| |
Abraxane is an albumin-stabilised nanoparticle formulation of paclitaxel designed to overcome various insolubility problems encountered with paclitaxel. This nano-technology eliminates the need for toxic solvents like cremophor, which limits the dose of paclitaxel that can be administered and hence affect overall drug efficacy. Cremophor is also know to cause various types of allergic reactions in patients who receive paclitaxel. Albumin receptor-mediated paclitaxel-transport mechanism is analogous to the opening of a 'trapdoor' on the endothelial cell wall within blood vessels. This facilitates easy passage of abraxane from the bloodstream via the blood vessels to the underlying tumour tissue. In addition to the standard infusion formulation of Abraxane, oral and pulmonary delivery formulations are also being investigated and explored. The new FDA approval for this drug is based on the successful completion of a phase III trial evaluating abraxane versus standard paclitaxel among 460 patients with metastatic breast cancer in the US. In September 2003, American Pharmaceutical Partners and American BioScience jointly announced positive interim results from the trial, which shows that the primary efficacy objective had been exceeded. American BioScience completed this phase III trial in early 2003 with the results unblinded in mid-2003. The phase III study directly compared the efficacy of abraxane 260 mg/m2 versus paclitaxel 175 mg/m2. Both agents were administered every 3 weeks. Abraxane was administered as a 30-minute infusion without steroid pretreatment. Paclitaxel-treated patients received steroid pretreatment and the drug was administered over 3 hours which is the standard dose regimen for paclitaxel. A phase II trial of abraxane was also underway in metastatic breast cancer patients who have failed taxane therapy. This trial was evaluating a weekly rather than 3-weekly regimen of abraxane. In February 2004, American BioScience initiated a multicenter phase II trial in patients with metastatic melanoma. In May 2003, American Pharmaceutical Partners announced that abraxaneis also being evaluated for the treatment of non-small cell lung cancer, ovarian cancer, melanoma and cervical cancers. Various other phase I/II trials have also been conducted in other solid tumours, including squamous cell cancer of the head and neck, and pelvis. Phase I trials have also been conducted in patients with solid tumours to evaluate the administration of Araxane on a weekly schedule.
Read more about abraxane:
FDA approves abraxane for breast cancer
|
|
|
|
|
|
|
|
|
