Business Wire - Friday October 30, 1998
The Phase I(a) study of GPI-2A was undertaken at the Health Science Centre, University of Manitoba, between December 1997 and May 1998. The purpose of the study was to evaluate the safety and pharmacokinetics of two formulations of GPI-2A. Thirty subjects were enrolled in the study. Twenty subjects were HIV-negative healthy volunteers, and ten subjects were HIV-infected but otherwise healthy subjects. The study design involved randomized, double blind administration of either the nascent GPI-2A formulation or GPI-2A formulated with cationic liposomes, and the appropriate saline or liposomal placebo controls to both healthy volunteers and persons infected with HIV.
The Phase I trial demonstrated that nascent GPI-2A administered intravenously is safe at the dosage level tested. Some unanticipated side effects were encountered with the administration of liposome formulated GPI-2A. The Company and its predecessor (Genesys Pharma Inc.) had previously selected the cationic liposomal formulation as a possible delivery system for GPI-2A. This delivery system was evaluated in the Phase I(a) trial. Pre-clinical testing and pre-clinical animal studies of liposomal GPI-2A did not indicate or create the side effects encountered during the Phase I(a) trial from the administration of liposomal GPI-2A.
Dr. Anthony Schincariol, president of Novopharm Biotech, commented "We are pleased that the results of the Phase I(a) safety and toxicity study were positive with respect to nascent GPI-2A. We have focused our antisense product development efforts on conducting additional pre-clinical testing and on selecting an alternate product delivery system, prior to continuing with further clinical trials of GPI-2A. At the same time, we will continue our focus on the clinical development of our monoclonal antibody therapeutic and diagnostic products."
Novopharm Biotech is a publicly traded subsidiary of Novopharm Limited-one of Canada's largest generic pharmaceutical companies. The company's mandate is to become a North American leader in the commercialization, development, and research of innovative and generic biopharmaceutical products.
This press release contains forward-looking statements which are subject to risks and uncertainties inherent in the process of developing and commercializing human therapeutics. Actual results could differ materially from those projected in this release.
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