Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 11, Num. 1, 2001, pp. 15-23

Australasian Biotechnology, Vol. 11 No. 1, 2001, pp. 15-23

BIOTECH BUSINESS

Code Number: au01005

• BIONOMICS PATENTS THIRD GENE FROM BREAST CANCER PROJECT
• MAJOR STEP FORWARD FOR DIABETIC NEUROPATHY TRIAL
• GLAXO & SKB MERGE
• SIMPLE BLOOD TEST FOR ATHEROSCLEROSIS
• MEDITECH RESEARCH BEGINS HUMAN TRIALS AT ROYAL MELBOURNE HOSPITAL
• MEDITECH RESEARCH SIGNS AGREEMENT WITH SKYEPHARMA PLC
• AXON INSTRUMENTS SIGNS SUPPLY AGREEMENT
• PRANA BIOTECHNOLOGY
• BIOTECH INTERNATIONAL FUND RAISING
• BIOTA JAPANESE SUCCESS
• AGEN BLOOD CLOTTING TECHNOLOGY HAS POTENTIAL
• COMPUMEDICS COMMENCES EUROPEAN THRUST
• PROTEOME SYSTEMS’ $3.3M R&D START GRANT TO ASSIST WITH MAJOR PROTEOMICS RESEARCH
• PROGEN CLEARS FIRST CLINICAL TRIAL HURDLE
• NOVEL VACCINE TO COMBAT HIV/AIDS
• PANBIO TO FLOAT
• ANALYTICA TARGETS TAIWANESE BIOTECH FUNDS
• NOVOGEN WINS FDA NOD FOR CANCER TRIALS
• EXODUS ACQUIRES ANTI-CANCER TECHNOLOGY
• ENTERIX SET FOR US EXPORTS
• MEDICA FUND RAISING
• BRESAGEN PATENTS
• TRIALS FOR OBESITY DRUG
• CLONING TECHNOLOGY ACQUIRED
• NEW OBESITY AND DIABETES GENES DISCOVERED

Bionomics Limited, the Adelaide-based biotechnology company, announced recently that it had lodged a patent application covering a third new gene identified from its breast cancer project.

The gene, named TSG18, is located on Chromosome 18. Changes in Chromosome 18 have been associated with breast, lung and brain tumours, as well as gastric and cervical carcinomas.

TSG18 is related to TSG16, a gene undergoing detailed study by Bionomics as a potential breast cancer tumour suppressor gene. The homology between TSG16 and TSG 18 suggests that these genes may constitute a previously unrecognised family of molecules involved in controlling cell growth.

Breast cancer is the leading cause of death in women between 40 and 50 years of age with the lifetime risk factor for developing the disease being up to 1 in 10. In Australia alone, more than 8,500 women are diagnosed with breast cancer annually with 2,600 dying each year.

The Bionomics focus is on the identification of genes, which suppress the growth of breast cancer. Changes in tumour suppressor genes can occur before a cancer becomes clinically evident. The aim of the research is to identify those genes that can be targeted by drugs at this early stage.

A novel treatment that could substantially reduce the number of amputations suffered by insulin-dependent diabetics has taken a major step forward in its development.

The final patient to take part in a Phase II clinical trial of the product PV705, developed by listed Adelaide biopharmaceutical company GroPep, has been recruited at the International Diabetes Institute in Melbourne and begun the seven-month treatment which will help determine the effectiveness of the product.

PV705 is a growth factor product that is rubbed into the skin in the form of a cream. It is being tested to see if it can regenerate feeling in the limbs of patients suffering from diabetic neuropathy, a condition in which the skin becomes numb.

This often results in diabetics injuring themselves and developing serious wounds and infections that can lead to the amputation of affected limbs.

GroPep’s Clinical Trials Manager, Ms Raelene West, said a total of 50 patients have been randomised into the double-blind Phase II trial with half the patients receiving PV705 treatment and the other half a placebo.

She said the trial, which started mid-1999, would complete treatment of the final patient by the middle of 2001. Already nearly half of the patients have completed the course of treatment.

