Post by guruzim on Apr 17, 2018 21:35:40 GMT
investor.biotimeinc.com/phoenix.zhtml?c=83805&p=irol-newsArticle&ID=2342631
Data from BioTime’s OpRegen® and Retinal Restoration Programs to Be Presented at ARVO 2018
OpRegen® is in a Phase I/IIa clinical trial for dry-AMD
Retinal Restoration – Our 3-Dimensional Retinal Tissue Program
ALAMEDA, Calif.--(BUSINESS WIRE)--Apr. 16, 2018-- BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on degenerative diseases, today announced that data from the ongoing OpRegen® clinical trial and Retinal Restoration program will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) meeting taking place from April 29th – May 3rd, 2018, in Honolulu, Hawaii.
The scheduled times (noted in local Hawaii time) and location of the BioTime data presentations at the Hawaii Convention Center are as follows:
OpRegen® Poster Presentation
Title: Phase I/IIa Clinical Trial of Human Embryonic Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen®) Transplantation in Advanced Dry Form Age-Related Macular Degeneration (AMD): Interim Results
Presentation Number – Posterboard Number: 77-A0124
Session Title: AMD and Retinal Therapies Excluding Anti-VEGF
Date/Time: April 29, 2018 from 8:15am – 10:00am
ARVO Minisymposium – The nuts and bolts of novel drug development
Title: Derivation of RPE cells from human embryonic stem cells: The journey from basic research to clinical application
Presentation Number: 2582
Date/Time: May 1, 2018 from 8:56am – 9:14am
Retinal Restoration Paper Presentation
Title: Transplantation of laboratory-grown human retinal tissue in the subretinal space of the cat eye
Presentation Number: 2986
Session Title: Retinal Gene Therapy and Stem Cell Transplantation
Date/Time: May 1, 2018 from 12:15pm – 12:30pm
As a reminder, BioTime’s Retinal Restoration program is based on the ability to generate 3-dimensional human retinal tissue derived from human pluripotent cells. The Company’s 3-dimensional retinal tissue technology may address the unmet need of implementing a retinal restoration strategy to address severe retinal degenerative diseases. In 2017, the Small Business Innovation Research program of the National Institutes of Health awarded BioTime a grant of up to $1.56 million to further develop this innovative, next generation retinal restoration program.
About OpRegen®
OpRegen®, which is being studied for the treatment of the dry form of AMD, consists of a suspension of retinal pigment epithelial (RPE) cells that are delivered subretinally during a simple intraocular injection. RPE cells are essential components of the back lining of the retina, and function to help nourish the retina including photoreceptors. A proprietary process that drives the differentiation of human pluripotent stem cells is used to generate high purity OpRegen® RPE cells. OpRegen® RPE cells are also “xeno-free," meaning that no animal products are used at any point in the derivation and production process. The avoidance of the use of animal products eliminates some potential safety concerns. Preclinical studies in rats have shown that following a single subretinal injection of OpRegen®, the cells can rapidly organize into its natural monolayer structure in the subretinal space and survive throughout the lifetime of the animal. OpRegen® is designed to be an “off-the-shelf” allogeneic (non-patient specific) product. Unlike treatments that require multiple, frequent injections into the eye, it is expected that OpRegen® will be administered in a single procedure. OpRegen® was granted Fast Track designation from the FDA, which allows more frequent interactions with the agency, and eligibility for accelerated approval and priority review. 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 degenerative diseases. Its clinical programs are based on two platform technologies: cell replacement and cell/drug delivery. With its cell replacement platform, BioTime is creating new cells and tissues with its proprietary pluripotent cell technologies. These cells and tissues are developed to replace those that are either rendered dysfunctional or lost due to degenerative diseases. BioTime’s cell/drug delivery programs are based upon its proprietary HyStem® cell and drug delivery matrix technology. HyStem® was designed to provide for the transfer, retention, engraftment and metabolic support of cellular replacement therapies. BioTime’s lead cell delivery clinical program is Renevia®, which consists of HyStem® combined with the patient's own adipose (fat) progenitor cells. Renevia® met its primary endpoint in an EU pivotal clinical trial for the treatment of facial lipoatrophy in HIV patients in 2017. BioTime has submitted Renevia® for CE Mark approval in the EU. There were no device related serious adverse events reported to date. BioTime’s lead cell replacement product candidate is OpRegen®, a retinal pigment epithelium transplant therapy, which is in a Phase I/IIa multicenter clinical trial for the treatment of dry age-related macular degeneration, the leading cause of blindness in developing countries. There were no related serious adverse events reported to date. 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: news.biotime.com.
View source version on businesswire.com: www.businesswire.com/news/home/20180416005393/en/
Source: BioTime, Inc.
