s intraday trading. ‘hui. Investors are responding positively to Lineage Cell Therapeutics today announcing that restoration of retinal tissue has been observed in a fourth patient enrolled in the company’s Phase 1 / 2a clinical study of its flagship product candidate OpRegen.

Restoration of retinal tissue and improvement in visual acuity have now been observed in the four patients with improved vision treated in Cohort 4, where surgeons were able to cover the majority of the area of ​​atrophy with a suspension. OpRegen cells. And the restoration of the outer retinal layer – which has been observed using clinical high-resolution optical coherence tomography (OCT) – has been evidenced by the presence of new areas of retinal pigment epithelium (RPE). monolayer with an overlying ellipsoid zone, an outer limiting membrane and an outer nuclear nucleus. layer, which were not present at the time of the baseline assessment.

These new and additive findings continue to support society’s view that atrophic AMD is not an irreversible degenerative disease and that part of diseased retinal tissue can be recovered. And OpRegen is an allogeneic RPE cell transplant in development for the treatment of age-related macular degeneration (AMD) with geographic atrophy (GA) or dry (atrophic) AMD.

OpRegen Phase 1 / 2a Interim Clinical Trial Results

– Retinal restoration, reported in four patients to date, has persisted for more than 12 months to more than 3 years after treatment and continues to be monitored.

– The restoration was evidenced by the presence of new areas of RPE monolayer with an overlying ellipsoid area, an outer limiting membrane and an outer nuclear layer, which were not present at the time of baseline assessment .

– Reductions, or no progression for at least 1 year, were observed in the total area of ​​the GA in the four patients of cohort 4 with better vision.

– Overall, using the Early Treatment Diabetic Retinopathy Study (EDTRS) assessment of best corrected visual acuity (BCVA), 7/12 (58%) for each of the treated eyes in the cohort 4 were at baseline or better at 15 months or at the last time point, which extends beyond 3 years in some patients. In comparison, at the same time points, 8/12 (67%) were below baseline in untreated eyes of other patients of these same patients.

a.) The 4 patients who underwent retinal restoration reported improvements in their visual acuity, which was maintained for at least 12 months in these four patients.

– Overall study, in patients with previously reported structural retinal improvements, decreased drusen density and a tendency for slower GA progression in treated eyes compared to eyes untreated continue to be present.

– The evidence of a durable OpRegen RPE cell transplant has extended to more than 5 years in the first patients treated, which confirms the potential of OpRegen as a one-time treatment.

Overall, OpRegen has been well tolerated to date and there have been no new and unexpected ocular or systemic adverse events or serious adverse events not previously reported.

KEY QUOTES:

“After reporting three previous cases of retinal restoration in the past two years, we carefully examined the remaining patients in Cohort 4. We devoted significant work to reviewing the images of the remaining patient who presented the majority of the area of ​​atrophy covered by OpRegen suspension at the time of surgical implantation. I am happy to report that at the scheduled postoperative visit at month 12 for this patient, although less important than the 3 previously reported cases due to a smaller area of ​​atrophy at baseline, there is clear evidence of retinal restoration in some areas, and the total area of ​​atrophy as calculated using square root transform, or SQRT, is less than the originally calculated size. The discovery of a fourth case of restoration further strengthens our goal of showing that age-related atrophic macular degeneration may be susceptible to this type of cell therapy. Dry AMD is a progressive disease and the arrest or reversal of an area of ​​atrophy does not occur spontaneously, which we believe makes the durability and reproducibility of these changes unprecedented in the field. With 12 months of follow-up completed, I look forward to these cases going to a peer-reviewed publication. “

– Jordi Monés, MD, Ph.D., Director, Institut de la Màcula and Director, Principal Investigator and Founder, Barcelona Macula Foundation

“We treated 24 patients with OpRegen, 12 of whom were not legally blind at baseline and represent our intended treatment population. Of these 12 patients, four received full coverage of OpRegen cells in the majority of the atrophic zone and experienced arrest or reversal of their atrophic zones at 12 months and continue to be followed. These patients also experienced an increase in their visual acuity in their treated eye. We believe these four patients represent the only examples of an experimental treatment for dry AMD that can reduce an area of ​​atrophy in humans, rather than just slow its growth. Restoration of retinal tissue using cell therapy represents a paradigm shift compared to conventional approaches, which to date have shown only a noticeable slowing of progression. In addition to being well tolerated to date, the durability of the atrophic zone changes and the improvements in visual acuity support the continued and rapid clinical development of OpRegen. Along with our advisors, we are currently preparing for multiple engagements with the FDA to discuss aspects of the OpRegen designation, our manufacturing plans, and the design of a later stage clinical trial that will begin the year. next. We expect the first of these engagements to begin next month and continue into the first quarter of 2022. ”

– Brian M. Culley, CEO of Lineage

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