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Re: [GIWorld-Hepatitis] Fw: NATAP: NM283, new HCV Oral Drug

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  • avansi7465
    We may be getting somewhere with this one! Fingers and toes are crossed! Anne
    Message 1 of 2 , Dec 23, 2005
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      We may be getting somewhere with this one! Fingers and toes are crossed! Anne

      -----Original Message-----
      >From: Alleypat <alleypat@...>
      >Sent: Dec 20, 2005 10:46 AM
      >To: happy heppers <happyheppers@yahoogroups.com>, GIWorld <GIWorld-Hepatitis@yahoogroups.com>
      >Subject: [GIWorld-Hepatitis] Fw: NATAP: NM283, new HCV Oral Drug
      >
      >
      >
      >NATAP http://natap.org/
      >_______________________________________________
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      >--------------------------------------------------------------------------------
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      >
      >Valopicitabine (NM283) Showing Continued Good Results in Hepatitis C: Presented at HEP DART
      >
      >By Bonnie Darves
      >DG News
      >
      >KOHALA COAST, HI -- December 19, 2005 -- The novel prodrug valopicitabine (NM283) continues to show promise in the treatment of hepatitis C in patients who have been refractory to standard HCV therapy, according to partial 24-week results from an ongoing phase 2b trial.
      >
      >Results from the trial show early virologic response (EVR) in up to 70% of patients who are taking high doses -- 400 to 800 mg daily -- of valopicitabine compared to 41% of controls on pegylated-interferon/ribavirin (peg-IFN/RBV) regimens, researchers reported here at the Frontiers in Drug Development for Viral Hepatitis HEP DART 2005 meeting.
      >
      >"We are seeing statistically superior antiviral effect [with valopicitabine], and overall safety has been satisfactory to date," said Christopher O'Brien, MD, Clinical Associate Professor of Medicine, University of Miami, Miami, Florida, in a presentation on December 13th. "There have been no viral breakthroughs to date."
      >
      >The "very encouraging early data" prompted Dr. O'Brien and colleagues to extend the trial to 48 weeks.
      >
      >The multicenter trial, which includes 178 patients, is interesting in several regards, Dr. O'Brien said. Stringent inclusion criteria require that participants be non-responders who have failed previous treatment "for efficacy, not for tolerability," he noted.
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      >For inclusion in the study, participants must have received at least 12 weeks of peg-IFN/ribavirin and at least 75% of the prescribed dose of both drugs. To remain in the current trial, patients also must meet mandatory response criteria at weeks 4, 12 and 24, a HCV RNA 0.5 log drop (1 IU/mL) by week 4, a 1.0 drop by week 12 and a 2.0 log drop by 24 weeks.
      >
      >"If patients did not meet the response criteria they were discontinued from the trial," Dr. O'Brien said.
      >
      >Patients were randomised 1:2:2:2:2, to receive valopicitabine alone, valopicitabine plus peg-IFN (400 mg, 400-800 ramping dose and 800 mg) or peg-IFN plus ribavirin in the re-treatment control group.
      >
      >Dr. O'Brien explained that the study population is unusual in that it includes a large number of Asians, Middle Easterners and Indians.
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      >The best results, as measured by HCV RNA levels, were seen in the two high-dose valopicitabine groups, who achieved -3.8 and -3.5 log10 copies/mL decreases, compared to 3 to 0.5 in the control arm.
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      >"We find these numbers encouraging because the drops appear to be continuing down from week 12 to 24," Dr. O'Brien said.
      >
      >"The consistency of response seen in the individual patient data in the valopicitabine combination arms compared to the control arm suggests that the differential in viral load reductions may continue to widen in favor of the valopicitabine combination arms as treatment progresses," he added.
      >
      >Four percent of participants discontinued treatment for serious adverse events and there were no hematologic toxicities for valopicitabine monotherapy. Neutropenia and thrombocytopenia, as expected, occurred in all arms on peg-IFN, Dr. O'Brien said.
      >
      >Transient nausea and vomiting were common in patients on high doses of the study drug but not severe enough to warrant discontinuation, he said.
      >
      >DATA REPORTED AT AASLD NOV 2005
      >NM283 +Pegasys for Nonresponders: phase II 12 weeks
      >(11/28/05)
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      >
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