- Phase II PC-DAC(TM):Exendin-4 Data in December -
- PC-Insulin Preclinical Study Results -MONTREAL, Nov. 5 /CNW/ - ConjuChem Biotechnologies Inc. (TSX:CJB)
announced today that dosing is complete for its Phase II clinical trial of
PC-DAC(TM):Exendin-4. This Phase II trial was a randomized, double-blind,
placebo-controlled, multiple dose study that evaluated the efficacy and safety
of three months of weekly injections of PC-DAC(TM):Exendin-4 in patients with
Type 2 diabetes not adequately controlled by metformin monotherapy. The trial
enrolled approximately 120 evaluable patients randomized to one of three
parallel treatment groups: a 1.5mg fixed-dose weekly cohort; a 1.5mg weekly
dose titrating to 2mg at the 5th week cohort; and a placebo group. Top line
data from the trial will be announced in December, 2008.
The Company also announced the results of a preclinical study evaluating
the pharmacodynamics of its PC-Insulin versus Lantus(R) (insulin glargine
(rDNA) injection) after repeated daily subcutaneous administration in
streptozotocin-induced diabetic rats. A similar reduction in blood glucose was
observed with both compounds at 2, 6, and 8 hours after each dose but glucose
levels at 24 hours were only normalized in animals treated with PC-Insulin. In
addition to a superior control of blood glucose, PC-Insulin was more effective
in normalizing physiologic parameters such as water intake in the diabetic
rats.
Commenting on the progress of the PC-Insulin program, Dr. Thomas Ulich,
Executive Vice President, stated, "We are very encouraged with the emerging
profile of PC-Insulin and believe it can achieve our objective of a more
peakless basal insulin with a longer duration of activity." Results of this
study will be submitted for the 2009 American Diabetes Association meeting.
The Company plans to submit an IND in mid-2009.
About PC-DAC(TM):Exendin-4
Exendin-4, like Glucagon-like peptide-1 (GLP-1), is an agonist for the
GLP-1 receptor. The clinical utility of Exendin-4 is limited by its short
half-life in plasma. Developed with ConjuChem's proprietary PC-DAC(TM)
technology, PC-DAC(TM):Exendin-4 is a modified Exendin-4 analogue that is
being developed for Type II diabetes. The Exendin-4 analog is covalently bound
to recombinant human albumin (Recombumin(R), provided by Novozymes Biopharma).
Data from Phase I/II clinical studies have demonstrated that the preformed
albumin-peptide conjugate has a much longer half-life than the peptide alone.
The product is a highly soluble liquid formulation that is injectable in a
small volume ((less than or equal to)0.2ml) with a 31 gauge needle.
About PC-Insulin
PC-Insulin is a basal insulin with potential use in patients with either
Type I or Type II diabetes. PC-Insulin is being developed to have advantages
over basal insulin therapies that may show clinically relevant peak-to-trough
ratios and may also not always provide adequate insulin coverage for the total
24-hour dosing period. Developed with ConjuChem's proprietary PC-DAC(TM)
technology, PC-Insulin is a recombinant insulin that is covalently bound to
recombinant human albumin (Recombumin(R), provided by Novozymes Biopharma).
About ConjuChem Biotechnologies
ConjuChem Biotechnologies, developer of next generation medicines from
therapeutic peptides, is creating long-acting compounds based on its
bioconjugation platform technologies. When applied to peptides, the Company's
systemic DAC(TM) and PC-DAC(TM) technologies enable the creation of new drugs
with significantly enhanced therapeutic properties as compared to the original
peptide. Detailed descriptions of the Company can be viewed on the Company's
website www.conjuchem.com.
Forward-Looking Statements
Some of the statements made herein may constitute forward-looking
statements. These statements relate to future events or our future financial
performance and involve known and unknown risks, uncertainties and other
factors that may cause ConjuChem Biotechnologies' actual results, performance
or achievements to be materially different from those expressed or implied by
any of the Company's statements. Actual events or results may differ
materially. We disclaim any intention, and assume no obligation, to update
these forward-looking statements unless requested to do so by securities
regulators.
For further information: Lennie Ryer, CA, Vice President, Finance & CFO,
ConjuChem Biotechnologies Inc., (514) 844-5558, ext. 224, ryer@conjuchem.com;
James Smith, Investor Relations, (416) 815-0700, ext. 229,
jsmith@equicomgroup.com
