clinical trials

STUDIES OPEN FOR ENROLMENT

Phase Ib/II study of CYT997 in combination with carboplatin and etoposide in relapsed glioblastoma multiforme

Cytopia anticipates this study opening to enrolment during July 2008.

Further details for this clinical trial will be made available once final regulatory approval is obtained.

Phase II study of CYT997 in relapsed or refractory multiple myeloma

Following the successful conclusion of its first clinical study with CYT997, Cytopia is now planning for a series of Phase II studies, primarily in solid tumours, which will commence during 2008.  Cytopia has received regulatory approval to commence a Phase II study in patients with multiple myeloma (a cancer of the plasma cells found in bone marrow) who have failed to respond to other available drug therapies. 

Patients receive CYT997 as a 24 hour intravenous infusion on two occasions in a 21 day cycle.  The study aims to determine whether this CYT997 treatment can favourably affect patients’ myeloma disease.

This study broadens the Phase I clinical programme for CYT997 by investigating the safety of the compound when given by mouth. The trial has similar primary and secondary goals to the intravenous Phase I clinical trial for CYT997 which concluded in late 2007 (see below).

Enrolment into this study, which is being conducted at The Alfred Hospital in Melbourne, commenced in December 2007.  It is anticipated that up to 24 patients will participate in the study which is expected to continue until the end of 2008.

For more information go to http://www.anzctr.org.au/trial_view.aspx?ID=82405

Phase I accelerated dose-escalation study of CYT997 given as an oral capsule every three weeks in patients with advanced solid tumours

This trial is also being conducted at the Royal Brisbane and Women’s Hospital and Q-Pharm Pty Ltd. The Study Chairman is Dr Jason Lickliter, Director of Cancer Services at the Frankston Hospital in Melbourne.

It is anticipated that 15-18 patients will participate in this study.  Enrolment remains open.

For more information go to http://www.anzctr.org.au/trial_view.aspx?ID=81754

STUDIES CONCLUDED

Phase I dose-escalation study of CYT997 given as a 24-hour intravenous infusion every three weeks in patients with advanced solid tumours

This study successfully concluded in late 2007.  The programme was led by Drs Jason Lickliter and Paul Vasey.

In total, 31 patients with advanced cancer were treated at the Royal Brisbane Hospital in Queensland.  Of those patients, 17 experienced stabilisation of their cancer as a best response during the study.  Seven of the patients were stabilised for a period in excess of four months and two patients with advancing disease continued therapy beyond their participation in the clinical trial.

In addition, analysis of data from the patient group indicated that CYT997 appeared to be affecting the function of tumour blood vessels, suggesting that the drug may be able to disturb the necessary supply of nutrients and oxygen to growing tumours.

Data from this study will be used to assist the design of future clinical trials.

For more information go to http://www.anzctr.org.au/trial_view.aspx?ID=945

Patients interested in learning more about the company’s various clinical studies should contact:

Dr Gregg Smith
Director, Drug Development & Operations
gregg.smith@cytopia.com.au