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Thursday, November 1, 2012

GEN's "Cellular Therapy Wave Finally Cresting". An overview and data set.


We first provided a listing (with very few details) of industry-sponsored late-stage (pivotal, phase 3 and 2/3) cell therapy clinical trials on this blog late last year (see the posting here).

We are now pleased to we have worked with Genetic Engineering and Biotechnology News and Enal Razvi of Select Biosciences to provide an updated (as of June 2012) and more detailed listing of industry-sponsored late-stage (pivotal, phase 3 and 2/3) cell therapy clinical trials (excluding cell-based immunotherapies which we intend to cover in a follow-up article).

A link to the listing can be found in an article published today entitled "Cellular Therapy Wave Finally Cresting" found in the November 1, 2012 issue of GEN.  

While not my favorite title, the article is a brief - but we hope useful - overview of the sector and its pipeline.  It also provides a snapshot of the cell therapy products already in commercial distribution. 

Some will quibble about the numbers. Certainly others have published larger revenue numbers, for instance, but in our view these have almost always included revenue from cord blood banking which we have excluded.

We encourage you to read the article but for convenience here is a direct link to the spreadsheet.  Of course it's already out-dated but we'll do an update again soon here on this blog.

Hope this is useful.


[post-publication clarification]: Regarding the last sentence of the article, this should read:

"No cell therapy products approved 2002-8 vs 12 cell therapy products approved 2009-12."

2009-12 saw 9 regulatory approvals of industry-backed products : 

  • ChondroCelect from TiGenix (EU),
  • Provenge from Dendreon (US), 
  • laViv from Fibrocell Sciences (US), 
  • GINTUIT from Organogenesis (US), 
  • HeartcelliGram-AMI from Pharmicell (S. Korea), 
  • Cupistem from Anterogen (S. Korea), 
  • Cartistem from Medipost (S. Korea),
  • Prochymal from Osiris (Canada) and
  • Prochymal from Osiris (NZ). 

This year also saw 3 regulatory (FDA) approval of two products from non-profits:

  • HemaCord from New York Blood Center (US), 
  • HPC, Cord Blood* from Clinimmune Labs, University of Colorado Cord Blood Bank (US)
  • DUCORD from Duke University

* please also note the correction of "HPC, Cord Blood" which is the correct product name incorrectly stated as "Clinimmune" in the article.

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