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Volume 396, Issue 6-7


Preclinical development of a C6-ceramide NanoLiposome, a novel sphingolipid therapeutic

Mark Kester
  • Department of Pharmacology, University of Virginia School of Medicine, Charlottesville, VA 22908, USA
  • Keystone Nano, Inc, 1981 Pine Hall Road, State College, PA 16803, USA
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Jocelyn Bassler / Todd E. Fox
  • Department of Pharmacology, University of Virginia School of Medicine, Charlottesville, VA 22908, USA
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Carly J. Carter / Jeff A. Davidson / Mylisa R. Parette
Published Online: 2015-04-01 | DOI: https://doi.org/10.1515/hsz-2015-0129


Despite the therapeutic potential of sphingolipids, the ability to develop this class of compounds as active pharmaceutical ingredients has been hampered by issues of solubility and delivery. Beyond these technical hurdles, significant challenges in completing the necessary preclinical studies to support regulatory review are necessary for commercialization. This review seeks to identify the obstacles and potential solutions in the translation of a novel liposomal technology from the academic bench to investigational new drug (IND) stage by discussing the preclinical development of the Ceramide NanoLiposome (CNL), which is currently being developed as an anticancer drug for the initial indication of hepatocellular carcinoma (HCC).

Keywords: ceramide; liposome; preclinical; sphingolipid; therapeutic


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About the article

Mark Kester

Mark Kester, Chief Medical Officer and co-founder of Keystone Nano, earned his PhD from the State University of New York at Buffalo. He has held faculty positions at Case Western Reserve University, Penn State University and currently serves as a Professor of Pharmacology and the Director of the NanoSTAR Institute at the University of Virginia. His research in the field of sphingolipids and nano-drug delivery systems led to the invention of the Ceramide NanoLiposome in his laboratory at Penn State University.

Jocelyn Bassler

Jocelyn Bassler received her BS in Biology from Virginia Polytechnic Institute and State University and worked with Southern Research Institute for 7 years before joining Keystone Nano as a Biological Researcher. She specializes in liposome formulation development and synthesis as well as cell-based assays.

Todd E. Fox

Todd E. Fox is an Assistant Professor of Pharmacology at the University of Virginia. He is the Director of the UVA Cancer Center’s Metabolomic and Lipidomic Core Facility. He is an expert in the utilization of mass spectrometry to quantify sphingolipid metabolites.

Carly J. Carter

Carly J. Carter received her BS in Chemistry from Penn State University in 2003 and her PhD in Chemistry and Biochemistry from the University of Colorado in 2010. Dr. Carter’s research background includes utilizing the interactions between biological molecules and materials to develop nanoparticle therapeutics. Dr. Carter is the Research Leader at Keystone Nano.

Jeff A. Davidson

Jeff A. Davidson holds a BS in Chemical Engineering from Purdue University and an MBA from the University of Minnesota. His 27 years of experience in industry and academia include serving as the Executive Director of the Penn State Bioprocessing Resource Center; founder and Executive Director of the Pennsylvania Biotechnology Association; publisher of Your World, a biotechnology applications magazine; founder of the Biotechnology Institute, a national biotechnology education nonprofit and founder of BioSciEd, Inc. Mr. Davidson co-founded Keystone Nano and has served as its CEO for the past 10 years.

Mylisa R. Parette

Mylisa R. Parette received her BS in Biology and Chemistry from Towson University, a MAT degree from Brown University and her PhD in Biochemistry, Microbiology and Molecular Biology from Penn State University. Dr. Parette has served as Research Manager at Keystone Nano for the past 9 years, leading the development of NanoLiposome and calcium phosphate NanoJacket programs from the bench to IND stage.

Corresponding author: Mylisa R. Parette, Keystone Nano, Inc, 1981 Pine Hall Road, State College, PA 16803, USA, e-mail:

Received: 2015-02-17

Accepted: 2015-03-21

Published Online: 2015-04-01

Published in Print: 2015-06-01

Citation Information: Biological Chemistry, Volume 396, Issue 6-7, Pages 737–747, ISSN (Online) 1437-4315, ISSN (Print) 1431-6730, DOI: https://doi.org/10.1515/hsz-2015-0129.

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