Hematologic Cancer

August 22, 2011

Bio-Path Holdings issued interim results from an ongoing phase I trial of BP-100-1.01 (Liposomal Grb-2) for hematological cancers. A total of 13 treatment experienced subjects received an intravenous dose of 5 mg/m2 twice a week for four weeks. Six of the 13 subjects were evaluable for response; the remaining seven failed to complete a full 28-day cycle due to disease progression. Liposomal Grb-2, at a dose of 5 mg/m2 was well tolerated. Lab parameters for blasts and bone marrow also demonstrated possible anti-leukemia activity. Two subjects had transient improvement and/or stable disease and received a total of five cycles each, representing five months on treatment with the drug. Two additional subjects had transient improvement on leukemia cutis lesions. In addition to the six evaluable subjects, a single subject with CML blast phase who had failed all available therapies showed a significant reduction in blasts from 81% to 4%.

April 11, 2011

Avila released results from a phase Ia trial of AVL-292 for B cell-related hematological cancers. This double blind, placebo-controlled, single ascending dose study, AVL-292-001, enrolled healthy subjects in five dosing cohorts. AVL-292 was successfully administered to all dose cohorts. It was well-absorbed with good systemic exposure and demonstrated a dose-proportional pharmacokinetic profile across all dose levels (ranging from 0.5 to 7.0 mg/kg) with low inter-subject variability. AVL-292 achieved statistically significant levels of target occupancy at all dose levels, with >80% Btk target site occupancy achieved at doses as low as 1.0 mg/kg.

June 9, 2008

Keryx issued positive interim results from a phase II trial of KRX-0401 for the treatment of relapsed/refractory Waldenstroms macroglobulinemia (WM). This study enrolled 37 subjects, most of who had been previously treated with at least one course of therapy on rituximab. The subjects received 150 mg of perifosine daily in a 28 day cycle for at least six cycles. Partial response, defined as a 50 percent reduction in Immunoglobulin M, was observed in 5% of the subjects and minimal response, defined as a 25 percent reduction in Immunoglobulin M, was observed in 28% of the subjects. This resulted in an overall response rate of 33%. An additional 61% of the subjects reached stable disease. Treatment was well tolerated. The median time to progression has not been reached. Eleven subjects are currently receiving treatment.

September 10, 2007

Poniard announced positive long-term results from a phase II trial of picoplatin for the treatment of small cell lung cancer (sclc). This open-label trial evaluated 77 subjects with platinum-refractory and resistant sclc who had relapsed within six months of first-line therapy. The subjects had a median one-year survival rate of 17.6%, compared to a median overall survival of approximately 17 to 22 weeks in subjects treated with existing second-line chemotherapies. In addition, the disease control rate was 48.1%, similar to current standard of care treatments. A phase III trial of picoplatin for small cell lung cancer is currently underway.

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