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anti-thymocyte globulin · 1 trial · 1 indication
Patients will be classified as responders if they have transfusion independence and meet two of the following three criteria: ANC greater than 500/mm3; platelet count greater than 20,000/mm3; and reticulocyte count greater than 40,000/mm3. Transfusion independence is defined as no need for transfusions for one month prior to response assessment.
| Arm | Type | Description |
|---|---|---|
| rATG + Cyclosporine | EXPERIMENTAL | Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity |
| Name | Type | Description |
|---|---|---|
| cyclosporine | DRUG | Given orally |
| anti-thymocyte globulin | BIOLOGICAL | Given IV |
Inclusion Criteria: * All patients with sAA as defined by Camitta who are candidates for IS therapy; these criteria include bone marrow cellularity \< 25% or 25-50% with \< 30% of hematopoietic cells; it should also have two of the following three parameters: peripheral blood neutrophils \< 0.5 x 1...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 1 | - | Anti-human thymocyte immunoglobulin, equine |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
Anti-thymocyte globulin is used for the treatment of severe aplastic anemia. It is being studied as a first-line therapy in combination with cyclosporine for patients with this condition. The drug is an investigational monoclonal antibody in Phase 2 clinical development for this hematologic indication.
Anti-thymocyte globulin is a monoclonal antibody that targets and depletes thymocytes, which are T-cell precursors. By reducing these immune cells, it aims to suppress the aberrant immune response that destroys hematopoietic stem cells in aplastic anemia, potentially allowing bone marrow recovery.
Anti-thymocyte globulin is being developed by Community Health Systems, Inc., a company traded on the New York Stock Exchange under the ticker symbol CYH. The company is conducting clinical research on this drug for the treatment of severe aplastic anemia.
Anti-thymocyte globulin is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied as a first-line therapy for severe aplastic anemia, with one completed Phase 2 trial involving 20 patients.
Anti-thymocyte globulin has one completed clinical trial, identified as NCT01231841. This Phase 2 study, titled "Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic Anemia," enrolled 20 patients in the United States. The trial was uncontrolled and not randomized or double-blinded.
Anti-thymocyte globulin is commonly abbreviated as ATG in clinical and medical contexts. The drug is also known by this abbreviation, which is frequently used in the medical literature and clinical trial descriptions. Both names refer to the same investigational monoclonal antibody being studied for aplastic anemia.