Testing SBG packaging containers after weak results from oral mucositis study
(Thomson Reuters ONE) -
(Oslo/Tromsø, 22 February, 2010) Biotec Pharmacon has received data showing that
SBG failed to show superiority over placebo in the phase III study for oral
mucositis. Newly available biological activity assays indicate that SBG used in
the diabetic ulcer program may have been inactivated as a result of interaction
with polyethylene in the product containers. The company plans to carry out
accelerated stability studies of SBG with alternative containers.
"We are not overly surprised by the results from the oral mucositis study, given
the outcome of the diabetic ulcer studies in November last year. As with the
diabetic ulcer studies, there was no statistically significant difference
between the two treatment groups, although a marginal advantage of SBG over
placebo was seen for the primary endpoint", says CEO Lars Viksmoen.
Biotec Pharmacon has since late November worked to identify the root cause
behind SBG failing the phase III diabetic ulcer program. "We're clearly dealing
with a systematic failure", says Viksmoen. "There is nothing wrong with our SBG
manufacturing process or with the design and conduct of the clinical trials.
However, we have early evidence that there has been an unexpected interaction
between the product container and SBG that has led to inactivation of SBG over
time".
Such interaction could not be discovered by the assays available at the start of
the studies but development of new biological assays has revealed a stability
issue related to certain containers. "We need further confirmation of this
theory, and are now planning to conduct similar analyses with the product used
in the phase III oral mucositis studies since the same type of containers have
been used in all these studies. We are also planning to initiate accelerated
stability studies with a number of different containers", says Viksmoen, who
expects the first results to be available by mid-2010.
The company recently divested its wholly-owned subsidiary Immunocorp Consumer
Health AS. Biotec Pharmacon retained the non-pharmaceutical activity in the
wholly-owned subsidiary Biotec Marine Biochemicals AS, which is expected to
double revenue from its profitable and fast growing enzyme business over a three
year period. Biotec Marine Biochemicals AS primarily targets the molecular
biology market.
For further information, please contact:
CEO Lars Viksmoen, tel: +47 40620870
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1386824]
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Datum: 22.02.2010 - 01:45 Uhr
Sprache: Deutsch
News-ID 1010685
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