BioTime Presents New OpRegen® Data at American Academy of Ophthalmology Annual Meeting
October 29 2018 - 8:00AM
Business Wire
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
BioTime, 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.
About OpRegen®
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, LinkedIn, Facebook, YouTube, and Google+. To
receive ongoing BioTime corporate communications, please
click on the following link to join the Company’s email alert
list: http://news.biotime.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20181029005118/en/
BioTime Inc. IRIoana C. Hone,
510-871-4188(ir@biotimeinc.com)orSolebury Trout IRGitanjali
Jain Ogawa, 646-378-2949(Gogawa@troutgroup.com)
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