Biothera has initiated a Phase I/II clinical trial to evaluate Imprime PGG in combination with alemtuzumab (Campath) and rituximab (Rituxan) in patients with earlier-stage, high-risk chronic lymphocytic leukaemia.
The Phase I, open-label, dose-escalation study will dose up to 16 patients and will determine the maximum tolerated dose of Imprime PGG in combination with alemtuzumab and rituximab.
The Phase II study will involve 55 patients, who will receive Imprime PGG at the dose level identified in Phase I of the study. It will evaluate the rate of complete response of patients 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.
Imprime PGG works by binding to and directing neutrophils, the most abundant type of immune cell in the body, to kill cancer.
Chronic lymphocytic leukaemia is cancer of the blood and bone marrow. It affects more than 100,000 Americans, with over 15,000 new diagnoses each year.
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