Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as horse anti-thymocyte globulin (hATG)
horse anti-thymocyte globulin · 1 trial · 2 indications
95% confidence interval (CI) will be calculated for subjects who achieve Complete response (CR), Partial response (PR), for all AA and MDS subjects, and hematological improvement (HI) for MDS subjects only. Measurement in percentages (%)
| Arm | Type | Description |
|---|---|---|
| BL-8040 plus hATG, methylprednisolone, cyclosporine | EXPERIMENTAL | BL-8040 0.75mg/kg will be administered Subcutaneously (SC ) on Days 1-10, then on first 5 days of months 2-6. Standard therapy: hATG: Days 11-14: 40mg/kg/day IV over 6-8 hours, in all AA subjects, or in MDS subjects less than 55 years old. 35mg/kg/day IV over 6-8 hours in MDS subjects 55 years and older. Standard therapy: methylprednisolone: Days 11-14: 40mg/kg/day IV over 6-8 hours, in all AA subjects, or in MDS subjects less than 55 years old. 35mg/kg/day IV over 6-8 hours in MDS subjects 55 years and older. Standard therapy: cyclosporine: 5mg/kg/day orally, given in 2 divided doses, starting on day 11 and continuing through Month 6 Day 30 (end of treatment) |
| Name | Type | Description |
|---|---|---|
| BL-8040 | DRUG | Subjects will receive subcutaneous (SC) injections of BL-8040 monotherapy on days 1-10 of the study. Beginning on Month 2 day 1, (M2/D1), and continuing monthly through Month 6, BL-8040 will be administered daily as part of the maintenance period for the first 5 days of each month. |
| horse anti-thymocyte globulin (hATG) | DRUG | From Day 11 through Day 14 of first month, subjects will receive hATG infusion over 6-8 hours each day. |
| Methylprednisolone | DRUG | From Day 11-14 of first month, subjects receive infusion of methylprednisolone 30 minutes prior to hATG infusion. Treatment with methylprednisolone will continue for 30 days. (After day 14, subjects may receive oral prednisone dose equivalent to IV methylprednisolone dose. The oral dose will be tapered off over 30 days. |
| Cyclosporine | DRUG | From Day 11 through end of treatment (Month 6 Day 30), subjects will receive oral dose of cyclosporine. |
Inclusion Criteria: 1. Adult men and women aged 18 and older 2. Patient must have the ability to understand the requirements of the study and provide informed consent. 3. Patients with the diagnosis of severe AA, who are not currently candidates for an allogeneic stem cell transplant, fulfilling th...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 1 | - | Anti-human thymocyte immunoglobulin, equine |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |