Updated listing of late-stage industry-sponsored cell therapy trials.

We've just updated our listing of industry-sponsored pivotal, ph3 and 2/3 cell therapy trials.  See the posting here.

Inactive and recently failed or terminated phase III or II/III cell therapy trials

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Updated 20 December 2011


In the two previous posts I have outlined what I believe to be the active phase III and II/III cell therapy trials, as well as the cell therapy products to have 'recently' obtained formal regulatory market approval in some jurisdiction.


In the course of doing that work, I came across the following industry-sponsored phase III cell therapy trials which appear to be inactive and those which failed or were terminated.


INACTIVE INDUSTRY PHASE III or II/III   

•     Aastrom              BRCs
•     Aldagen              ALD-101
•     Arblast               AMT-301
•     Avax                  Mvax
•     Vioheart             Myocell    
•     HepaLife Tech      HepaMate
•     KeraCure             KeraPac
•     Northwest Bio      DCVax-Prostate
•     t2cure                 BMCs
•     TVAX                  TV-Brain
•     TVAX                  TV-Kidney-1

   
RECENTLY FAILED /TERMINATED INDUSTRY PHASE III   

•     ABH (now Shire)        Dermgraft
•     Cellerix                    Cx401

I don't imagine this is an exhaustive list but as I have encouraged in previous posts, I welcome feedback as to errors, corrections, or omissions.   I'm using the 2009-11 time-frame here.  I'll update the post accordingly.

Late-stage industry-sponsored cell therapy trials

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Updated 22 August 2012 (originally posted December 2011)

At Cell Therapy Group, we track cell therapy industry activity globally but  particularly activity related to the clinical development and commercialization of cell based therapeutic products globally.

Below is a synopsis of the pivotal, phase 3 or 2/3 industry-sponsored cell therapy trials we are currently tracking globally.  

There is a database behind this that includes more data fields like therapeutic category, cell/tissue source, cell type, expansion, indication, expected completion date, clinical trial site locations, etc. 

Industry-sponsored pivotal, phase 3 or 2/3 trials*
    *active or expected to be active in 2012 

Aastrom                         

• Ixmyelocel-T

Argos

• Arcelis - AGS-003

Avita Medical

• ReCell

Baxter                           

• ACT34-CMI

Bone Therapeutics           

• PROEB

Cardio3 Biosciences         

• C-CURE

Cell Medica                     

• adoptive cellular therapy

CellCoTec

• INSTRUCT

CellSeed France               

• CAOMECS (Cultured Autologous Oral Mucosal Epithelial Cell-Sheet)

co.don                            

• co.don chondrosphere

Cook Myosite                  

• AMDC

Cytori                            

• ADRCs

DePuy Mitek

• CAIS

ERYtech Pharma              

• GRASPA

GamidaCell - Teva           

• StemEx

Harvest Technologies       

• SmartPReP 2 BMAC

Healthpoint                     

• HP802-247

Histogenics                     

• NeoCart

Innocell

• Immunecell-LC

Innovacell                        

• IES13 (Urocell?)

ISTO Technologies            

• DeNovo ET

JW Creagene

• CreaVax-RCC

Kiaidis Pharma                

• ATIR

MacroCure                       

• CureXcell

Mesoblast

• Revascor    

Miltenyi                          

• CliniMACS CD34 Selection System

MolMed                          

• TK

Newlink Genetics             

• HyperAcute Pancreas

NKBio

• Biocell Natural Killer Mixture

Northwest Biotherapeutics

• DCVax-L

NovaRx                          

• Lucanix

NuVasive                        

• Osteocel Plus

Osiris                            

• Prochymal

Pharmicell

• Heartcellgram-AMI

Prima Biomed                  

• Cvac

Sanofi (Genzyme)

• MACI

SOTIO

• DVAC/Pca

Tigenix (Cellerix)

• Cx601

The Hawkins Foundation (in collaboration with Depuy Mitek

• CAIS

TissueTec

• amniotic membrane

Some of the products listed above are in more than one clinical trial - different regions and/or different indications.

In total we are tracking 48 industry sponsored, active (or expected to be active 2012) cell therapy trials in pivotal, ph III or II/III expected to involve over 11,000 patients.  Some of the products listed above are the subject of multiple trials.

The 50 trials are sponsored by 40 companies.  The trials roughly break down as follows:

• 59% are autologous
• 45% are allogeneic
• Two are gene-modified allogeneic
• One involves autologous and allogeneic cells (we counted it for both)

• 30% for oncology or related indications
• 13% for cardiac-related indications
• 13% for non-cardiovascular (PAD, CLI, VLU, etc)  & wound 
• 34% (6) for cartilage and bone repair

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I encourage readers to comment below or email direct with any errors and/or omissions.

Clinical trial costs

Based on a survey* of 21 drug makers, 12 biotechs, nine device makers and 23 contract research organizations, PharmaLot has recently published the following metrics for current clinical trial costs (see full article here)

Average per-patient trial costs across all therapeutic areas:

Phase I: $21,883

Phase II: $36,070

Phase IIIa: $47,523

Phase IIIb: $47,095

Phase IV: $17,042

Average cost per patient for a cardiovascular trial:

Phase II: $33,700

Phase IIIa: $21,750

Phase IIIb: $6,830

In oncology, the average per patient trial cost:

Phase II: $73,303

Phase IIIa: $57,207

Phase IIIb: $65,900

For central nervous system disorders:

Phase II: $28,197

Phase IIIa: $33,768

Phase IIIb: $41,824

For diabetes:

Phase II: $ 8,854

Phase IIIa: $12,667

Phase IIIb: $10,700

Anyone have any thoughts or data as to how this compares to cell therapy trials?

--Lee

*survey conducted by Cutting Edge Information.