Akan Biosciences Announces FDA Acceptance of IND Application for StroMel™ in Osteoarthritis of Knee

Although the current IND is for autologous administration, Akan is planning to explore allogeneic applications as well.

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Provider: 
PR NewswirePR Newswire
Retrieved on: 
Tuesday, February 16, 2021
Information
Tags: 
Medical specialties, Medicine, Akan, Allotransplantation, Health care, Food and Drug Administration
Geotags: 
MARYLAND, US, AKAN, UNITED STATES
Organisation: 
AKAN BIOSCIENCES
Website: 
http://www.akanbio.com
Summary
Key Points: 
  • Although the current IND is for autologous administration, Akan is planning to explore allogeneic applications as well.
  • The President of Akan, Dr. Mukesh Kumar, is a veteran of FDA regulated products having taken hundreds of products through FDA.
  • ABOUT THE COMPANY: Akan Biosciences, LLC (Akan), aMaryland based, clinical stage biotech company innovating cellular technology and proprietary manufacturing methods to produce stem cell-based therapeutics.
  • Akan is part of the Maryland Tech Council and Biohealth Innovation, Inc..
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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 Application (IND) for StroMel™, its lead candidate for the treatment of Osteoarthritis of Knee. The active IND enables Akan to start clinical trials.

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, [email protected]

 

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SOURCE Akan Biosciences



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