Very low recurrence rate after treatment with BF-200 ALA
(Thomson Reuters ONE) -
Biofrontera AG / Very low recurrence rate after treatment with BF-200 ALA processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Leverkusen, Germany - Biofrontera AG (DSE: B8F) Biofrontera announces that the
phase III trial with BF-200 ALA for actinic keratosis has not only produced an
almost 100% removal of keratotic lesions but also a very low recurrence rate.
BF-200 ALA was tested in a pivotal, placebo-controlled phase III trial. The
results, published already in 2009, showed the complete remission of up to 99%
of the actinic keratoses after maximally two treatments. The 112 patients, each
with 4 to 8 keratoses, were re-examined 6 and 12 months after their last
treatment to assess the recurrence rates of the neoplastic changes. In this
process, it was now shown that of 164 keratoses emitted by the combination of
BF-200 ALA and irradiation with a red LED-light, only 11 (6.7%) showed
recurrence.
Already when assessing the efficacy the light sources applied in the combination
therapy of BF-200 ALA and subsequent irradiation greatly influenced the success
of the therapy. With the use of a broad wave-length lamp the efficacy was only
71% and, consistent with the lower efficacy, it was now seen that the recurrence
after 12 months was, with 22%, considerably higher.
The comparison to published studies with other drugs shows that BF-200 ALA did
not only produce the best efficacy ever published but also more efficiently
controls the recurrence of the lesions.
"The low recurrence rate enforces the high expectations we have in BF-200 ALA
since seeing the first clinical results. In a direct comparison with competing
drug Metvix® in a second phase III trial, we could clearly demonstrate the
superior efficacy of our product. Therefore, it is our goal to position BF-200
ALA as first-choice treatment after its expected approval in 2011, consistent
with the international guidelines for the treatment of actinic keratosis,"
commented Prof. Hermann Lübbert, CEO of Biofrontera AG.
About BF-200 ALA
BF-200 ALA gel is developed for the use in "photodynamic therapy" or "PDT", in
which application of the gel with a photoactive ingredient is followed by an
irradiation. The international guidelines for the treatment of actinic keratosis
recommend PDT as first-choice treatment.
About Biofrontera AG
Biofrontera AG specializes on the development and distribution of pharmaceutical
or cosmetic products in the area of dermatology. The company is characterized by
a broad, relatively close to the market product portfolio. Biofrontera is listed
in the regulated market of the Düsseldorf stock exchange under the symbol B8F
and the ISIN number DE0006046113.
www.biofrontera.com
This press release contains forward-looking statements based on the currently
held beliefs and assumptions of the management of Biofrontera AG, which are
expressed in good faith and, in their opinion, reasonable. Forward-looking
statements involve known and unknown risks, uncertainties and other factors,
which may cause the assumptions expressed or implied in this press release to be
faulty. Given these risks, uncertainties and other factors, recipients of this
document are cautioned not to place undue reliance on the forward-looking
statements. Biofrontera AG disclaims any obligation to update these
forward-looking statements to reflect future events or developments.
For further information please contact:
Anke zur Mühlen
Corporate Communication
+ 49 (0) 214 87632 22
+ 49 (0) 214 87632 90
a.zurmuehlen(at)biofrontera.com
Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany
[HUG#1418924]
--- End of Message ---
Biofrontera AG
Hemmelrather Weg 201 Leverkusen Germany
WKN: 604611;ISIN: DE0006046113;
Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München,
Regulierter Markt in Börse Düsseldorf;
Unternehmensinformation / Kurzprofil:
Datum: 26.05.2010 - 15:32 Uhr
Sprache: Deutsch
News-ID 21491
Anzahl Zeichen: 0
contact information:
Town:
Leverkusen
Kategorie:
Business News
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