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- AST-OPC1 Safety Profile Continues To Be Favorable -
The DMC, comprised of an independent group of medical and scientific experts, has reviewed study data at regular intervals, with the primary responsibilities of reviewing and evaluating patient safety and efficacy data for the purpose of ensuring the safety of all patients enrolled in the study, the quality of the data collected, and the continued scientific validity of the study design.
“The DMC's recommendation to continue our SCiStar study without modification reaffirms the committee's previous safety reviews of AST-OPC1, and confirms the safety data to date from the high dose 10 and 20 million cell cohorts in the study,” said Dr.
Asterias has dosed 25 subjects with AST-OPC1 in the SCiStar study and a total of 30 subjects including the five subjects from the previous Phase 1 safety trial. The results-to-date, which include subjects from the Phase 1 safety trial who have been followed for as long as seven years, continue to support the safety of AST-OPC1. In particular, there have been no serious, unexpected, adverse events related to AST-OPC1, the injection procedure, or the drug used for immunosuppression in any of the 30 subjects. Additionally, long-term follow up in the Phase 1 safety trial with annual magnetic resonance imaging scans through five years post-injection of AST-OPC1 has shown no evidence of adverse changes in any of the subjects treated with AST-OPC1.
In
Anticipated 2018 Data Readouts for the SCiStar Study
The company intends to report the following AST-OPC1 data readouts later this year:
- Six-month update for the entire SCiStar study, including Cohort 5 (AIS-B; 20M AST-OPC1 cells), late in the second quarter or early third quarter of 2018.
- 12-month update for Cohort 3 (AIS-A; 20M AST-OPC1 cells) and Cohort 4 (AIS-B; 10M AST-OPC1 cells) in the third quarter of 2018.
- 24-month update for Cohort 2 (AIS-A; 10M AST-OPC1 cells) in the third or fourth quarter of 2018.
- 12-month update for the entire SCiStar study, including Cohort 5, late in the fourth quarter of 2018 or early in the first quarter of 2019.
About AST-OPC1
AST-OPC1, an oligodendrocyte progenitor cell population derived from human embryonic stem cells, has been shown in preclinical testing in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed in demyelination disorders, such as spinal cord injuries, and multiple neurodegenerative diseases, including multiple sclerosis and white matter stroke. These potential reparative functions of AST-OPC1 include the production of neurotrophic factors, the stimulation of vascularization, and the induction of remyelination of denuded axons, all of which are critical for survival and regrowth of—and conduction of nerve impulses through—axons at the injury site.
Each year in
About the SCiStar Trial
The SCiStar trial completed enrollment in
Asterias has received a Strategic Partnerships Award grant from the
Additional information on the Phase 1/2a trial, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com).
About
FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, 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 businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias' filings with the
Contacts:
Investor Relations
(510) 456-3892
InvestorRelations@asteriasbio.com
or
(732) 232-6914
mpolyviou@evcgroup.com