September 5, 2008
Cytopia Initiates Enrollment for Second Phase II Brain Cancer Study
Australia-based biotechnology company Cytopia has initiated enrollment for its Phase Ib/II study of CYT997, the company's novel vascular-disrupting anticancer agent, in patients with an aggressive form of brain cancer known as glioblastoma multiforme.
The glioblastoma multiforme (GBM) clinical trial is the first Phase II efficacy study in highly vascular, solid tumor indications for the company and the second in its suite of Phase II studies designed to investigate the anticancer activity of CYT997. Patient recruitment for the study will now commence, following regulatory approval in Australia and the US.
The clinical study will investigate the activity of CYT997 in combination with two other marketed anticancer agents in approximately 30 patients at a number of clinical centers in Australia and overseas. Jason Lickliter, director of oncology at the Frankston Hospital, will be the study chairman for the program.
This trial follows the successful conclusion last year of the company's Phase I safety study for intravenous CYT997, in which a prolonged delay in tumor growth was observed in seven of the study's 31 advanced cancer patients.
Cytopia is also investigating the safety and anti-vascular activity of CYT997 when administered by mouth. Preliminary data from the company's Phase I oral study indicates that the compound is well absorbed after administration in capsule form.
Enrollment for the company's Phase II study of CYT997 in relapsed multiple myeloma, a disorder of the bone marrow, is also ongoing.