CONJUCHEM DEVELOPS
NEW PLATFORM, PC-DAC FIRST CLINICAL CANDIDATE, PC-DACTM:EXENDIN-4, TO ENTER
CLINIC IN Q1 2006
Montreal,
Canada, August 24, 2005
ConjuChem Inc. (TSX: CJC)
today announced that it will be progressing into clinical development the first
compound from its new platform technology, PC-DAC (Pre-formed Conjugate-Drug Affinity Complex). Pre-formed
conjugates represent a natural extension of ConjuChems core DAC platform
technology, and builds on the Companys considerable albumin bonding expertise
and intellectual property. Both DAC peptides and now PC-DAC peptides are
designed to retain the therapeutic activity of the original peptides, with a
much longer duration of activity.
In-vitro bioconjugation for developing Pre-formed Conjugates has only become a viable
option recently for ConjuChem in human applications because previously the only
available albumin was purified from human serum. Despite its abundance, this
human derived source of albumin cannot be used as part of a drug product due to
safety concerns inherent to the source. ConjuChem selected Delta Biotechnology
Ltd.s Recombumin® as its GMP-grade human recombinant albumin
source due to its clear leadership in the field.
Developed
to complement the original core DAC Technology, PC-DAC is intended to
create new therapeutic opportunities for ConjuChem. One of the principal
advantages of PC-DAC technology is that it ensures that essentially all DAC
peptide is bound to cysteine 34 of albumin. Based on pre-clinical data generated
to date the Company expects a significant improvement in tolerability which will
allow for less frequent dosing (up to a week or more) when the dose might
otherwise be limited due to side effects with the in-vivo technology. .
The
initial PC-DAC project candidates are PC
-DAC:Exendin-4 and PC-DAC:Insulin. The Company expects to dose its first patients with PC
-DAC:Exendin-4 in Q1 2006 . The pre-clinical studies have produced
very encouraging data, showing a significantly longer duration
of action and an improved tolerability profile for PC-DAC:Exendin-4 as
compared to Exendin-4. This data
supports a human dosing interval of once a week or longer. PC-DAC:Exendin-4
is expected to be stable in an injectable solution at room temperature, thus
being highly convenient for patients. The additional costs associated with Recombumin® are offset by the fact that
the product is stable in solution and will not require lyophilization
Combining
DAC peptides with albumin before injection, thereby creating PC-DAC
Peptides, allows the DAC Technology to be applied to a broader range of
therapeutic peptides, including those which were difficult to develop through an in vivo bioconjugation approach, said Dr. Jean-Paul Castaigne, Chief
Operating Officer of ConjuChem. With our first clinical candidate, PC-DAC:Exendin-4,
we expect to see a long-acting compound with an excellent tolerability and
safety profile, including minimal to no nausea and improved immunogenicity when
compared to other exendin-4 peptides not bound to albumin.
As
well, the Company intends to initiate a Phase 2 study for DAC:GRF in Q4 2005,
Conjuchems second compound in development using its in-vivo bioconjugation
technology. The initial indications in adults will be HIV lipodystrophy and
visceral obesity with metabolic syndrome and GHD in children. The drug product
will be administered once a week in the first trial and subsequent trials will
investigate longer dosing intervals.
Recombumin®
was developed by Delta Biotechnology Ltd. to prevent transmission of viruses or
prions from human donor to
About
ConjuChem
ConjuChem,
developers of next generation medicines from therapeutic peptides, is creating
long-acting compounds based on bioconjugation platform technologies. When
applied to peptides, the Company's systemic DAC Technology enables the
creation of new drugs with significantly enhanced therapeutic properties as
compared to the original peptide. The Company is developing compounds to treat
various disorders including diabetes, human growth deficiencies, HIV/AIDS, and
congestive heart failure.
Detailed
descriptions of the Company can be viewed on the Company's website www.conjuchem.com.
About
Delta Biotechnology Ltd
Delta
Biotechnology Ltd, a wholly owned subsidiary of Sanofi-Aventis, is based in