ConjuChem Reports Positive Efficacy and Tolerability Results in Phase II Clinical Trial - DAC(TM):GLP-1 Hits Primary Endpoint in Type 2 Diabetes Trial

- New diluent study producing materially positive results with a
clear increase in tolerability -

MONTREAL, Dec. 15 /CNW/ - ConjuChem Inc. (TSX:CJC) today announced the main results from its Phase II clinical trial that is evaluating the Company's proprietary compound DAC(TM):GLP-1 to treat Type 2 Diabetes in combination with Metformin. The study demonstrated that DAC(TM):GLP-1 significantly reduced blood glucose levels in patients who were on oral anti-diabetic medications, however not in glycemic control. The Company also announced today initial positive results from an ongoing Phase I program evaluating new diluents for DAC(TM):GLP-1 which are being developed to further enhance the drug's tolerability profile and dosing convenience.

"Today's results confirm that DAC(TM):GLP-1 is both highly effective, even at low dose levels, and tolerable - re-establishing this compound's potential to become a best-in-class product," said Dr. Jean Paul Castaigne, Chief Operating Officer of ConjuChem. "As well, there has been encouraging progress in the new diluent study, with a marked improvement in tolerability which holds the promise for an even more convenient dosing regimen."

Phase II Trial Design/Patient Profile

The data from this three-month, double blind, placebo controlled combination therapy trial are from 85 patients (of which 4 were non-evaluable and were excluded from the efficacy analysis for serious protocol violations) who were enrolled in 16 centers across North America (7 in the U.S. and 9 in Canada). Patients were randomized into one of three groups: Metformin plus a
once-per-day "high" dose of DAC(TM):GLP-1 (mean dose attained: 2.60 (+/-) 0.97 mcg/kg), Metformin plus a once-per-day "low" dose of DAC(TM):GLP-1 (mean dose attained: 2.10 (+/-) 1.06 mcg/kg) and Metformin plus a once-per-day dose of placebo. The primary end-point was a comparison of HbA1c levels, a measure of a patient's average three month glucose level, between the active treatment
groups and the placebo controlled group at the end of the treatment period.

Patients were either on Metformin (1,500 to 2,550 mg/day) alone or a Metformin-Sulfonylurea combination, in which case the Sulfonylurea therapy was washed out for 4 weeks prior to randomization. The patient's Metformin dose was unchanged during the course of the study. After randomization, patients were titrated during the first month with the daily dose level attained at the end of the titration period being maintained for the remainder of the trial.

The male to female ratio was 62/38 and other main demographic data at randomization includes:
(n equals 81)
Avg SD
Age - years 56 9
Disease Duration - years 7.4 5.8
HbA1c - % 7.9 0.8
Weight - lbs 203.7 40.7
BMI - kg/m(2) 32.0 4.5

Safety and Tolerability Results

There were no serious drug-related adverse events reported during the study, including no injection site irritations, no modification of blood pressure, no hypoglycemia and no immune reactions. The compound was well tolerated with mild to moderate transient nausea and vomiting observed, which is consistent with the known side-effects of the GLP-1 class of compounds. The
drop out rate due to nausea/vomiting was 8.6% in the active treatment cohorts.

High Low Placebo Total
Drop-out (n equals 30)(n equals 28)(n equals 27)(n equals 85)
Nausea/Vomiting 3 2 0 5 (5.9%)
Other - treatment
related 3 6 5 14 (16.5%)
An additional four (4) patients withdrew from the study for reasons not
related to treatment

Efficacy Results

DAC(TM):GLP-1 treatment led to statistically significant reductions (p less than 0.00002) in reducing mean HbA1c levels compared to placebo. In the high dose cohort, HbA1c levels were reduced by 1.01 percentage points compared to placebo. Ninety percent of the patients in the high dose cohort entered the trial with HbA1c levels in excess of the American Diabetes Association recommended target of 7% or less, despite being treated with one or two oral therapies. Fifty-eight percent (58%) of patients who completed treatment in the high dose cohort and whose entry level HbA1c was greater than
7% (n=19), had their HbA1c reduced to 7% or less. The mean weight loss versus baseline for all patients treated with DAC(TM):GLP-1 was 5.6 lbs.

New Diluent Study

The ongoing Phase I study in both healthy volunteers and patients that is evaluating different diluents to be used in the reconstitution of DAC(TM):GLP-1 is producing materially positive preliminary results. While not yet in a position to draw final conclusions, at doses tested to date a clear reduction in terms of nausea/vomiting and an improvement in the VASn (Visual Analogue Score for evaluating nausea) were observed, as compared to the current diluent and historical data, with no change in efficacy on the control of glucose in patients. Additional cohorts of patients will be dosed in the first quarter of 2005 to complete the program, after which the main results will be reported. Following a comprehensive review of the data from both of these clinical trials, ConjuChem intends to provide details of its go-forward clinical strategy for both the existing formulation and the new diluent program early in the New Year.
The Company will be hosting a conference call to discuss these results on Thursday, December 16th, 2004 at 8:30 a.m. EST. The call will be audio-cast live and archived for 90 days at and

About GLP-1

GLP-1, the body's most potent insulinotropic hormone, is a naturally occurring 36 amino acid peptide. GLP-1 has been shown to normalize blood glucose levels by a) stimulating insulin secretion and lowering glucagons secretion in a glucose-dependent manner; b) delaying gastric emptying; c) induces Beta cell proliferation; d) restores Beta cell sensitivity to glucose;
and e) increases peripheral sensitivity to insulin (glycogen synthesis). Moreover, GLP-1 appears to have an attractive safety profile, with a low probability of inducing hypoglycemia. However, the half-life of native GLP-1, without the benefit of DAC(TM) Technology, is only about 5 minutes, as it is simultaneously degraded by serum enzymes and cleared through renal excretion.

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(TM) 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, obesity and congestive heart failure. Detailed descriptions of the Company, DAC(TM) Technology and ConjuChem's product pipeline can be viewed on the Company's web page

For further information: Dr. Jean-Paul Castaigne, COO, ConjuChem Inc.,
(514) 844-5558 ext 223,; Lennie Ryer, Vice
President, Chief Financial Officer, ConjuChem Inc., (514) 844-5558 ext. 224,; Michael Polonsky, Investor Relations, (416) 815-0700
ext. 231, (416) 815-0080,