Belief BioMed Group, a biomedical company based in Shanghai, successfully dosed its foremost patient in its hemophilia B gene therapy clinical trial on December 30th, 2021. BBM-H901, an adeno-associated virus vector expressing the factor IX gene, was infused intravenously into the first patient of the study.
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In a press release, Dr. Xiao Xiao, the co-founder, Chief Science Officer, and Chairman of Belief BioMed said, "As the company's first major product made in our own state-of-art cGMP facility, we are pleased that Belief BioMed has reached an important milestone in the clinical research after dosing the first subject in the pivotal clinical study. BBM-H901 has previously demonstrated good safety and long-term efficacy in an investigator initiated clinical trial (IIT)."
The previous study Dr. Xiao Xiao mentioned had an annualized bleeding rate that was greatly reduced, as well as the level of coagulation factors significantly increased. These qualities pertained to all patients after the intravenous infusion of the treatment. According to the doctor, "No serious adverse event (SAE) was reported."
"We are thankful to our clinical collaborators, our patient community and our entire team who made this happen," Dr. Xiao said. We certainly wish Dr. Xiao and the patient(s) the best and will be following along.
You can read the press release here: https://www.prnewswire.com/news-releases/belief-biomed-completed-dosing-of-the-first-subject-in-the-registrational-gene-therapy-clinical-trial-for-hemophilia-b-301452471.html
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