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Australasian Biotechnology (backfiles)
AusBiotech
ISSN: 1036-7128
Vol. 11, Num. 3, 2001, pp. 12-16
Untitled Document

Australasian Biotechnology, Vol. 11 No. 3, 2001, pp. 12-16

BIOTECH BUSINESS

Code Number: au01034

AGEN REINFORCES PATENT POSITION WITH SETTLEMENT OF SUIT AGAINST US COMPANY

Brisbane-based diagnostic manufacturer AGEN Biomedical Ltd announced the strengthening of its patent position with the settlement of a D-dimer patent suit against US company, Biopol International Inc, and the signing of a license agreement with Biopol.

AGEN, a world leader in blood clot diagnostics, initiated the suit in March last year, alleging infringement of AGEN's D-dimer patent. D-dimer is a molecule specific to blood clots and is used to assist in the diagnosis of thrombotic conditions such as deep vein thrombosis and pulmonary embolism. AGEN's patents - issued in the US, Europe and Japan - cover testing to diagnose such conditions.

AGEN announced in February this year a breakthrough in the diagnosis and detection of blood clots. The company's new technology, ThromboviewTM, uses AGEN's clot-binding humanized 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. The technology is expected to commence phase1 human trials next year.

Scientists expect this to revolutionise the imaging of blood clots and hence improve the diagnosis of conditions like deep vein thrombosis and pulmonary embolism.

PRANA'S METAL TECHNOLOGY THEORY FOR ALZHEIMER'S DISEASE SUPPORTED BY FINDINGS

Prana Biotechnology Limited recently announced that the research paper titled Alzheimer's Disease Amyloid Beta Binds Cu and Zn to Generate an Allosterically-ordered Membrane-penetrating Structure Containing SOD-like Subunits, published in the Journal of Biological Chemistry on March 27, 2001, bolsters Prana's platform theory of metals and amyloid in the treatment of Alzheimer's disease.

Dr Colin L. Masters, M.D, executive director of Prana, Dr Ashley I. Bush, M.D., PhD, chief scientific advisor to Prana, Dr Kevin J. Barnham PhD, chief of structural biology and medicinal chemistry at Prana, and Dr Cyril Curtain, PhD, were part of the ten-scientist team that conducted the research.

The research highlights their findings that amyloid (the protein associated with Alzheimer's disease), when it binds copper and zinc, adopts an elegant structure that strongly resembles antioxidant enzyme, superoxide dismutase-like bridging histidine residues. Moreover, the paper describes how copper and zinc bind amyloid b-peptide, the most important element of extracellular plaques and perivascular amyloid deposits; inducing aggregation thus giving rise to reactive oxygen species. These reactions play a highly dangerous role in the disease state, as high concentrations of iron, copper and zinc have been located in amyloid in disease brains. The scientists demonstrated that coordination of metal ions to amyloid b-peptide is the same in both aqueous solution and lipid environments.

This effect was abolished if the histidine residues were methylated at nitrogens of the imidazole ring, indicating the presence of bridging histidine residues, as found in the active site of superoxide dismutase. The end result suggests that metal binding to amyloid b-peptide generated an allosterically ordered membrane-penetrating oligomer linked by superoxide dismutase-like bridging histidine residues.

METABOLIC ANNOUNCES POSITIVE INTERIM RESULTS FROM PHASE ONE HUMAN TRIALS

Melbourne-based biotechnology company, Metabolic Pharmaceuticals Limited, recently announced encouraging results from its near-completed phase 1 human clinical trials for its obesity drug AOD9604. The trials are being undertaken in Manchester, UK.

The company reported that the drug has shown excellent clinical tolerability and there have been no clinically significant adverse events noted in any of the treatment sessions to date. As a consequence, to speed the further clinical development of AOD9604, Metabolic's board has resolved to bring forward a number of preparatory steps for Phase 11 human clinical trials.

Preparations, including animal oral toxicity studies, are proceeding smoothly prior to the oral-dosing Phase 1b human clinical trial. This trial will establish whether AOD9604 can be safely administered orally in humans. The Phase 1b trial is scheduled for the second half of 2001 and must precede the Phase 11 efficacy trials, which will assess fat loss in obese subjects.

