PHARMAXIS UP 9% ON PHASE III RESULTS
August 30th 2007 01:28
Biotech Daily
Wednesday August 29, 2007
Daily news on ASX-listed biotechnology companies
Wednesday August 29, 2007
Daily news on ASX-listed biotechnology companies
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* ASX, BIOTECHS DOWN: CLINUVEL UP 10%, CYTOPIA DOWN 7%
* PHARMAXIS’ BRONCHITOL PASSES PHASE III TRIAL; SHARES UP 9.2%
* POLARTECHNICS PREPARING HOME SAMPLE HPV TEST KIT
* MONSANTO PAYS GENETIC TECHNO $US1m FOR PIG DNA LICENCE
* MEDICAL DEVELOPMENTS PROFIT UP 52% TO $1.2m
* OPTISCAN REVENUE UP 68% TO $9.4; LOSS HALVED
THE MARKETThe Australian stock market tumbled as much as 2.3 percent before closing down 1.2 percent on Wednesday August 29, 2007, with the All Ordinaries falling 75.9 points to 6,101.4 points.
Ten of the Biotech Daily Top 40 stocks were up, 19 stocks fell, six traded unchanged and five were untraded.
Clinuvel was best, up seven cents or 9.72 percent to 79 cents on strong volumes, followed by Pharmaxis up 34 cents or 9.21 percent to $4.03 with 2.6 million shares traded, Starpharma up three cents or 8.82 percent to 37 cents and Living Cell up one cent or 8.7 percent to 12.5 cents.
Biota and Polartechnics climbed more than three percent; with Acrux, Metabolic, Peplin and Progen up more than one percent.
Cytopia led the falls, down 4.5 cents or 7.14 percent to 58.5 cents on small volumes; followed by Proteome down 6.9 percent to 27 cents and Cellestis losing 6.07 percent to $2.32.
Antisense, Bionomics and Clinical Cell fell more than five percent; Mesoblast and Optiscan lost more than four percent; Alchemia, Peptech and Phylogica fell more than three percent; Agenix, Avexa, Circadian and Ventracor shed more than two percent; with Cochlear, CSL, Novogen and Prana down more than one percent.
PHARMAXIS
Pharmaxis says its phase III clinical study of Bronchitol for bronchiectasis has met both primary efficacy endpoints of quality of life and mucous clearance.
Pharmaxis said data from the 362 subject study “demonstrated a highly significant improvement in quality of life” after 12 weeks of treatment with Bronchitol.
The assessment used the St George Respiratory Questionnaire, which Pharmaxis said was a patient reported outcome tool for measuring health-related quality of life, (p < 0.005) and a significant improvement in quality of life compared to placebo (p < 0.05).
The company said there was “a highly significant difference in mucous clearance at 12 weeks” for patients receiving Bronchitol as compared to those patients receiving the placebo (p < 0.001).
The trial was conducted at 22 hospitals in Australia, New Zealand and the United Kingdom.
There were no serious adverse events attributable to treatment and the incidence of adverse events did not significantly differ between the placebo and the Bronchitol groups. The dropout rate was less than 10 percent indicating that treatment was well accepted.
Participants received either Bronchitol or placebo for 12 weeks, after which participants were provided with Bronchitol for a total of 12 months to determine the safety of long term treatment.
Bronchiectasis is an incurable, degenerative and chronic lung condition.
Pharmaxis expects Bronchitol to be the first targeted medication for this patient group in more than 20 years.
Pharmaxis said there were more than 600,000 bronchiectasis patients worldwide with 110,000 in the US and 20,000 in Australia.
Widespread availability of high resolution scanners is leading to increasing diagnosis and the understanding that bronchiectasis is more common than previously thought. Pharmaxis is developing Bronchitol as a daily treatment administered by inhalation to the patient’s lungs.
Pharmaxis’ chief executive officer Dr Alan Robertson said completion of the study and achievement of its primary endpoints was “a major advance towards our goal of having Bronchitol available for patients with bronchiectasis”.
“This is the largest single study ever conducted in bronchiectasis and we have collected a large amount of data on a variety of secondary endpoints which are still being analyzed,” Dr Robertson said.
He said there were no products indicated for bronchiectasis and his company would be discussing the data with regulators.
Dr Robertson told Biotech Daily that he hoped to begin the US trial in early 2008.
He said the phase III US Food and Drug Administration approved trial would cost about $6 million and at June 30, 2007 Pharmaxis had $76 million in cash, so there would be no need to raise funds for the trial.
Earlier this month, Pharmaxis requested a special protocol assessment review with the FDA to commence a US phase III trial with Bronchitol.
Full study results will be submitted for presentation at an upcoming international scientific meeting.
Pharmaxis climbed 34 cents or 9.21 percent to $4.03 with 2.6 million shares traded.
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