Biofrontera AG: Patient recruitment started in phase III study for field-therapy of actinic keratosis
(Thomson Reuters ONE) -
Biofrontera AG /
Biofrontera AG: Patient recruitment started in phase III study for field-therapy
of actinic keratosis
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Leverkusen, Germany, 14. October 2013 - Biofrontera AG (B8F) announced today
that first patients were included in its clinical phase III study for field
treatment of actinic keratosis. Actinic keratoses commonly occur in larger areas
damaged by excess UV exposure, most frequently the forehead, bald scalp or
cheeks. Thus, treatment is often required for the entire skin area rather than
just individual lesions. In the study, Ameluz(®) is specifically tested for the
treatment of larger areas in combination with Biofrontera's PDT lamp BF-
RhodoLED(®). In addition to eradicating all actinic keratoses, the general
cosmetic result plays an important role. The strong skin rejuvenating effect of
PDT is broadly discussed in the dermatologic literature.
The results of the study will complement the data from the previous phase III
studies presented for Ameluz(®) registration. The study is performed on 84
patients. Two thirds of the patients will be treated by photodynamic therapy
with Ameluz(®) and one third with a placebo medication. The study is performed
at 7 German medical centers under the medical coordination of Prof. Dr. Uwe
Reinhold, Bonn. The treatment entails the application of the entire 2 g tube of
Ameluz(®) or placebo onto the affected skin area, followed by a 10-minute red
light illumination 3 hours later. The cure rate is determined after 12 weeks and
the treatment repeated once if required.
In addition to expanding the European approval of Ameluz(®) on field therapy,
the results of the study are of relevance to approval in the United States and
will be included in the registration package. Registration of Ameluz(®) in the
United States, the largest pharmaceutical market in the world, will more than
double the sales potential.
Prof. Hermann Lübbert, CEO of Biofrontera AG, commented: "Patient recruitment is
anticipated to be completed by the end of the year, and we expect the final
results of the study in the summer of 2014. The filing in the United States can
thus proceed as planned. We are convinced that this study will confirm the very
positive results of the previous phase III studies."
Actinic keratoses are the third most frequent reason for visiting a
dermatologist's office in the United States. Five million new cases of actinic
keratosis occur each year in Europe. This superficial skin cancer develops
initially in the form of single, small lesions, usually in the face or on the
patient's head, and spreads further in sun-exposed areas such as the nose,
forehead or cheeks. In about 10% of the patients at least one lesion crosses the
basal membrane and progresses to a potentially hazardous squamous cell
carcinoma. Since this event cannot be predicted, an effective treatment of the
entire field containing multiple actinic keratoses is required.
Background
Ameluz(®) was approved by the European Commission as a first-line therapy for
the treatment of mild and moderate actinic keratosis on the face and scalp in
December 2011. Clinical studies have shown the highest cure rates of actinic
keratosis ever reported in Phase III studies with prescription drugs. The
product is a photosensitizing agent used in photodynamic therapy (PDT). Actinic
keratosis is mostly seen in fair-skinned people on skin areas that have had
long-term sun exposure. The condition affects about 10% of the entire Caucasian
population world-wide. About 5-20% of patients with actinic keratosis lesions
develop malignant and potentially fatal squamous cell carcinomas.
About Biofrontera AG
Biofrontera Pharma GmbH is a wholly-owned subsidiary of Biofrontera AG. The
Biofrontera group aims at attending and treating the skin, recognizing the
aesthetic needs of a person's visual reflection. Biofrontera is listed at the
regulated market of the Frankfurt 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
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originality of the information contained therein.
Source: Biofrontera AG via Thomson Reuters ONE
[HUG#1734873]
Unternehmensinformation / Kurzprofil:
Datum: 14.10.2013 - 10:10 Uhr
Sprache: Deutsch
News-ID 305339
Anzahl Zeichen: 6242
contact information:
Town:
Leverkusen
Kategorie:
Business News
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