Cytopia's first Phase II clinical trial
MELBOURNE, Australia, Dec. 18 /PRNewswire/ -- Cytopia Limited (ASX: CYT) has obtained regulatory approval to proceed with a Phase II clinical study assessing its lead anti-cancer drug in up to 24 multiple myeloma patients. Patient enrolment will soon commence.
This Phase II study is the first in a number of further clinical studies planned for the anti-cancer vascular-disrupting agent CYT997 and will be conducted at the Alfred Hospital in Melbourne, Australia. It will investigate the activity of CYT997 in patients with relapsed or refractory multiple myeloma.
Multiple myeloma is an incurable cancer of plasma cells of the bone marrow, where the cells divide in an uncontrolled manner invading not only the marrow but the solid bone tissue. The human clinical trial follows promising laboratory studies which indicate that CYT997 potently disrupts myeloma cells, including those collected from patients with the disease.
While some significant advances in myeloma therapy have occurred in recent years, disease recurrence almost always occurs with increasing drug resistance leading to uncontrollable and fatal disease.
To be eligible for the study, patients must have failed at least one previous line of approved therapy. The trial is a single-arm, two-stage design with an interim analysis after 14 patients and maximum enrolment of 24 subjects. The company anticipates releasing interim data for this study in the third quarter of 2008.
"We are keen to unlock the potential of CYT997 as a next-generation cancer drug, particularly in indications with unmet medical need," said Mr Andrew Macdonald, CEO of Cytopia. "This study is the first of Cytopia's planned suite of Phase II studies for CYT997 and is a substantial value-adding milestone for the company."
The market for multiple myeloma drugs was estimated at US$930 million in 2006 and is expected to grow to approximately US$3 billion by 2013.
Cytopia is also currently conducting a Phase I study investigating the
safety and tolerability of CYT997 following oral administration. The
company also intends to file regulatory applications in support of other
Phase II studies over the coming months.
The following table provides a summary of the key aspects of the Phase II multiple myeloma trial.
Name of trial A prospective, single-arm, two-stage, open-label
Phase II trial of CYT997 in relapsed and
refractory multiple myeloma (CCL07001)
Primary endpoints Determination of the overall response rate to CYT997
Secondary endpoints Time to progression; number of cycles of CYT997 to
achieve maximum response; overall survival and
safety and tolerability
Blinding status Not blinded
Product development Drug substance and drug product are manufactured to
status GMP standards
Route 24 hour intravenous infusion dose
Frequency Days 1 and 8 of a 21 day cycle
Dose-levels 202 mg/m2 CYT997 dihydrochloride
Number of trial 24 patients maximum
Subject selection Eligible patients must have a diagnosis of
criteria multiple myeloma (per World Health Organisation
criteria) and have received at least one but no
more than three previous lines of therapy
Trial location Melbourne, Australia
Expected completion Interim analysis (14 patients) Q3, 2008
Trial standard ICH-GCP
Cytopia Ltd is an Australian biotechnology company focused on the discovery and development of new drugs to treat cancer. Cytopia conducts its research and development via subsidiaries based in Melbourne, Australia and New York and specializes in discovering new molecules that can inhibit enzymes known as kinases, an exciting new class of drugs.
|SOURCE Cytopia Limited|
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