Akan Biosciences Announces FDA Acceptance of IND Application for StroMel™; in Osteoarthritis of Knee
GERMANTOWN, Md., Feb. 16, 2021 /PRNewswire/ — Akan Biosciences, LLC (Akan), a Maryland based, clinical-stage biotech company innovating cellular technology and proprietary manufacturing methods to produce stem cell-based therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug.
StroMel™ is a proprietary adipose-derived Stromal Vascular Fraction (SVF) product. StroMel™ will be frozen and stored allowing multiple administrations with each lot. Although the current IND is for autologous administration, Akan is planning to explore allogeneic applications as well.
StroMel™ would be a relatively unobtrusive therapy (intra-articular injections) for an indication described by the Arthritis Foundation as “a chronic disease … with no cure.” According to ABC News, medical care for osteoarthritis patients in the United States costs $185.5 billion a year.
The President of Akan, Dr. Mukesh Kumar, is a veteran of FDA regulated products having taken hundreds of products through FDA. Dr. Kumar commented that “StroMel™ is designed as an off-the-shelf SVF product direly needed by patients in the US. Our proprietary technology will eventually lead to a paradigm shift in the development and manufacturing of affordable cellular therapies.” The clinical trial is scheduled to initiate in March 2021.
ABOUT THE COMPANY: Akan Biosciences, LLC (Akan), a Maryland-based, clinical-stage biotech company innovating cellular technology and proprietary manufacturing methods to produce stem cell-based therapeutics. Akan is focused on advancing next-generation therapies for degenerative diseases and injury. Akan is part of the Maryland Tech Council and Biohealth Innovation, Inc..
CONTACT: Paul Burton, 219-243-5889, firstname.lastname@example.org
SOURCE Akan Biosciences
- About the Author
- Latest Posts
BioBuzz is a community led, experience focused, biotech and life sciences media and events company. BioBuzz highlights regional breaking news, industry professionals, jobs, events, and resources for business and career growth. Their weekly newsletter is subscribed to by thousands in the BioHealth Capital Region and Greater Philadelphia as the go-to for industry updates.