DIA-B TUMBLES 55% ON ORAL INSULIN PHASE I RESULTS
December 6th 2007 22:58
Biotech Daily
Thursday December 6, 2007
Daily news on ASX-listed biotechnology companies
Thursday December 6, 2007
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS UP: PHYLOGICA UP 14%, PEPLIN DOWN 8%
* DIA-B TUMBLES 55% ON ORAL INSULIN PHASE I RESULTS
* KARMELSONIX, SANDHILL COLLABORATE ON ASTHMA, REFLUX
* TGA APPROVES BIOMD’S BOVINE PATCH FOR SOUTH AFRICAN TRIAL
* PRANA HOSTS DISCUSSION ON DEMENTIA MARKERS
* BRENDA SHANAHAN REPLACES DR ROGER ASTON AS CLINUVEL CHAIR
* PHYLOGICA’S CEO DR STEWART WASHER TO RETIRE
* CHEMGENEX APPOINTS DONALD SANTEL DIRECTOR
* MESOBLAST REQUESTS TRADING HALT
* BIOTECH DAILY SUBSCRIPTION INCREASE
THE MARKET
Seventeen of the Biotech Daily Top 40 stocks were up, eight stocks fell, nine traded unchanged and six were untraded.
Phylogica was best, up three cents or 13.95 percent to 24.5 cents with 101,917 shares traded, followed by Apollo up 1.5 cents or 7.89 percent to 20.5 cents.
Peplin led the falls, down six cents or 7.69 percent to 72 cents on small volumes, followed by Stem Cell down more than 6.85 percent to 68 cents.
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DIA-B TECH
Dia-B Tech fell 55.2 percent to 6.7 cents on phase I trial results for its oral insulin ISF402 for type 2 diabetes.
The company said ISF402 was orally available in preclinical trials and the phase I trial had confirmed oral availability but without statistical significance in the key metabolic indicators for diabetics.
Dia-B says an interim report analyzing the pharmacodynamics and pharmacokinetics of ISF402 in healthy volunteers and patients with type 2 diabetes, confirms “encouraging dose response trends in the key metabolic parameters, plasma insulin and C-peptide, which is an indicator of insulin release”.
Dia-B chairman Dr Michael Wooldridge said the results in humans were consistent with the work performed in pre-clinical animal trials.
The phase I study was a single centre, double-blind, one-way pharmacokinetic study in 32 healthy male volunteers (stage A) and 11 subjects with type 2 diabetes (stage B).
The report said there were “no significant differences were noted between insulin pharmacodynamic parameters including AUC [area under curve] effect for ISF402 and placebo administrations.
On the measure of C-peptide there were “no significant differences were noted between C-peptide pharmacodynamic parameters including AUC effect for ISF402 and placebo administrations” the report said.
“Notwithstanding the small sample sizes there was a tendency toward a percentage increase Cmax [maximum concentration] above baseline (p=0.16), which reflected both a lower baseline and higher Cmax for ISF402 compared to placebo. A larger study (more subjects) is required to confirm this effect,” the report said.
The pharmacodynamic analysis undertaken in Stage B did not detect statistically significant differences in glucose, insulin and C-peptide due to the low number of subjects and high variability.
Since the study was primarily designed to assess safety, identification of significant differences in these parameters was not expected.
In stage A, there were linear dose response trends in the key metabolic parameters, plasma insulin and C-peptide. In stage B, conducted in people with diabetes, there were trends towards lower blood glucose, lower basal C-peptide and higher increases in C-peptide after a standard meal, “but these did not reach statistical significance” Dia-B said.
Dia-B said that given the small sample size, “the absence of statistical significance was not unexpected”.
“This will be a specific focus of a much larger phase II trial,” Dr Wooldridge said. “The trends in these key measurements are in the right direction,” he said.
ISF402 co-inventor Prof Paul Zimmet told Biotech Daily the phase I trial had no adverse events.
In a Dia-B media release Prof Zimmet said it was “encouraging to see positive trends in insulin and C-peptide and lower blood glucose after a standard meal in some of the patients with type 2 diabetes when given ISF402 compared to placebo”.
“Our earlier analysis of pharmacokinetic data showed rapid absorption of the drug. A large body of research suggests that poor control of post-meal blood sugars is a major risk factor for heart disease in people suffering from diabetes and so rapid absorption of the drug would be a very important benefit of ISF402 therapy,” said Prof Zimmet.
“The report shows very encouraging trends to support the continued development of this drug,” Dr Wooldridge said.
Dia-B closed down 3.5 cents or 33.33 percent to 7.0 cents with 3.8 million shares traded.
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