Graft versus Host Disease

Phase 2 Acute GvHD Data   |   Pediatric Treatment Refractory GvHD Data

Click Here for more information about our GvHD clinical trials. 

Prochymal is currently in clinical trials for the treatment of acute graft versus host disease (GvHD). GvHD is a life-threatening immune reaction that can occur in patients following bone marrow transplantation. Steroids are typically used to control the disease, however they are often ineffective. In patients that fail to respond to steroids, mortality can reach 85%.

Below is a pediatric patient with severe acute GvHD of the skin that failed to respond to multiple lines of therapy including high dose steroids and other immunosuppressants. At the time of treatment with Prochymal (left), severe skin GvHD is characterized by peeling of the skin and inflammation. At five days post treatment, the inflammation is no longer present and skin regeneration is beginning to take place. At day 18, no signs of GvHD are present.



Prochymal® Phase 2 Clinical Trial for the Treatment of Acute GvHD

The objective of this Phase 2 study was to evaluate the safety and efficacy of two dose levels of Prochymal plus standard steroid therapy. Patients were given two doses of Prochymal, three days apart at the onset of newly diagnosed acute GvHD, grades II-IV.

Trial Overview

Thirty-two patients were enrolled in the trial. Male and female patients were eligible and must have been between the ages of 18 and 65. Patients must have received an allogeneic hematopoietic stem cell transplant and must not have previously received treatment for graft versus host disease.

Trial Highlights

Patient Characteristics

  • 32 Patients
  • Grade ll n=20; Grade lll/lV n=11

Efficacy Results

  • Overall Response Rate, Complete Response (CR) + Partial Response (PR) of 94%
  • Complete Remission: 77% (24/31)
  • GI Involvement: 72% (13/18) Complete Response

Safety

  • Well tolerated – no infusional toxicity

Click here to read more about the Phase II results.

Click here to view the poster presented at the 2006 American Society of Hematology Meeting.


Prochymal® Clinical Trial Information for treatment-refractory acute GvHD

The objective of this study was to evaluate the safety and efficacy of Prochymal in pediatric patients with end-stage treatment-refractory acute GvHD. Patients in this trial were treated with Prochymal every 72 hours as needed for a response, for a maximum of eight treatments.

Trial Highlights

Patient Characteristics

  • 12 Pediatric Patients
  • All reasonable therapeutic options had been exhausted
  • Patients failed an average of 3 lines of therapy prior to treatment with Prochymal

Efficacy Results

  • Overall Response Rate (CR + PR) of 100%
  • Complete Remission: 58% (7/12)
  • 100 day survival of 58%
  • 75% (9/12) achieved complete resolution of GI symptoms

Safety

  • Well tolerated–no infusional toxicity
  • No safety concerns with repeat administration

Click here to view the poster presented at the 2007 American Society of Hematology Meeting.

 

If you have questions about this clinical program, please email us at GvHD@Osiris.com


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