New Hep C Drug: XTLbio Receives Fast Track Designation for Hepatitis C
Therapy from US Food and Drug Administration
Rehovot, Israel, 18 July 2005 - XTL Biopharmaceuticals Ltd ("XTLbio") (LSE:
XTL) today announced that it has received Fast Track designation from the
United States Food and Drug Administration for XTL-6865 (formerly known as
HepeX-C). Fast Track designation is granted to facilitate the development
and expedite the regulatory review of new drugs that are intended to treat
serious or life threatening conditions and that demonstrate the potential to
address unmet medical needs. XTL-6865 is being developed to prevent
hepatitis C (HCV) re-infection following a liver transplant and for the
treatment of chronic HCV disease. The Fast Track designation was limited by
the Agency to the post-transplant indication.
XTL-6865 is a combination of two fully human monoclonal antibodies (Ab68 and
Ab65) against the hepatitis C virus E2 envelope protein. A single antibody
version of this product was tested in a pilot clinical program that included
both Phase I and Phase II clinical trials. In April 2005, XTLbio submitted a
US investigational new drug application (IND) to the FDA in order to
commence a Phase Ia/Ib clinical trial later this year for XTL-6865, the
dual-MAb product.
A Biologics License Application (BLA) is submitted before a drug is approved
for marketing by the FDA. Fast track designation gives XTLbio the
opportunity to submit a BLA for XTL-6865 in sequential sections, and to have
these sections reviewed as they are submitted. Fast track designation also
opens the possibility for receiving a priority review or accelerated
approval of the BLA where the review time at the Agency would be six months,
further reducing the time to market.
Michael Weiss, Interim Non-Executive Chairman, commented:
"The designation of XTL-6865 as a Fast Track programme recognises the need
for new forms of treatment for patients with recurrent HCV following a liver
transplant."
cilibrar - 23 Jul 2005 14:55 GMT
This drug is also mentioned on my website,
http://hcvaction.org/
in the Research News. Let's get this info outside the HCV community where
it can do even more good! We need attention before we can get the money we
need to live. Remember what happened with peg inf being delayed 2 years in
the USA on approval. Attention is key, outside the community of
sufferers!!
Cheers
Rudi
elmoemerson@webtv.net - 23 Jul 2005 15:25 GMT
Re: New Hep C Drug: XTLbio Receives Fast Track Designation
Group: alt.support.hepatitis-c Date: Sat, Jul 23, 2005, 9:55am (CDT+1)
From: cilibrar@gmail.com (cilibrar)
This drug is also mentioned on my website,
http://hcvaction.org/
in the Research News. Let's get this info outside the HCV community
where it can do even more good! We need attention before we can get the
money we need to live. Remember what happened with peg inf being delayed
2 years in the USA on approval. Attention is key, outside the community
of sufferers!!
Cheers
Rudi
//////////
Rudi, there are already hcv advocy groups here in the USA. Perhaps your
efforts would have more exposure and meaning if you joined one of them.
One strong voice will have more effect than twelve little ones, such as
you and your website.
Go get em, man!!
Elmo
(I'm behind you all the way.....ahahahahahahahahaha!!!!)
http://community.webtv.net/elmoemerson/DocElmosHepFile
http://community.webtv.net/elmoemerson/TheFamilyAlbum