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Trastuzumab

AryoTrust™, is a biogeneric form of Trastuzumab and is used for treatment of breast cancer. It is a monoclonal antibody against Human Epidermal Growth Factor Receptor 2 (HER2). The recommended loading dose is 4mg/kg as a 90-minute intravenous infusion along with 175 mg/m2/ dose on day 1 of therapy.

The weekly maintenance dose is 2 mg/kg over 30 minutes if the first dose was well tolerated on days 1, 8, and 15 except for day 1 of the first cycle.
AryoTrust™ is available as a single-dose vial containing 60 or 150 mg of Trastuzumab and 440 mg/21 ml multi-dose vials and can be administered in an outpatient setting.
 AryoTrust is a common product of AryoGen and Kawsar company.
AryoTrust™  is a recombinant DNA-derived humanized monoclonal antibody that selectively targets the extracellular domain of the human epidermal growth factor receptor 2 protein (HER2). The antibody is an IgG1 kappa that contains human framework regions with the complementary-determining regions of a murine anti-p185 HER2 antibody that binds to HER2. Trastuzumab is composed of 1,328 amino acids and has a molecular weight of ~148 KDa.

The HER2 (or c-erbB2) proto-oncogene encodes for a single trans-membrane spanning, receptor-like protein of 185 KDa, which is structurally related to the epidermal growth factor receptor. Over-expression of HER2 is observed in 25%- 30% of primary breast and 6.8%- 42.6% of advanced gastric cancers. A consequence of HER2 gene amplification is an increase in HER2 protein expression on the surface of these tumor cells, which results in a constitutively activated HER2 receptor.

Studies indicate that patients whose tumors have amplification or over-express HER2 have a particularly aggressive form of tumor and a shortened disease-free survival compared to patients whose tumors do not have amplification or over-expression of HER2. HER2 over-expression or amplification can be diagnosed using an immunohistochemistry-based (IHC) assessment of fixed tumor blocks or In Situ Hybridization (ISH) technology. The original studies of Trastuzumab showed that it improved overall survival in late-stage (metastatic) breast cancer from 20.3 to 25.1 months. Trastuzumab is also being studied for use with other cancers. It has been used with some success in women with uterine papillary
Trastuzumab removal most likely occurs by opsonization via the reticuloendothelial system.


 

 



   
       
 
 
AryoTrustTM is under clinical trial and will be available in the mid of 2014