Metabolic has contracted Canadian firm SemBioSys to assess the feasibility of a candidate manufacturing market scale quantities of the obesity drug. The analysis is due to completed later this year.

AOD9604, discovered at Melbourne's Monash University, acts specifically on the body's fat cells to cause accelerated utilisation of stored fats. The drug is modelled on the active fat-reducing portion of the human growth hormone molecule. Scientists at Monash University have shown that, when orally dosed to laboratory animals, AOD9604 has all the natural fat-reducing effects of the intact growth hormone without its other unwanted effects. More than 300 million people worldwide - 20% of the population in developed countries - are obese.

Major shareholders in Metabolic Pharmaceuticals are Circadian Technologies (30%, ASX:CIR) and Monash University (26%).

Metabolic is also investigating potential veterinary applications of the AOD technology. Back fat reduction in pigs is a prominent economic benefit of daily growth hormone injections, a technique currently used in the pig industry.

The company also announced results from a recent experiment using single doses of AOD9604 administered to pigs, either intravenously or orally. "Results confirm that AOD is orally active in pigs, which is positive news for a veterinary application,"> said Metabolic Pharmaceuticals Managing Director, Dr Chris Belyea. "We believe this indicates it is more likely to be orally available in humans.">

MEDITECH ANNOUNCES PROGRESS ON PHASE ONE HUMAN CANCER TRIALS

Directors wish to announce that rapid progress has occurred with Phase I human clinical trials of HyACT anti-cancer therapies in the treatment of advanced breast and colon cancer.

The specific objective of the trials is to establish the safety of new therapeutics and to demonstrate a lack of new treatment toxicity. To date, in both the breast and colon cancer trials, both Meditech formulations have been successful, by demonstrating that HyACT technology does not cause new treatment toxicity.

Both Phase I trials are expected to be completed within the next three to five months, at which stage these preliminary results can be used as a basis for advancement into Phase II clinical trials.

The human trials, the commencement of which was announced in January, are taking place in Melbourne. Pre-clinical trials on human breast cancers implanted in animals confirmed 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 adverse side-effects.

AGEN SIGNS DIAGNOSTIC AGREEMENT WITH CORBETT RESEARCH

AGEN Biomedical Limited recently announced the signing of an agreement with Sydney-based Corbett Research to collaborate on the commercialisation of DNA-based clinical diagnostic test kits for Corbett's Rotor-Gene.

Rotor-Gene is a centrifugal real-time DNA amplification analyser which detects the presence and amount of DNA from a sample in order to better diagnose disease.

AGEN is developing the reagent kits to be used in the Rotor-Gene. The partnership of instrument and reagent manufacturer has the potential to be successful for both partners.

Corbett Research specialises in the design, manufacture and international distribution of scientific instruments for the analysis of molecular biology. The Rotor-Gene has unique advantages - particularly in relation to the centrifugal aspect of the machinery - and is well positioned in the DNA analysis market.

STEM CELL SCIENCES AND AVENTIS PHARMA COLLABORATE IN SEARCH OF ALZHEIMER'S TREATMENT

Australian biotechnology company Stem Cell Sciences Pty Ltd (SCS) has announced an extension of its collaboration with world-leading pharmaceutical company, Aventis Pharma, following the completion of a pilot study to produce pure populations of nerve cells from mouse embryonic stem cells.

Aventis Pharma has paid Stem Cell Sciences a $1 million milestone payment for completion of the study, and will use the pure nerve cell populations as a key tool to validate the function of genes in differentiated neuronal systems and for screening drug candidates to treat Alzheimer's disease.

Results from the pilot study have validated Stem Cell Sciences' proprietary technologies covering engineering, growth and differentiation of stem cells, allowing the scaling up of nerve cell production to provide the large numbers of living nerve cells needed for effective high-throughput drug screening programs.

