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XTL-2125 Hep C Drug Fails
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XTL Provides Update on Phase I Clinical Trial of XTL-2125
VALLEY COTTAGE, New York, June 06, 2007 /PRNewswire-FirstCall/ -- XTL Biopharmaceuticals Ltd. announced today that it has completed the analysis of results from a Phase I clinical trial with XTL-2125 in patients with chronic Hepatitis C. This Phase I trial was a placebo controlled, randomized, dose escalating study, which evaluated the safety, tolerability and antiviral activity of single and multiple doses of XTL-2125. The study enrolled 56 patients into seven cohorts comprised of eight patients each (of which two are placebo patients). Each patient received a single dose, followed by a 14-day multi-dosing regimen commencing one week after the single dose administration. The highest daily multi-dose regimen that was evaluated in the trial was 1800mg per day (600mg three times per day).
The analysis of the data indicates that XTL-2125 was generally well tolerated. However, HCV-RNA viral load reductions in patients treated with XTL-2125 were not significantly different from those observed in the placebo group. Based on these results, XTL has decided to suspend further development of XTL-2125.
XTL's CEO, Ron Bentsur, commented: "The completion of this Phase I trial concludes our research on the XTL legacy compounds that we inherited. Through an aggressive business development effort, XTL's new management team has successfully reinvented the company's product portfolio - with Bicifadine as a lead product in late stage clinical development, and the XTL-DOS program, which is emerging as a very promising program in Hepatitis C. We look forward to an exciting rest of 2007, with the initiation of a late-stage clinical trial with Bicifadine in chronic neuropathic pain, and the initiation of IND-enabling studies with a novel hepatitis C inhibitor from the XTL-DOS program. We will also continue to opportunistically seek to broaden our portfolio through the in-licensing and acquisitions of additional clinical stage products."
XTL stock dived as clinical trial of hepatitis drug failed 07.6.07
By Shirley Yom-Tov
Shares of triple-listed XTL Biopharmaceuticals (LSE: XTL) dived in London, Tel Aviv and New York yesterday after the company admitted the failure of clinical trials testing a drug to treat hepatitis C, and said it is abandoning development of the drug - XTL-2125.
In Tel Aviv the stock dropped 24% but it clawed back some ground on Nasdaq, starting with a 25% dive but stopping with a loss of 18%.
Specifically, the drug development company advised investors that it will not continue developing XTL-2125 following the sorry results of its first-phase trial.
The trial started a year ago: 56 patients were divided into seven cohorts of eight patients each, some of which received a placebo and some of which were treated with XTL-2125.
The drug was absorbed well into the body, the trial found. It was tolerated, too.
Unhappily, it didn't do a thing to make the patients with the chronic disease any better, from the perspective of reducing their viral load compared with the control group taking the placebo.
"The completion of this Phase I trial concludes our research on the XTL legacy compounds that we inherited," commented CEO Ro Bentsur.
This company is not a one-trick pony, though. Bentsur says it's pinning its hopes on bicifadine, which is undergoing advanced clinical trials for treating neuropathic pain. At the start of the year XTL acquired the rights to the drug from Dov Pharmaceutical for $7.5 million in cash and future payments, depending on milestones.
"We look forward to an exciting rest of 2007, with the initiation of a late-stage clinical trial with Bicifadine in chronic neuropathic pain, and the initiation of IND-enabling studies with a novel hepatitis C inhibitor from the XTL-DOS program. We will also continue to opportunistically seek to broaden our portfolio through the in-licensing and acquisitions of additional clinical stage products," Bentsur stated.
At the end of March, XTL reported positive results from safety tests of another hepatitis C drug, namely XTL-6865. Indeed, it proclaimed the drug safe even at high doses. If the following trials are successful, the drug could play a role in preventing reinfection in the event of liver transplants.
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