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CAL-101 CLINICAL RESULTS
Results from an ongoing Phase 1 study of CAL-101 as a single agent were presented in June 2010 at the American Society of Clinical Oncology (ASCO) annual meeting. The results presented were from an interim assessment of 106 patients with relapsed or refractory chronic lymphocytic leukemia (CLL), indolent and aggressive non-Hodgkin's lymphoma (NHL), acute myeloid leukemia (AML) and multiple myeloma (MM).
Single agent CAL-101 treatment in patients with relapsed or refractory indolent non-Hodgkin's lymphoma (NHL), mantle cell lymphoma, and chronic lymphocytic leukemia (CLL), resulted in overall responses rates of 57 percent (13 of 23 patients), 67 percent (8 of 12 patients), and 30 percent (10 of 33 patients) were observed, respectively. Furthermore, 94 percent of patients with CLL had greater than 50 percent decrease in their lymph node disease, demonstrating a high degree of biologic activity.
Over half of the patients enrolled in the trial were refractory to their last therapy prior to entering the study, and the median number of prior treatment regimens was five. Patients received continuous, twice daily, oral dosing of CAL-101 on a 28-day cycle for up to 12 cycles.
The majority of responding patients remain on CAL-101 treatment. The median duration of response is not yet achieved at this interim assessment, although 12 patients have experienced a duration of response of more than 6 months. Three of these patients have completed more than 12 cycles (336 days) of treatment and are continuing to receive treatment with CAL-101 as part of an extension protocol.
Overall, CAL-101 was generally well tolerated. A low incidence of hematological toxicity was observed. Some patients had elevation of liver transaminases, which was monitorable and reversible following discontinuation of dosing. Most patients who experienced an elevation in transaminases resumed CAL-101 at a reduced dose.
CAL-101 is currently being investigated in clinical trials and has not received U.S. F.D.A. approval. Calistoga Pharmaceuticals does not claim that this technology or any of its product candidates are safe or will be effective in preventing, treating or curing any disease or condition.
