One Door Closes For TH-070, But Another May Open, Threshold Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The company discontinued development of drug for BPH, but will explore other potential uses.
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Threshold Pharmaceuticals has terminated its development of TH-070 for benign prostatic hyperplasia, but will explore the possibility of using the drug "for potential other applications," the company's Chief Medical Officer Alan Colowick said in a July 17 call. The Redwood City, Calif.-based company said its Phase II and Phase III trials of TH-070 (lonidamine) did not meet the primary endpoint of symptomatic improvement as measured by International Prostate Symptom Score, prompting the discontinuation. Though the Phase II trial failed to generate a statistically significant dose relationship and the Phase III trial did not demonstrate a statistically significant difference in IPSS between TH-070 and placebo, Threshold CEO Harold Selick said the firm will further investigate the statistically significant reductions seen in prostate specific antigen. "While that didn't translate into clinical benefits in this study, at these doses and these durations of therapy for TH-070, we obviously will take more time to try to understand what this reduction in PSA means biologically, what we think it means and whether or not that opens the door for potential other applications of TH-070 or other analogs that we have been actively working on," Colowick said. Lack of statistically significant data was not the first problem Threshold encountered in the development of TH-070. FDA placed a partial clinical hold on the program in May after reports of liver abnormalities in some patients (1 (Also see "FDA Puts Hold On Threshold Prostate Treatment Clinical Program" - Pink Sheet, 12 May, 2006.)). Separately, despite difficulties with TH-070, Selick stressed that Threshold remains "on track with [its] ongoing glufosfamide trials for the treatment of pancreatic cancer." Glufosfamide is in Phase III for second-line treatment of pancreatic cancer and in Phase II in combination with gemcitabine (Lilly's Gemzar ) for first-line treatment. Colowick said Threshold expects to have data from both studies by year-end. Threshold also plans to start at least one additional glufosfamide study this year, for "an indication separate from pancreatic cancer," Colowick said. Shares of Threshold closed at $1.55, down 51%. -Daniel Fowler |