MELBOURNE, Australia, Sept. 4 Cytopia Limited (ASX: CYT)today announced that it is commencing enrolment for its Phase Ib/II study ofCYT997, the company's novel vascular-disrupting anticancer agent, in patientswith an aggressive form of brain cancer known as glioblastoma multiforme(GBM).
The GBM clinical trial is the first Phase II efficacy study in highlyvascular, solid tumor indications for the company and the second in its suiteof Phase II studies designed to investigate the anticancer activity of CYT997.Patient recruitment to the study will now commence, following regulatoryapproval in Australia and the United States.
The clinical study will investigate the activity of CYT997 in combinationwith two other marketed anticancer agents in approximately 30 patients at anumber of clinical centres in Australia and overseas. Dr Jason Lickliter,Director of Oncology at the Frankston Hospital, will be Study Chairman for theprogram.
GBM is currently treated by surgical resection, and/or radiation andchemotherapy. Despite these treatments, the condition recurs in most patients,leading to a poor prognosis and median survival of less than 12 months. GBMtumors are highly vascular and heavily dependent on their own abnormal bloodsupply for growth, rendering them potentially susceptible to destruction by ananti-vascular agent such as CYT997.
This trial follows the successful conclusion last year of the company'sPhase I safety study for intravenous CYT997, in which a prolonged delay intumor 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 fromthis study were recently presented at the American Society of ClinicalOncology Annual Meeting which attracts some 30,000 cancer specialists fromaround the globe.
Cytopia is also investigating the safety and anti-vascular activity ofCYT997 when administered by mouth. Preliminary data from the company's Phase Ioral study indicates that the compound is well absorbed after administrationin capsule form. This key finding differentiates CYT997 from other vasculardisrupting agents currently in development which can only be administeredintravenously, limiting their clinical utility.
Enrolment into the company's Phase II study of CYT997 in relapsed multiplemyeloma, a disorder of the bone marrow, is also ongoing.
Cytopia Ltd is an Australian biotechnology company focused on thediscovery and development of new drugs to treat cancer and other diseases.Cytopia conducts its research and drug development through subsidiaries basedin Melbourne, Australia and San Francisco, USA and specializes in developingnew small molecule compounds with an improved therapeutic profile for thetreatment 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 trialedin Phase I and Phase II clinical studies. Cytopia is continuing to build onits range of JAK inhibitors and kinase expertise, with CYT387, a novel oralJAK2 inhibitor focused on the treatment of myeloproliferative disorders,expected to enter Phase I clinical studies in early 2009.
Website: www.cytopia.com.auThe following table provides a summary of the key aspects of the Phase IIGBM 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