Inflazyme Pharmaceuticals Ltd -
Inflazyme plans phase Ib clinical studies on possible asthma therapy
Inflazyme Pharmaceuticals Ltd IZP
Shares issued 44,379,628 1999-10-14 close $1.31
Friday Oct 15 1999
Mr. Jeffrey Bacha reports
Inflazyme Pharmaceuticals has received preliminary data from Inveresk Research, Scotland, on the Phase Ia clinical trials of IPL576,092, a potential oral asthma therapy under development in collaboration with Hoechst Marion Roussel, the pharmaceutical company of Hoechst AG. Based on an analysis of the results received to date, the company plans to progress development into Phase Ib multiple dosing studies.
The Phase Ia studies were designed to assess the safety and tolerability in humans of single-dose administration of IPL576,092. The Phase Ib studies will evaluate the safety and tolerability of the compound when administered as repeated doses to healthy volunteers.
"These results enabling the advancement of IPL576,092 from single-dose to multiple-dose human clinical studies mark important progress in the development of this product," said Ian McBeath, president and chief executive officer of Inflazyme. "We expect to receive the results of the Phase Ib studies in early 2000. We are pleased to confirm that we are on track to meet our goal of entering Phase II human clinical trials by the middle of next year."
IPL576,092 is Inflazyme's lead clinical candidate from its IPL576 series of compounds. The IPL576 series is based on a molecule originally isolated from a sea sponge by researchers at the University of British Columbia and the University of Alberta. Inflazyme has demonstrated that IPL576,092 has a significant effect on mediators of inflammation in vitro and in standard preclinical in vivo studies of asthma when administered orally or by inhalation. These preclinical studies demonstrate that IPL576,092 may have the efficacy of inhaled glucocorticoids without the related side effects.
IPL576 is being developed for the treatment of asthma and respiratory disease in collaboration with Hoechst Marion Roussel, a world leader in pharmaceutical healthcare. Under the terms of the collaboration, Inflazyme is responsible for the development of IPL 576 through Phase IIa clinical trials. After Phase IIa trials are completed, Hoechst Marion Roussel will have the option to acquire exclusive worldwide rights (non-exclusive in Canada) to an oral dosage form of a product developed from the IPL576 series for the treatment of asthma and respiratory disease upon payment of a milestone to Inflazyme. Hoechst Marion Roussel will then be responsible for further development and commercialization of the product.
Phase Ia clinical trials began in June 1999 at Inveresk Research, in Edinburgh, Scotland. These trials were double-blind, placebo-controlled studies in a population of healthy male volunteers, designed to assess the safety, tolerability and pharmacokinetics of single, ascending, oral doses of IPL576,092. Phase Ib clinical studies will also be carried out by Inveresk Research. Inflazyme expects these studies to commence before the end of the year. |
