publication date: Aug. 30, 2014

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Researchers Plan to Extend Phase IIa Asonep Trial

Based on progression-free survival data, a single-arm, open-label phase IIa study of Asonep in metastatic renal cell carcinoma will be extended to a second cohort.

The decision followed an interim analysis of RCC patients that have failed at least one therapy involving a VEGF inhibitor and no more than one mTOR inhibitor, with a maximum of three failed treatments in all. This patient population is considered “last line,” and the literature suggests cancer progression in this population within a one-to-two month time frame, according to Asonep’s sponsor, Lpath Inc.

Lpath has enrolled 26 patients in the study. Asonep has a favorable safety profile thus far, with no drug-related serious adverse events.

The first 17 patients were initiated at a dose of 15 mg/kg. Of these, seven had progressive disease at or before the end of four months; eight were progression-free at the four-month mark—with one of these patients deemed a partial responder, and three experiencing reduced tumor volume, but not enough to be categorized as a partial responder. Two exited the study due to serious adverse events unrelated to the drug prior to the four-month mark, and are not considered evaluable.

Notably, of the eight patients that were stable or better as of the fourth month, two are now in month 15 of the study, one is in month 13, and one is in month 10. An additional patient was stable through month seven, but then missed six treatments during a vacation, and shortly thereafter progressed.

The next nine patients were initiated at a dose of 24 mg/kg. Of these higher-dose patients: four … Continue reading CCL August – Kidney Cancer

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