I Think DNAG Hold 18% from Biofronrera?????
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First human study with Biofrontera´s migraine prophylaxis product
Leser des Artikels: 42
Corporate news announcement processed and transmitted by Hugin ASA.
The issuer is solely responsible for the content of this
announcement.
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Leverkusen, Germany - Biofrontera AG today announced that the
responsible local Authority and the Ethical Committee have approved
the first study in humans of Biofrontera´s drug candidate BF-1.
Biofrontera develops BF-1 for the prophylactic treatment of severe
migraine. The clinical trial represents the first application of the
compound to human volunteers.
The trial is supervised by Xeleron Inc., York, England and will be
performed by Xendo Drug Development B.V. in the Netherlands. The goal
of the study is to assess the rate at which applied BF-1 enters the
blood stream, how long it will be present in the blood and to which
extent it will be degraded before elimination. Provided that the
enrollment of test persons will proceed as planned, Biofrontera
expects preliminary results by the end of the year.
BF-1 is the leading product of Biofrontera´s maturing preclinical
product portfolio of anti-inflammatory drugs which acts as a highly
selective and potent 5-HT2B receptor inhibitor.
"We believe that the medical need for the prophylaxis of migraine is
enormous. We expect BF-1 to be effective in migraine prophylaxis
without any relevant adverse side effects. Our hope is that this
initial clinical trial will provide information that is relevant for
the strategic planning of the further development," commented Dr.
Reinhold Gahlmann, Biofrontera´s Head of Drug Development.
Migraines are acute, periodically occurring attacks of very severe
headache, usually affecting only one side of the head and often
accompanied by nausea and vomiting. It is estimated that
approximately 10-12% of the population in industrialized countries
suffer from migraine attacks. Biofrontera believes that prophylactic
treatment is indicated for the 10-20% of the patients with frequent
attacks.
About Biofrontera AG
Biofrontera AG is specialized in the development of pharmaceutical
products in the area of dermatology. The company is characterized by
a broad, relatively close to the market product portfolio and a solid
liquidity. Biofrontera is listed in the regulated market of the
Düsseldorf stock exchange under the symbol B8F and the ISIN number
DE0006046113.
For further information please contact:
Anke zur Mühlen
Corporate Communication
+ 49 (0) 214 87632 22
+ 49 (0) 214 87632 90
a.zurmuehlen@biofrontera.com
Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany
The press release can be downloaded from the following link:
Nachricht vom 11.12.2006 | 12:46 10 mal gelesen
Rapid progress in Clinical Phase IIb/III trial for actinic keratosis
Leser des Artikels: 10
Corporate news announcement processed and transmitted by Hugin ASA.
The issuer is solely responsible for the content of this
announcement.
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--------------
Leverkusen, Germany - Biofrontera AG (Stock market symbol: B8F) today
announced that the enrolment of patients in the first part of its
phase IIb/III clinical trial with BF-200 ALA is completed.
The study evaluates the efficacy and safety of BF-200 ALA in the
treatment of actinic keratosis. Initially, clinical results for three
different doses of the active ingredient 5-aminolevulinic acid (ALA)
and placebo are compared. Following the treatment and 2-month
observation of 80 patients enrolled in the first part of the study,
independent experts will perform an interim analysis to select the
optimal dose of the drug. All 80 patients have already completed the
treatment and Biofrontera expects the results of the interim analysis
in the first quarter 2007. Subsequently, efficacy and safety of
BF-200 ALA will be verified with additional 160 patients.
The randomized, placebo-controlled clinical phase IIb/III trial is
conducted in 13 centers in Germany. In parallel to the ongoing trial,
a second phase III trial is currently prepared with approximately 200
patients to compare BF-200 ALA with a standard therapy. Excellent
clinical efficacy of combinations of ALA with nanoemulsions has
already been demonstrated for superficial basal cell carcinoma in two
earlier phase II trials, where a single treatment eliminated more
than 80 % of the tumors.
BF-200 ALA
Biofrontera´s lead product BF-200 ALA combines a nanoemulsion with
5-aminolevulinic acid (ALA). The product is developed for the
photodynamic therapy of pre-cancerous skin lesions (actinic
keratosis). The ALA nanoemulsion is applied to the skin lesions and,
upon irradiation, a chemical reaction is triggered which destroys the
affected skin without scar formation.
Actinic keratosis
Actinic keratosis or solar keratosis is a precancerous skin lesion.
These lesions develop as single, small plaques on the face or bald
scalp of a patient and then gradually progress in sun-exposed areas,
such as the nose, the forehead, and the cheeks. About 10% of
non-treated actinic keratosis progresses to invasive squamous cell
carcinoma.
Actinic keratosis is the 3rd most common reason for attending a
dermatologist. The estimated incidence for actinic keratosis is 5
million new cases per year in Europe.
About Biofrontera AG
Biofrontera AG is specialized in the development of pharmaceutical
products in the area of dermatology. The company is characterized by
a broad, relatively close to the market product portfolio and a solid
liquidity. Biofrontera is listed in the regulated market of the
Düsseldorf stock exchange and other German stock markets under the
symbol B8F and the ISIN number DE0006046113.
www.biofrontera.com
For further information please contact:
Anke zur Mühlen
Corporate Communication
+ 49 (0) 214 87632 22
+ 49 (0) 214 87632 90
a.zurmuehlen@biofrontera.com
Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany
The press release can be downloaded from the following link:
--- End of Message ---
WKN: 604611; ISIN: DE0006046113;
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Wertpapiere des Artikels:
DE0006046113
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