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New Zealand Biotech Industries News
2005/05/26

FDA fast-tracks Lazarin

In what may be a first for a New Zealand company, the US Food and Drug Administration (FDA) has granted fast track status for Protemix Corporation's lead compound, LaszarinT (trientine) for treatment of heart failure in people with diabetes.

Studies by Protemix have implicated undesired copper levels as an important factor in the progression of diabetic complications, and the company has demonstrated that its LaszarinT compound can be used to remove surplus copper.

"Fast Track" is a formal mechanism that facilitates FDA-company interactions concerning clinical testing of a proposed therapeutic. By law, Fast Track status is reserved to facilitate the development and expedite review of a drug only "if it is intended for the treatment of a serious or life-threatening condition and it demonstrates the potential to address unmet medical needs for such a condition" .

Benefits of Fast Track status include scheduled meetings to seek FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints.

Protemix co-founder and winner of the 2005 NZBio Distinguished Biotechnologist of the Year Award, Professor Garth Cooper explained: “This is an important first for New Zealand science and means that market approval for LaszarinT in the designated indication could be hastened. The FDA has granted this important designation because LaszarinT is being developed for the treatment of heart failure in diabetic patients and there is an unmet need for these patients. We intend to study the benefits of LaszarinT in respect of clinically important endpoints including mortality and hospitalistion.”

Protemix CEO, Larry Ellingson said the news from the FDA confirmed there is an important unmet clinical need for patients with diabetes suffering from heart failure and that LaszarinT has a potentially important role to play.

“We are negotiating with several clinical research organisations to expand our clinical trials, after further discussion with the FDA,” Mr Ellingson said.

Diabetes is often accompanied by heart enlargement, heart dysfunction and coronary heart disease and these are major causes of death in people with type 2 diabetes. Previous work by Protemix researchers showed that six month's treatment with trientine resulted in a significant decrease in heart size in people with diabetes that had enlarged hearts.

The FDA decision also follows the publication last month of Protemix research showing, among other things, a positive effect of Laszarin on the levels of oxidised copper in the body. The company believes that this may be as important as lowering blood glucose levels in preventing cardiovascular complications in diabetes mellitus.

If successful in remaining Phase II and III trials, LaszarinT has a potential worldwide market of more than three million people with diabetic heart failure.

Protemix Corporation Press Release, 26 May 2005
 

Seaside inspiration behind cancer breakthrough

Some of the best ideas start on the beach. And so it was in 1982 when, fresh from a conference, New Zealand scientists Bill Denny and Bill Wilson came up with an idea that resulted in a way to kill cancer while leaving the healthy cells intact, and the platform for multinational company Proacta.

Proacta’s science has two underpinnings: prodrugs are inactive until they go through a metabolic conversion and hypoxia, or a lack of oxygen, effects tumours in approximately 65 percent of people diagnosed with cancer. Hypoxia results because tumors grow more quickly, than their ability to develop blood vessels.

Not only can oxygen not get through, but neither can chemotherapeutic drugs, making those regions particularly deadly and difficult. If you can see past limitations, sometimes it’s what you don’t have that makes all the difference. And that’s what chemist Denny and biochemist Wilson’s seaside inspiration was based on: using the lack of oxygen to turn on anticancer drugs.

They put their heads together and came up with some extremely potent cytotoxic prodrugs that are ‘turned-on’ when oxygen is absent (normal cells, because they are oxygen-rich, are spared the destructive effects of the drugs). And then they came up with methods to get the drugs through the vessel-free hypoxic regions. All this is quite exciting on its own, but getting ideas from a laboratory on a small Pacific island to the rest of the world, well, that’s another challenge that also required creative thinking. But it’s definitely worth the effort.

Proacta CEO Paul Cossum estimates the total market for this new generation of anti-cancer drugs to be in the billions of dollars. A lot of companies brag about being international, but few can equal the connections that Proacta has achieved. While the initial research was carried out in Auckland, when it came time to go global, Proacta didn’t focus on just one locale or, for that matter, one partnership model. It made sense to partner with tumour hypoxia experts Martin Brown and Amato Giaccia at Stanford and, in exchange for IP, Stanford was given equity in the company and Brown and Garcia joined the team as founding scientists.

GBS Venture Partners in Australia led a syndicate that provided US$8 million Series A funding. Other syndicate members include Genentech from the United States, Roche, from Switzerland and No 8 Ventures and Endeavour Capital from back home in New Zealand.

