On December 4, 2020 Angiocrine Bioscience Inc., a clinical-stage biopharmaceutical company reported that they have been selected by the American Society of Hematology (ASH) (Free ASH Whitepaper) for an oral presentation on the preliminary results of a Phase 1b/2 study of AB-205 to prevent or reduce severe organ toxicities associated with high-dose therapy followed by autologous hematopoietic cell transplantation used with curative intent in patients with aggressive systemic lymphoma (Press release, Angiocrine Bioscience, DEC 4, 2020, View Source [SID1234572187]).
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"Our investigators and Angiocrine are honored to be selected by ASH (Free ASH Whitepaper) to present at its annual meeting this December," commented Paul Finnegan, MD, Angiocrine CEO. "We look forward to Dr. Michael Scordo’s presentation of AB-205’s efficacy and safety results from our Phase 1b/2 study as well as preparing for the upcoming Phase 3 registration study for this indication."
Session Name: 723. Clinical Allogeneic and Autologous Transplantation: Late Complications and Approaches to Disease Recurrence I
Session Date: Saturday, December 5, 2020
Session Time: 7:30 AM – 9:00 AM ET
Presentation Time: 7:45 AM ET
About Severe Regimen-Related Toxicities
High-dose therapy and autologous hematopoietic cell transplantation is considered a standard-of-care method to cure aggressive systemic lymphoma. High dose therapy effectively eradicates cancer cells but also damages healthy tissue, which can lead to severe toxicities. Most affected is the lining of the oral-gastrointestinal (GI) tract. The oral GI tract renews its mucosal lining every 3 to 7 days. Because of the collateral damage from high dose chemotherapy, the oral GI tract loses its ability to renew its lining, leading to inflammation (mucositis) and breakdown, causing nausea, vomiting and diarrhea that are refractory to available medications and require prolonged hospitalization. Severe oral GI toxicities can occur as frequently as 50% and cause profound misery to patients. The rates and severity increase with age and, thus, many older patients are turned away from the curative high dose therapy due to the risks of severe toxicities.
About AB-205
AB-205 represents a new and unique approach to repairing damaged tissue through advanced cell-and-gene therapy. AB-205 consists of allogeneic (off-the shelf) ‘universal’ E-CEL (human engineered cord endothelial) cells. Intravenous AB-205 is given after chemotherapy/radiation (high-dose therapy) conditioning and on the same day as autologous transplant. AB-205’s immediate action repairs damaged tissue and thereby prevents (reduces) the extent of breakdown of tissues, which is the root cause of severe toxicities experienced by patients. Reducing or preventing severe toxicities means better quality of life and shorter stay in the hospital—i.e., savings to the healthcare system. AB-205 was recently granted both the Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). Angiocrine is actively planning to advance AB-205 into a multi-center single registration Phase 3 trial based on the results of the Phase 1b/2 study.