Photocure announces results from phase II study in acne with Visonac(TM)
(Thomson Reuters ONE) -
(Oslo, 28 May 2010) Photocure (OSE: PHO), a Norwegian specialty pharmaceutical
company focused in dermatology and cancer, announces results from its phase II
study in acne with Visonac(TM) in combination with its new full face acne lamp.
The efficacy results received in the last phase II study in acne with a
simplified VisonacTM procedure were not as good as phase II results previously
obtained with VisonacTM .
The study was initiated following discussions with the US Food & Drug
Administration (FDA) in 2009, during which the agency requested additional
clinical data on paediatric patients (aged nine and above). The trial was
conducted with a simplified Visonac(TM) treatment procedure compared to previous
studies, with Photocure's new full-face acne lamp, the CL 512 photodynamic
therapy (PDT) lamp.
The placebo controlled study included 107 patients at 11 clinical centres in the
US and Canada. All patients were treated four times with two week intervals. The
treatment procedure consisted of Visonac(TM) cream applied on acne affected
areas and incubated for 1.5 hours without covering the treatment site with a
plastic film to enhance skin absorbtion of the active ingredient (known as
occlusion). This was followed by illumination of nine minutes 15 seconds by the
new full face lamp.
The primary endpoints for the trial were a reduction in lesion count and
treatment success six weeks after the last treatment. The results showed a
median reduction of 39.8% for the inflammatory lesions and 36.3% for the
non-inflammatory lesions after Visonac(TM). While the reductions observed in the
Visonac(TM) treated group were higher than in the placebo group, it did not
reach a significant level. In line with previously reported phase II studies,
this study documented the favourable side-effect profile of the Visonac(TM)
procedure in patients down to nine years with low frequency of pain and
erythema.
These reductions in lesion counts were lower than previously reported in a
previous phase II Visonac(TM) study which included occlusion, where the median
reduction for inflammatory lesions was 57.0% and for the non-inflammatory
lesions was 47.0%, and in which there was a significant difference compared to
placebo treated patients.
Photocure performed a subgroup analysis in this recent phase II study of
patients with moderate to severe acne that had previously received oral
antibiotics. This is the population that Photocure has identified as the most
appropriate target population, and one where there is an increasing medical need
for new treatment options. Of this subgroup, approximately 40% of the patients
had been previously treated with oral antibiotics with low or no effect on their
acne. The results in this population demonstrated a promising benefit of
Visonac(TM) treatment compared to more naïve patients. For these patients, where
the only treatment option is repeated oral antibiotics treatment or oral
isotretinoin, there is a clear need for a new treatment such as Visonac(TM).
Photocure are considering the options for the further development of
Visonac(TM), and plan to present these plans in the third quarter 2010. It
believes that promising data from previous studies, including the results in a
major subpopulation, demonstrates the potential of Visonac(TM) as a new
treatment for patients with moderate to severe acne with a favourable
side-effect profile.
"Acne is the most common skin disease in the world and current treatment options
are unsatisfactory with significant side effects. While we are disappointed that
the results recorded in earlier clinical studies were not confirmed in the last
phase II study, we remain confident in the future potential for Visionac(TM)"
said Dr. Kjetil Hestdal, President and CEO of Photocure.
Notes to editors
For further information, please contact
President & CEO Kjetil Hestdal, + 47 913 19 535, email: kh(at)photocure.no
CFO Christian Fekete, + 47 916 42 938 email: cf(at)photocure.no
About Acne
Acne is the single most common skin disease worldwide, and affects up to 85% of
all adolescent. Adults in their twenties, even into their forties, can get acne.
While it is not a life threatening condition, acne can be disfiguring and
upsetting. Severe acne can lead to serious and permanent scarring, and even
moderate cases can lead to scarring.
Acne is graded as mild, moderate or severe. Each year, US dermatologists
register nearly 3 million visits concerning acne. Of those who seek medical
advice from a dermatologist, about 50% have moderate, and 20% have severe acne.
Due to serious side-effects from existing treatments, a major medical
requirement exists for a new, milder treatment of acne. Sales of medicines for
treating acne generate around USD 3 billion per year worldwide.
About Visonac
Visonac(TM) is a photodynamic therapy that combines the Visonac(TM) cream with
illumination by a red light source to treat acne. Visonac(TM) cream contains MAL
(methylaminolevulinate). The cream is applied to the acne area to be treated and
after a short incubation time, the skin is illuminated with red light. The PDT
procedure kills bacteria and appears to have a beneficial effect on sebaceous
glands and inflammatory cells.
Photocure has patents in acne until 2025.
About Photocure
Photocure is a Norwegian pharmaceutical company listed on the Oslo Stock
Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical
devices for the photodynamic treatment and diagnosis of cancer and selected
dermatology indications.
Photocures commercial activities includes own marketing and sales in selected
markets as well as out-licensing to leading pharmaceutical companies on a
regional or global basis prior to phase III.
Photocure has one proprietary pharmaceutical product on the market: Hexvix®, for
the diagnosis of bladder cancer. Hexvix is approved in EU and under priority
review by FDA in the US. In addition, the company has developed a proprietary
light source, which is used in combination with the Visonac(TM) cream. Through
worldwide studies, Photocure is continuously testing its products for new
indications, and the aim is to develop a pipeline of follow-on products based on
the Photocure Technology(TM) platform.
Photocure® and Hexvix® are registered trademarks of Photocure ASA.
For more information about Photocure, visit our website at www.photocure.com
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1419570]
Unternehmensinformation / Kurzprofil:
Datum: 28.05.2010 - 08:06 Uhr
Sprache: Deutsch
News-ID 21620
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