Aventis Pharma will expand its gene and drug-screening license to include a primary gene screening application, through a worldwide, non-exclusive licence to use Stem Cell Sciences in-house.

CEO of Stem Cell Sciences, Dr Peter Mountford, said that with the proving of the technology, it will be possible to produce economically a highly purified population of virtually any type of cell, such as heart cells, liver cells and other kinds of nerve cells.

Stem Cell Sciences has exclusive access to stem cell research from the Centre for Genome Research in Edinburgh University, and has forged a number of collaborative agreements with other biopharmaceutical companies including SmithKline Beecham, CurGen and BioTransplant Inc.

Aventis Pharma will use these pure populations of nerve cells as a key tool to validate the function of genes in differentiated neuronal systems and for screening drug candidates to treat Alzheimer's disease. Completion of the pilot study marks a significant milestone achievement in SCS' alliance with Aventis Pharma for stem cell based gene and drug screening.

Importantly, results from the pilot study have validated SCS's proprietary technologies covering engineering, growth and differentiation of stem cells. Achieving this milestone now allows SCS and Aventis Pharma to scale up nerve cell production to provide large numbers of these living nerve cells needed for effective high-throughput drug screening programs.

Dendrimer Inventor in Australia to Further Research

World-renowned US inventor of dendrimers, Dr Donald Tomalia, has arrived in Australia to further ongoing research collaboration with biotechnology company, PanBio, to commercialise nanotechnology dendrimers.

PanBio Chief Executive Officer, Mel Bridges, said that, once commercialised, the dendrimers could be used to improve the company's existing diagnostic tests and technology platforms and could have application to the drug development programs of large pharmaceutical companies.

"Because nanotechnology dendrimers enable greater levels of sensitivity, medical diagnosis in some cases could be up to a week earlier than from previously available technologies,"> Mr Bridges said.

Dendrimers are small man-made spherical molecules that can be coded to travel to specific parts of the human body to treat a range of diseases and medical conditions.

The dendrimers bind to infected cells to deactivate viruses or deflect them from infecting healthy cells within the human body. Because they treat diseases at exact sites within the human body, the side effects of drugs are also minimised.

The Dean of Queensland University of Technology's Faculty of Science, Professor Graeme George, predicts that during the next decade nanotechnology will revolutionise science.

"Medical nanotechnology will open up exciting possibilities for diagnostics and therapeutics because molecular manipulation enables accurate targeting of parts of the human body using novel delivery systems,"> Professor George said.

The Queensland Government has strongly supported nanotechnology in its latest round of innovation funding with a $95,000 grant for the opening of Australia's first nanotechnology centre at the University of Queensland last week.

PROGEN ALLIANCE PARTNER TO CONDUCT INDEPENDENT PHASE 1B CLINICAL TRIAL OF ANTI-CANCER DRUG PI-88 IN TAIWAN

Progen Industries Ltd announced its strategic alliance partner Medigen Biotechnology Corporation had received Ethics Committee approval from the National Taiwan University Hospital (NTUH) in Taipei to conduct its first Phase 1b trial of anti-cancer drug PI-88.

Pre-clinical testing has shown PI-88 has the potential to work in two ways to treat cancer. Firstly, it inhibits the growth of new blood vessels (angiogenesis), effectively stopping the growth of the primary cancer tumour. Secondly, it stops tumour cells from migrating through blood vessel walls, effectively preventing the spread of secondary tumours (metastasis).

The Phase 1b trial will provide Medigen with information about the safety and tolerability of PI-88 in Taiwanese patients suffering from advanced forms of cancer. The data gathered from the trial will assist Medigen to design and conduct its planned Phase II trial of PI-88 in hepatoma (liver cancer) patients, in accordance with the strategic alliance agreement formed by the two companies in June 2000.

INHALIX APPOINTS DR GRAEME WOODROW AS CEO

Inhalix, a private biotechnology company operating in the field of detection and avoidance of airborne allergens, today announced on 29 May the appointment of Dr. Graeme Woodrow as Chief Executive Officer and Director. Dr. Woodrow will take over from acting CEO, Dr Kate Grenot, who becomes Chairman of the Board.

