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
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
inflammatory diseases, including
Crohn's Disease. A multiple oral dose Phase I study of
CDC 801 found that the agent was
``In the laboratory, the SelCIDs have an apparent
dramatic and sustained effect on TNF overproduction. Many
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.
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
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
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.
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 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
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?
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.