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Calistoga begins Phase II study of CAL-101 in elderly CLL patients.

M2 PHARMA-October 19, 2010-Calistoga begins Phase II study of CAL-101 in elderly CLL patients(C)2010 M2 COMMUNICATIONS

19 October 2010 - Calistoga Pharmaceuticals Inc said today it has started a Phase II combination trial of CAL-101, its oral, delta-selective PI3K inhibitor, plus rituximab (Rituxan) in previously untreated, elderly patients with chronic lymphocytic leukemia (CLL).

The Phase II study will enroll up to 60 patients over the age of 65 with CLL or small lymphocytic lymphoma (SLL). Patients will receive treatment with rituximab, administered in eight weekly doses, together with oral CAL-101, administrated twice daily; they will not take chemotherapy as part of the regimen. Patients will remain on CAL-101 therapy as long as they continue to benefit. The trial is designed to evaluate the safety and clinical activity of the new combination treatment.

In addition to the new Phase II combination trial, Calistoga is conducting an ongoing Phase I single-agent trial of CAL-101 in patients with relapsed or refractory CLL, indolent non-Hodgkin lymphoma (iNHL), or mantle cell lymphoma (MCL). The company is also conducting an ongoing Phase I trial of CAL-101 given in combination with either rituximab or bendamustine (Treanda) in patients with relapsed or refractory iNHL or CLL. An extension study has been instituted to permit those patients who are deriving clinical benefit past 12 months to continue long-term CAL-101 treatment. Calistoga said it is currently finalising plans for registration-enabling trials of CAL-101.

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Publication:M2 Pharma
Date:Oct 19, 2010
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