"Industry partnership provides next-generation painkilling drugs"
Australian pharmaceutical company AMRAD is working with researchers from The University of Queensland's Centre for Drug Design and Development (3-D Centre) to develop the next- generation of painkilling drugs.
Tuesday 26 February 2002
AMRAD FAST TRACKS DEVELOPMENT OF CHRONIC PAIN DRUG
Leading Australian biotechnology company, Amrad Corporation Limited (Amrad) (ASX:AML), today announced that positive findings from its Phase I/II clinical trial in patients with chronic severe pain have led to early completion of the study, enabling the Company to advance AM336 to the next stage of development — additional safety studies and a full Phase II trial to commence during 2002.
AM336 is a synthetic version of the molecule [omega-conotoxin]-CVID which was originally isolated from the venom of a fish-eating species of cone snail from Australia’s Great Barrier Reef [Conus catus]. Amrad has exclusive worldwide rights to commercialise the compound.
The AM336 trial involved cancer patients with chronic severe pain from investigating centres in Sydney, Perth and Melbourne. Each patient received AM336 over a 12 day period to investigate the safety of the drug and tolerability to different dosage levels. In addition, under Australia’s Special Access Scheme and in consultation with their investigating doctor, patients could elect to continue with the AM336 treatment beyond the 12 day study period if they felt it was benefiting them.
While a full review and analysis of the data is currently being completed by the study investigators and our clinical development team, Amrad Managing Director Dr Sandra Webb said the potential of AM336 for major clinical benefit is now obvious. “From our perspective the most exciting finding relates to the fact that the majority of patients elected to stay on AM336 after they had completed the 12 day clinical trial study period. This tells us that AM336 can be safely administered at doses required to provide pain relief. These early findings are showing that AM336 has the potential to treat one of the most distressing symptoms of cancer, the pain,” Dr Webb said.
“Our decision to finish the study earlier than planned means we can move toward commencement of international Phase II clinical trials. The potential market size for this category of drugs to treat severe pain is valued at around US$400 million. “At present severe pain treatment is dominated by the use of narcotic analgesics and morphine is the most common of these. However, serious side effects and the development of tolerance limit the use of these drugs. AM336 has the potential to overcome these obstacles as it works via a different mechanism to morphine. This really is an Australian breakthrough in the treatment of pain,” Dr Webb said.
Dr Webb said Amrad would now concentrate its efforts on further development of AM336 and will meet in March with the US Food and Drug Administration to discuss the details of the development pathway for AM336.
“Importantly, future studies will investigate the efficacy of AM336 in treating pain arising from a variety of diseases which cause chronic severe pain. These are diseases such as cancer, toxic and traumatic nerve damage, diabetes and viral infections,” said Dr Webb.
AM336 was discovered through a collaborative research program at the University of Queensland, supported by a Generic Industrial Research and Development (GIRD) grant, exploring the pharmaceutical potential of cone snail venoms. Amrad Corporation Limited
Amrad Corporation Limited is an Australian research-based biotechnology company. Amrad's in-house pharmaceutical R&D expertise is focused on three key areas: infectious diseases; neurological conditions; and, allergy and inflammation. R&D activity targets the clinical development of compounds for serious chronic human diseases, focused on early commercial returns. Amrad currently has seven projects in preclinical and clinical development, three of which are in Phase II clinical trials. The lead clinical projects include emfilermin for the treatment of neuromuscular disorders (Phase II); emfilermin for the treatment of reproductive health in collaboration with Serono (Phase I); AM336 for the treatment of chronic severe pain (Phase I/II complete); AM365 for the treatment of hepatitis B virus infection (Phase II); AM132 and AM133 for the treatment of cardiovascular disease (preclinical testing) in collaboration with Gencell Inc (a wholly owned subsidiary of Aventis) and Edwards Lifesciences respectively; and AM36 (preclinical testing) for the treatment of stroke in collaboration with DevCo Pharmaceuticals. For further information please contact: Anne Hayward Investor Relations Telephone: 61 3 9208 4320 Mobile: 0419 893 922
Melbourne, 6 Mar 2000
AMRAD Corporation Limited (AMRAD) (ASX:AML) today announced clearance from the Therapeutic Goods Administration (TGA) to commence clinical trials with two of its exciting compounds - AM336 for treatment of uncontrollable severe pain and AM365 for treatment of Hepatitis B virus infection.
The Phase I trials are the first administration of these compounds into people and will occur in hospitals in Adelaide, Sydney and Melbourne. Phase I trials test the safety and human tolerance of the compounds, which have already been extensively studied and tested in the laboratory.
AMRAD Managing Director John Grace said the company's strategy to focus on biotechnology and pharmaceutical research and development has resulted in this successful application to the TGA.
"We are a biotech company with world-class compounds and opportunities. The TGA approval to proceed is exciting and is a natural outcome of careful business planning over the past few months," Mr Grace said.
"The go-ahead for the severe pain and Hepatitis B clinical trials now means AMRAD has three compounds in clinical development. These compounds join AM424, a treatment of nerve damage experienced by patients undergoing chemotherapy, which entered a Phase II clinical trial last September," he said.
"Success with any one of these compounds will lead to a major pharmaceutical product which addresses global needs."
AM336 is being developed to treat severe pain which is uncontrolled by existing therapies. It was discovered by scientists from the University of Queensland, as part of an AMRAD collaborative project sponsored by an AusIndustry grant. Originally identified in the venom of a fish-eating marine cone snail collected from the Great Barrier Reef, AM336 is a synthetic form of the naturally-occurring compound. The potential market size for this category of medicines to treat severe pain is $500 million.
AM365, a pharmaceutical compound discovered in a collaborative project with the CSIRO Division of Molecular Science, is a potential treatment for Hepatitis B virus infection which can lead to fatal liver disease. Hepatitis B infection is a major worldwide health problem and current treatments are limited. The potential market size for Hepatitis B drugs is greater than $1 billion.
"The fact that AMRAD can announce on the same day that it has clearance to start clinical trials in Australian hospitals with two new compounds discovered within Australia demonstrates the depth of our drug discovery and development programs," said Mr Grace.
"AMRAD's strategy is to add significant value to its portfolio of potential pharmaceutical products, to the point where they can be licensed to international pharmaceutical companies. If the projects are successful, AMRAD receives a return on research and development expenditure comprising cash receipts and a royalty stream based on product sales."
For further information, please contact:
Dr. Sandra Webb
AMRAD Corporation Limited
ACN 006 614 375
576 Swan Street
Richmond, 3121, Victoria, Australia
Telephone: 61 3 9208 4000
Facsimile: 61 3 9208 4350
Last updated 5 March 2002 bgl