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Celgene Corporation Message Board

  • Rob_Cos Rob_Cos Nov 24, 1998 8:37 AM Flag

    SelCids for Crohns

    Celgene Corporation Files SelCID(TM)
    IND as Possible Treatment for Crohn's

    Phase II Clinical Trials to be Launched at Cedars-Sinai
    Medical Center in Los Angeles

    WARREN, N.J., Nov.
    24 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG
    - news) announced today that the
    Company, has
    filed an Investigational New Drug (IND) application to
    the Food and Drug Administration (FDA) for its
    Selective Cytokine Inhibitory Drug (SelCID�) CDC 801, for
    the treatment of Crohn's Disease. Celgene anticipates
    that it will
    soon initiate Phase II clinical trials
    of CDC 801 at the Cedars-Sinai Medical Center in Los

    ``Results of earlier Crohn's Disease
    trials inhibiting TNF yielded highly promising results,
    even in patients with severe disease.
    experience afforded an excellent foundation for pursuing
    drugs such as CDC 801,'' said Stephan Targan, M.D.,
    of the Division of Gastroenterology and the
    Inflammatory Bowel Disease Center at Cedars-Sinai, and lead
    investigator on the
    planned Phase II trial.

    Extensive preclinical studies determined that SelCIDs are
    selective, potent inhibitors of the overproduction of tumor
    factor (TNF). TNF is a cytokine that causes a
    destructive immune response implicated in the pathology of
    several prevalent
    inflammatory diseases, including
    Crohn's Disease. A multiple oral dose Phase I study of
    CDC 801 found that the agent was
    well tolerated.

    ``In the laboratory, the SelCIDs have an apparent
    dramatic and sustained effect on TNF overproduction. Many
    patients with
    Crohn's Disease have TNF overproduction
    in the gut lining,'' said Dr. Targan.

    Crohn's and Colitis Foundation of America (CCFA)
    estimates that between one and two million Americans suffer
    Crohn's and related inflammatory bowel disease. Incidence
    rates for Crohn's Disease have significantly increased
    in the 60
    years since it was first described,
    according to the CCFA. Economic costs for Crohn's Disease
    and ulcerative colitis are
    estimated at between
    $1.8 and $2.6 billion per year.

    ``Filing of
    the IND and the pending Phase II evaluation of CDC
    801 are major milestones for our SelCIDs program, and
    our Company's development,'' said Sol J. Barer,
    Ph.D., President and COO of Celgene. ``We are excited
    that our novel
    SelCID product portfolio has made
    such rapid and continual progress. The SelCID family
    is poised to offer substantial
    commercial and
    medical opportunities as it moves through development and
    clinical evaluation.'' Celgene has already filed
    than 20 patents worldwide related to SelCIDs; eight
    have issued in the U.S., all covering novel structural
    families of

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    • Concerning Celgene history, including insider
      activity, I just didn't know about the contents of your
      message. Its funny, but on some subjects I am adolescent
      in my knowledge. But unlike when I was a genuine
      adolescent, rather than challenge better information from a
      more knowledgable source, I appreciate your efforts to
      set the community straight.

      But even if they
      bought Celgene stock to make more money, I am sure they
      are really sitting on the board because they see the
      great good that they can contribute with their
      executive experience and outstanding skills.

      I have
      been fortunate enough to work with several brilliant
      people over the years, and I appreciate the insight and
      wisdom that a truely gifted mind can contribute to the
      efforts of average folks and how their guidance can cut
      down an insurmountable problem to a mere distraction.
      And then I always kick myself and ask, "Why didn't I
      think of that?"

      moranpicks -- you must not be
      hooked on chocolate like me!!!

      Thanks again.

    • i would like to sell my celg in the am for 9.5 ,so i will post as isld-so for all of you who love this stock -help someone out who got burned this summer during the runup-thnx

    • Thanks for your replies. While past buying is
      nice & I can certainly understand that some people as
      enzyman says are in it for the good they can do, I still
      feel that shareholders would have felt real comfort if
      when the stock tanked down to 4 & change a few months
      back, had the insiders shown some support at that low
      level. There are several biotech stocks that I follow,
      that have shown serious insider buying despite their
      total holdings & options. And, I might add that the
      stock price after insider buying generally is higher a
      short time later. A vote of confidence is what we are
      looking for.
      On the flip side, maybe the company has
      been involved in top secret negotiations for the past
      6 months & insiders have been barred from buying on
      "inside information" . Just Hoping.

    • The SelCID IND is an exciting development for the
      CELG pipeline, but does this mean that there will be
      no further studies of thalidomide for inflammatory
      bowel disorders? Will CELG run concurrent Phase 2

      Also, does anyone know the actual design/results of the
      SelCID Phase 1 (or where they will be published)? And
      when will the new studies begin?


      • 2 Replies to peasmoo
      • CELG will continue to develop thalidomide, IMIDs
        and SelCIDs for every indication in which they appear
        to be therapeutic. There are currently thalidomide
        trials ongoing in Crohn's, RA and various cancers.
        Thalidomide is on the market now and they have to maximize
        its value - there is no certainty that either the
        IMIDs or SelCIDs will ever be approved. The same group
        that is conducting this SelCIDs trial conducted a
        pivotal Crohn's trial for Centocor's Remicade, and also
        for thalidomide. They alone know the results of the
        thalidomide trial and will publish them next spring. I would
        guess that the SelCIDs results are a year or more away.
        But the fact that Cedars is conducting this trial
        tells me that they believe that thalidomide and the
        SelCIDs can be far more potent that Remicade. The Phase I
        trial for the SelCIDs was completed about a year ago.
        It was only a safety trial. Healthy adult males took
        the SelCID over a few weeks in doses up to one gram
        (10-20 times the likely eventual dosage) and found the
        drug to be safe and produce no meaningful side
        effects. This is the first efficacy trial of a SelCID.

      • My guess is they'll promote every TNF inhibitor they've got. This TNF stuff is really red hot in the medical field. I'm still wondering when the stock price will reflect this enthusiasm.

98.07+0.37(+0.38%)Oct 24 4:00 PMEDT