Australasian Biotechnology, Vol. 10 No. 4, 2000, pp. 13-15
Code Number: au00039
Bresagen Anti-Cancer Drug Completes Phase 1 Trial
BresaGen has announced the successful completion of the Phase 1 human safety trial for its revolutionary anti-cancer drug e21R. The trial was conducted at the Royal Adelaide Hospital Cancer Centre.
E21R, a potential therapeutic drug for the treatment of various cancers - such as leukaemia and breast cancer, was found to be safe and well-tolerated at all doses tested.
BresaGen will now seek approval for Phase 11 clinical trials, to test the therapeutic effectiveness of E21R, initially in myeloid leukaemia patients who are most likely to benefit from the drug. The first Phase 11 trial is expected to begin in September 2000 at several clinical centres around Australia. Funding for the Phase 11 trials will be assisted by BresaGens 1998 AusIndustry START Grant of $2.9 million.
Genetic manipulation of pigs for organ donation has taken another leap forward with Adelaide-based biotechnology company BresaGen receiving further US funding. The cloning and gene knock-out methodology could be of major significance in the field of xenotransplantation - the provision of transplant organs for humans from animal sources.
This further funding of our pig organ transplant program is very important to BresaGens continuing work in this field, said BresaGens Managing Director, Dr John Smeaton. At present, humans reject pig organs because of one particular bad gene. By eliminating this gene, we are well on the way to eliminating one of the largest problems facing the transplantation of pig organs into humans. This funding is also an endorsement of the quality of the BresaGen research team.
An agreement has been signed by BresaGen, Baxter Healthcare (Illinois, USA), Nextran Inc. (Princeton, NJ, USA, a fully-owned subsidiary of Baxter), St. Vincents Hospital, Melbourne, and BXM (BresaGen Xenograft Marketing, a joint venture between BresaGen and St. Vincents Hospital). The agreement provides research funding that will support continued xenotransplantation research at BresaGen specifically in the area of pig cloning and gene knock-out technology.
Bionomics to Make $5 Million Placement
Bionomics Limited, the Adelaide-based genomics company, is to raise $5 million by way of a placement of 5 million ordinary shares.
The funds raised by this placement will be used primarily to accelerate the companys epilepsy gene discovery program.
The placement price of 97 cents represents 6.4% discount on the 5 day average closing price of Bionomics shares prior to the day the terms of the placement were agreed with Taylor Collison Limited, who arranged the placement.
This company is focusing on an outsourcing policy of mid-stage development projects. It is working in the areas of drugs for cancers, weight control and inflammatory diseases. It also has an established modern Chinese medicines business with TGA-approved products to provide cash flow. The company aims to raise a minimum of $6 million with the current offer, which is expected to close on 12 September.
Sirtex Medical Ltd
15 million shares are being issued to raise $15 million. It is commercialising three products relating to liver cancer. The business was formed to develop techniques to target micro-particles into tumours within the liver. It has connections to the Cancer Research Institute (Univ. of WA), and was formed in 1997. It has three products developed, the first of which is being marketed, called SIR-Spheres, DOX-Spheres, and Thermo-Spheres. Chris Roberts and Bruce Gray are key personnel in the company.
GroPep is an Adelaide based biopharmaceutical company, founded in 1988 to commercialise growth factors. Its main business is in pharmaceutical cell culture. It also sells biotechnology reagents to researchers world-wide. It also has a drug development business and is conducting phase 1 clinical trials on a number of new drugs currently. It aims to raise $15 million, and is expected to list on 30 August.
Laser vision correction company, Q-Vis, has listed on the Australian Stock Exchange, raising $10 million after the initial $5 million was heavily over-subscribed. The company has attracted an $8.5 million investment by Kerry Packer, giving him a 20% share on a fully-diluted basis.
Q-Vis, formerly Telco Medical Technologies, has been granted conditional approval by the US Food and Drug Administration to start clinical testing of its solid-state laser vision correction technology.
Biotechnology company, Pi2 Limited, which has been formed to commercialise PAI2, a treatment for skin conditions such as ulcers and psoriasis, has floated on the Australian Stock Exchange, following an IPO to raise $7 million. This follows a mezzanine capital raising from Australian institutions in March this year of $8.85 million.
Pi2 Limited is an offshoot of the Human Therapeutics Pty Ltd (HTPL) group which includes Biotech Australia Pty Limited. The HTPL group was purchased from Hoechst Australia Limited in December 1999, by Human Therapeutics Limited, a consortium of investors and management and staff.
The HTPL group initiated the wound healing project and invested approximately $30 million over the last 10 years, taking it to its current mid-Phase II trials stage and entitling it to licence fees from Pi2 as development milestones are reached.