GroPep’s Managing Director, Dr John Ballard, said that should the Phase II trial be successful the product may undergo further testing to establish an optimum dose before undergoing Phase III trials, which could involve hundreds of patients.

He said that even if the trials proved successful, it is likely to be at least four years before the product could be registered for use and made available generally.

Dr Ballard said the product challenged common thinking that protein-based treatments could not be absorbed through the skin. However, this method of drug administration has been suggested by earlier tests conducted at the International Diabetes Institute in Melbourne on insulin absorption through the skin.

The Phase I trial which tested the safety of PV705 was completed in 1999.

Further information, tel: (08) 8354 7701.

GlaxoSmithKline (GSK) Australia has been formed from the merger of Glaxo Wellcome and SmithKline Beecham, creating one of the largest pharmaceutical companies in the country.

GSK Australia will be a major contributor to the Australian economy through the creation of employment, exports, manufacturing activity, research and development and commercial partnerships with Australian companies and academic institutions.

As a significant investor in Australian pharmaceutical R&D, GSK Australia is committed to the advancement of Australian R&D excellence. Maintaining the broadest R&D product pipeline, GSK Australia currently has many new chemical entities and vaccines in clinical development.

GSK Australia’s Pharmaceutical Division will initially operate out of two Melbourne sites - the former Glaxo Wellcome site in Boronia and SmithKline Beecham’s Dandenong base, with plans to co-locate in the future.

GSK Australia’s consumer Healthcare Division, comprising over-the-counter healthcare products such as Panadol™, will continue to operate from the former SmithKline Beecham site at Ermington in Sydney.

Further information: GW Pharmaceutical Products tel: 1800 033 109; SB Pharmaceutical Products tel: 1800 032 474; SB Consumer Healthcare Products tel: 1800 028 533

Australian biotechnology company, Psiron Ltd, aims to change cardiovascular diagnostics with its latest innovation, the development of a simple blood test for atherosclerosis.

The Company hopes it will have a simple blood test, which will determine the presence and extent of atherosclerosis on the market within three to four years.

According to Professor Roland Stocker of the Heart Research Institute (HRI), the successful development of this test has the potential to change outcomes for patients with heart disease.

“For years now we have measured blood cholesterol as a means to establish levels of risk for heart disease, but we have not been able to quantify or qualify the level of vascular damage and plaque actually present in the vessels without quite invasive and costly procedures. This new research and the diagnostic we aim to develop, has the potential to provide this vital information to practitioners easily and accurately.

“Almost all practitioners would agree early detection and treatment of atherosclerosis is a key to reducing the incidence of heart disease and maximising outcomes for their patients,” Prof Stocker said.

Psiron is funding a three-year research program through the Heart Research Institute, which identified that specific oxidised forms of apolipoproteins were associated with oxidised lipoproteins. Apolipoproteins are present in the vessel walls at levels proportional to their concentrations in the blood stream. The research investigates whether blood levels of these agents correlate with the presence and extent of atherosclerosis.

“At present diagnostic tests for atherosclerosis can be invasive, high risk, expensive and only available in major centres, or are based on markers of cardiovascular risk. Many of these tests can be unreliable as they do not directly measure the extent of the disease in individuals. Importantly, not all individuals with atherosclerosis present with these identifiable markers,” Prof Roger Dean, the Director of the HRI, said.

Biotechnology company Meditech Research Limited (ASX:MTR) announced in January that human trials in colon cancer patients have recently begun at Royal Melbourne Hospital.

The objective of these Phase 1 trials - trialing Meditech’s HyACT cancer-targeting technology - is to document the anticipated reduction in toxicity of the anti-cancer drug Fluorouracil in patients with colon cancer as well as the effects of this therapy on the cancerous process. Patients will receive increasing doses of Fluorouracil in conjunction with Hyaluronan, over which Meditech owns intellectual property. Researchers will then carefully assess the effects of therapy.

Preclinical trials on human cancers implanted in animals have successfully demonstrated that Hyaluronan, a naturally-occurring carbohydrate, when used in combination with commonly used anti-cancer drugs, can significantly curtail the spread of cancer while minimising toxic side effects.

