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Biotech Daily

‘MARKED IMPROVEMENT’ FOR TISSUE THERAPIES’ 1st PATIENT

September 4th 2008 21:43

Wednesday September 3, 2008

Daily news on ASX-listed biotechnology companies

* ASX, BIOTECHS DOWN: STEM CELL UP 25%, POLARTECHNICS DOWN 19%

* ‘MARKED IMPROVEMENT’ FOR TISSUE THERAPIES’ 1st PATIENT

* ISRAEL APPROVES ANADIS CANCER-RELATED MUCOSITIS TRIAL

* SPINIFEX RAISES $12m FOR PAIN RESEARCH

* NEURODISCOVERY WINS $170k RESEARCH CONTRACT

* OCCUPATIONAL & MEDICAL IN $3m SOUTH AFRICAN DEAL

* BIO-MELBOURNE WORKSHOP: THE ABC OF BUSINESS DEVELOPMENT

* OPPENHEIMER FUNDS TAKES 20% OF PROTEOME

* MICHAEL SPOONER SELLS MESOBLAST SHARES TO EXERCISE OPTIONS

* DR MEGAN CLARK APPOINTED CSIRO CHIEF EXECUTIVE

* STEM CELL CENTRE TRAINS YOUNG SCIENTISTS

* PEPLIN CEO TOM WIGGANS STARTS ON $US350k; AGM NOTICE

To read all these articles in full, subscribe to Biotech Daily at the link above or at www.biotechdaily.com.au

TISSUE THERAPIES

Tissue Therapies says the first of eight Perth patients to be treated with Vitrogro for venous ulcers has demonstrated “a marked improvement” with no adverse events.

Tissue Therapies said 70-year old Dot Harrison suffered from a venous ulcer on her right ankle which had not healed with conventional dressings.

The company said that following treatment with Vitrogro “her venous ulcer reduced in area by more than 60 percent in only 21 days, there was a marked improvement in the health of the tissue at the edge of the wound and full healing is expected”.

There were no adverse reactions, the company said.

Tissue Therapies chief executive officer Dr Steven Mercer said while the clinical progress of one patient was not conclusive, the company was “very excited” by the results because this was how it expected Vitrogro to perform clinically.

“There is no doubt that the rapid reduction in ulcer size and improvement in health of the skin in the wound area are highly unusual for a chronic venous ulcer,” Dr Mercer said.

“With the use of Vitrogro, it appears that Mrs Harrison’s ulcer is healing in a way that is exceptional,” Dr Mercer said.

Dr Mercer told Biotech Daily that the remaining seven patients in the Perth trial (see Biotech Daily July 9, 2008) would be treated by the end of December with results by the end of January.

Dr Mercer said progress had been made in the long-delayed Toronto trial and he hoped to have regulatory approval in the coming months.

Tissue Therapies climbed 1.5 cents or 17.65 percent to 10 cents.

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VENTRACOR’S PETER CROSBY HITS THE INVESTMENT ROAD

September 3rd 2008 12:59

Tuesday September 2, 2008

Daily news on ASX-listed biotechnology companies

* ASX, BIOTECHS DOWN: OPTISCAN UP 9.5%, BENITEC DOWN 19%

* STEM CELL: ‘WORLD’S FIRST TRUE RAT EMBRYONIC STEM CELLS’

* BIO-GUIDE BRIEF: DO WE REALLY NEED MERGERS?

* VENTRACOR’S PETER CROSBY HITS THE INVESTMENT ROAD

* ABSOLUTE CAPITAL SELLS 20% STAKE IN CLINUVEL

* CSL APPOINTS MERCK & CO’S DAVID ANSTICE DIRECTOR

To read all these articles in full, subscribe to Biotech Daily at the link above or at www.biotechdaily.com.au

VENTRACOR

Despite exponential revenue from sales of Ventracor’s heart pump, chief executive officer Peter Crosby says capital raising is difficult.

In Melbourne to see investors and media, Mr Crosby told Biotech Daily the company was “actively assessing several financing options” in the quest to raise up to $22 million to take the company to mid-2009.

Over the past three years total revenue has increased from $1.1 million at June 30, 2006 to $4.9 million in 2007 increasing to the $17.3 million reported last week (see biotech Daily August 28, 2008).

“We’d be really pleased if we could double the revenues in the next 12 months,” Mr Crosby said.

He said the company’s third generation left ventricular assist device had approval in Australia and Europe with significant sales in both continents, but the US remained the key market.

He said that if everything went according to plan Ventracor was hoping for US Food and Drug Administration registration for the bridge-to-transplant indication by mid-2010 and the more lucrative destination therapy by mid-2013.

The bridge-to-transplant market was worth $US300 million per year but the destination therapy was much larger at $US4 billion a year, Mr Crosby said.

He said that to reach the mid-2010 point when the bridge-to-transplant indication was registered and retuning revenue to fund all further work, Ventracor would need a total of about $40 million.

Mr Crosby said that when the leading supplier Thoratec passed its FDA pre-market approval in April 2008 sales of their second generation pump “took off”.

