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Fwd: NATAP: New Hep C Drug Study for Nonresponders

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  • claudine intexas
    nataphcv@natap.org wrote:Date: Thu, 11 Aug 2005 15:13:35 EDT To: nataphcv@natap.org, nataphcvhiv@natap.org, natapdoctors@natap.org, natapindustry@natap.org CC:
    Message 1 of 1 , Aug 11, 2005
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      nataphcv@... wrote:Date: Thu, 11 Aug 2005 15:13:35 EDT
      To: nataphcv@..., nataphcvhiv@...,
      natapdoctors@..., natapindustry@...
      CC:
      From: nataphcv@...
      Subject: NATAP: New Hep C Drug Study for Nonresponders

      NATAP http://natap.org/
      _______________________________________________
      Phase I Study New Hep C Drug for Peg/RBV Nonresponders

      Peregrine Pharmaceuticals' anti-viral Phase 1 trial is designed to evaluate the safety of escalating doses of Tarvacin in patients with chronic Hepatitis C virus infection.

      Below is a summary of the trial parameters:

      Tarvacin is a monoclonal antibody designed for solid-tumor cancers.
      http://www.tarvacin.com

      Protocol Title:
      A Phase I Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody (Tarvacin™) in Patients Chronically Infected with Hepatitis C Virus (HCV) who are Non-responders or Relapsers after Treatment with Pegylated Interferon plus Ribavirin

      Contact Information
      Karen Roberts, MS 714.508.6035 kroberts@...

      PHASE I STUDY SITE
      Bach & Godofsky, MD, PA, Bradenton, Florida, 34205, United States; Recruiting
      Mickey Mays, RNMS, ARNP 941-746-2711 Ext. 39
      Eliot W Godofsky, MD, Principal Investigator

      Phase: I
      Indications: Chronic Hepatitis C virus (HCV) Infection

      Objectives:
      --Determine safety and tolerability
      --Characterize blood pharmacokinetics and viral kinetics
      --Define the maximum tolerated dose (MTD) and/or maximum effective dose (MED)

      Selected Eligibility Criteria:

      Inclusion
      --Must be 18 years of age
      --Chronic HCV infection based on medical history and detectable serum HCV RNA

      --Failure to respond to or relapse after treatment with pegylated interferon plus ribavirin

      Exclusion
      --No prior exposure to any chimeric antibody
      --No decompensated clinical liver disease or cirrhosis or other cause of liver disease such as alcoholic liver disease
      --No uncontrolled intercurrent disease
      --No requirement for chronic daily treatment with NSAIDs, anti-platelet drugs or steroids
      --Must not be pregnant or nursing
      --No prior thrombotic or hemorrhagic disorders
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