“The beginning of human trials, after very successful preclinical trials, represents an exciting phase in our company’s progress,” said Meditech Chief Executive Officer, Mr Brian Nathanson. “Directors are very encouraged that human trials have commenced on one of the most common forms of cancer in the western world. Approximately 12,000 cases of colon and rectum cancer are diagnosed in Australia each year, while some 180,000 cases are detected annually in the USA.”

The trials will continue for approximately 12 months, with interim results progressively available every two months.

Meditech also announced that it expected to begin human trials in patients with breast cancer within the next few weeks at Royal Melbourne Hospital. The objective of these trials is similar to the colon cancer trials, combining Hyaluronan technology with the anti-cancer drug Doxorubicin.

Meditech Research Limited (ASX: MTR) announced on 16 January an agreement with UK pharmaceutical company SkyePharma PLC.

The agreement covers the distribution and marketing rights for SkyePharma’s anti-cancer gel Solarase™ and associated products, clarification of Meditech’s intellectual property rights, and future collaboration between the two companies.

Under the agreement Meditech:

• will gain the right to market Solarase™ in Australia, New Zealand, Singapore and Malaysia. Solarase™ is a topical gel for actinic keratosis, a pre-cancerous skin condition caused by over exposure to the sun;
• will receive CAN$1 million (A$1.2 million) from Hyal Pharmaceutical Canada;
• is now able to conclude negotiations with potential partners for its anti-cancer (HyACT™) project.

SkyPharma is a major London-based pharmaceutical company and is one of the world’s leading drug delivery companies. SkyPharma develops and manufactures advanced drug delivery solutions, the technologies of which include injectable, inhalation and topical systems.

Phase-1 Molecular Toxicology, Inc. announced recently an OEM supply agreement with Axon Instruments (Foster City, CA) to distribute Axon Instruments’ GenePix 4000B microarray scanner in combination with Phase-1’s repertoire of specialised microarrays for toxicogenomics and toxicoproteomics, augmented by the Phase-1 database and software tools for data manipulation and information processing.

Phase-1 Molecular Toxicology, Inc. is the world leader in providing microarrays and joint software and database tools to enable toxicologists to both speed the process of drug discovery and development as well as ensure new drug safety. The agreement with Axon Instruments enables customers to have a complete solution for state-of-the-art molecular toxicology analysis. High-quality scanning combined with verified, toxicologically relevant genes provide the tools essential for reducing the delays associated with toxicological evaluation resulting from the enormous increase in candidate compounds generated by high-throughput screening techniques.

Prana Biotechnology Limited (ASX: PBT) (“Prana”), the neurodegenerative disease biotechnology company, has reached an agreement for the placement of up to 6.67 million new shares. The placement will raise approximately A$5 million at a subscription price of A$0.75 per share. Terms of the placement are as follows:

• CIBC World Markets will place their shares with leading Australian institutional investors;
• Intersuisse Corporate will place their shares with US institutions who have recently expressed strong interest in Prana.

The funds raised from this placement will be applied towards accelerating the development of Prana’s platform technology.

Executive Chairman Dr Geoffrey Kempler of Prana commented, “We are very pleased to have received such strong support from US and Australian institutions for this placement of securities. The funds raised will significantly accelerate Prana’s commercialisation goals and the further development of our science in relation to the other disease targets addressed by Prana’s platform technology.”

Prana is currently involved in Phase II human clinical trials of its lead compound PBT1 for the treatment of Alzheimer’s disease at the Royal Melbourne Hospital and the Mental Health Research Institute. The Phase II trial places Prana amongst the leading organisations in the world attempting to find a successful therapeutic for the treatment of Alzheimer’s disease. Prana’s platform technology, if proven successful, could access a global market estimated to be worth US$9.2 billion in annual sales.

Sydney-based Biotech International Limited has raised $4.05 million through a placement of 9 million shares with investment bank, UBS AG.

Chairman of Biotech International, Ravindran Govindan, said the proceeds of the placement would be used for future acquisitions and to fund working capital for the group.

