APstem Therapeutics, Inc., a private biopharmaceutical company developing breakthrough stem cell therapies, today announced the completion of an INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) meeting with the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT)
Fremont, CA , Oct. 28, 2020 (GLOBE NEWSWIRE) -- APstem Therapeutics, Inc., a private biopharmaceutical company developing breakthrough stem cell therapies, today announced the completion of an INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) meeting with the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT). The meeting, which included CBER OTAT staff together with the APstem team, focused on the development plan for AP-Skin-01, a novel “off-the-shelf” allogeneic stem cell product derived from adult pluripotent stem cells (APSCs™) for the initial treatment of diabetic ulcers.
Previous efforts to treat diabetic ulcers have been hampered by persistent inflammation, ischemia and delayed re-epithelialization, which together have posed an insurmountable challenge for drug developers. APstem’s proprietary stem cell technologies and unique attributes of APSCs™ may circumvent these obstacles. Preclinical results generated to date by APstem support the potential of AP-Skin-01 to treat difficult-to-heal diabetic ulcers by accelerating healing. AP-Skin-01 is designed to provide full skin structural reconstruction with less scar formation, promote angiogenesis and reduce inflammation during the repair process.
“The INTERACT meeting we conducted with the FDA is an important first step in our development of AP-Skin-01. We considered the meeting to be very successful, with productive feedback from the FDA reviewers and strong alignment of APstem’s development approach for AP-Skin-01,” said Dr. Min Hu, CEO and president of APstem Therapeutics. “I would like to thank the reviewers from FDA CBER OTAT for their time and helpful guidance. We look forward to continuing our planned pre-clinical work into 2021.”
Dr. Jane Lebkowski, APstem’s scientific advisor and an expert in the development of cell and gene therapies, added: “The field of chronic diabetic wounds remains a critical unmet medical need in the expanding diabetic population worldwide. This new therapy has high potential to accelerate full skin regeneration. Therefore, we are grateful for FDA’s positive feedback to accelerate the development of this product that could treat millions of patients.”
INTERACT is the first available FDA interaction and is a key step in the pathway towards an Investigational New Drug (IND) application, the first regulatory step before experimental therapies may be tested in human clinical studies.
About APstem Therapeutics, Inc.
APstem Therapeutics is a biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing novel stem cell therapies. APstem’s breakthrough stem cell therapy platform using our unique APSCs™ can be applied to multiple indications, including skin (diabetic ulcers), liver, lungs, bone/cartilage, heart, neuron and other tissues. For more information, please visit www.apstemtx.com.
Bowen Liu bowenliu@apstemtx.com (510) 573-0910
