NEW YORK, Dec. 18, 2015 (GLOBE NEWSWIRE) -- Saronic Biotechnology, Inc. announces the filing of an Investigational New Drug application with the United States Food and Drug Administration (FDA) for the launch of a randomized phase I/II clinical trial of its lead immunotherapeutic, SBI1997.
The proposed study, named the AUDIT Trial (Adjuvant Use Dendritic Cell ImmunoTherapy), aims to assess the efficacy of SBI1997 in extending recurrence-free and overall survival among patients with hepatocellular carcinoma (HCC) in the adjuvant setting. HCC is the most prevalent form of liver cancer, for which there are currently no chemotherapy regimens or therapeutics which are proven to effectively prevent cancer recurrence after surgical resection. The AUDIT trial is on track to launch in Q1-Q2 2016 at a single institution in the metropolitan New York area.
About Saronic Biotechnology, Inc.:
Saronic Biotechnology, Inc. (SBI) is a preclinical and clinical-stage drug development company established to bring novel immunotherapeutics to clinical use for patients with liver cancer. Founded in New York City by a dedicated team of physicians and scientists with broad expertise in oncology and immunology, Saronic Biotechnology developed its lead product, SBI1997, an immunotherapy for hepatocellular carcinoma (HCC). In addition to its innovative clinical program, Saronic Biotechnology has also created a streamlined research pipeline to develop additional therapeutics for launch into phase I clinical trials.
About SBI1997 Therapy:
SBI1997 is an autologous dendritic cell immunotherapy for hepatocellular carcinoma developed by Saronic Biotechnology’s team of cancer scientists and immunologists. A personalized therapeutic, SBI1997 primes each patient’s immune system to recognize tumor-specific antigens and destroy malignant cells that may emerge after surgery, thereby inhibiting cancer recurrence. In a preclinical model of hepatocellular carcinoma, SBI1997 demonstrated dramatic efficacy in stimulating tumor regression and extending overall survival.
Forward-looking Statements:
With the exception of cited historical data, this press release includes predictive statements which represent Saronic Biotechnology’s current expectations of future events. Statements describing objectives, expectations, and valuations involve risks and uncertainties which may cause results to differ from statements included herein. Risks and uncertainties include but are not limited to: Company’s ability to raise funds necessary to initiate and maintain operations, successful completion of clinical studies, and regulatory approvals by federal and institutional entities for research activities.