New potential application for SUBA-Itraconazole in oncology

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New potential application for SUBA-Itraconazole in oncology

PharmaLive.com - Newtown,PA*

http://www.pharmalive.com/News/index.cfm?

articleid=547989 & categoryid=40

Improved anti-fungal drug targets oncology market

MELBOURNE Australia,11 June 2008 - HalcyGen Pharmaceuticals Limited

(ASX: HGN) can confirm that itraconazole, the active ingredient in

HalcyGen's lead drug SUBA-Itraconazoleä, is a potent inhibitor of

the proliferation of endothelial cells. These are the key cells

involved in tumour-angiogenesis and related growth of tumours.

This finding emerged from the collaborative research agreement with

the University of Otago, New Zealand (announced 16 January 2008) to

investigate the anti-tumour activities of the Company's lead product

SUBA-Itraconazoleä.

Research at the s Hopkins School of Medicine published last year

in the American Chemical Society's Chemical Biology*, demonstrated

that itraconazole has the ability to inhibit the growth of tumour

vasculature (anti-angiogenesis). The physiological process of

angiogenesis is important in the body for wound healing and tissue

growth, however, it is also important in the transition to

malignancy and growth of tumours. Tumours can induce new blood

vessels (angiogenesis) to provide nutrients and oxygen essential for

tumour growth. Researchers and companies have been searching for

many years to find a potent drug that can inhibit or prevent tumour-

related angiogenesis as a potential treatment for cancer.

Genentech's AvastinÒ, the first anti-angiogenesis drug, is used to

treat colorectal cancer. Anti-angiogenesis drugs target a multi-

billion dollar market.

The successful completion of the initial work at Otago paves the way

to evaluating the ability and benefits of SUBA-Itraconazoleä in

inhibiting tumour growth following oral administration.

HalcyGen's SUBA-Itraconazoleäformulation was licensed from Hospira

Inc. to treat fungal infections. Under the terms of the license

agreement, HalcyGen may pursue and commercialise other clinical

applications of SUBA-Itraconazoleä.

SUBA-Itraconazoleä is a proprietary formulation of itraconazole that

has been clinically evaluated by HalcyGen in five pharmacokinetic**

clinical studies. These studies have demonstrated that HalcyGen's

formulation has significantly improved bioavailability (absorption

by the gastrointestinal track) compared with the market leader

Sporanoxâ***, hence providing the opportunity for launching a lower

dose form of the drug. HalcyGen is currently preparing for a program

of pivotal registration trials to register SUBA-Itraconazoleä as an

anti-fungal agent.

The current global market for itraconazole for the treatment of

fungal infections is in excess of US $600 million per annum.

HalcyGen's SUBA-Itraconazoleä is targeting this market. The oncology

application could substantially enlarge the market potential.

*Curtis R. Chong, Jing Xu, Jun Lu, Shridhar Bhat, J. Sullivan,

Jr., and Jun O. Liu, Vol . 2, No. 4 - American Chemical Society,

Chemical Biology

**Pharmacokinetic Studies (PK): Clinical pharmacokinetic studies are

performed to examine the absorption, distribution, metabolism and

excretion of a drug under investigation (investigational drug and

approved drug) in healthy volunteers and/or patients. Pivotal

pharmacokinetic studies are studies that form part of the

registration dossier for a new drug application (NDA).

***Sporanox is owned by Janssen Pharmaceutical Products LP-part of

the & Group.

-ENDS-

Enquiries:

Dr Aston Craig Bottomley

0402 762 204 03 8614 7777

Rudi Michelson

Monsoon Communications

0411 402 737

Background on HalcyGen:

HalcyGen has been founded to bridge the gap between mainline

pharmaceutical companies and high volume generics companies through

the development and licensing of new improved proprietary generic

formulations known as " Super Generics " or " High Functionality

Generics " . HalcyGen's strategy is to capitalise on the value

associated with the development and commercialisation of novel,

improved variants of existing proprietary pharmaceuticals known as

Super Generics.

The basis of the HalcyGen's strategy is a strategic licensing

partnership with Hospira, Inc. The Company will initially develop

and market two products in partnership with Hospira. Subject to

performance and meeting certain other criteria, the Company has the

opportunity to develop further products with Hospira.

Through the global exclusive license granted to HalcyGen by Hospira,

Inc., for the commercialisation of SUBA-Itraconazole, Hospira

has a first right of refusal to manufacture SUBA-Itraconazole to

support sales. Hospira is a global specialty pharmaceutical and

medication delivery company.

Monsoon Communications Level 1 350 Street Melbourne VIC 3000

Ph: 03 9620 3333 www.monsoon.com.au