CLL patients receive Biothera's new combination therapy in Phase I/II clinical trial

Patients with earlier stage high-risk Chronic Lymphocytic Leukemia (CLL) recently began receiving a new combination treatment in a Phase I/II clinical trial that researchers believe could result in a more effective therapy for this disease, Biothera announced today.

The study will evaluate Biothera's Imprime PGG® in combination with alemtuzumab (Campath®) and rituximab (Rituxan®). Imprime PGG is a developmental drug that binds to and directs neutrophils, the most abundant type of immune cell in the body, to kill cancer. Imprime PGG works synergistically with anti-tumor monoclonal antibodies, such as alemtuzumab and rituximab.

"Imprime PGG's unique mechanism of action, which engages and directs innate immune cells to kill cancer, has been successfully demonstrated in multiple clinical and preclinical studies involving several types of cancer," said Dan Conners, president of Biothera's Pharmaceutical Group. "We are confident that combining Imprime PGG with Rituxan and Campath will result in similarly significant improvements in outcomes for CLL patients."

Imprime PGG recently completed a successful Phase II clinical study in colorectal cancer patients. The drug candidate is also currently in multiple Phase II clinical trials for non-small cell lung cancer and a Phase III trial for colorectal cancer.

Study Design
Researchers will dose up to 16 patients in the Phase I open-label, dose-escalation part of the study designed to determine the maximum tolerated dose (MTD) of Imprime PGG in combination with alemtuzumab and rituximab.

In Phase II of the clinical trial, 39 CLL patients will be dosed with Imprime PGG at the dose level identified in Phase I of the study, for a total of up to 55 patients. The goal of this study is to assess the rate of complete response of subjects with high-risk, earlier-stage CLL who are treated with Imprime PGG, alemtuzumab, and rituximab. The study will also evaluate overall subject response, time to progression, time to next treatment, duration of response, and safety of the therapeutic regimen.