Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology company dedicated to developing cellular immunotherapies to treat cancer and cell-based therapeutics to treat neurological conditions associated with demyelination, today announced that the Safety Review Committee (SRC) for the first clinical trial of AST-VAC2, held a scheduled meeting to review the safety and tolerability data generated in the first patient enrolled in the study and recommended continuation of the study and moving to parallel enrollment of the second and third patients in the advanced cancer cohort (Arm A), as planned per the studys protocol. This initial clinical trial, which is being sponsored, managed and funded by Cancer Research UK under a collaboration between Asterias and Cancer Research UK, will examine the safety and tolerability of AST-VAC2 in non-small cell lung cancer (NSCLC) as the studys primary endpoints. Secondary and tertiary endpoints of the study include evaluations of the immunogenicity of AST-VAC2 in NSCLC.
"Based on its review of all available study data after five doses in the first patient, the Safety Review Committees recommendation to continue the trial without modification reaffirms our belief that AST-VAC2 is safe and well-tolerated," commented Dr Edward Wirth, Chief Medical Officer of Asterias Biotherapeutics. The committee concluded that the trial can proceed as planned per protocol - an important step as we continue the clinical development of AST-VAC2."
The Safety Review Committee reviewed all of the accumulated safety data generated to date for the first patient in Arm A (advanced disease), who by the time of the review had received five, weekly doses of 10 million AST-VAC2 cells.
As specified in the AST-VAC2 clinical trial protocol, the Safety Review Committee meets on a dosing-driven basis to review safety and tolerability data from the ongoing trial. The committee is comprised of a group of medical and scientific experts and is responsible for reviewing and evaluating patient safety data in order to safeguard the wellbeing of trial participants.
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