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experimentalandunconventional · Experimental and Unconventional - New Therapies for Colon Cancer
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New Trial of fully human monoclonal antibody   Message List  
Reply | Forward Message #1020 of 1454 |
Re: [Experimental and Unconventional] New Trial of fully human monoclonal antibody

Is there anyone here that has taken this drug?

My husband is the lone survivor of 48 weeks of this in
it's 1st run, as far as we know. His met in his liver
is now back and we're either getting compassionate use
of ABX-EGF or Erbitux. Does anyone know how one's
side effects differ from the other?

Tonya

--- Eric Stockel <estockel@...> wrote:
> Abgenix Announces ABX-EGF Enters Pivotal Trial in
> Advanced Colorectal Cancer Patients
>
>
> Business Wire
>
>
> January 20, 2004
>
> Abgenix, Inc. today announced that its partner,
> Amgen, is beginning a pivotal trial for its fully
> human monoclonal antibody, ABX-EGF, as a third-line
> monotherapy in colorectal cancer patients, with
> enrollment expected to begin shortly. The trial
> initiation follows the receipt of a Special Protocol
> Assessment (SPA) letter from the U.S. Food and Drug
> Administration (FDA). The SPA endorses the design of
> the trial to support a regulatory submission for a
> potential accelerated approval. SPA was introduced
> by the FDA modernization act of 1997 and was first
> implemented in May 2002. A second pivotal trial is
> being initiated concurrently outside the US, as part
> of a comprehensive global development program for
> ABX-EGF.
>
> "We are pleased that this important goal has been
> achieved early in the year," said Ray Withy, Ph.D.,
> president and CEO of Abgenix. "We look forward to
> further progress on the program, as ABX-EGF moves
> toward commercialization."
>
> About ABX-EGF
>
> ABX-EGF is a fully human monoclonal antibody that
> targets the epidermal growth factor receptor (EGFr),
> which is expressed in a variety of cancers including
> lung, breast, pancreatic, bladder, prostate,
> colorectal, kidney and head and neck cancers.
> Research has demonstrated that cancer cells can
> become dependent on growth signals mediated through
> EGFr for their survival. In preclinical research,
> ABX-EGF monotherapy has been shown to inhibit the
> growth of human tumors in mice. Clinical studies to
> date have demonstrated single-agent activity and a
> favorable pharmacokinetic and tolerability profile.
>
> Co-developed by Abgenix and Amgen, ABX-EGF is being
> evaluated in a comprehensive global clinical
> program.
>
>
> [Non-text portions of this message have been
> removed]
>
>


=====
Tonya Allen
Creative Memories Consultant
Scrapbooks aren't expensive, they're priceless!

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Fri Mar 19, 2004 2:00 pm

boes_t
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Message #1020 of 1454 |
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Abgenix Announces ABX-EGF Enters Pivotal Trial in Advanced Colorectal Cancer Patients Business Wire January 20, 2004 Abgenix, Inc. today announced that its...
Eric Stockel
areyougonnae...
Offline Send Email
Jan 22, 2004
12:22 am

Is there anyone here that has taken this drug? My husband is the lone survivor of 48 weeks of this in it's 1st run, as far as we know. His met in his liver is...
Tonya Allen
boes_t
Online Now Send Email
Mar 19, 2004
2:00 pm
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