Lpath Inc. (Nasdaq: LPTN), which specializes in bioactive lipid-targeted therapeutics, has reported interim results in its Phase 2a trial investigating the drug Asonep as a treatment for metastatic renal cell carcinoma.
Asonep has a favorable safety profile thus far, Lpath reports, with no serious adverse events deemed to be drug-related among 26 patients enrolled in the study. The trial, described as a single-arm, open-label trial is targeted at patients that have failed at least one therapy involving a vascular endothelial growth factor inhibitor and no more than one mammalian target of rapamycin (mTOR) inhibitor such as Afinitor, with a maximum of three failed treatments in all.
The patient population is considered "last line," and the literature suggests cancer progression in this population within a one- to two-month time frame.
Lpath reports that the first 17 patients were initiated at a dose of 15 miligrams per kilogram of body weight. Of these "lower-dose" patients, seven had progressive disease at or before the end of four months while eight were progression-free at the four-month mark. Of the eight patients that were stable or better as of the fourth month, two are now in their 15th month on the study, one is in the 13th month and one is in the 10th. An additional patient was stable through month seven, according to Lpath, but then missed six treatments during a vacation and experienced progression shortly thereafter.
The next nine patients were initiated at a dose of 24 miligrams per kilogram of weight. Of those higher-dose patients, four had progressive disease at or before the end of four months while two were progression-free at the four-month mark. The remaining three have not yet reached their four-month mark, but Lpath added that of the two who were progression-free, one was deemed a partial responder per RECIST criteria, which classifies response evaluation criteria in solid tumors. The partial responder designation means that the patient experianced at least a 30 percent decrease in the sum of the longest diameter of target lesions.
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