Liponex receives approval to initiate CRD5 clinical trial for treatment and prevention of heart disease
Liponex Inc., a biopharmaceutical company specializing in developing advanced products related to High density Lipoprotein (HDL), often called "good cholesterol", announced that it has received Health Canada approval to initiate a clinical trial in a patient population using a new formulation of its lead pharmaceutical product, CRD5, being developed for the treatment and prevention of heart disease.
The Phase I/II dose-ranging trial will take place at a Canadian academic health sciences centre, and will involve 50 dyslipidemic patients (patients with low HDL and high LDL). Following dietary lead in, patients will be given daily doses of the latest formulation of CRD5 in capsule form. The treatment period for each patient will be 12 weeks. The primary endpoints for the trial are safety and an increase in serum HDL, with triglyceride and LDL reductions as secondary endpoints. The results of this trial will be used to determine an optimal dose for use in subsequent trials to confirm the efficacy of CRD5 in larger patient populations.
Liponex also announced it will delay the expected start of the patient-dosing phase of the trial in order to address a concern with the stability of the current batch of CRD5 bulk active material previously received from its supplier and formulated specifically for this trial. Liponex, as part of its ongoing quality assurance program, recently obtained results from an independent laboratory analysis of the current batch of clinical material, which showed that the active ingredient in the drug product had oxidized to an extent exceeding company specifications. Liponex is working closely with its contract manufacturer to ensure an acceptable product and to maintain the high degree of quality required for clinical trial purposes. Although patient screening will continue, the Company now expects patient dosing to start in the third quarter of this year with results from the trial available in the first quarter of 2007.
CRD5 is a plant-derived lipid that is closely related to a molecule already present in the human body and important to lipid metabolism. CRD5 increases the levels of HDL in the blood by increasing apoA-I (a key component of HDL) production and reducing its clearance from the body. In parallel, CRD5 inhibits the process by which cholesterol is stored in the blood and stimulates the elimination of Low Density Lipoprotein (LDL) or "bad cholesterol" through the reverse cholesterol transport pathway. In three completed Phase I trials, CRD5 was shown to be safe and well-tolerated and demonstrated indications of efficacy in raising HDL.
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