Late last year, Biotech International announced the intended purchase of 35% of Singapore-based PhytoProtein Biotech Pte Ltd which produces kits for the diagnosis of infectious diseases including malaria, melioidosis, typhoid, tuberculosis and dengue fever.

The purchase will enable Biotech International to develop kits for the diagnosis of infectious diseases like malaria, melioidosis, typhoid, tuberculosis and dengue fever.

According to Biotech, PhytoProtein is positioned to be the leading Asian biomanufacturing facility, providing immunogenic proteins using plant cell expression systems to manufacture antigens, animal vaccines and human vaccines. Initial production will be targeted at tropics-based infectious diseases.

Plant cell expression systems offer significant advantages in the manufacture of recombinant proteins. The proper folding and glycosylation of recombinants made by plant cells make these proteins more immunogenic, thereby improving the sensitivity of antigens and the efficacy of vaccines.

The intended purchase will allow Biotech International to enter the animal and human vaccine market. The development will be in three stages - the production of antigens (immunogenic proteins) for use in diagnostic kits, followed by the production of animal and human vaccines. Initial production will be the melioidosis antigen - the first in the world - with subsequent products targeted at malaria, typhoid, dengue fever, as well as other antigens and animal vaccines.

In other news, Biotech Pharmaceuticals Australia Pty Ltd, a 65% subsidiary of Biotech International, has purchased the Milton Infant Hygiene brand from Procter & Gamble for $3 million.

This purchase allows Biotech Pharmaceuticals to distribute Milton products in 12 countries including Australia, New Zealand, Indonesia, Singapore and Malaysia. Biotech Pharmaceuticals believes the purchase will increase its existing sales base by around 25% per annum and should add additional growth in future years. The business will generate annual revenue of between $2.5 - 3 million per year for Biotech Pharmaceuticals and will almost double the company’s annualised earning base.

“Biotech International will provide global marketing strength for the new business which we expect to list on the Singapore Stock Exchange within three years.” Mr Govindan said.

The worldwide in vitro diagnostic business is estimated to be valued at more than A$35 billion, growing at 8% per annum. Veterinary vaccines generated global sales of more than A$4.5 billion in 1998 and the worldwide market for human vaccines is estimated to grow to A$14 billion by 2001.

Biotechnology International will raise $4.5 million via a placement with investment bank UBS AG.

UBS AG has bought 9 million shares at 45 cents. Each share has an option attached. The options have a strike price of 55 cents, with an expiry date of 31 January 2003.

Biota Holdings Limited (ASX: BTA) has been notified by GlaxoSmithKline that the Japanese Central Social Insurance Medical Council (Chuikyo) has approved a reimbursement price for Relenza (zanamivir for inhalation). As a result, all Japanese prescriptions of Relenza will be covered by National Health Insurance from February 2, 2001.

Chief Executive of Biota, Dr Hugh Niall said, “This is a another positive step for Relenza. It follows closely after the launch of the drug in early December and the timing is especially favourable as it falls in the middle of the Japanese influenza season. The season normally occurs from December to March, although it appears to be running a little late this year.” Dr Niall added, “Going forward, Japan, which represents about 15% of the world pharmaceutical market, is likely to be a significant player in the overall development of the world neuraminidase inhibitor market.”

Diagnostic technology for imaging blood clots that has been developed by Brisbane-based biotechnology company AGEN Biomedical Limited could be “revolutionary” if results of US animal experiments can be replicated in humans, a world expert has said.

The technology, Thromboview™, uses AGEN’s clot-binding humanised antibody attached to an injectable radiolabelled molecule. Following injection of the product into patients, the radiolabelled antibody moves to D-dimer sites present on clots. Subsequent imaging of the patient with a gamma camera allows for confirmation of the diagnosis.

“With this new technology, the guesswork can be taken out of the diagnosis, since the clot images are distinct enough to be read without a great deal of subjectivity,” said Dr Timothy Morris, who has been researching AGEN’s new imaging technology in San Diego for 12 months. Dr Morris is Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine, at the University of California, San Diego.

