On Friday 29 August, an independent Data Safety Monitoring Board ‘DSMB’ unanimously agreed that the trial of Alloplex Biotherapeutics Inc.’s SUPLEXA Therapeutic Cells should to continue to full enrollment.
The DSMB – which was convened to evaluate safety and tolerability data – arrived at the decision after observing no safety signals or adverse events (either during or after receiving full course of therapy) in the first cohort of three patients with solid cancer who have completed treatment with SUPLEXA Therapeutic Cells in Australia.
The decision to open enrolment to the wider group of solid tumor patients is in keeping with the Board’s primary responsibility which is to safeguard the interests of study participants (based upon the scheduled treatment and assessments) and to provide recommendations to Alloplex about amending, continuing or stopping the study.
The first three patients were enrolled at Cancer Research SA under the direction of A/Prof Rohit Joshi. “I am very pleased to see this novel therapy tolerated so well by our patients with advanced cancer — it is unprecedented and brings hope. I am really keen to determine the impact on the course of their illness.”, said Dr. Joshi.
Commenting on the announcement, Alloplex Biotherapeutic’s Chief Executive Officer, Dr. Frank Borriello, said “This positive decision by the independent safety board evaluation marks a major early milestone in developing SUPLEXA and we are very grateful to these trail blazing patients who found the courage and confidence to be among the first to try our novel therapy.”
Alloplex will present additional data at the Society for Immunotherapy of Cancer ‘SITC’ 37th Annual Meeting and Conference in Boston MA this November.
Alloplex is a clinical stage company focused on developing SUPLEXA; a potential first-in-class autologous, pan-cancer therapy for the treatment of cancer patients. The privately-held company was established in 2016 by Scientific Founder and CEO, Dr. Frank Borriello, MD, PhD.
SUPLEXA Therapeutic Cells are a novel and highly-differentiated PBMC-derived, autologous cellular therapy intended to treat cancer via a multi-modal anti-tumor mechanism of action. Following a short 2-week ex vivo activation procedure, the PBMCs are differentiated in SUPLEXA cells – which contain NK, NK-T, CD8 and CD4 positive cells as well as gamma delta T cells. They are administered as three weekly IV infusions.
Associate Professor Rohit Joshi is a Medical Oncology Consultant working with GenesisCare (formerly Adelaide Oncology and Haematology), at Calvary Central Districts and St Andrews Hospitals in Adelaide, Australia.
Dr S Bishnoi, A/Prof R Joshi, Dr V Kwatra and Dr M Okera are the Directors at Cancer Research SA (CRSA), which is based at St Andrews Hospital. cancerresearchsa.com.au
References to SUPLEXA, Suplexa, Suplexa therapy and Suplexa therapeutic cells relate to SUPLEXACELLS™ a trademark of Alloplex Biotherapeutics Inc.
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Attn: Lesley White, Alloplex Australia
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