MONTREAL, Feb. 9 /CNW/ - ConjuChem Biotechnologies, Inc. (TSX:CJB)
announced final results today confirming that PC-DAC(TM):Exendin-4 achieved
statistically significant glycemic control and weight loss in Phase II
clinical trials in Type 2 diabetes.
The final data confirmed the previously reported statistically
significant reductions in HbA1c versus both baseline and placebos seen in all
active treatment groups throughout the treatment period. The most robust
reduction in HbA1c attained was 1.4% versus baseline in the highest dosing
Mean weekly glucometer readings, measuring fasting glucose each day
during the last week of treatment, demonstrated a dose response. Decreases
from baseline of 18 mg/dL, 24 mg/dL and 33 mg/dL were noted for the 1.5 mg,
pooled 2 mg, and 3 mg cohorts, respectively, versus the decrease of 3 mg/dL
for the pooled placebo groups.
Also confirmed were the previously reported statistically significant
weight losses of up to 2.0 kg versus baseline weight. When a single placebo
outlier who experienced an extreme weight loss of 14 kg is excluded, the
weight loss of 2.0 kg was also statistically significant versus the pooled
The two Phase II trials were randomized, double-blind,
placebo-controlled, multiple dose studies that evaluated the efficacy and
safety of three months of weekly or twice-weekly injections of
PC-DAC(TM):Exendin-4 in patients with Type 2 diabetes not adequately
controlled by metformin monotherapy. In the first trial, 144 ITT patients were
randomized to one of three parallel treatment groups: a 1.5 mg per week
cohort; a 1.5 mg per week cohort titrating to 2 mg per week after one month;
and a placebo cohort. In the second trial, 80 ITT patients were randomized to
one of three parallel treatment groups: a 1.5 mg twice-weekly cohort titrating
to 2 mg per week after one month; a 3 mg (1.5 mg twice per week) cohort; and a
placebo cohort. Since the two trials had the same entry criteria and study
assessments, an integrated analysis was also performed, pooling the placebos
and 2 mg groups, respectively.
The final data also confirmed that the drug was extremely well tolerated.
The drug-related nausea, vomiting and diarrhea rates across all treatment arms
in both trials were 23%, 11%, and 10% respectively, versus 10%, 6%, and 8% in
the placebo groups. There were no reports of pancreatitis or drug-related
serious adverse events (SAEs). There was no evidence of increased
cardiovascular risks as measured by pulse, blood pressure, lipid profile and
ECGs, or cardiac adverse events.
Each dose was easily given in a small volume ((less than or equal
to)0.2ml) with a fine needle (31 gauge). Total adverse events (AEs) relating
to the injection site were 8% for all treated patients versus 17% for placebo
Antibodies to the study drug were confirmed in 16% of treated patients
across the two trials. The antibody response disappeared in 4% of these
patients by the end of the one-month follow-up. There was no statistically
significant effect of antibody on the reduction of HbA1c.
Pharmacokinetic analysis showed that the drug attained steady state
levels in a dose-proportional fashion.
ConjuChem has submitted an abstract of the study results to the American
Diabetes Association (ADA) Scientific Sessions 2009.
Exendin-4, like Glucagon-like peptide-1 (GLP-1), is an agonist for the
GLP-1 receptor. The clinical utility of native 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 analog that is being
developed for Type II diabetes. The Exendin-4 analog is covalently bound to
recombinant human albumin (Recombumin, 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 and efficacy 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 and is stable in prefilled syringes at room temperature for a minimum
of one month.
ConjuChem, developer 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 PC-DAC(TM)
technologies enable the creation of new drugs with significantly enhanced
therapeutic properties as compared to the original peptide.
The Company has two major development programs: PC-DAC(TM):Exendin-4, a
GLP-1 agonist in Phase II and PC-Insulin, a long-acting basal insulin in
Detailed descriptions of the Company and its technologies can be viewed
on the Company's website www.conjuchem.com.
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's 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
For further information:
For further information: Lennie Ryer, CA, Vice President, Finance & CFO,
ConjuChem Biotechnologies Inc., (514) 844-5558 ext 224, firstname.lastname@example.org;
James Smith, Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080,