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ConjuChem to Initiate Phase I/II Clinical Study of PC-DAC(TM): Exendin-4 for Type 2 Diabetes |
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27 Feb 2006 |
FDA clears protocol, first dosing by mid-March 2006
MONTREAL, Canada | Feb 27, 2006 | ConjuChem Inc. (TSX: CJC) today announced that the U.S. Food and Drug Administration (FDA) has cleared its Phase I/II protocol for the treatment of Type 2 diabetes using the Company's proprietary PC-DAC(TM):Exendin-4 compound. This protocol has also been approved by an independent IRB (Institutional Review Board). Patient dosing will begin mid- March 2006. Preliminary data is expected to be available in mid-2006.
Phase I/II Trial Design
The Phase I/II trial will be a randomized, double-blind, single escalating dose study. The study 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. The study will enroll a maximum of 68 patients with HbA1c levels between 6.5% and 11% and will consist of six cohorts (plus two optional cohorts) and a MTD group.
"We are excited to start this clinical program with PC-AC(TM):Exendin-4 which should ultimately confirm the positive efficacy and the excellent tolerability profile we saw for this compound in our 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 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 has been limited by its relatively short half-life in plasma.
Developed with ConjuChem's proprietary technology, PC-DAC(TM):Exendin-4 is a modified Exendin-4 analogue that is bonded to recombinant human albumin (Recombumin(R), provided by Delta Biotechnology Limited). 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(TM):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.
PC-DAC(TM):Peptides are engineered such that the DAC(TM):Peptide attaches covalently to recombinant human albumin outside the body (ex vivo bioconjugation). The PC-DAC(TM):Peptide is subsequently injected subcutaneously into a patient. Ex vivo bioconjugation of preformed conjugates only recently became a viable option with the introduction of a recombinant source of albumin. Previously, the only available albumin was purified from human serum, which could not be used as part of a drug product due to safety concerns inherent to the source.
About ConjuChem
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 DAC(TM) Technologies enable 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 and HIV/AIDS.
Detailed descriptions of the Company can be viewed on the Company's website www.conjuchem.com.
SOURCE: ConjuChem Inc |