“In animal models of pulmonary emboli, blood clots were imaged reliably with this technique as hot spots on nuclear scans,” Dr Morris said. “Using widely available imaging technology, pulmonary emboli were visualised non-invasively and without exposure to potentially harmful contrast dye. Furthermore, the same technique could be used to diagnose leg thrombi almost simultaneously, saving money and time. If similar results are observed in humans, this technique could revolutionise how pulmonary emboli are diagnosed clinically.

Each year $US 3 billion ($A 4.6 billion) is spent worldwide on imaging procedures to diagnose blood clots. “If the current indications for use with Deep Vein Thrombosis and Pulmonary Embolism prove to be correct AGEN’s conservative estimate of revenue from end-user sales (eg. sales to hospitals, etc.) for an imaging product is $US 250 million ($A 380 million) per year,” said Mr Richards.

Compumedics Limited (ASX: CMP), has signaled its intention to establish European headquarters this year, with the announcement of a senior executive based in the United Kingdom.

Compumedics, a global leader in the development and export of medical diagnostic and monitoring devices, with a principal focus on sleep disorders, has appointed Mr Peter Fawcett to the key position of General Manager, European Sales.

Mr Fawcett, a physiology graduate of Sheffield University, has 28 years experience in the sales and marketing of biomedical technology throughout Europe, with organisations such as Carl Zeiss, Nicolet Medical Systems and Medelec. The appointment of Mr Fawcett, currently based in Farnborough, UK, is the first step in the process of Compumedics launching a direct presence in Europe.

The chairman of the Industry Research and Development Board, Professor Don Anderson, recently announced that Sydney biotechnology company, Proteome Systems, had been awarded an R&D Start grant of $3.3 million to support a $12 million initiative by the company to develop instruments for proteomics research.

Proteome Systems is a discovery and technology innovation company set up to develop and commercialise products to support high through-put protein analysis and to pioneer the commercial applications of protein science. Proteomics deals with identifying the structure and functions of proteins.

The R&D Start grant will be used to support development of three instruments that will allow quality screening in proteome (protein component of a genome) research for drug discovery and agricultural biotechnology projects.

The grant complements a private capital raising of $16.3 million by Proteome Systems and substantial support for its technology programs through strategic international alliances with Shimadzu Corporation of Japan and MicroFab Technologies of the USA.

Progen Industries Ltd has announced that it has received the final report marking the conclusion of its P1-88 Phase 1b trial in human cancer patients, and confirmed its plans to proceed with Phase 11 trials of the drug.

Progen’s Managing Director, Mr Lewis Lee, commented, “The results of the Phase 1b trial were valuable to Progen’s ongoing clinical trial program. These results, coupled with those of our continuing preclinical research and current healthy volunteer study investigating P1-88 subcutaneous (under the skin) administration, have provided vital data for the design of the next phase of our drug development program. We are in final planning stages for the first P1-88 Phase 11 cancer study, which is to be conducted in a major US medical centre. This will improve not only our exposure in that market, but also allow us to strengthen relationships with the US regulatory, scientific and medical communities.

“As part of Progen’s P1-88 clinical development program, we are also planning to initiate two additional Phase 11 cancer trials and are evaluating our options with respect to specific cancer indications and study centres. The purpose of our planned Phase 11 trials is to test P1-88 in a larger number of patients of the same cancer type, with the aim of refining the safety parameters of the drug as well as investigating its efficacy profile. The initial part of the first Phase 11 study will seek to define an appropriate subcutaneous dosing schedule, based on encouraging results from the current UK healthy volunteer study that support this route of administration. The potential advantage of subcutaneous drug administration over the presently used intravenous infusion is the possibility for the patient to administer the drug him/herself.”

The Centre for Development Cancer Therapeutics (CDCT) conducted the Phase 1b study at the Royal Melbourne Hospital and the Peter MacCallum Cancer Institute. The objective of the Phase 1b study was to examine the safety and tolerability of P1-88 when administered intravenously.

P1-88, a sulfated oligosaccharide, is Progen’s lead product candidate and has been shown to have anti-angiogenic and anti-metastatic properties. The compound has also been shown to be a potent anti-thrombotic.

