Pipeline

Biothera has two active Investigational New Drug (IND) filings with the U.S. Food and Drug Administration. Imprime PGG® has successfully completed three Phase 1 safety studies (single dose, multiple dose, multiple dose combination with an approved drug). The company has initiated a clinical trial in metastatic colorectal cancer patients that is evaluating the safety and efficacy of Imprime PGG in combination with Erbitux® (Cetuximab), a monoclonal antibody from ImClone Systems, and Irinotecan, a chemotherapy drug from Pfizer. Complete results are expected in the fall of 2008. Biothera is planning a clinical study in lung cancer patients this year using a combination of Imprime PGG, Avastin® (Bevacizumab), a Genentech monoclonal antibody, and two chemotherapy drugs.
