2009.08.25 – JAK2 inhibitor CYT387

http://newsstore.smh.com.au/apps/previewDocument.ac?docID=GCA00980874CYT

Preliminary Final Report

Announced by: CYT

Announced on: 25/08/2009 14:55:00

ASX RELEASE

25 August 2009

Cytopia Preliminary Final Report

Cytopia Limited (ASX:CYT) today announced its audited financial results for the year to 30

June 2009, reporting operating revenue of $4.2m and an operating loss of $6.5m.

·

Anti-cancer Vascular Disrupting Agent (VDA) CYT997

Cytopia’s development programme accelerated during the year with the conclusion of the

company’s second Phase I clinical trial investigating the safety and tolerability of the

compound dosed orally in advanced cancer patients. Data from this study confirmed that

the drug is well absorbed following oral administration, suggesting that CYT997 has a key

advantage over most other VDAs which can only be administered intravenously. The oral

Phase I clinical study was supported in part by the company’s now expired Commercial

Ready Grant from the Commonwealth Government.

The company’s Phase II clinical trial in relapsed brain tumours (GBM) has continued

throughout the year. Promising preliminary data has been obtained. The trial is now open

at three clinical centres in Australia with further sites in Australia and overseas to be

opened shortly.

The company’s Phase II myeloma study remains open to enrolment.

·

JAK2 inhibitor CYT387

Cytopia concluded the formal preclinical development programme for CYT387 and filed an

Investigational New Drug Application (IND) with the United States Food and Drug

Administration (FDA) in June. Preparatory activities for the Phase I/II clinical trial in

myelofibrosis patients (a severe disorder of the bone marrow mediated by upregulation of

JAK2) are well advanced. Subject to final regulatory approval, the company intends to

commence enrolment into the study in late 2009.

·

Novartis JAK3 Collaboration

The company has completed the initial three year funded laboratory research term that

commenced in 2006. Novartis is now responsible for the subsequent development of drug

candidates that have arisen from the collaboration, with milestone and royalty payments

due to Cytopia as development ensues.

·

Preclinical collaborations

With a shift in internal activites to development of clinical stage programs, the company

continues to pursue collaborations and outsourced arrangements to progress early stage

and preclinical programs. The company will seek to expand collaborations such as that

with the Cancer Therapeutics CRC for the development of a FAK inhibitor to treat cancer

to deliver new value opportunity for shareholders.

Financial Results

The reported operating loss after tax for the year ended 30 June 2009 was $6.5m (2008:

$7.6m).

Operating revenue totalled $4.2m (2008: $4.4m), while operating expenses totalled $11.5m

(2008: $12.7). R&D expenditure decreased to $7.9m (2008: $9.5m).

The year concluded with a cash position of $4.0m (2008: $11.0m), which is sufficient for

existing operations to continue into early calendar 2010.

About Cytopia

Cytopia Ltd is an Australian biotechnology company focused on the development of new

drugs to treat cancer and other diseases. Cytopia conducts its drug development through

subsidiaries based in Australia and USA and specialises in developing new small molecule

compounds with an improved therapeutic profile for the treatment of cancer.

The lead program for the company is CYT997, a vascular disrupting agent (VDA) for the

treatment of various cancers, currently being trialed in Phase II clinical studies. This

compound is delivered orally as well as intravenously. Cytopia also has built on its range of

JAK and other kinase inhibitors with CYT387, a novel oral JAK2 inhibitor focused on the

treatment of myeloproliferative disorders and cancer, expected to enter Phase I clinical

studies in 2009.

Enquiries:

Mr. Andrew Macdonald

Chief Executive Officer

T: +61 3 9208 4222

andrew.macdonald@cytopia.com.au

website:

www.cytopia.com.au


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