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

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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.

--Lee

[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.

Anticipated short-term cell therapy industry clinical milestones

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What follows is an interesting but not exhaustive list of cell therapy industry clinical milestones we anticipate in the next 3-9 months as selected from the list of cell therapy products we are tracking in late-stage or post-commercial development.  

There are other commercial milestones we are monitoring as well as other clinical milestones we expect to see related to cell therapy products in earlier stages of the development pipeline that are not included below.

CellCoTec (www.cellcotec.com)

• Having completed a trial in Europe of their device to enable POC production of an autologous chondrocyte cellular product in/with a biodegradable, load-bearing scaffold for the treatment of articular cartilage defects, they have now submitted their CE market application.  The CE mark application is under review and they anticipate a response in October.  

• This device and the potential emergence of Sanofi's MACI in the European market next year may have an impact on Tigenix (EBR:TIG) most directly.

ERYtech Parma (www.erytech.com)

• Their 'pivotal' phase 2/3 trial in Europe of lead product, GRASPA, for the treatment of Acute Lymphoblastic Leukemia (ALL) is scheduled for completion 2H 2013. 

GamidaCell (www.gamidacell.com)

• Their 'pivotal' phase 2/3 trial in the US, Israel, and Europe of lead product, StemEx, for the treatment of leukemia and lymphoma, in joint development with Teva, completed enrollment in February and is scheduled for completion 2H 2012.  They have not been shy about the fact they expect to be in the market in 2013.

Innovacell (www.innovacell.com)

• They raised over 8m Euro in April for a phase 3 trial in Europe for their lead product, ICES13, for the treatment of stress-urinary incontinence which was scheduled for a preliminary clinical data readout in Q4 2012 and be ready for market authorization in 2013. Since announcing the capital raise the company has been stone silent and no clinical trial registry has been filed.  Status unknown.

Miltenyi Biotec (www.miltenyibiotec.com)

• Their phase 3 trial in Germany of CD133+ cells as an adjunct to CABG surgery for myocardial ischemia or coronary artery disease is scheduled for completion in January.

NovaRx (www.novarx.com)

• Their phase 3 trial in US, Europe, and India of their lead product, Lucanix, for the treatment of advanced Non-small Cell Lung Cancer (NSCLC) following front-line chemotherapy is scheduled in clnicaltrials.gov for completion in October but we have learned they expect their next 'interim analysis' in February.

NuVasive (www.nuvasive.com)

• They have a series of trials scheduled to complete 2H 2012 intended to provide additional clinical data to support its marketing of Osteocel Plus for the treatment of a growing number of orthopedic applications.

Sanofi's Genzyme (www.genzyme.com)

• Having completed their phase 3 trial in Europe of MACI for knee repair (symptomatic articular cartilage defects of the femoral condyle including the trochlea), they expect to file their market authorization application (MAA) in 1H 2013.

Hope that's helpful and gives you a sense some of the late-stage things to watch for in the coming weeks and months.  

--Lee