Results from Phase II trials are expected in the third quarter of 2000, and Phase III could begin in 2001, leading to registration application in 2003 and marketing in 2004. Commercialisation of PAI-2 is planned in conjunction with a major pharmaceutical partner and Pi2 will seek to manufacture and supply the product.
Progen Industries Ltd and Medigen Biotechnology Corporation have entered Strategic Alliance to Accelerate Development of P1-88 in Cancer and Cardiovascular Disease.
Under a separate subscription agreement, MBC will purchase an equity stake in Progen for A$11 million, which will be subject to Progen shareholder approval. In addition Progen will receive a 19.9% equity stake in MBC and certain anti-dilution rights.
Promising pre-clinical results indicate that P1-88 has potential application in cardiovascular disease as a potent anticoagulant and antithrombotic agent with a unique mode of action. P1-88, a potent inhibitor of metastasis and angiogenesis, is currently in a Phase 1b cancer clinical trial at two sites in Australia to determine dosage and safety aspects of the drug.
The A$11 million raised from the subscription agreement will allow Progen to accelerate and expand its own development program of P1-88 in cardiovascular disease. Progen is currently planning Phase 11 clinical trials in these areas.
MBC is a Taiwanese corporation formed to expand investigation of P1-88 in diseases with high I incidence in the Asian population.
Progens Phase 1b clinical trial, conducted with cancer patients at Melbournes Royal Melbourne Hospital and Peter MacCallum Institute, is progressing according to schedule. Phase 11 clinical trials with P1-88 for treatment of cancer are planned for early 2001.
Virax and IDT win $27 million contract
Virax Holdings Limited and Institute of Drug Technology Australia Limited announced that the Australian consortium, of which they are a member, is to receive $27 million (US$16) from the US National Institutes of Health (NIH) to fast track the development and testing of vaccines to prevent HIV. Go-C-Gene technology is to be used in these vaccines.
The NIH was particularly attracted to the Australian consortiums innovative prime and boost vaccine concept. The prime vaccine will be DNA-based. The boost vaccine will be based on FPV (fowlpox virus) vaccine using Co-X-Gene technology licensed by Virax from Australian National University and CSIRO. The vaccines will be used in Phase I/II clinical trials, initially in Australia and then in a developing country. Our prime and boost concept is one of the most promising approaches to a safe and effective HIV vaccine, said Professor David Cooper, Program Director, National Centre in HIV Epidemiology and Clinic Research (NCHECR).
Clinical trials using the developed vaccines will be managed by the University of New South Wales through the NCHECR and the National Centre in HIV Social Research (NCHSR).
Viraxs Co-X-Gene technology will be used to develop the boost vaccines. The manufacturing and testing of boost vaccines will be undertaken in Viraxs specialised GMP manufacturing facility by Viraxs strategic partner, IDT. IDT has used its world ranking expertise to develop the necessary technical capability for such manufacture and testing. The costs of the manufacturing and testing are fully reimbursable under the contract award. Virax has rights to commercialise vaccines developed from the initiative.
Virax has also announced that it has signed an agreement to benefit from Aventis Pasteur SA expertise for the development of HIV/AIDS vaccines using Viraxs Co-X-Gene technology.
The agreement provides Virax access to Aventis Pasteurs scientific, clinical and commercialisation expertise. Aventis Pasteur is granted the first right to negotiate licences with Virax for products arising from the collaboration.
Viraxs Chief Executive Officer, Dr David Beames, said, We believe this collaboration with Aventis Pasteur, the world leader in the vaccine market, will provide Virax with access to key development expertise to progress the Companys platform technology for the treatment and prevention of HIV/AIDS. Aventis Pasteur is the clear leader in the use of poxviruses as vaccine vectors and it has extensive and world-wide experience in the conduct of HIV/AIDS human clinical trials.
Perkin Elmer Biosystems, a business of PE Corporation, has changed its name to Applied Biosystems. Although the name has changed, the company still offers the same products, services and support as over the past years.
Axon Instruments and CSIRO Announce Collaboration
A new generation of instruments for rapidly screening potential wonder drugs is the goal of a new research partnership.
Axon develops instrumentation and software for rapid, accurate protein and DNA analysis. They are currently developing CellPix, a system for rapidly screening pharmaceutical drugs.
Dr Andy Blatz, Axons Director of Cell-Based Screening Technology, says that researchers looking for new drugs must screen them for their effects on human and animal cells.
The CellPix system works by capturing and analysing images of cells using chemical fluorescence to mark cellular features. Under different conditions, different parts of the cell become visible so we can compare the effects of many potential drugs on many different features. says Dr Blatz.