BioTime
David Nakasone, 510-871-4188
Dnakasone@biotime.com
Data from BioTime’s OpRegen® and Retinal Restoration Programs to Be Presented at ARVO 2018
OpRegen® is in a Phase I/IIa clinical trial for dry-AMD
Retinal Restoration – Our 3-Dimensional Retinal Tissue Program
ALAMEDA, Calif.--(BUSINESS WIRE)--Apr. 16, 2018-- BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on degenerative diseases, today announced that data from the ongoing OpRegen® clinical trial and Retinal Restoration program will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) meeting taking place from April 29th – May 3rd, 2018, in Honolulu, Hawaii.
The scheduled times (noted in local Hawaii time) and location of the BioTime data presentations at the Hawaii Convention Center are as follows:
OpRegen® Poster Presentation
Title: Phase I/IIa Clinical Trial of Human Embryonic Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen®) Transplantation in Advanced Dry Form Age-Related Macular Degeneration (AMD): Interim Results
Presentation Number – Posterboard Number: 77-A0124
Session Title: AMD and Retinal Therapies Excluding Anti-VEGF
Date/Time: April 29, 2018 from 8:15am – 10:00am
ARVO Minisymposium – The nuts and bolts of novel drug development
Title: Derivation of RPE cells from human embryonic stem cells: The journey from basic research to clinical application
Presentation Number: 2582
Date/Time: May 1, 2018 from 8:56am – 9:14am
Retinal Restoration Paper Presentation
Title: Transplantation of laboratory-grown human retinal tissue in the subretinal space of the cat eye
Presentation Number: 2986
Session Title: Retinal Gene Therapy and Stem Cell Transplantation
Date/Time: May 1, 2018 from 12:15pm – 12:30pm
As a reminder, BioTime’s Retinal Restoration program is based on the ability to generate 3-dimensional human retinal tissue derived from human pluripotent cells. The Company’s 3-dimensional retinal tissue technology may address the unmet need of implementing a retinal restoration strategy to address severe retinal degenerative diseases. In 2017, the Small Business Innovation Research program of the National Institutes of Health awarded BioTime a grant of up to $1.56 million to further develop this innovative, next generation retinal restoration program.
About OpRegen®
OpRegen®, which is being studied for the treatment of the dry form of AMD, consists of a suspension of retinal pigment epithelial (RPE) cells that are delivered subretinally during a simple intraocular injection. RPE cells are essential components of the back lining of the retina, and function to help nourish the retina including photoreceptors. A proprietary process that drives the differentiation of human pluripotent stem cells is used to generate high purity OpRegen® RPE cells. OpRegen® RPE cells are also “xeno-free," meaning that no animal products are used at any point in the derivation and production process. The avoidance of the use of animal products eliminates some potential safety concerns. Preclinical studies in rats have shown that following a single subretinal injection of OpRegen®, the cells can rapidly organize into its natural monolayer structure in the subretinal space and survive throughout the lifetime of the animal. OpRegen® is designed to be an “off-the-shelf” allogeneic (non-patient specific) product. Unlike treatments that require multiple, frequent injections into the eye, it is expected that OpRegen® will be administered in a single procedure. OpRegen® was granted Fast Track designation from the FDA, which allows more frequent interactions with the agency, and eligibility for accelerated approval and priority review. 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 degenerative diseases. Its clinical programs are based on two platform technologies: cell replacement and cell/drug delivery. With its cell replacement platform, BioTime is creating new cells and tissues with its proprietary pluripotent cell technologies. These cells and tissues are developed to replace those that are either rendered dysfunctional or lost due to degenerative diseases. BioTime’s cell/drug delivery programs are based upon its proprietary HyStem® cell and drug delivery matrix technology. HyStem® was designed to provide for the transfer, retention, engraftment and metabolic support of cellular replacement therapies. BioTime’s lead cell delivery clinical program is Renevia®, which consists of HyStem® combined with the patient's own adipose (fat) progenitor cells. Renevia® met its primary endpoint in an EU pivotal clinical trial for the treatment of facial lipoatrophy in HIV patients in 2017. BioTime has submitted Renevia® for CE Mark approval in the EU. There were no device related serious adverse events reported to date. BioTime’s lead cell replacement product candidate is OpRegen®, a retinal pigment epithelium transplant therapy, which is in a Phase I/IIa multicenter clinical trial for the treatment of dry age-related macular degeneration, the leading cause of blindness in developing countries. There were no related serious adverse events reported to date. 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: news.biotime.com.
View source version on businesswire.com: www.businesswire.com/news/home/20180416005393/en/
Source: BioTime, Inc.
BioTime
David Nakasone, 510-871-4188
Dnakasone@biotime.com