Progen is engaged in the research of carbohydrate-protein interactions as a source of potential therapeutics for a variety of disease conditions including cancer, cardiovascular diseases and inflammation. Progen is a world leader in the research and development of inhibitors of heparanse, a glycosaminoglycan degrading enzyme. Progen’s objective is to develop and commercialise novel therapeutics by leveraging its expertise in pharmaceutical manufacturing processes and, through alliances with academia and research institutions, conduct proof-of-concept human clinical trials prior to selective out-licensing. The Company has a world class manufacturing facility that manufactures drug candidates under GMP for clinical trials.

The CRC for Vaccine Technology and Vaccine Solutions Pty Ltd have announced the signing of a licensing agreement with the international vaccine company Bavarian Nordic (Copenhagen, Denmark) to develop a novel vaccine to combat HIV/AIDS.

Dr. Peter Wulff, President and CEO of Bavarian Nordic said, “We are very pleased to be working with the CRC for Vaccine Technology and Vaccine Solutions. They have important proprietary technology which when combined with our own technology and expertise will give Bavarian Nordic a competitive edge in the development of this new vaccine.”

In the year 2000 there was an estimated 40 million people living with HIV, according to the Joint United Nations Program on HIV/AIDS, with 14,500 new cases every day. The total number of deaths from AIDS to date is a staggering 22 million and last year 3 million people lost their lives to the disease.

So far, efforts to develop a vaccine for HIV/AIDS have been disappointing. The virus has baffled scientists by constantly mutating and changing - a vaccine which trains the immune system to respond to one form quickly becomes redundant as the virus changes and escapes immune detection and destruction. Furthermore, traditional vaccines (against for example tetanus and measles) work by inducing antibodies. But antibodies may be of little value in protecting people against HIV/AIDS. A successful vaccine might need to activate a different arm of the immune system - white blood cells known as killer T cells.

“There is now considerable evidence that cytotoxic or ‘killer’ T cells (CTL) can control HIV infection. Small regions of the virus recognised by these killer T cells (HIV CTL epitopes) have been identified and can be used to develop a HIV vaccine,” said Dr Andreas Suhrbier, CRC for Vaccine Technology.

“Our Polytope™ technology allows large numbers of these HIV CTL epitopes to be combined and delivered as a Multi-Epitope HIV Vaccine. When the virus mutates one epitope, the immune system - primed by our vaccine - should still be able to recognise and kill the mutated virus, via another epitope,” he said.

“Through our partnership with Bavarian Nordic we gain the ability to combine our Polytope™ technology with their proprietary MVA-BN vector technology and HIV CTL epitopes and test the vaccine in the clinic.”

Brisbane-based biotechnology firm, PanBio, is undertaking a $20 million capital raising with plans for a $60 million float on the ASX in March.

Analytica Limited has formed a Taiwanese subsidiary to access the Taiwan Government’s A$1 billion funding commitment to biotechnology. The subsidiary also plans to tap into Taiwan’s capital markets and world-class scientific institutions.

In September last year, the governments of Taiwan and Australia signed a Letter of Understanding to develop both countries’ biotechnology capabilities. As part of the agreement, the Taiwan Government announced it would provide an A$1 billion funding commitment to further develop the biotechnology industry in Taiwan.

CEO of Analytica, Bob Reardon, said his company had been working closely with Taiwan’s Ministry of Economic Affairs to demonstrate the quality and the substantial savings - up to 30% - by using Taiwan’s biotech infrastructure.

Analytica’s Taiwan company, Analytica Biotechnology Company (ABC) which has been formed in collaboration with US subsidiary Analytica Therapeutics Inc., already has a substantial biotechnology development program with some of Taiwan’s leading scientific institutions.

These include the 2200-bed Veterans General Hospital, Academica Sinica, the Culture Collection Research Centre, Industrial Technology Research Institute and the Development Center for Biotechnology.

Late last year, ABC signed a Research and Licence Agreement with the Taipei-based Yang Ming University and the Sun Yat-Sen University with the aim of accelerating development of the second generation of Analytica’s anti-cancer compound Cytonin.

