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12:00 AM
 | 
May 15, 2006
 |  BioCentury  |  Product Development

Threshold's revolution on hold

While investors understandably bailed out of Threshold Pharmaceuticals Inc. last week after the company placed its TH-070 program on partial clinical hold, THLD believes it has some rational reasons to believe the potential treatment for benign prostatic hyperplasia isn't dead despite three serious cases of elevated liver enzymes.

Investors have been excited by the compound because it could revolutionize the treatment of BPH(see BioCentury, May 23, 2005). The condition currently is treated with two drugs: Flomax to provide symptomatic relief and Proscar to shrink the prostate. Neither Proscar nor Flomax affects the increase in cells that is the underlying problem. A better drug would treat the symptoms and the underlying disease.

TH-070 (lonidamine) is an indazole-3-carboxylic acid that is believed to disrupt energy metabolism via the inactivation of hexokinase, the enzyme that catalyzes the first step in glycolysis. Inhibiting glycolysis should lead to a shutdown in energy production followed by cell death.

TH-070 was in three ongoing trials. A Phase III Canadian and European study was originally planned to enroll 480 patients but had been expanded to 567 patients based on good recruitment, according to CEO Barry Selick. That trial had three arms: 50 or 150 mg of lonidamine or placebo. All patients had finished 28 days of dosing, while some had completed two or three months of dosing. There was a one-month follow-up after dosing was completed.

A U.S. Phase II study in 216 patients looked at doses of 5, 25, 50 and 150 mg/day for 28 days versus placebo. Patients in that trial had completed dosing and are being followed for three months.

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