Dr. Woodrow has more than 25 years experience in the biotechnology industry. He comes to the company from Aventis (Belgium) where he had a leadership role in technology acquisition and licensing in crop science and was previously in charge of genomics and bioinformatics acquisitions for AgrEvo. Originally trained as a molecular biologist at the Australian National University (Canberra), he held research positions at Cambridge University (UK), University of Basel (Switzerland), and Monash University (Melbourne) before joining Biotech Australia in 1983. He is also a former President of the Australian Biotechnology Association (now AusBiotech), the nation's peak industry advocacy organisation.

SUMICH ANNOUNCES COLLABORATION WITH POWDERJECT

Australian-based biotechnology company Sumich Group Limited (ASX:SMG) - soon to be renamed pSiVida Limited - has announced the first licensing opportunity for its BioSilicon™ (porous silicon) joint venture technology, signing a collaborative agreement with PowderJect Pharmaceuticals Plc (London: PJP, http://www.powderject.com) to develop porous silicon for use with its advanced drug delivery systems.

The collaborative agreement will result in a work program to evaluate the application of porous silicon in combination with PowderJect's proprietary needle-free drug delivery system. The agreement also gives the international pharmaceutical group the option to license specific applications of BioSilicon™ technology.

PowderJect is the world's 6th largest vaccines company, with a range of products sold worldwide under its Evans Vaccines brand. Its technology focus is on the delivery of medicines with its proprietary powder injection technology, a field in which it leads the world. Powder injection involves the use of a specially engineered device to deliver minute amounts of "powder-form"> medicine into the outer layer of the skin, painlessly, without the use of the needle.

GENETIC ABNORMALITY LINKED TO EPILEPSY

Ground-breaking Australian research which definitely links a genetic abnormality to the most common form of epilepsy was presented in May to a major world conference.

The findings, to be detailed at the 24th International Epilepsy Congress in Buenos Aires, Argentina, follow the discovery of a new gene by Adelaide-based biotechnology firm Bionomics Ltd.

The presentations, by Bionomics Scientific Advisory Board member, Professor Sam Berkovic, and Bionomics senior research officer, Dr Robyn Wallace, focus on a mutation linked to febrile seizures and childhood absence epilepsy. Febrile seizures affect about three per cent of all children and childhood absence epilepsy is a major form of the idiopathic generalised epilepsies, which are the commonest form of inherited epilepsy.

The abnormality lies in a gene, which belongs to a receptor for a molecule called GABA. GABA is an important brain chemical which stops nerve cells "firing"> and has long been suspected of being involved in epileptic seizures. However, this is the first time a GABA receptor mutation has been definitely linked to epileptic seizures within a particular family.

Professor Berkovic, director of the Epilepsy Research Institute at the Austin & Repatriation Medical Centre campus of the University of Melbourne, says the findings are "very significant">. He has been honored at the conference with an award from giant Swiss multinational, Novartis.

His clinical work with one Australian family with a genetic history of epilepsy has been crucial in discovering the gene link.

Bionomics Ltd filed a provisional patent application describing this gene on June 21, 2000.

PANBIO CLOSER TO FDA APPROVAL FOR GLANDULAR FEVER DIAGNOSTICS

Biotechnology company PanBio Limited has announced that it is preparing to lodge for FDA approval of its glandular Fever diagnostic test kit to capitalise on the lucrative US market.

Following its initial release, the company has quickly become market leader for glandular fever diagnostic test kits in Australia and has successfully launched the product in Europe this year.

PanBio Limited Chief Executive Officer, Mel Bridges, said FDA approval would enable PanBio to market its product in the US which accounts for 45 per cent of the international market for diagnostic testing.

The company plans to market and distribute its glandular fever diagnostic test kits through its wholly owned subsidiary located in Baltimore, Maryland.

Researchers have found that Epstein-Barr virus (EBV), a common herpes virus, causes glandular fever and is likely to infect more than 90 per cent of adult populations worldwide.