In other developments, Analytica recently signed a letter of intent with Taiwan-based Kung HWA Chemicals to manufacture the company’s biofriendly insecticide - Galaxy V4C. The company estimates the agreement will reduce the time to market for Galaxy by half, and set the stage for sale of Galaxy initially in the US and ultimately world-wide.

Analytica has also been approached by the Institute of Medical and Veterinary Science in Adelaide as facilitator to access the Pacific Basin’s only FDA approved toxicology unit located in Taipei.

Analytica has strategic alliances with the Taiwanese contract research organisation, Apex International, to undertake its first clinical trials in Adelaide and with Caleb Pharmaceuticals to develop new therapeutic applications for Analytica drugs and other over-the-counter products using its proprietary transdermal delivery systems.

Analytica is a biotechnology intellectual property portfolio manager that is also involved in developing therapeutic drugs from both natural and synthetic sources, three of which are in the preclinical phases.

Novogen has been given US Food and Drug Administration (FDA) permission to begin human clinical trials of its anti-cancer drug, phenoxidol, in the United States.

Subject to protocol approval, the study will take place at a clinical cancer centre with patients with advanced solid tumours, and in particular, prostate cancer.

Novogen’s research director, Professor Alan Husband, said phenoxidol had undergone successful Phase 1a testing in patients with advanced cancer in Australia, showing that it could be delivered to humans at blood levels which have been effective in animals.

Phenoxidol is a multiple-acting anti-cancer drug with a wide range of effects on signal transduction mechanisms within cancer cells. It has been shown to cause anti-proliferation, induction of differentiation and induction of apoptosis in human cancer cells.

Exodus Minerals Ltd, a company that is transforming itself into a biotechnology company, has acquired the right to commercialise cancer vaccine technology developed at St Vincent’s Hospital in Sydney.

The technology is based on the p53 tumour suppressor gene, which helps regulate tumour development by preventing the proliferation of cells with DNA damage.

Abnormal p53 molecules, which are present in around half of all cancers, can be inhibited in their action by human antibodies discovered by St Vincents researchers.

The team, led by Associate Professor Robyn Ward, is currently developing a cancer vaccine based on p53 antibodies for human trials later this year.

Under its agreement with St Vincent’s, Exodus has exclusive rights to acquire the cancer vaccine technology which is to be trialled by St Vincent’s on its behalf.

Exodus will fund the research and clinical trials at St Vincent’s over the next two years, subject to the project meeting milestones. St Vincent’s has world-wide patent applications for 16 different p53 antibodies it has developed.

Clinical trials are planned over the next 12 months with patients suffering a range of advanced cancers including prostate, bowel, lung and breast cancers to determine the vaccine’s safety, immunological response and effectiveness on different cancers.

The deal with St Vincent’s follows the acquisition from Murdoch University late last year by Exodus of an interest in research into a new diagnostic tool for multiple sclerosis.

Exodus is the former suspended and dormant Minerals Mining & Metallurgy Limited which was reconstructed by the new management team and relisted on ASX in 1997. While it continues with exploration activities, it is expanding its biotechnology interests and, according to managing director, Dr Alistair Cowden, is expected to become involved in other national and international projects in the near future.

Healthcare company, Enterix (Australia) Pty Ltd, will begin exporting its bowel cancer screening technology to the US next month following approval from the Food and Drug Administration (FDA) in January.

Developed by Australian scientists, the Inform Annual Bowel Check test has been available in Australia since June last year and will be launched in pharmacies later this year.

Enterix (Australia) Pty Ltd is a wholly owned subsidiary of US firm, Enterix Inc, established in 1997.

Biotechnology investment firm and pooled development fund, Medica Holdings Ltd, has raised $4.5 million through a share placement, with the aim of increasing its stake in several of its investments.

The new subscribers include Merrill Lynch Growth Fund and other Australian institutions.

Medica has also reported a number of significant developments by its investee companies in the past month or so.

Xenome,which has licensed a portfolio of novel venom-based molecules from the University of Queensland, has been offered a $1.6 million R&D Start grant as matching funds for a project to develop novel therapeutic compounds for pain and urological disorders.

