XTLbio - XTL Provides Update on Phase I Clinical Trial of XTL-2125
Wednesday June 6, 2:53 am ET
VALLEY COTTAGE, New York, June 6 /PRNewswire-FirstCall/ -- XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB; LSE: XTL; TASE: XTL) 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).
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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."
I suppose this failure could have been foreseen by a mgmnt who then decided it would be best for them to bolster the pipleline w/ Bicifadine from DOVP.
NEW YORK, NEW YORK, 16 January 2007 - XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, LSE: XTL, TASE: XTL) announced today that, through a wholly-owned subsidiary, it has signed an agreement with DOV Pharmaceutical, Inc. (PS: DOVP.PK) to in-license the worldwide rights for Bicifadine, a serotonin and norepinephrine reuptake inhibitor (SNRI).
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