Leadership, too has also been a multinational affair. The founding CEO, Aki von Roy, is a German national who first came to New Zealand when he was the New Zealand managing director for Schering. He later served as vice-president for Schering in the US and Germany and then joined Squibb, where he became president for Europe. In 1999, von Roy retired, founded RvR Associates (a private investment firm that specialises in health) and moved to New Zealand. Not able to let retirement get in the way of a good idea, he led the start up of Proacta (Proacta Inc is registered in Delaware, USA; Auckland-based Proacta Therapeutics is a wholly-owned subsidiary).

When von Roy left Proacta in 2004, Paul Cossum joined the team as chief executive. Cossum’s credentials are equally impressive: originally from Tasmania in Australia, Cossum spent two decades in drug development, including serving as executive vice president at NewBiotics, vice president at Aronex Pharmaceuticals and director of preclinical development at Genentech.

Cossum had one other thing going for him that helped in Proacta’s business plan: he lived in San Diego. Proacta was looking for a US home base and the Southern California biotech hub was a logical choice. Cossum now leads Proacta from both sides of the Pacific, splitting his time between the two. Proacta’s lead compound, PR-104, is set to enter Phase I clinical safety trials in December 2005 but, with finite resources, Proacta knows it must be clever about how it manages the trials and the money.

Trials with the greatest chance of proof of compound will come first and, like most other cancer drugs, PR-104 will be given in combination with other treatments. The ability to rapidly recruit patients for trials will figure strongly in the decision of where trials will be run. New Zealand, the US and Australia are being considered. While the second lead has yet been decided, Proacta holds 25 worldwide patent rights from which to choose and the company expects to identify that second lead by mid-2005. The search for Series B funding is slated for third-quarter 2006.

Auckland will remain the drug discovery engine for Proacta, but the development part of the organisation will be run from the US. Cossum says he’s delighted to take IP developed in New Zealand through to commercialisation and, one day, bring a return on New Zealand’s investment back home to fund further research investment.

Luckily, New Zealand has a lot of coastline and beaches for inspiration, so it doesn’t seem like a lack of ideas will slow this group down.

www.proactatherapeutics.com

 

NZ & Australia working together

Cooperation rather than competition is the watchword for the relationship between the New Zealand and Australian biotechnology communities – a situation formally recognised by the creation of the Australia-New Zealand Biotech Alliance.

Together New Zealand and Australia constitute the world’s fifth largest biotech hub worth a combined NZ$14 billion and employing more than 10,000 people. Through cooperation the region has created a platform for greater success in global markets.

New Zealand brings significant critical mass to the biotech alliance as more than 40 percent of employees in the two biotech communities are based in New Zealand. The trans-Tasman partnership approach is driven by a common economic reliance on the primary industries and the fact both New Zealand and Australian biotech companies and organisations face similar economic and geographic issues.

There are more than 50 commercial trans-Tasman biotech collaborations already underway. These joint initiatives include human health projects such as the development of new human therapeutics and agricultural biotech projects that are improving the health, breeding, productivity and processing of forests, crops and animals.

In the area of medical biotechnology, New Zealand research institute Industrial Research Ltd (IRL) is working with Australian company Starpharma on a new class of drugs, called dendrimers, applying these to the prevention of sexually transmitted diseases. Another human health collaboration is between New Zealand company Neuren Pharmaceuticals and Australia’s Metabolic Pharmaceuticals to develop a drug targeted at spinal cord injury and multiple sclerosis.

In forestry, the region’s two largest forestry R&D providers – New Zealand’s Scion and Australia’s CSIRO Forestry and Forest Products – have formed a joint venture to improve forestry industry profitability through science. And in vegetables, New Zealand and Australian scientists are looking to find great tasting vegetables with optimum levels of cancer fighting components.

The Australia-New Zealand Biotech Alliance is further leveraged by initiatives such as the NZ$12 million Australia New Zealand Biotechnology Partnership Fund designed to increase the rate and magnitude of cooperation between New Zealand and Australian biotech companies and organisations.

Other examples of New Zealand-Australian activities include:

 • The Australia New Zealand Biotech CEO Forum, an annual meeting of commercial biotech leaders from both nations.
• Co-location of New Zealand and Australian stands at international events, such as the annual BIO trade show and convention.
• The NZ$150 million Australia-New Zealand life sciences venture capital fund run by New Zealand-based BioPacificVentures.
• Regular New Zealand Government-led commercial biotechnology and agribusiness missions to Australia.
• Memorandums of Understanding to work collaboratively in biotech development between New Zealand and each of the Australian states of Queensland, Victoria and New South Wales.

www.biotechalliance.org

 

Harnessing natural power protein

New Zealand research company Canesis has unlocked the secrets of keratin, nature’s power protein and the main building block of human and animal protectors such as skin, nails, hair, horns and shells.

