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Additional Data From BioTime’s OpRegen® Clinical Trial in Dry-AMD to be Presented at ARVO 2017

-Data from patients in Cohort 1 and Cohort 2 to be presented-

ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 19, 2017-- BioTime, Inc. (NYSE MKT:BTX), a clinical stage biotechnology company with a focus on pluripotent stem cell technologies, and its subsidiary, Cell Cure Neurosciences, Ltd., today announced that an abstract evaluating OpRegen® in patients with advanced dry Age-Related Macular Degeneration (dry-AMD) based on the ongoing Phase I/IIa clinical trial will be presented at the Association for Research in Vision and Opthalmology (ARVO) meeting taking place from May 7-11, 2017, in Baltimore, Maryland.

The abstract, titled “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”, will be presented by Professor Eyal Banin, M.D., Ph.D., Director of the Center for Retinal and Macular Degenerations at Hadassah Medical Center, Jerusalem, Israel. Professor Banin will be presenting complete data on patients in cohort 1, including follow-up of up to one year, and the most up-to-date data from patients in cohort 2 of the clinical trial. Patients in cohort 1 and cohort 2 received 50,000 and 200,000 OpRegen® cells in suspension, respectively.

As previously announced, upcoming program milestones are expected to include:

  • Expansion of OpRegen® into the initial U.S. clinical sites in the coming weeks,
  • Further data from cohort 2 in the first half of this year,
  • Beginning enrollment of cohort 3 of this trial in the coming months,
  • Completing enrollment of cohort 3 and 4 this year and
  • Reporting data from cohort 3 of the trial this year.

About Dry Age-Related Macular Degeneration (Dry–AMD)

Macular degeneration affects approximately 11 million people in the U.S. It is the leading cause of blindness in people over the age of 60. Approximately 90 percent of these patients suffer from the dry form, for which there are no FDA-approved therapies. In dry-AMD, there is a loss or dysfunction of the layer of retinal pigment epithelial (RPE) cells, generally in the region of the eye called the macula, which is the part of the retina responsible for sharp, central vision that is important for facial recognition, reading and driving. These RPE cells support the light detecting photoreceptor cells that are so critical to vision. When people look at something, the photoreceptors (rods and cones) detect the light and send the information to their brain allowing them to perceive their surroundings. The age-dependent loss of RPE cells leads to degeneration of nearby photoreceptors, which can lead to severe vision loss or even legal blindness. Generally, the damage caused by the “dry” form is not as severe or rapid as that of the “wet” form. However, in the advanced stage of dry macular degeneration, widespread loss of RPE and photoreceptors in the macular area, called geographic atrophy, leads to severe vision impairment. While therapeutics are available to treat the wet form of AMD, there are currently no FDA-approved therapies for dry-AMD.

About OpRegen®

OpRegen® for the treatment of the dry form of age-related macular degeneration (AMD), consists of a suspension of Retinal Pigment Epithelial (RPE) cells that are delivered subretinally during a simple intraocular injection. 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® would 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 the OpRegen® Clinical Trial

The Phase I/IIa open label safety and efficacy clinical trial is designed to evaluate three different dose regimens of OpRegen® in four cohorts. Cohort 1 includes three patients each receiving 50,000 cells, cohort 2 includes three patients each receiving 200,000 cells, upon DSMB approval cohort 3 will include three patients each receiving 500,000 cells, and upon DSMB approval cohort 4 will include six patients each receiving 500,000 cells.

Following transplantation, the patients will be followed for 12 months at specified intervals in order to evaluate the safety and tolerability of the product. Following the initial 12 month period, patients will continue to be monitored at longer intervals.

A secondary objective of the clinical trial will be to examine the ability of transplanted OpRegen® to engraft, survive, and modulate disease progression in the patients. In addition to thorough characterization of visual function, a battery of vision tests will be used to quantify improvements in reducing the progression of the disease.

About BioTime

BioTime, Inc. is a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases. The foundation of BioTime’s core therapeutic technology platform is pluripotent cells. Pluripotent cells are capable of becoming any of the cell types in the human body. Pluripotent cells have potential application in many areas of medicine with large unmet patient needs, including various age-related degenerative diseases and degenerative conditions for which there presently are no cures. Unlike pharmaceuticals that require a molecular target, therapeutic strategies based on the use of pluripotent cells are generally aimed at regenerating or replacing affected cells and tissues, and therefore may have broader applicability than pharmaceutical products.

BioTime common stock is traded on the NYSE MKT and TASE under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.

Forward-Looking Statements

Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime, Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. BioTime, Inc. specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

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Source: BioTime, Inc.

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