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Friday, September 28, 2012

Anticipated short-term cell therapy industry clinical milestones


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 (
  • 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 (
  • 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 (
  • 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 (
  • 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 (
  • 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 (
  • 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 for completion in October but we have learned they expect their next 'interim analysis' in February.

NuVasive (
  • 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 (
  • 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.  



Denis English said...

How does the autologous chondrocyte replacement described above in a scaffold differ from the 20 or so that haven't worked to date; using autologous collagen, manufactured collagen preparations (Alloderm) , cartilage explants (autologous and allogeneic and xenogenic),with or without autologous chondrocytes, allogeneic chondrocytes, transplanted chrondrocytic "stem" cells, and several other variations. A seminal paper in 2008 concluded these treatments, all of them, had shown some initial relief, but as time crept on, the therapy aggravated the disease or did nothing at all, ever. This is from a review of only long term studies (all to that time and there were many), both in horses and humans.

Denis English said...

PS: There have not been any successful long term clinical trials since that publication either.

Anonymous said...

thanks for sharing..

Lee Buckler said...

Always a pleasure to hear from you Dennis.

I'm not in a position to have any useful comment on the efficacy of particular products or the adequacy of clinical evidence related to them. What I observe is that enough docs keep using Genzyme's Carticel to keep it on the market and TiGenix is slowly expanding sales of ChondroCelect.

I certainly agree with you that we should expect far more in terms of the efficacy and commercial success of these second or third generation products but that would be typical of any industry.

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