EBV is also associated with the development of certain cancers, Burkitt's lymphoma as well as almost 50 per cent of Hodgkin's disease cases.

The company has forecast sales of $1.5 million for its glandular fever diagnostic gtest kits this financial year.

BLUE-GREEN ALGAE RESEARCH MEANS EUREKA PRIZE FOR UNSW SCIENTIST

University of New South Wales scientist Dr Brett Neilan has won a Eureka Prize for his groundbreaking study of the evolution and toxin production of blue-green algae.

Based in the School of Microbiology and Immunology, Dr Neilan won the UNSDW Eureka Prize for Scientific Research, for under-appreciated research by a young Australian scientist. His work characterises the different kinds of toxic and bloom-forming blue-green algae (cyanobacteria) and determines the genetic basis for their toxicity.

SEAWEED: UNSW WINS AGAIN

The University of New South Wales has been recognised as a world leader in scientific research with two academics winning two of 11 Merrill Lynch Global Innovation Grants.

Merrill Lynch awarded the grants, totalling US$175,000, to 11 academics and six universities from around the world with the aim of helping move academic research into real-world commercial applications.

Dr Diane McDougald, from the UNSW School of Microbiology and Immunology, was awarded second place for her research, which proposes using seaweed to develop a new class of antibiotics.

She was awarded US$20,000 for her discovery that some seaweed uses chemicals to stop bacteria from communicating, which then stops the bacteria organising themselves to colonise the seaweed and interfere in the seaweed's growth. Dr McDougald believes that it is possible to use molecules similar to those found in the seaweed to stop invading pathogenic bacteria from organising themselves inside the human body.

She said: "Many species of bacteria that cause human infections use the same type of communications system that the seaweed-produced chemical can interrupt. We are confident some of these mimicry tricks could be used to combat bacterial infections in people.

ROTHSCHILD BIOSCIENCE LAUNCHES NEW FUND

Venture capital firm, Rothschild Bioscience, has launched its second biotechnology investment fund, the Rothschild Bioscience Ventures Fund, which will provide an extension to the investment capacity of the firm's existing fund, the Australian Bioscience Trust (ABT).

The ABT is a $42.5 million fund operating under the Federal Government Innovation Investment Fund (IIF) program which invests at the seed, start-up or early expansion stage of Australian technology companies involved in human and animal therapeutics and diagnostics, medical devices and services, agribusiness, food technology and environmental technology.

The new fund has raised $40 million in its first close and is planning to raise a further $20 million by the end of the year. Key investors are Sun Super, Macquarie Funds Management, Temasek (the Singapore Government's venture capital investment fund), and the Meat Industry Superannuation Fund. The fund will extend the range of investments to health services companies and to overseas companies that are doing all their R&D in Australia. http://www.bioscience.com.auhttp://www.bioscience.com.au

Biotechnology firm, Analytica Ltd, has gone into voluntary administration seven months after listing on the Australian Stock Exchange.

Deloitte Touche Tohmatsu was appointed administrator with the aim of investigating possible ways of raising capital to enable the firm to continue trading.

Analytica listed with a portfolio of lead compounds for development as therapeutic drugs, including treatments for cancer, weight control and inflammatory diseases. It was also focusing on applying western drug development techniques to Chinese medicines, and planned to set up a franchise operation of acupuncture and Chinese medicine clinics.

BIOTA BRANCHES OUT

Biota Holdings Limited has purchased NuMAX Pharmaceuticals Inc., a privately held, US-based biotechnology startup company with novel MAX (Matrix Anti-Enzyme) technology for the rapid identification of new drug candidates.

The technology, developed by pharmaceutical chemist and founder of NuMax, Dr P Dan Cook, will be applied to viral targets such as hepatitis B and herpes as well as to other infective agents. The technology also has potential application in the identification of new therapies that can stimulate or suppress the immune system, an area with wide applicability in infectious diseases. The technology involves rapid screening of an in-house library of compounds against selected viral enzyme targets.

