Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Prochymal- 2 Million cells/kg · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Prochymal® - 2 Million cells/kg | ACTIVE_COMPARATOR | Participants will receive Prochymal® consisting of 2 million hMSCs/kg actual body weight, intravenously (IV) on Days 1 and 4 along with daily standard of care which includes methylprednisolone 2 milligrams (mg)/kg IV or prednisone 2.5 mg/kg orally. Participants will also continue cyclosporine, tacrolimus, and/or mycophenolate mofetil (MMF) at full therapeutic doses. |
| Prochymal® - 8 Million cells/kg | ACTIVE_COMPARATOR | Participants will receive Prochymal® consisting of 8 million hMSCs/kg actual body weight IV on Days 1 and 4 along with daily standard of care which includes methylprednisolone 2 mg/kg IV or prednisone 2.5 mg/kg orally. Participants will also continue cyclosporine, tacrolimus, and/or mycophenolate mofetil (MMF) at full therapeutic doses. |
| Name | Type | Description |
|---|---|---|
| Prochymal® - 2 Million cells/kg | DRUG | 2 million hMSCs/kg actual body weight, IV on study Days 1 and 4 |
| Prochymal®- 8 Million cells/kg | DRUG | 8 million hMSCs/kg actual body weight IV on study Days 1 and 4 |
| Methylprednisolone | DRUG | Methylprednisolone 2 mg/kg administered intravenously. |
| Prednisone | DRUG | Prednisone 2.5 mg/kg administered orally. |
| Cyclosporine | DRUG | Administered as prescribed by the caregiver. |
| Tacrolimus | DRUG | Administered as prescribed by the caregiver. |
| Mycophenolate Mofetil | DRUG | Administered as prescribed by the caregiver. |
Protocol 260 Inclusion Criteria: * Participant must be 18 to 70 years of age inclusive. * If female and of child-bearing age, participant must be non-pregnant, not breast feeding, and use adequate contraception. Males must use adequate contraception. * Participant must have newly diagnosed, Grade I...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 10 | PHASE3 | INCA034176 |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | Belumosudil, Prednisone, Prednisolone |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Ibrutinib |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Theriva Biologics, Inc. | TOVX | 1 | PHASE1 | Undisclosed |
Prochymal is an investigational cell therapy being studied for the treatment of Graft Versus Host Disease (GVHD), a condition where donor immune cells attack the recipient's tissues after a stem cell transplant. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Prochymal is being developed by Mesoblast Limited, a biopharmaceutical company publicly traded under the ticker symbol MESO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for Graft Versus Host Disease.
Prochymal is in Phase 2 clinical development for Graft Versus Host Disease. It is an investigational therapy, meaning it has not yet received regulatory approval and is still being evaluated in clinical trials to determine its safety and effectiveness.
Prochymal has one completed clinical trial, identified as NCT00136903, titled 'Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)'. This Phase 2 study enrolled 32 participants in the United States and was active-controlled, though it was not double-blinded.
Prochymal is an investigational therapy based on adult human mesenchymal stem cells. The clinical trial NCT00136903 evaluated these cells for treating acute Graft Versus Host Disease, and Prochymal is the product name associated with this cell therapy being developed by Mesoblast Limited.