Treatment with OpRegen® Continues to be Well Tolerated with Signs
of Structural Improvement in the Retina and Decrease of Drusen Density
Observed in Some Patients
ALAMEDA, Calif.--(BUSINESS WIRE)--Oct. 29, 2018--
Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology
company focused on degenerative diseases, today announced positive
additional results from an ongoing Phase I/IIa study of its lead product
candidate, OpRegen®, a retinal pigment epithelium cell
therapy transplant currently in development for the treatment of dry
form age-related macular degeneration (dry-AMD). The data were presented
at the 2018
American Academy of Ophthalmology Annual Meeting (AAO 2018)
on October 28th, 2018, in Chicago, Illinois, USA. Data
from the study demonstrate that treatment with OpRegen® continues to be
well tolerated and shows signs of structural improvement in the retina
and decreases in drusen density in some patients. Notably, early data
are encouraging from Cohort 4 patients with earlier-stage dry-AMD. The
early data indicate structural improvement within the retina, evidence
of the continued presence of the transplanted OpRegen® cells,
and improvements in visual acuity.
Eyal Banin, MD, PhD, Professor of Ophthalmology, Director, Center for
Retinal and Macular Degenerations, Department of Ophthalmology at
Hadassah-Hebrew University Medical Center, the presenting author and one
of the investigators participating in the study, presented data from the
Phase I/IIa study.
Data presented at AAO showed that both the surgical procedure and the
OpRegen® cells were generally well tolerated and there have
been no unexpected adverse events or treatment-related systemic serious
adverse events reported in the first fifteen patients enrolled into this
Phase I/IIa safety and tolerability study. The most common and expected
ocular adverse events were the formation of mild epiretinal membranes.
One instance of retinal detachment occurred in a patient who was legally
blind prior to treatment. The event was not able to be assigned as
related to treatment, procedure, or to the combination and the patient
continued in the study following successful surgical repair. Imaging of
several Cohort 1-3 patients, and of particular interest, those from the
Cohort 4 (n=3), demonstrated structural improvement within the retina
and evidence of the continued presence of the transplanted OpRegen®
cells. Within the area of the OpRegen® cell transplant, signs
of a reduction and change in drusen material as well as improvements or
possible restorations of the ellipsoid zone and retinal pigment
epithelium (RPE) layers have persisted. The photoreceptor layer and
ellipsoid zone assumed a more regular structural appearance in areas of
the transition zone where OpRegen® was administered,
suggesting potential structural restoration of the retina in areas
receiving the RPE cells. This is of particular importance because in
dry-AMD the structure of the retina can be impacted by the formation of
excess drusen and ultimately death of RPE cells and photoreceptors,
which are critical to sight. Other changes observed following OpRegen®
treatment, persisted through the last time point examined (>3 years in
some patients), included subretinal pigmentation and hyper-reflective
areas seen on OCT.
The Best Corrected Visual Acuity (BCVA) and areas of geographic atrophy
(GA) for patients have remained relatively stable thus far in both the
treated and fellow eye. Notably, the visual acuity of the first 3 Cohort
4 patients have all seen improvements from baseline levels, which will
need to be followed for longer periods of time. OpRegen®,
which is currently enrolling Cohort 4 patients with less severe disease
(i.e. smaller areas of GA and better vision acuity of between 20/64 and
20/250), appears well tolerated with preliminary evidence of improved
structural changes and potential improvement in visual acuity following
treatment in some patients.
To view the actual presentation, please refer to the events and
presentation section of the BioTime website at www.biotime.com.
OpRegen® is a retinal pigment epithelium transplant therapy
in Phase I/IIa development for the treatment of dry age-related macular
degeneration, the leading cause of adult blindness in the developed
world. OpRegen® consists of a suspension of retinal pigment
epithelial (RPE) cells delivered subretinally as an intraocular
injection. RPE cells are essential components of the back lining of the
retina and function to help nourish the retina including photoreceptors.
OpRegen® has been granted Fast Track designation
from the U.S. Food and Drug Administration. OpRegen®
is a registered trademark of Cell Cure Neurosciences Ltd., a
majority-owned subsidiary of BioTime, Inc.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company focused on the
development and commercialization of novel therapies for the treatment
of degenerative diseases. BioTime’s pipeline is based on two platform
technologies which encompass cell replacement and cell/drug delivery.
BioTime’s lead cell replacement product candidate is OpRegen®,
a retinal pigment epithelium transplant therapy in Phase 2 development
for the treatment of dry age-related macular degeneration, the leading
cause of blindness in the developed world. BioTime’s lead cell delivery
clinical program is Renevia®, an investigational medical
device being developed as an alternative for whole adipose tissue
transfer procedures. BioTime also has significant equity holdings in two
publicly traded companies, Asterias Biotherapeutics, Inc. (NYSE
American: AST) and OncoCyte Corporation (NYSE American: OCX), and a
private company, AgeX Therapeutics, Inc.
BioTime common stock is traded on the NYSE American and TASE under the
symbol BTX. For more information, please visit www.biotime.com or
connect with the company on Twitter,
To receive ongoing BioTime corporate communications, please click on the
following link to join the Company’s email alert list: http://news.biotime.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181029005118/en/
Source: BioTime, Inc.
BioTime Inc. IR
Ioana C. Hone, 510-871-4188
Gitanjali Jain Ogawa, 646-378-2949