As a world leader in keratin ultrastructure – which explores the smallest elements making up the protein – Canesis Network Ltd and its spinoff venture Keratec Ltd are reconstructing these elements into innovative natural health, lifestyle and wellbeing alternatives.

Canesis has identified how to extract natural keratin in a form that is soluble and therefore digestible by and acceptable to the human body. This process is able to separate wool fibre into its natural protein components, rather than mangling the constituent amino acids as other processes do.

The protein is non-allergenic and rivals the efficacy and safety of most synthetic ingredient alternatives. Keratec is using this technology to commercialise premium ingredients for consumer health, cosmetic and medical products.

A Keratec ingredient preventing joint breakdown and building joint resilience called Cynatine was recently released to an enthusiastic nutraceuticals market. Keratec is also commercialising materials for medical devices made from keratin, including orthopaedic devices such as bone fixation and grafting products using technologies originally developed jointly with Otago University in Dunedin.

Other applications include keratin wound dressings, adhesives, bioplastics, and fibres. By breaking keratin down to its pure, constituent amino acids, Canesis has created a significant new building block with a wide range of applications. These applications are natural, sustainably sourced, and potent. In this work Canesis is building on New Zealand’s strong capability in pasture-based plant and animal genomics.

Of particular importance is New Zealand’s unique disease-free animal populations and the best possible animal health status. There is no history of List A diseases and New Zealand is one of only five countries in the world to achieve a category 1 rating by the OIE in respect of BSE and related diseases.

Canesis applied sciences general manager Dr Rob Kelly says many blue-chip international biotechnology and consumer product leaders have accessed Canesis knowledge, although the details are commercially sensitive.

“A large part of our fundamental research is funded by international companies. They come across the world to source our knowledge about keratin.”

The company is also emerging as a leader in formulation and efficacy science. “This means we can scientifically substantiate the marketing claims made about ingredients, with full understanding of the proteins’ interactions with other substances and each other,” says Dr Kelly.

Commercial focus

Canesis is one of the largest private research and development companies in New Zealand. It is owned by investment company Wool Equities Ltd (75 percent) and the Wool Research Organisation of New Zealand (25 percent).

Canesis was set up in 1961 as the Wool Research Organisation of New Zealand. It was created to add innovation value to one of New Zealand’s most significant agricultural commodities – wool.

The company has four divisions: textiles, carpets, fundamental and applied sciences. It is now a US$20 million global company with offices in six countries, 290 partner companies in 23 countries, and 180 staff. Canesis has itself launched significant enterprises. Canesis and Wool Equities own SOFTswitch Ltd, an electronics textile company based in Yorkshire, in the United Kingdom.

SOFTswitch is developing and marketing textile-based pressure sensing and switching devices. Burton Snowboards has been one of the first innovative apparel companies to utilise the new technology. Their product, which uses a SOFTswitch sleeve panel to control an integrated personal stereo, was named by TIME Magazine as “one of the coolest inventions of 2002”.

Other applications include pressure sensing for medical uses such as hospital bedding and smart interior textiles to control lighting, security, temperature or electronic appliances. New Zealand-based companies have used Canesis research as a launch pad for products in global demand. HotRot, recently acquired from Canesis by New Zealand’s R5 Solutions group, applied research into in-vessel composting technology to create new ways of handling organic waste products.

The creators of ecoglo®, a world-leading passive emergency lighting system, contracted Canesis to apply knowledge gained from research into carpet manufacture to its photoluminescent lighting recipe.

Dr Nigel Johnson, Canesis’ deputy CEO, attributes Canesis’ research and development strength in natural fibres, textiles, and keratin biopolymers to its holistic commercial approach, which combines fundamental and applied science, engineering and manufacturing with marketing know-how. Canesis collaborates widely with other research and industry bodies. Its partnership in the New Zealand Biopolymer Network has enabled its scientists to collaborate with those exploring other technologies in proteins, cellulose and starches.

International research collaborations include Australia’s Commonwealth Science and Industrial Research Organisation (CSIRO) and Germany’s Deutsches Wollforschungsinstitut (DWI). New Zealand has often been colloquially described as “living off the sheep’s back”. With the seemingly infinite applications that Canesis can create from wool-sourced keratin, that ovine base looks like the launching pad for generations of new products and market-leading alternatives to myriad existing products.

www.canesis.com

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For the further information, please contact Mago(Tze-Ching) Hsiao (Trade Development Executive)
Tel: 02-2757-6721#214, Fax: 02-2757-6972, e-mail: mago.hsiao@nzte.govt.nz

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