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BAYLX,INC. Announces US FDA Clearance of IND Application for Its Umbilical Cord Tissue Mesenchymal Stem Cells Product to Initiate Clinical Trial in Rheumatoid Arthritis

June 5, 2020 Off By BusinessWire

IRVINE, Calif.–(BUSINESS WIRE)–Baylx, Inc. (Baylx), a clinical-stage biopharmaceutical company dedicated to developing novel stem cell therapeutics and products to address unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has cleared Baylx’s Investigational New Drug (IND) application for BX-U001, a fresh, non-frozen human umbilical cord tissue mesenchymal stem cells (hUC-MSC) product in patients with Rheumatoid Arthritis (RA).

“We are pleased to have received clearance for the company’s first IND in the United States, and are excited to initiate the trial later this year,” said Dr. Wenbin Liao, Chief Executive Officer of Baylx, Inc. “We look forward to working with investigators as we advance Baylx’s BX-U001 into the clinic for the treatment of Rheumatoid Arthritis.”

Prior to the clearance of this IND in the US, Baylx’s strategic partner Beijing Beilai Biosciences Co. Ltd. (Beijing), a leading stem cell biotechnology company in China, have received the IND approval for clinical testing of the same stem cell product in RA from the National Medical Products Administration (NMPA), a China agency equivalent to the US FDA. This was also the first IND approval in China on stem cells for the treatment of RA or autoimmune disease.

“Our stem cell product candidates distinguish from others in that, the stem cells are harvested shortly before the administration to the recipient, in order to keep the cells fresh, and maintain the optimal viability and biological activities of the cells without the supplement of any cryoprotectant (e.g. DMSO). This is in line to our strong belief that the fitness of the cells at the time of administration is an important factor for their therapeutic effects,” said Dr. Liao. “Although this is challenging to us for the manufacturing process and testing, we have been able to figure it out through our decade long research and development and numerous dialogues with FDA and NMPA.”

It has been known that MSC have great potential for the treatment of many inflammatory and other diseases. Baylx is also developing the hUC-MSC product for other indications including inflammatory bowel disease (IBD), multiple sclerosis, liver cirrhosis, stroke etc.

“Current interventions do not prevent the progression of injury in RA patients. We believe that BX-U001 has the potential to inhibit the inflammation, diminish or prevent the degenerative process on joints so that patients not only have alleviated symptoms, but also can avoid disabilities that commonly result from the joint deterioration at the late stage of the disease,” said Dr. Liao. “We are hopeful that BX-U001 can be a revolutionary therapy for physicians to offer their RA patients, and patients with other disorders in the future.”

For more information about Baylx, please visit www.Baylxinc.com.