Pipeline

 

 

Biothera has a robust pharmaceutical development pipeline based on two active Investigational New Drug (IND) filings with the U.S. Food and Drug Administration.

 

Phase I Safety Trials

Imprime PGG® has successfully completed three Phase 1 safety studies (single dose, multiple dose, multiple dose combination with an approved drug).

 

Phase II Clinical Trials

 

Metastatic Colorectal Cancer (MCRC)

The company has initiated dual-arm clinical trial with MCRC patients to evaluate the safety and efficacy of Imprime PGG in combination with other approved drugs.

  • First Arm Therapy: A combination of Imprime PGG, Erbitux® (Cetuximab), a monoclonal antibody from ImClone Systems, and Irinotecan, a chemotherapy drug from Pfizer.
  • Second Arm Therapy: A combination of Imprime PGG and Erbitux.

Non Small Cell Lung Cancer (NSCLC)

Biothera expects to launch a dual-arm Phase II clinical trial in NSCLC patients in the third quarter of 2008. 

  • First Arm Therapy:  A combination of Imprime PGG, Avastin® (Bevacizumab), a Genentech monoclonal antibody, and two chemotherapy drugs, Carboplatin and Paclitaxel.
  • Second Arm Therapy:  A combination of Imprime PGG, Erbitux, Carboplatin and Paclitaxel.

 


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