He is expecting the same will happen once the Ventracor pump is approved.

“With regulatory approval we can go to everyone, not just FDA-limited centres,” Mr Crosby said.

He said Ventracor would have “an early look” at the ongoing clinical trial results for the bridge-to-transplant trials, as early as December 2008.

He said the Ventracor centrifugal device was superior to its leading axial competitors and was significantly advanced compared to other centrifugal pump companies.

“It’s a time to market play,” Mr Crosby said.

“The first two or three will take 90 percent of the market,” he said.

Mr Crosby said that with more than half of its total 325 heart pump sales in the past 12 months he expected to sell “hundreds” of pumps in the 12 months following bridge-to-transplant registration and “thousands” once the pump has been registered for destination therapy.

He also said that any development of stem cell technology to repair hearts would assist his business as the heart would require resting while the stem cells were transplanted and grown.

He said Ventracor’s share price had been hit by the market turmoil, but also believed day-traders were part of the reason the price was depressed.

Mr Crosby said there was also the possibility that some investors thought that any capital raising would have to be at a discount.

He said the top 100 investors were stable or buying.

Mr Crosby said he was hoping to increase the level of US corporate investment into the company which has “the only class 3 life-saving active implantable device made in Australia”.

“It’s a pump. It works. And we’re building a business,” Mr Crosby said.

Ventracor was unchanged at 20 cents.

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STEM CELL: ‘WORLD’S FIRST TRUE RAT EMBRYONIC STEM CELLS’

September 3rd 2008 12:53

Tuesday September 2, 2008

Daily news on ASX-listed biotechnology companies

* ASX, BIOTECHS DOWN: OPTISCAN UP 9.5%, BENITEC DOWN 19%

* STEM CELL: ‘WORLD’S FIRST TRUE RAT EMBRYONIC STEM CELLS’

* BIO-GUIDE BRIEF: DO WE REALLY NEED MERGERS?

* VENTRACOR’S PETER CROSBY HITS THE INVESTMENT ROAD

* ABSOLUTE CAPITAL SELLS 20% STAKE IN CLINUVEL

* CSL APPOINTS MERCK & CO’S DAVID ANSTICE DIRECTOR

To read all these articles in full, subscribe to Biotech Daily at the link above or at www.biotechdaily.com.au

STEM CELL SCIENCES

Stem Cell Sciences says laboratories in Britain and the US using its technology have achieved germ-line transmission from embryonic stem cells in rats.

Stem Cell Sciences non-executive director Dr Peter Mountford said that over the past 25 years researchers had been unable to produce germ-line transmission via embryonic stem cells into any species other than mice.

“None have previously been able to create cells that make sperm or eggs,” Dr Mountford said.

“Germ-line transmission refers to the ability of the cells to make eggs and sperm and thereby the ability of those cells to transfer the introduced genetic modification into whole animals,” Dr Mountford said.

“This is the number one priority of the US National Institutes of Health in the field of rat genomics,” Dr Mountford said.

In a media release to the ASX Stem Cell Sciences said the achievement in two independent laboratories, using technologies licenced to the company by Edinburgh University, was “believed to be the first time that germ-line transmission from rat [embryonic stem] cells has been demonstrated”.

The company said full scientific reports on the independently verified breakthrough had been submitted to a major scientific journal for publication.

Stem Cell said that under the Edinburgh University agreement it had “global exclusive rights to commercialize the rat [embryonic stem] cells, the specific culture medium used to generate and grow the cells, and rats derived therefrom”.

Stem Cell said it had licenced two important patents covering the technology from the University and would meet interested parties seeking a sublicence for the rat stem cells.

“The main advantage of this important new technology is that it allows the generation of both knockout rat models, in which the effect of gene deletion is studied, as well as the generation of knock-in models, which involves the insertion of genes,” Stem Cell said.

For example, in the case of knock-out models, the rat’s response to drugs could provide information on safety and efficacy.

Alternatively, the insertion of genes such as those involved in drug metabolism in the human liver means that knock-in models could provide information on human safety and pharmacokinetics.

Stem Cell’s chief executive officer, Dr Alastair Riddell, said the breakthrough would enable “the generation of transgenic rat models for drug discovery in a very similar manner to the already widely used transgenic mice models”.

“The advantage here is that rats are viewed as more predictable human models than mice for several psychiatric, neurological and cardiovascular drug targets,” Dr Riddell said.

“The ability to knock-in human genes should also enable drug metabolism studies to be undertaken with higher predictability in rats than previously available,” Dr Riddell said.

“This opens the way to new and more effective drug discovery and expect there to be considerable commercial interest in access to this exciting technology,” he said.

Stem Cell said the culture medium patent family, which was filed in multiple territories including the US, contained several specific enzyme inhibitors which when used in certain combinations, could be used to grow embryonic or pluripotent rat stem cells reliably in a serum-free environment.

The rat embryonic stem cell patent family, which was also filed in multiple territories including the US, gave Stem Cell the exclusive right to make and commercialize unique rat models for biopharmaceutical research and development, a market of more than $US80 million.

Stem Cell Sciences was unchanged at 20 cents.

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