Study in Brain Cancer

Cytopia Commences Second Phase II Study in Brain Cancer
Thursday September 4, 7:14 pm ET

MELBOURNE, Australia, Sept. 4 /PRNewswire/ -- Cytopia Limited (ASX: CYT - News) today announced that it is commencing enrolment 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 (GBM).

The 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 to the study will now commence, following regulatory approval in Australia and the United States.

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 centres in Australia and overseas. Dr Jason Lickliter, Director of Oncology at the Frankston Hospital, will be Study Chairman for the program.

GBM is currently treated by surgical resection, and/or radiation and chemotherapy. Despite these treatments, the condition recurs in most patients, leading to a poor prognosis and median survival of less than 12 months. GBM tumors are highly vascular and heavily dependent on their own abnormal blood supply for growth, rendering them potentially susceptible to destruction by an anti-vascular agent such as CYT997.

The following table provides a summary of the key aspects of the Phase II
GBM trial.

Name of trial A Phase Ib/II Study of CYT997 in Combination with
Carboplatin and Etoposide in Relapsed Glioblastoma
Multiforme (CCL08001).

Primary endpoints Assess safety and tolerability of escalating doses
of CYT997 given in combination with standard
carboplatin and etoposide therapy (Ph Ib), and
estimation of progression-free survival at six
months using the dose of CYT997 identified in the
Phase Ib component (Ph II).

Secondary endpoints Objective response rate, overall survival, safety
and tolerability, effects on pharmacodynamic
markers of vascular disruption and tumor apoptosis,
and pharmacokinetic analyses.

Blinding status Not blinded.

Product development Drug substance and drug product are manufactured to
status GMP standards.

Treatment method
Route 24 hour intravenous infusion dose (CYT997).
Frequency Day 2 of a 21 day cycle.
Dose-levels Maximum dose of 200 mg/m2 CYT997 dihydrochloride.

Number of trial
subjects Estimated 35 patients.

Subject selection Eligible patients must have glioblastoma multiforme
criteria that has progressed after surgery, radiation
therapy and temozolomide chemotherapy.

Trial location Initial site in Melbourne, Australia.

Expected completion 2Q 2010

Trial standard ICH-GCP



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.

Significant perturbations in tumor blood flow were also demonstrated, suggesting that CYT997 potently disrupts tumor blood vessels. Findings from this study were recently presented at the American Society of Clinical Oncology Annual Meeting which attracts some 30,000 cancer specialists from around the globe.

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. This key finding differentiates CYT997 from other vascular disrupting agents currently in development which can only be administered intravenously, limiting their clinical utility.

Enrolment into the company's Phase II study of CYT997 in relapsed multiple myeloma, a disorder of the bone marrow, is also ongoing.

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 specializes 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.