On March 29, 2022 Angiocrine Bioscience, Inc., a clinical-stage biopharmaceutical company, reported that the first patient has been dosed in its Phase 3 registration study AB-205-301 (E-CELERATE), a multi-center, randomized, double-blind, placebo-controlled study of AB-205 in adults with lymphoma undergoing high-dose chemotherapy (HDT) and autologous hematopoietic cell transplantation (AHCT) (Press release, Angiocrine Bioscience, MAR 29, 2022, View Source [SID1234611148]). AB-205 is an intravenous investigational engineered cell therapy product being developed for multiple indications.
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E-CELERATE has been designed to evaluate the efficacy and safety of AB-205 as a treatment for damaged organ vascular stem cell niches caused by off-target cytotoxicity of HDT and prevent the progression of severe multi-organ complications, which can be life threatening and prolong hospitalization. The US Food and Drug Administration has conferred special regulatory status to AB-205 via the Regenerative Medicine Advanced Therapy and Orphan Drug designations for this indication.
More information about the E-CELERATE trial and participating sites may be found at the National Institute of Health’s ClinicalTrials.gov website – NCT05181540.
"We expect 2022 to be a transformational year at Angiocrine, and we are excited to initiate this pivotal Phase 3 study," said Paul Finnegan, MD, Angiocrine’s CEO. "We look forward to continuing to work with many of the leading cancer centers in the United States as we advance into the final clinical stages of this exciting program."
Series B Financing
Angiocrine Bioscience recently completed a Series B equity financing led by Cobro Ventures along with participation from Angiocrine’s existing stockholders. The newly raised capital will be used to accelerate Angiocrine’s clinical assets and expand its research pipeline. "We are enormously excited about the potential of Angiocrine’s E-CEL platform," said Dennis Klinman, MD, PhD, Chief Scientific Officer at Cobro Ventures. "Angiocrine’s approach is truly innovative and has great potential to regenerate tissues that have been injured or damaged by diseases including degenerative, auto-immune, and ischemic diseases, in addition to high-intensity cancer treatments."
About AB-205
AB-205 is an experimental, genetically engineered cell therapy consisting of allogeneic engineered human endothelial cells (E-CEL cells). AB-205 is being developed for multiple indications and is currently being studied in a single, pivotal Phase 3 registration trial, designed to evaluate the efficacy and safety of AB-205 in the treatment of severe multi-organ complications related to systemic, diffuse injury to the vascular stem cell niches of multiple organs sustained during high-dose chemotherapy.
About Severe Toxicities and Complications during High-Dose Chemotherapy (HDT) and Autologous Hematopoietic Cell Transplant (AHCT)
HDT followed by AHCT is considered a standard-of-care consolidative treatment to cure patients with aggressive systemic lymphoma who have failed 1st-line chemotherapy and respond to chemotherapy induction. Although highly effective in eradicating aggressive cancer cells, HDT also causes collateral damage to healthy tissue, which can lead to severe toxicities and serious, costly complications. Complication rates and severity increase with age and, thus, many older patients are turned away from this potentially curative therapy due to concerns over complication risks.