ConjuChem Reports Positive Interim Phase II DAC:GLP-1 Results- Statistically significant data in key efficacy parameters -
Montreal, Canada, April 12, 2004 - ConjuChem Inc. (TSX:CJC) today announced interim results from its ongoing monotherapy Phase II clinical trial that is evaluating the Company's proprietary compound DAC:GLP-1 to treat Type 2 Diabetes.
"All of the data available from patients who have completed the first 28 days therapy in this study substantiates the results seen in our Phase I/II multi-dose trial with a much larger population of patients that more closely resemble typical patients with Type 2 diabetes," said Dr. Jean Paul Castaigne, Chief Scientific Officer and Vice President of ConjuChem. "In particular, to observe a 0.8% reduction of HbA1c (A1c) after only a month of monotherapy with DAC:GLP-1 is very encouraging."
Trial Design/Patient Profile
This Phase II monotherapy trial began in October 2003 and has been designed to assess the compound's effectiveness in reducing glucose levels as measured by multiple parameters including A1c after three months of treatment and to assist in determining the optimum subcutaneous dosage regimen for this drug. The study will also evaluate the drug's impact on weight control. This international trial has centers in the United States, Canada and Europe.
Inclusion in the study required each patient to have an A1c level greater than 7.5%. The vast majority of these patients were on one or two oral anti-diabetic medications and in need of further medical intervention. The trial has now completed enrolment at 196 patients, all of whom were washed out of all oral medications for 15 days prior to receiving DAC(tm):GLP-1. The male to female ratio is 60/40, the mean age for the study population is 58±10 years and the mean duration of disease is 5.9±3.3 years. The mean A1c level at the time of inclusion in the study was 8.7±0.9% with an average basal fasting glucose level of 11.2±2.5 mmol/l. Both of these values are significantly higher than those recorded in the preceding Phase I/II multi-dose trial and reflect the more severely diseased patient profile of this monotherapy Phase II trial.
The trial has two principle stages. Stage one (titration stage) entailed each patient receiving, for 28 days, escalating daily doses of DAC:GLP-1 in a monotherapy protocol to safely build a targeted plasma concentration of the drug in a patient. After this initial 28 day period, each patient is subsequently randomized into one of five dosing cohorts (administration once a day, three times a week, twice a week, once a week, no treatment) in the 60-day second stage of the trial (maintenance stage). The data reported on today only addresses results from the titration stage of the trial.
>From a safety perspective, the results to date are entirely consistent with the results from the Company's Phase I/II multi-dose trial. The compound has been well tolerated with no serious adverse events reported. Specifically, there has been no injection site irritation, no modification of blood pressure and no immune reaction. Consistent with side-effects seen with the GLP-1 class of compound, some mild to moderate transient nausea and vomiting was observed. However, treatment guidelines were developed that, in almost all cases, effectively controlled these side-effects. From an efficacy perspective, of the 100 patients that have completed the titration stage of the protocol, an analysis of the interim data available to date from more than 80 patients reveals the following results:
· A highly statistically significant reduction of A1c levels was observed at this early stage of analysis (mean of 0.8%, p value = 0.001); Glucose normalization or a therapeutically meaningful improvement as measured by A1c levels achieved in 80% of the patients; furthermore 27% of patients have reached the target of 7.0% or less. A1c reflects the previous three months average plasma glucose level. As such, the full impact of a drug's reduction on glucose as measured by A1c is best analyzed after a three month course of therapy; · A highly statistically significant reduction in body weight (mean of 2.3 kg (5.1 lbs.), p value = 0.001);
· A highly statistically significant reduction in the average mean daily glucose level (mean of 26%, p value = 0.001);
· A highly statistically significant reduction in average fasting glucose level (mean of 24%, p value = 0.001);
The Company anticipates reporting the main results from this study including data from the five maintenance dose cohorts around mid-year.
The Company will be hosting a conference call to discuss these results on Tuesday, April 13, 2004 at 8:30 a.m. EST. The call will be audio-cast live and archived for 90 days at www.financialdisclosure.ca and www.conjuchem.com.
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 a very attractive safety profile, with a low probability of inducing hypoglycemia. However, the half-life of native GLP-1, without the benefit of DAC Technology, is only about 5 minutes, as it is simultaneously degraded by serum enzymes and cleared through renal excretion.
ConjuChem, the albumin bioconjugation company, is developing long-acting therapeutic 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, HIV/AIDS, human growth deficiencies and congestive heart failure.
Detailed descriptions of the Company, DAC Technology and ConjuChem's product pipeline can be viewed on the Company's web page www.conjuchem.com.
For more information, please contact:
Vice President, Chief Financial Officer
514-844-5558 ext. 224
416-815-0700 ext. 231