Monday - June 26: (RWE Australian Business News) -Cytopia Ltd...

Monday - June 26: (RWE Australian Business News) -
Cytopia Ltd (ASX:CYT) has provided an update on the progress of its
Phase I trial for the cancer drug candidate CYT997.
CYT997 is an orally available vascular targeting and cytotoxic
agent that has proven effective in animal models of a wide range of
tumour types including breast, prostate and colon, as well as some
leukemias.
In March 2005, Cytopia successfully lodged an Investigational
New Drug (IND) Application for CYT997 with the Food and Drug
Administration of the United States (FDA) and in July 2005 commenced a
Phase I dose escalation study in cancer patients at the Royal Brisbane
and Women’s Hospital (RBWH).
The trial is under the direction of medical oncologists, Drs
Jason Lickliter and Paul Vasey.
The clinical study is designed to determine the safety and
tolerability, dose-limiting toxicities and maximum tolerated dose of
CYT997 when given as a 24-hour intravenous infusion every three weeks.
Eligible trial participants are cancer patients with advanced solid
tumours who have failed one or more first-line therapies or for whom no
standard therapy exists.
Pharmacokinetic and biological activity data is also being
collected. The dose levels of CYT997 administered to date have been well
tolerated by patients and no dose limiting toxicities (DLTs) have yet
been identified.
To date, sixteen patients have received a total of 46 doses of
CYT997 across six incremental dose levels. Dose escalation will continue
until two or more patients within a dose level exhibit a DLT. The
maximum tolerated dose will then be determined in accordance with the
approved clinical trial protocol.
While the company cannot be certain when dose-limiting
toxicities will be identified, Cytopia anticipates that the trial will
continue in the third quarter of 2006. Regulatory oversight for the
trial continues to be provided by the institutional Human Research
Ethics Committees and the FDA.