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Press Release: BIOTEC COMPLETES PATIENT ENROLLMENT IN DIABETIC ULCER TRIAL
Biotec Pharmacon has completed patient
enrollment in a double-blinded, therapeutic
exploratory clinical phase II trial to evaluate
the efficacy of its soluble beta-1,3/1,6-glucan
(SBG) on chronic foot ulcers in diabetic
patients. The trial, which is performed at
hospitals in Archangelsk and St. Petersburg,
Russia, involves 60 patients. Patient treatment
and follow-up is expected to continue for
approximately 16 weeks, and the data from the
study will be reported in the fourth quarter
Diabetic patients often suffer from complicated
ulcers due to dysfunctional immune cells. Biotec
Pharmacon`s concept for treatment of ulcers is
based on the company`s pharmaceutical compound
SBG which acts on immune cells to advance
healing of the ulcers.
Biotec Pharmacon has already completed, with
very good results, an open human pilot study
with SBG in 20 patients with diabetic foot
ulcers. In addition to the ongoing phase II
study where patient inclusion now is completed,
the company is also preparing a phase II trial
at Nottingham City Hospital involving 104
Chronic wounds in diabetes patients represent a
severe medical problem. Within OECD, an
estimated 3 million diabetics are believed to be
affected by ulcers, and there are few effective
forms of treatments available today.
Press release: Biotec Pharmacon Enters Phase III with the Diabetic Ulcers Indication
OSLO, June 11, 2007-Biotec Pharmacon has during the past several months cooperated with and obtained scientific advice from the European Medicines Agency (EMEA) regarding the clinical development program for SBG for treatment of diabetic ulcers.
Biotec Pharmacon has completed clinical phase II studies within the diabetic ulcers indication, and has recently initiated a new study in the UK. EMEA has now confirmed that the company may be in a position to file for marketing authorisation based on two positive, confirmatory phase III studies, of which the ongoing study in the UK will qualify as one of these. The size of the second study will be approximately of the same size as the current UK study, and both studies may be conducted in parallel.
The scientific advice from EMEA is very positive for Biotec Pharmacon since it implies that time and costs associated with a marketing authorisation application for SBG within the diabetic ulcer indication may be reduced compared to earlier estimates.
Biotec Pharmacon maintains an optimistic objective to file for marketing authorisation in Europe during 2009. A similar process is being planned with FDA for the US market.
The Board of Directors has not yet decided whether the company shall complete the final phase of the clinical development program by its own. Value creation potential, competence and capacity as well as capital requirements will be important factors to consider in this respect.
Biotec Pharmacon's concept for treatment of wounds is based on the company's pharmaceutical compound SBG which acts on immune cells in the skin to support healing of ulcers. Diabetic patients often suffer from foot and leg ulcers due to dysfunctional immune cells in the skin. SBG stimulates and activates these immune cells in such a way that new tissue develops. Chronic ulcers among diabetic patients represent a severe medical problem. Within OECD, more than 3 million diabetics are believed to require treatment every year, and there are only very few therapeutic alternatives available on the market today.
Press Release: Phase III results with SBG for diabetic foot ulcer not positive
Biotec Pharmacon has received the
results from both its phase III studies with SBG for diabetic foot
ulcer and regrets to inform that the results are not positive. The
studies failed to show superiority of SBG vs. placebo in terms of
ulcer healing, and the company will thus not proceed with the further
activities planned for this indication.
"The completion of these phase III studies was a major milestone for
Biotec Pharmacon, and the results are a disappointing setback for
everybody involved, internally as well as externally," says CEO Lars
Viksmoen in Biotec Pharmacon.
Overall, the results from both studies are very consistent. Both
groups received the best available general wound care, and on top of
that either SBG or placebo. The primary endpoint of the phase III
diabetic ulcer program was the percentage of target ulcers healed
after eight weeks, which was at a 30 percent level in both treatment
groups. No harmful effects to patients were reported.
From a study design point of view, selecting another primary endpoint
would not have resulted in a different outcome. Furthermore, response
rates were similar between different clinical centres and countries.
Samples are being collected for analysis of biological activity to
exclude that SBG was exposed to any unexpected harm.
Blinded interim analyses for both studies had already provided advice
not to increase the size of the patient populations. The company has
stressed that this merely outlined the following possible study
outcomes; (i) that the treatment response from the two patient groups
were trending towards demonstrating a significant difference between
the two treatment groups, in either direction, or, (ii) that the
difference was so small that not even a large increase in the size of
the patient population would be expected to yield a statistically
significant difference. As described above, the latter turned out to
be the case.
"We have been very careful not to take a positive outcome for granted
but are obviously very disappointed to see that results received in
earlier clinical stages were not confirmed in phase III. This is
unfortunate, although not unique in the pharmaceutical industry,"
"We proceed with our ongoing phase III study with SBG for oral
mucositis, where the results are expected in the first quarter next
year. The Board and management will carefully consider the options
for the further development of the SBG portfolio", says Viksmoen.
Although the oral mucositis study is a completely different study, it
is still part of the company's ulcers and wound franchise, and Biotec
Pharmacon's expectations for these results have been lowered due to
the outcome of the diabetic foot ulcer studies.
Biotec Pharmacon also has a clinical program with SBG in
immunotherapy of cancer, where pre-clinical and early stage clinical
data indicate a synergistic effect between SBG and monoclonal
antibodies. The company has also done pre-clinical research with
interesting results looking into other indications for SBG.
Furthermore, Biotec Marine Biochemicals, a fully owned subsidiary of
Biotec Pharmacon, has a profitable and fast growing business with
cold adapted enzymes targeting the molecular biology market.