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Paclitaxel Nanoparticle Albumin Bound · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 35mg/m\^2 infusion time is 3.5 minutes |
| 2 | EXPERIMENTAL | 2 doses of 35mg.m\^2 with the second dose given 2 months later |
| Name | Type | Description |
|---|---|---|
| Paclitaxel Nanoparticle Albumin Bound | DRUG | Single or duel doses of 35mg/m\^2 ABI-007, administered IV, administered after placement of denovo stent(s). |
Inclusion Criteria: * Undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries * Diagnosis of angina pectoris * At least 18 yrs old * If female, negative pregnancy test, non-lactating, and agree to utilize methods to prevent pregnancy * No previous trea...
Paclitaxel nanoparticle albumin bound is an investigational small molecule being studied by Bristol-Myers Squibb Company (NYSE: BMY) for angina pectoris and coronary artery disease. It is a nanoparticle albumin-bound formulation of paclitaxel, developed under the code ABI-007, and has been evaluated in a Phase 2 safety study for in-stent restenosis.
Paclitaxel nanoparticle albumin bound has been studied in patients with angina pectoris and coronary artery disease, specifically for in-stent restenosis. The Phase 2 trial NCT00093223 evaluated its safety in this cardiovascular setting. It is not approved for angina pectoris and remains an investigational therapy in clinical development.
Paclitaxel nanoparticle albumin bound targets tubulin proteins, including TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. It acts as a tubulin inhibitor. By binding these beta- and alpha-tubulin subunits, the agent interferes with microtubule dynamics, which is the mechanism underlying its antiproliferative activity in the cardiovascular restenosis setting.
Paclitaxel nanoparticle albumin bound is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is the sponsor of the clinical program evaluating this nanoparticle albumin-bound paclitaxel formulation, referenced by the code ABI-007, in cardiovascular indications.
Paclitaxel nanoparticle albumin bound is in Phase 2 development. Its single registered trial, NCT00093223, was a Phase 2 safety study that has been completed. The drug is investigational and has not been approved for angina pectoris or any cardiovascular indication.
Paclitaxel nanoparticle albumin bound has been evaluated in one clinical trial, NCT00093223, titled A Safety Study of ABI-007 for In-Stent Restenosis. This completed Phase 2 trial enrolled 76 participants in the United States, was randomized and controlled, and included adults aged 18 years and older of all sexes.