Cytopia Doses First Brain Cancer Patient In Phase Ib/II Study

Main Category: Neurology / Neuroscience
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 17 Nov 2008 - 1:00 PDT

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Cytopia Limited (ASX:CYT) has commenced dosing patients in its Phase Ib/II study of CYT997, the company's novel vascular-disrupting anticancer agent, to treat glioblastoma multiforme (GBM), an aggressive brain cancer.

The GBM clinical trial is the company's first Phase II efficacy study in highly vascular, solid tumour indications and the first time CYT997 is being investigated in a tumour of the central nervous system.

GBM is currently treated by surgical resection, and/or radiation and chemotherapy. Despite these treatments, the condition recurs in most patients resulting in significantly limited life expectancy. GBM tumours are highly vascular, rendering them potentially susceptible to destruction by an anti-vascular agent such as CYT997.

The clinical study will investigate the activity of CYT997 in combination with two other marketed anticancer agents in approximately 30 patients. Dr Jason Lickliter, Director of Oncology at Frankston Hospital, is the program's Study Chairman.

Cytopia is also well advanced to opening its second clinical site for the study at a leading cancer centre in Sydney. Trial enrolment at that centre is expected within weeks.

The company also intends to file the requisite submissions to enable dosing at two additional sites in Australia to begin early in 2009, bringing the total number of Australian clinical sites for this program to four. Foreign clinical sites are also being assessed for the later stages of the study.

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 tumour growth was observed in seven of the study's 31 advanced cancer patients.

About Cytopia

Cytopia Ltd is an Australian biotechnology company focused on the discovery and development of new drugs to treat cancer and other diseases. Cytopia conducts its research and drug development through subsidiaries based in Melbourne, Australia and San Francisco, USA and specialises in developing new small molecule compounds with an improved therapeutic profile for the treatment of cancer.

The company's lead drug candidate is CYT997, a vascular disrupting agent (VDA) for the treatment of various cancers, which is currently being trialed in Phase I and Phase II clinical studies. Cytopia is continuing to build on its range of JAK inhibitors and kinase expertise, with CYT387, a novel oral JAK2 inhibitor focused on the treatment of myeloproliferative disorders, expected to enter Phase I clinical studies in early 2009.

Cytopia Ltd