Automatically processing these images is a highly specialised and computationally intensive activity which requires the sophisticated image analysis techniques that CSIRO can offer.
The CellPix system will be used for drug discovery based on measurements of a range of cellular characteristics including cell shape, neurite outgrowth, changes in adhesion and other morphological changes.
Axon Instruments announces profit INCREASE
Silicon Valley-based Axon Instruments, Inc. today announced a record unaudited half-yearly after-tax profit for the six months to June of $1.98 million.
Research and development expenses increased 31% over the corresponding period in 1999 to $5.12 million. All research and development was fully expensed during the period under review. Axon Instruments has cash reserves of $15.789 million.
Unaudited sales for the six months to June 30, 2000 increased 98% to $22.0 million compared with $11.1 million in the corresponding six months of 1999. Sales and orders of the Genepix 4000 DNA microarray scanner have continued to be strong.
Meditech Research to Conduct Human Trials
Perth-based biotechnology company Meditech Research Limited has announced the imminent start of two human trials, in both London and Melbourne, for its novel Hyaluronan drug-delivery technology.
London-based Hammersmith Hospital has agreed to conduct human trials based on radioisotope, a radioactive compound that can hone in on, and be traced to, particular parts of the body. This technology is available only in the UK. The objective of the trial is to see if PET scanning - a high technology imaging tool - can demonstrate increased entry of anti-cancer drugs into colorectal cancer by Meditechs Hyaluronan targeting technology. Results from patients will be available progressively throughout the trial. Meditech is currently looking at a draft agreement on procedure and cost. The trials in London are expected to begin at Hammersmith Hospital within two months.
ANADIS BLOOD TECHNOLOGY TRIALLED
Bioscience research company, Anadis Ltd, has entered into a collaboration and research agreement with the Centre for Heart and Chest Research at Southern Health Care Network, Monash University for preclinical testing of the companys Clearan cartridge.
NORWOOD ABBEY FLOAT
Melbourne-based medical instrument company, Norwood Abbey, is raising $30 million in a public float with the aim of commercialising a laser device for drug injection.
The device removes a small area of the outer layer of skin so that a patch can be used to administer drugs. It would be appropriate for drug delivery in a range of conditions including pain management, diabetes, and osteoporosis.
Norwood is also currently developing a local anaesthetic product aimed at the pediatric market, and in particular reducing the pain of injections and vaccinations.
A report prepared by Acuity Technology Management for Norwood Abbey values its intellectual property at between $78 and $102 million, assuming sales of 13,000 of the injection or drug-laser units in 2000-01.
BIOENTERPRISES TO MAKE MELANOMA VACCINE
Sydney biotechnology firm, Bioenterprises, has won approval from the Therapeutic Goods Administration to manufacture M-Vax, a vaccine for the treatment of melanoma developed by the US company, Avax Technologies.
The Bioenterprises plant will be the first in the world to manufacture the vaccine, which could be available in Australia later this year.
CHEMEQ ULCER TREATMENT PROGRESSES
Listed Perth biotechnology company, Chemeq, has developed and patented a treatment for stomach ulcers. The treatment, CHEMYDE, has been proven active in animal tests conducted at Murdoch University in combating Helicobacter pylori, the bacterium that causes ulcers.
Chairman and chief executive of Chemeq, Graham Melrose, said animal testing would continue, but the company would need to raise further funds to prgress on to human clinical trials.
AMRAD HANDS OVER ICT BUSINESS
AMRAD Corporation Ltd has completed the winding down of AMRAD ICT with the transfer of its distribution and supply obligations to US biotechnology company, Binax Inc.
Under the terms of the agreement, AMRAD will receive equity in Binax and a royalty on future sales.
Binax, located in Portland, Maine, is a privately owned company specialising in point-of-care diagnostics. AMRAD ICT technology will be transferred to Binax over the next nine months. Production will continue at AMRAD ICT during the transfer period in order to fulfil existing contracts.
CROWN SCIENTIFIC TO DISTRIBUTE GENELINE
Crown Scientific is pleased to announce it has been appointed a full distributor for the GeneLine range of Gel Documentation Systems from Spectronics Corporation.
Gel Documentation Systems deliver consistent gel images in seconds
The GeneLine Series is the next generation of this companys gel documentation systems. The series comprises two systems: Gelink and GeneCam.
For more information on the GeneCam products.
Life Sciences Division, Crown Scientific Pty Ltd, 144 Moorebank Avenue, Moorebank NSW 2170. Tel: (02) 9602-9800 Fax: (02) 9602-4608 Email: email@example.com
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