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ANTICIPATED 2018 MILESTONES
AST-OPC1 – Spinal Cord Injury
- The Company expects to report 6-month data from Cohort 3 (AIS-A 20 million-cell cohort) and Cohort 4 (AIS-B 10 million-cell cohort) in
February 2018, and the 12-month data from Cohorts 3 and 4 in August 2018.
- The Company anticipates reporting the six-month top-line readout for the entire study in
June 2018and 12-month top-line readout for the entire study in December 2018.
- The Company intends to continue discussions with the
FDAto achieve clearance on the design of the next study for AST-OPC1.
AST-VAC2 – Allogeneic Cancer Immunotherapy
- The Company anticipates the first patient treated to occur in 2018 and the study will enroll up to 24 patients into one of two cohorts, depending on the stage of each patient’s non-small cell lung cancer.
- Assuming the first patient treated occurs in the first half of 2018, the Company will report the initial safety and immunogenicity readouts in the second half of 2018.
"Asterias achieved significant operational, clinical and regulatory achievements in 2017, highlighted by the 12-month efficacy and safety results from Cohort 2 of our SCiStar Phase 1/2a clinical trial,” said
- Completed the enrollment of the SCiStar study with a total of 25 subjects enrolled in the study.
- Published 12-month data from the study’s Cohort 2 (AIS-A 10 million-cell cohort), which included six subjects. The 12-month data showed that all subjects maintained or improved upon the gains observed at 6 months. By 12 months, 67% (4/6) of Cohort 2 subjects recovered 2 or more motor levels on at least one side, exceeding the company’s 12-month target of 45-50% of subjects achieving this level of improvement.
- Reported continued positive safety profile for AST-OPC1 based on trial results to date.
Obtained U.S. Food and Drug Administration( FDA) designation as a Regenerative Medicine Advanced Therapy (RMAT) under the 21st Century Cures Act. The RMAT designation is intended to facilitate expedited development, review and approval for important new regenerative medicine therapies for which preliminary clinical evidence indicates the potential to address a serious or life-threatening disease or condition.
August 2017, the company published new efficacy and safety data from preclinical studies of AST-OPC1 in the peer-reviewed journal “Stem Cells Translational Medicine.” The preclinical studies described in this paper were among those submitted in Asterias’ 2014 Investigational New Drug Amendment in support of the SCiStar trial.
- Received regulatory clearance in the
United Kingdomto initiate the clinical trial of Asterias’ cancer immunotherapy product AST-VAC2 in subjects with early and late stage non-small cell lung cancer (NSCLC). This First-In-Human (FIH) trial, which is being sponsored and managed by Cancer Research UK, will examine the safety, tolerability, immunogenicity and activity of AST-VAC2 in subjects with NSCLC.
- Published positive AST-VAC1 Phase 2 clinical data in Acute Myeloid Leukemia in 'Cancer,' a leading peer-reviewed journal of the
American Cancer Society.
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