One of these compounds acts on a key protein in the central nervous system which may lead to novel treatment for central nervous system disorders such as depression and peripheral conditions such as pain and urinary incontinence.

The grant funds will be used to optimise the pharmacological activity of the molecules and conduct preclinical testing.

Another Medica subsidiary, Cytopia, has announced the discovery of a means of identifying lead molecules for new drugs for immune diseases, including inflammatory diseases such as rheumatoid arthritis.

Cytopia is attempting to find specific inhibitors of a class of enzymes known as kinases, which act as switches that activate cells of the immune system in diseases such as rheumatoid arthritis, as well as certain cancers.

Because this is a large class of enzymes which act similarly to each other, it is extremely difficult to selectively hit one disease target whilst leaving normal functions unimpaired.

The new invention is based on a feature which differs from the usual kinase mode of action and the company has already shown that the technology works by identifying a number of active molecules.

It will now begin design and testing of a range of improved molecules with the objective of commencing preclinical testing by mid year.

Patent applications have been filed to protect several groups of molecules, which have already demonstrated specific activity against the company’s proprietary drug discovery targets.

Medica’s Managing Director, Dr Kevin Healey, said that further patent applications were expected to be lodged in the near future.

Medica’s other major investee company, Alchemia, which focuses on the synthesis of carbohydrates as potential therapeutic, diagnostic and prophylactic agents for a variety of diseases, recently announced a major research and manufacturing alliance with the Dow Chemical Company.

Biotechnology company, BresaGen Limited, has filed two international patent applications in the field of cell therapy for degenerative diseases such as Parkinson’s disease.

The first patent application relates to a novel nerve stem cell (neurectoderm cell) and all nervous system cell types that differentiate from this stem cell. The second patent covers the formation of a definitive ectoderm stem cell and claims this cell and cells derived from it eg skin, cornea, retina and other tissues of the eye.

Metabolic Pharmaceuticals has begun Phase I clinical trials of its anti-obesity drug AOD9604.

The trials follow the successful completion of preclinical testing, and will take place at a human clinical trials unit in Manchester, UK.

The Phase 1 trial will be a single dose intravenous study on 16 volunteers, to be followed by oral and multiple-dose Phase 1 studies. The aim of the trial is to demonstrate that the drug is safe in humans.

Metabolic Managing Director, Dr Chris Belyea, said that results were expected in 8 - 10 weeks .

Metabolic’s drug is a synthetic molecule which replicates the natural fat-reducing mechanism of human growth hormone.

Growth hormone is progressively less active as people age and is thought to contribute to the propensity to gain weight in middle age.

The company anticipates its drug, AOD9604, may be more effective and have fewer side effects than the current drugs.

Clone Australia, a company established by two scientists from the University of Melbourne, has secured a non-exclusive licence to use the nuclear transfer cloning technology owned by US firm, Geron Corporation, that was used to create Dolly the sheep.

The technology, which Geron purchased from the Roslyn Institute in Edinburgh, will be used to clone Australian high-performance cattle and sheep for export as breeding stock and to produce sheep and cattle breeding stock in China.

Clone Chairman, Dr Malcolm Brandon, said the licence would enable the breeding of disease-free Australian animals for sale in countries whose stock was infected with mad cow disease, foot and mouth disease and scrapie.

He said several animals had been impregnated with genetic material from top breeding lines as soon as the licence was signed, and clones animals are expected to be ready for sale by the end of the year.

Autogen Ltd has discovered five new genes associated with obesity and diabetes. Patent applications have been filed for the five new genes, which may provide novel targets for developing treatments for diabetes and obesity.

The new genes, discovered by researchers at Deakin University, are in addition to the `Beacon’ gene for obesity and the `Tanis’ gene for diabetes, and bring Autogen’s portfolio of new gene discoveries in obesity and diabetes to 15.

Professor Greg Collier, Autogen’s Chief Scientific Officer, said that the gene discovery facility and Autogen’s animal model and exclusive access to human/DNA samples were enabling the company to discover rapidly new genes that could lead to new treatments for common metabolic diseases.

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