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ConjuChem's PC-DAC(TM):Exendin-4 Advancing into Human Clinical Testing For Type 2 Diabetes |
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26 Jan 2006 |
Montreal. CA | Jan. 25, 2006 | ConjuChem Inc. (TSX: CJC) today announced it has filed with the U.S. Food and Drug Administration (FDA) a submission toinitiate a Phase I/II trial for the treatment of Type 2 diabetes using the Company's proprietary PC-DAC(TM):Exendin-4 compound. Regulatory clearance is anticipated prior to the end of February 2006 with patient enrollment starting in March 2006. Preliminary data is expected to be available at the end of the second quarter of calendar 2006.
Phase I/II Trial Design
The Phase I/II trial will be a randomized, double-blind, single escalating dose study that will evaluate the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetic and pharmacodynamic (duration of activity after one injection) profile of PC-DAC(TM):Exendin-4 in patients with stable Type 2 diabetes with HbA1c levels between 6.5% - 11%. Enrolling a maximum of 68 patients, the study will consist of six cohorts (plus two optional cohorts) and a MTD cohort.
"We anticipate this study with PC-DAC(TM):Exendin-4 will confirm the positive efficacy and the excellent tolerability profile we saw for this compound in pre-clinical studies," said Dr. Jean-Paul Castaigne, Chief Operating Officer. "Moreover, we expect the data to support our efforts to produce a once-per-week GLP-1 receptor agonist compound."
Following the completion of this study, ConjuChem intends to start a
phase I/II multiple dose trial.
About PC-DAC(TM):Exendin-4
Exendin-4 is a Glucagon-like peptide-1 (GLP-1) homolog and an agonist for the GLP-1 receptor. It lowers the blood glucose levels through a distinct mechanism complementary to the mechanisms of action of currently available anti-diabetic drugs. By decreasing glucagon and increasing insulin secretion in a glucose-dependent manner, Exendin-4 may stimulate (B)-cell proliferation, restore (B)-cell sensitivity to glucose, delay gastric emptying, and increase peripheral sensitivity to glucose. Historically, the clinical utility of Exendin-4 was limited by its relatively short half-life in plasma. Developed with ConjuChem's proprietary technology, PC-C(TM):Exendin-4 is a modified Exendin-4 analogue that is bonded to recombinant human albumin. This preformed conjugate has a much longer half-life (up to one week) than its natural
counterpart. In addition, by conjugating exendin-4 to albumin ex-vivo (PC-DAC:Exendin-4), ConjuChem expects to control the pharmacokinetic surge of drug responsible for causing nausea and vomiting in patients and, to shield the exendin-4 peptide from immune system recognition.
About PC-DAC(TM)
ConjuChem developed Preformed Conjugate-Drug Affinity Complex (PC-DAC(TM)) to complement its Drug Affinity Complex (DAC(TM)) technology. Preformed conjugates are a natural extension of the Company's core albumin bonding expertise. Both DAC(TM) and PC-DAC(TM) peptides are designed to have much longer durations of activity while retaining the therapeutic properties of the original peptides.
SOURCE: Conjuchem |
