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 I safety studies (single dose, multiple dose, multiple dose combination with an approved drug).
Phase II Clinical Trials
Colorectal Cancer
The company has two clinical trials in colorectal cancer.
One is a dual-arm trial with second- and third-line metastatic colorectal cancer 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) and irinotecan, a chemotherapy drug.
- Second Arm Therapy: A combination of Imprime PGG and Erbitux.
Biothera has launched another clinical trial in stage IV KRAS-mutated colorectal cancer patients with Imprime PGG in combination with Erbitux.
Non Small Cell Lung Cancer
Biothera has initiated two Phase II clinical trials in NSCLC patients.
- First Clinical Trial: A combination of Imprime PGG, Avastin® (bevacizumab) and two chemotherapeutic agents, carboplatin and paclitaxel.
- Second Clinical Trial : A combination of Imprime PGG, Erbitux, carboplatin and paclitaxel.
Melanoma and Chronic Lymphocytic Leukemia
Biothera is collaborating with a major medical center on two clinical trials.
- Melanoma: This trial combines Imprime PGG and Avastin in melanoma patients.
- Chronic Lymphocytic Leukemia: This trial combines Imprime PGG and two monoclonal antibodies, Rixutan and Campath.