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FW: NATAP: New Peg-Intron Maintenance Study

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  • alleypat
    New Peg-Intron Maintenance Study Press announcement today from Schering Plough. There is a symposium at the Coinfection Workshop, where I am now, tomorrow
    Message 1 of 1 , Jan 15, 2006
      New Peg-Intron Maintenance Study

      Press announcement today from Schering Plough. There is a symposium at the
      Coinfection Workshop, where I am now, tomorrow morning discussing this



      AMSTERDAM, Netherlands, Jan. 13, 2006 - Schering-Plough announced today that
      it is initiating a large multinational clinical trial to evaluate the use of
      low-dose PEG-INTRON (peginterferon alfa-2b) maintenance monotherapy in
      preventing or delaying hepatitis C disease progression and thus potentially
      reducing the occurrence of clinical events such as liver transplantation,
      liver cancer and death in cirrhotic patients with hepatitis C who are
      coinfected with HIV. Known as the ENDURE study, the trial is targeted to
      enroll 448 patients at approximately 80 sites worldwide, including centers
      in the United States, Europe and Canada.

      Approximately one third of HIV patients, or about 10 million people
      worldwide, are coinfected with the hepatitis C virus (HCV) and HIV.1 Liver
      disease caused by chronic hepatitis C is now a leading cause of morbidity
      and mortality among HIV-infected patients in the developed world.2,3
      Furthermore, studies have shown that HCV can aggravate the course of HIV

      bThe principal goal for treating patients infected with hepatitis C is
      viral eradication, with pegylated interferon and ribavirin combination
      therapy being the current standard of care. However, many coinfected
      patients fail to respond to this combination therapy and there currently is
      no approved treatment for such patients. Until more effective HCV agents
      such as protease and polymerase inhibitors are available, it is critically
      important to try to prevent or delay progression of liver disease in these
      patients,b said Mark S. Sulkowski, M.D., associate professor of medicine in
      the Division of Infectious Diseases, Johns Hopkins University School of
      Medicine, Baltimore, USA, and co-lead investigator of the study.

      bAnother patient group that may benefit from low-dose PEG-INTRON
      maintenance monotherapy is cirrhotic patients with coinfection who are
      ineligible for combination therapy due to contraindications to ribavirin or
      who simply cannot tolerate full-dose combination therapy,b added co-lead
      investigator Massimo Puoti, M.D., associate professor in the Department of
      Infectious Diseases, University of Brescia, Italy, directed by professor G.
      Carosi. bThe purpose of the ENDURE study is to address this question with
      a large, randomized, controlled clinical study.b

      Study Design

      ENDURE is a randomized, open-label, multicenter, Phase III, parallel-group
      clinical study evaluating the efficacy and safety of maintenance therapy
      with low-dose PEG-INTRON (0.5 mcg/kg once weekly) versus standard supportive
      care in patients with cirrhotic hepatitis C who are coinfected with HIV.
      The primary objective of the study is to compare efficacy for the two
      treatment groups at the end of the study, using the time to any of the
      following clinical events as primary endpoints: death, liver decompensation,
      liver transplant or liver cancer (hepatocellular carcinoma). All patients
      will be enrolled within the first 12 months of this 36-month study and
      treated until the end of the study or until a clinical event occurs.
      Written informed consent will be obtained and all other regulatory
      requirements adhered to for all patients participating in the study.

      The ENDURE study is consistent with Schering-Plough's research strategy to
      conduct and support clinical studies with weight-based PEG-INTRON therapy,
      particularly in hepatitis patients with difficult-to-treat forms of the

      bAlthough we have made great advances over the past decade in the effective
      treatment of chronic hepatitis C, one of the most common blood-borne
      infections in the world, improved treatment options are still neededb said
      Robert J. Spiegel, M.D., chief medical officer and senior vice president of
      medical affairs, Schering-Plough Research Institute. bSchering-Plough is
      undertaking studies with our existing hepatitis C products to explore new
      approaches to treatment, including maintenance therapy with our ongoing
      EPIC3 study5 in HCV patients and the new ENDURE study in coinfected
      patients, while at the same time developing new antiviral agents such as our
      investigational hepatitis C protease inhibitor.6 These research efforts
      underscore our long-term commitment to this therapeutic area and the
      hepatitis community.b

      About PEG-INTRON
      PEG-INTRON is approved in the United States as monotherapy and for use in
      combination therapy with REBETOLB. (ribavirin, USP) for the treatment of
      chronic hepatitis C in patients with compensated liver disease who are at
      least 18 years of age, and is not approved for treatment of patients who are
      coinfected with HCV and HIV.

      PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton
      polyethylene glycol (PEG) molecule, is a once-weekly therapy dosed according
      to patient body weight that is designed to achieve an effective balance
      between antiviral activity and elimination half-life.

      Important Safety Information Regarding U.S. Labeling for PEG-INTRON and

      Alpha interferons, including PEG-INTRON, cause or aggravate fatal or
      life-threatening neuropsychiatric, autoimmune, ischemic, and infectious
      disorders. Patients should be monitored closely with periodic clinical and
      laboratory evaluations. Patients with persistently severe or worsening
      signs or symptoms of these conditions should be withdrawn from therapy. In
      many but not all cases these disorders resolve after stopping PEG-INTRON

      Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy
      may exacerbate cardiac disease that has led to fatal and nonfatal myocardial
      infarctions. Patients with a history of significant or unstable cardiac
      disease should not be treated with REBETOL. It is advised that complete
      blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy
      or more frequently if clinically indicated.