Biota will pay for the acquisition by funding a US$8 million drug discovery program over two years, and through the issue of employee stock amounting to no more than 20% of the issued capital of the new US-based company, Biota Inc. Biota Inc will be based in Carlsbad in northern San Diego County, headed by CEO, Sterling Johnson and with Dr Cook appointed as chief science officer.

The acquisition comes in the wake of projections by Biota of lower turnover this financial year affected by the low incidence of influenza in Europe in the past winter season.

IDT TAKES ON NEW CANCER DRUG

Institute of Drug Technology Australia Limited (IDT) has signed a contract with the UK-based pharmaceutical company AstraZeneca for the development and manufacture of a new cancer fighting agent designated ZD9331.

The new agent, which arose from a collaboration between AstraZeneca, British Technology Group and the Institute for Cancer Research, has already undergone preclinical testing and Phase 1 human trials.

Under the terms of the contract, IDT will initially scale up and validate the production process for the active pharmaceutical ingredient of the new drug. The drug is presently undergoing Phase 2 clinical evaluation internationally and, if it successfully passes the clinical testing stage and proceeds to commercialisation, IDT will become the supplier of the active ingredient for worldwide sale.

START GRANT FOR ALCHEMIA

Brisbane-based biotechnology firm, Alchemia, has been offered a $4.3 million R&D Start grant to support the development of technology for producing large numbers of sugar-based compounds for testing as potential drug candidates.

Alchemia received a $2.1 million R&D Start Grant in 1998 to develop a cost-effective process to produce carbohydrate molecules for the potential treatment of cancer and other illnesses.

The research undertaken in this program led to a commercial manufacturing alliance with the Dow Chemical Company

The synthesis of carbohydrates has been, until now, highly labour intensive, requiring very specialized knowledge and a high degree of chemical skill. This has made the use of such compounds cost-prohibitive.

FUNDS FOR VIRAX HIV TRIALS

Biotechnology company, Virax, has been awarded a $910,000 R&D Start Grant to fund a trial of its therapeutic HIV/AIDS vaccine, VIR201.

The grant will support half of the cost of Virax's Phase I/IIa clinical trial to test the vaccine, which utilises the company's Co-X-Gene(TM) + FPV technology.

The Phase I/IIa clinical trial will be conducted with clinical investigators at Melbourne's Alfred Hospital, and Sydney's Westmead and St Vincent's Hospitals.

In July 1998, Virax received a Start Grant for $700,000 for preclinical studies leading to current clinical trial.

New AusBiotech Members

We would like to welcome the following people who have joined our Association since the last edition of the journal.

  • Dr Gregory Pullen Peptech Limited (Corporate)
  • Ms Imbi Semenov Amersham Pharmacia Biotech (Corporate)
  • Ms Felicity Marks Phillips Fox
  • Ms Sally-Ann Watts Austrade
  • Dr Tim Oldham McKinsey & Company
  • Mr Peter Marks Peregrine Corporate Ltd (Corporate)
  • Mr Tom Lewis BioDevelopment Consulting Pty Ltd
  • Ms Erin Quak The Canberra Hospital
  • Mr Patrick Loughlin ANU
  • Mr Roger Hemingway Avax Australia (Corporate)
  • Mr Jason Sullivan World Courier (Aust) (Corporate)
  • Miss May Ghee Lum Monash University (Student)
  • Mr Bill Ingram William Ingram & Company
  • Mr Severin Zinocker Univ of Ag Sciences, Vienna (Student)
  • Ms Christine Morrison IMBcom, University of Queensland
  • Dr Mile Terziovski University of Melbourne
  • Ms Sally Ting Mallesons Stephen Jaques
  • Dr Susanna Muttilainen
  • Dr Jeremy Chrisp BSI Management Pty Ltd
  • Mr Edi Widjaja Dr Dianne Glenn University of NSW
  • Dr Derrick Sim University of Melbourne (Student)
  • Mr Matt McNamara SciCapital Pty Limited (Corporate)
  • Dr John Raff Starpharma (Converted from Individual to Corporate)
  • Dr Lyndal Thorburn Advance Consulting (Converted from Individual to Corporate)

Copyright 2001 - AusBiotech

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