Biota
It has been a very busy and exciting year for Biota with our influenza
drug GG167 going into Phase III Clinical Trials and the first field
trials of our influenza diagnostic test kit. We have also brought new
projects into our portfolio in the area of cancer, as well as advancing
our existing projects in diabetes and cancer to the next stages of their
development. We are undertaking research into RSV, a virus causing a
very common flu-like illness in young children, and into rhinovirus, the
cause of the common cold. For these projects we are using the same
discovery techniques as were employed in the influenza project. All of
these targets are in keeping with Biota's goal of addressing important
diseases with no suitable or effective current treatment.
GG167 - The Influenza Therapeutic
Biota is pleased to advise that the Southern Hemisphere Phase III
clinical trials of GG167, conducted by our partner Glaxo Wellcome
Australia, are now complete. A total of 455 patients with a clinical
diagnosis of influenza were enrolled, well in excess of the target
number of 350. Analysis of the data from the study is now under way.
This Southern Hemisphere trial is part of a comprehensive world-wide
Phase III programme which includes two separate pivotal proof of
efficacy studies which commence in the Northern Hemisphere this month.
This continued progress, and the positive results of earlier Phase II
trials give us encouragement that the goal of filing for market approval
towards the end of next year should be met.
Point of Care Influenza Diagnostic
Over 100 patients with a clinical diagnosis of influenza have been
enrolled into a pilot study of the influenza diagnostic test kit. This
study was carried out in Adelaide, in conjunction with our development
partner BioStar, Inc of Boulder, Colorado and compared the rapid, on the
spot test to existing laboratory methods which require several days to
generate a diagnosis. The study was conducted through 5 clinics in the
Adelaide area with two scientists from BioStar working at the Institute
of Medical and Veterinary Science (IMVS) Infectious Diseases
Laboratories. Final analysis of samples is still in progress. Further
trials will now be undertaken in the United States this forthcoming
winter (1997/98), in preparation for FDA submission in 1998. |