      REBETOL and combination REBETOL/PEG-INTRON therapy must not be used by
      women, or male partners of women, who are or may become pregnant during
      therapy and during the 6 months after stopping therapy. REBETOL and
      combination REBETOL/PEG-INTRON therapy should not be initiated until a
      report of a negative pregnancy test has been obtained immediately prior to
      initiation of therapy. Women of childbearing potential and men must use
      effective contraception (at least two reliable forms) during treatment and
      during the 6-month post-treatment follow-up period. Significant teratogenic
      and/or embryocidal effects have been demonstrated for ribavirin in all
      animal species in which adequate studies have been conducted. These effects
      occurred at doses as low as one twentieth of the recommended human dose of
      REBETOL. If pregnancy occurs in a patient or partner of a patient during
      treatment or during the 6 months after treatment stops, physicians are
      encouraged to report such cases by calling (800) 727-7064.

      There are no new adverse events specific to PEG-INTRON as compared to INTRON
      A (interferon alfa-2b, recombinant) for Injection, however, the incidence of
      some (e.g., injection site reactions, fever, rigors, nausea) were higher.
      The most common adverse events associated with PEG-INTRON were bflu-likeb
      symptoms, occurring in approximately 50% of patients, which may decrease in
      severity as treatment continues. Application site disorders were common
      (47%), but all were mild (44%) or moderate (4%) and no patient discontinued,
      and included injection site inflammation and reaction (i.e., bruise,
      itchiness, irritation). Injection site pain was reported in 2% of patients
      receiving PEG-INTRON. Alopecia (thinning of the hair) is also often
      associated with alpha interferons including PEG-INTRON.

      Psychiatric adverse events, which include insomnia, were common (57%) with
      PEG-INTRON, but similar to INTRON A (58%). Depression was most common at
      29%. Suicidal behavior including ideation, suicidal attempts, and completed
      suicides occurred in 1% of patients during or shortly after completing
      treatment with PEG-INTRON.

      PEG-INTRON/REBETOL is contraindicated in patients with autoimmune hepatitis,
      decompensated liver disease, and in patients with hemoglobinopathies (e.g.,
      thalassemia major, sickle-cell anemia).

      The following serious or clinically significant adverse events have been
      reported at a frequency less than or equal to 1% with PEG-INTRON or
      interferon alpha: Severe decreases in neutrophil or platelet counts,
      hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and
      hemorrhagic colitis, development or exacerbation of autoimmune disorders
      including thyroiditis, RA, systemic lupus erythematosus, psoriasis,
      pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and
      pneumonia, some resulting in patient deaths), urticaria, angioedema,
      bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool

      In the PEG-INTRON/REBETOL combination trial the incidence of serious adverse
      events was 17% in the PEG-INTRON/REBETOL groups compared to 14% in the
      INTRON A/REBETOL group. The incidence of severe adverse events in the
      PEG-INTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL
      group and 31-34% in the PEG-INTRON/REBETOL groups. Dose reductions due to
      adverse reactions occurred in 42% of patients receiving PEG-INTRON (1.5
      mcg/kg)/ REBETOL and in 34% of those receiving INTRON A/REBETOL.

      REBETOL should not be used in patients with creatinine clearance less than
      50 mL/min.

      Schering-Plough Corporation is a global science-based health care company
      with leading prescription, consumer and animal health products. Through
      internal research and collaborations with partners, Schering-Plough
      discovers, develops, manufactures and markets advanced drug therapies to
      meet important medical needs. Schering-Plough's vision is to earn the trust
      of the physicians, patients and customers served by its more than 30,000
      people around the world. The company is based in Kenilworth, N.J., USA, and
      its Web site is www.schering-plough.com.

      SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release
      includes certain bforward-looking statementsb within the meaning of the
      Securities Litigation Reform Act of 1995, including statements relating to
      PEG-INTRON and the potential market for drugs that treat hepatitis.
      Forward-looking statements relate to expectations or forecasts of future
      events. Schering-Plough does not assume the obligation to update any
      forward-looking statement. Many factors could cause actual results to
      differ materially from Schering-Plough's forward-looking statements,
      including market forces, economic factors, product availability, current and
      future branded, generic or over-the-counter competition and the regulatory
      process, among other uncertainties. For further details about these and
      other factors that may impact the forward-looking statements, see
      Schering-Plough's Securities and Exchange Commission filings, including the
      company's third quarter 2005 10-Q.

      1. Rockstroh J, Mocroft A, Soriano V, et al. Influence of hepatitis C
      coinfection on HIV disease progression within the EuroSIDA cohort for the
      EuroSIDA study group. 9th European AIDS Conference (EACS), Warsaw, 2003;
      2. Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA,
      et al. Declining morbidity and mortality among patients with advanced human
      immunodeo,ciency virus infection. HIV Outpatient Study Investigators. N
      Engl J Med 1998; 338:853-860.
      3. Sulkowski M, Thomas D. Hepatitis C in the HIV-infected person. Ann Intern
      Med 2003; 138:197-207.
      4. Fischer HP, Willsch E, Bierhoff E, Pfeifer U. Histopathologic findings in
      chronic hepatitis C. J Hepatol. 1996;
      24 (2 suppl) 35-42.
      5. EPIC3 (Evaluation of PEG-INTRON in Control of Hepatitis C Cirrhosis), a
      large multicenter, multi-part treatment and maintenance therapy clinical
      study involving nearly 4,000 patients at approximately 140 sites worldwide.
      Schering-Plough Research Institute.
      6. SCH-503034, an investigational oral HCV NS3 protease inhibitor,
      Schering-Plough Research Institute.


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