PHARMAXIS BRONCHITOL IMPROVES CYSTIC FIBROSIS LUNG FUNCTION
August 15th 2008 00:18
Tuesday August 12, 2008
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS UP: VENTRACOR UP 17%, AGENIX DOWN 10%
* PHARMAXIS BRONCHITOL IMPROVES CYSTIC FIBROSIS LUNG FUNCTION
* ACRUX EXPANDS KV DEAL: WINS DATA RIGHTS, MORE US PRODUCTS
* BIOGUIDE BRIEF: ACRUX; PHARMAXIS
* FDA ACCEPTS VENTRACOR TRIAL CHANGES; TGA APPROVES DEVICE
* MESOBLAST GROWS KNEE CARTILAGE IN SHEEP
* COCHLEAR PROFIT UP 15% TO $115m ON REVENUE UP 8%
* COGSTATE SIGNS $2.3m SALES IN 6 WEEKS
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* SIRTEX SEEKS TO RESTRAIN FOUNDER DR BRUCE GRAY
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* NEUREN CALLS PLACEMENT, SHARE PLAN EGM; ACORN TAKES 9%
* STEM CELL ASX CASH FLOW QUERY: COSTLY RESTRUCTURE OVER
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PHARMAXIS
Pharmaxis says its phase II Bronchitol trial in subjects with cystic fibrosis achieved its primary end point of demonstrating a dose dependent improvement in lung function.
Pharmaxis says the two measurements of forced vital capacity (FVC) and the amount of air that can be forcibly exhaled in one second (FEV1) showed significant changes in lung function at the end of the two-week Bronchitol treatment period.
In the 400mg treatment group FEV1 increased by 8.6% (139mls, p=0.0006 v 40mg).
In the 240mg treatment group FEV1 increased by 4.6% (87mls).
In the 120mg treatment group FEV1 increased by 3.7% (42mls).
In the 40 mg treatment group FEV1 decreased by -1.6% (-33mls).
FVC improved by 7.9% in the 400mg group (p=0.0004 vs 40mg), by 3.9% in the 240mg group, by 1.5% in the 120mg group and decreased by 0.6% in the 40mg group.
Pharmaxis chief executive officer Dr Alan Robertson said the results from the trial “reaffirms that the 400mg Bronchitol dose being used in the phase III trials is optimal for its clinical effectiveness”.
“We look forward to the results from the ongoing phase III studies and to bringing Bronchitol to the market as rapidly as possible,” Dr Robertson said.
The study was an open, randomized comparison of 400mg, 240mg, 120mg and 40mg of Bronchitol in 48 patients with cystic fibrosis at 12 centres in Canada and Argentina.
Bronchitol was administered twice a day for 14 days in a crossover design.
Dr Robertson told Biotech Daily that there were practical limits to using higher doses than the 400mg dose.
“We believe we are at the top of the dose-response curve,” Dr Robertson said.
He said that the 40mg baseline comparison resulted from the need to measure effective doses against an ineffective dose and it was “impossible to have placebo to a dry powder”.
In its media release to the ASX Pharmaxis said the secondary endpoints of the study included other spirometry and quality of life measures.
These measures also showed a positive effect for 400 mg Bronchitol on maximum mid-expiratory flow and the respiratory domain of the cystic fibrosis quality of life questionnaire, Pharmaxis said.
Additionally, no serious adverse events emerged during the 400 mg treatment period and the adverse event profile was similar across all doses.
People affected by cystic fibrosis typically experience a decline in lung function of one to two percent per year during their life, as measured by FEV1.
Pharmaxis has orphan drug designation and fast track status from the US Food and Drug Administration for Bronchitol in cystic fibrosis.
Bronchitol is designed to hydrate the airway surface, improve lung hygiene and promote normal lung clearance.
Additional data from this trial will be presented at a forthcoming scientific congress, Pharmaxis said.
A Pharmaxis-sponsored European regulatory phase III clinical trial, designed to lead to a marketing application for Bronchitol in adults and children with cystic fibrosis is due to report preliminary data early in 2009.
About 75,000 people in the major pharmaceutical markets are affected with cystic fibrosis and no products have been approved to improve lung hydration.
Pharmaxis was up two cents or 1.05 percent to $1.93.
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