Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Prochymal · 8 trials · 10 indications
Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ
Treatment was considered a success if all of the following conditions were met: Achieved induction of a complete response (CR) within 28 days after first infusion; CR followed by 28 days maintenance of a clinically meaningful response defined as the response that did not require an increase in corticosteroid dose (methylprednisolone doses \>2 milligram/kilogram/day \[mg/kg/d\] or prednisone doses \>2.5 mg/kg/d) for more than 7 consecutive days; Did not require second line/escalation therapy through Study Day 56; and survived 90 study days.
A complete response was defined as complete resolution of all clinical signs of Graft versus host disease (GVHD)- that had to be maintained for at least 28 consecutive days (durable complete response \[DCR\]) within 100 days post first infusion.
Responses included complete response (CR), partial response (PR), failure to respond. CR is defined as a complete resolution of graft-versus-host disease (GVHD). PR is defined as improvement in at least one organ by at least one full stage in the absence of progression in any other organ, or resolution of GVHD in at least one organ with a need for additional treatment because of abnormalities persisting in another organ. Failure to respond is defined as progression of GVHD.
| Arm | Type | Description |
|---|---|---|
| Prochymal® | EXPERIMENTAL | Infusions of Prochymal on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 6 infusions of placebo-matching Prochymal® intravenously (IV) during the first 4 weeks of the study. The first infusion will be administered within 72 hours of the start of systemic corticosteroid therapy. Participants will receive 4 infusions during the first 2 weeks (twice weekly at least 3 days apart), followed by 2 infusions administered once weekly over the subsequent 2 weeks up to Day 28. |
| Prochymal® 2x10^6 hMSC/kg | ACTIVE_COMPARATOR | Participants will receive 6 infusions of Prochymal® 2x10\^6 human mesenchymal stem cells (hMSC)/kg IV during the first 4 weeks of the study. The first infusion will be administered within 72 hours of the start of systemic corticosteroid therapy. Participants will receive 4 infusions during the first 2 weeks (twice weekly at least 3 days apart), followed by 2 infusions administered once weekly over the subsequent 2 weeks up to Day 28. |
| Prochymal® - Low dose | ACTIVE_COMPARATOR | Participants will receive a total dose of Prochymal® 600 x 10\^6 cells, IV infusion, on four days, once daily. |
| Prochymal® - High dose | ACTIVE_COMPARATOR | Participants will receive a total dose of Prochymal® 1200 x 10\^6 cells, IV infusion, on four days, once daily. |
| Prochymal | EXPERIMENTAL | PROCHYMAL® |
| Prochymal™ | EXPERIMENTAL | Participants received Prochymal™ a total of 400×10\^6 cells, intravenous (IV) infusions on Days 0, 30, 60, and 90. |
| Name | Type | Description |
|---|---|---|
| Prochymal® | DRUG | PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603. |
| Placebo | OTHER | Placebo-matching Prochymal® intravenous infusion. |
| Corticosteroid | OTHER | Administration will be intravenously as prescribed by the caregiver. |
| Standard of Care for GVHD | DRUG | Institutionally defined standard of care (e.g., maintenance of steroid treatment and the addition of a second-line therapy) |
| Prochymal™ | DRUG | IV infusion of ex- vivo cultured adult human mesenchymal stem cells. |
| Prochymal | DRUG | Intravenous infusion of ex-vivo cultured adult human mesenchymal stem cells |
Inclusion Criteria: * Participant must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3, 2010. * Participant successfully completed all screening asses...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Risankizumab On-Body Injector |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
PROCHYMAL is an investigational stem cell therapy being studied for graft versus host disease, Crohn's disease, type 1 diabetes mellitus, myocardial infarction, and chronic obstructive pulmonary disease. It has been evaluated in clinical trials for treatment-resistant moderate-to-severe Crohn's disease, moderate to severe COPD, and acute myocardial infarction.
PROCHYMAL is being developed by Mesoblast Limited, a biopharmaceutical company. Mesoblast is publicly traded under the ticker symbol MESO. The company has conducted multiple clinical trials of PROCHYMAL across various indications.
PROCHYMAL is an investigational therapy that has completed Phase 2 and Phase 3 clinical trials. It is not approved by the FDA and remains in clinical development. All three completed trials were randomized, double-blind, and placebo-controlled, with a total enrollment of 463 participants.
PROCHYMAL has completed three clinical trials. NCT00482092 and NCT01233960 evaluated it for treatment-resistant moderate-to-severe Crohn's disease. NCT00683722 studied it for moderate to severe chronic obstructive pulmonary disease. NCT00877903 assessed it following acute myocardial infarction. All trials are completed with no active trials ongoing.
Yes, PROCHYMAL and Prochymal refer to the same investigational stem cell therapy developed by Mesoblast Limited. The drug name appears in both uppercase and standard capitalization across clinical trial records, but they represent the same product being studied for multiple conditions.