Photocure - Inclusion completed in phase II study with Visonac(TM) for acne
Oslo, Norway, January 6, 2010.
Photocure announces that inclusion is completed in a phase 2 study carried out
with Visonac(TM), its 2(nd) generation PDT treatment for moderate to severe
acne. In this placebo controlled study, 107 patients from 11 clinical sites in
the US and Canada are included. The study is done on patients down to 9 years
and with Photocure?s new proprietary full-face acne lamp.
The patients are followed for 12 weeks after inclusion. The follow-up will be
completed in the end of March 2010, and preliminary results are expected in the
second quarter of 2010.
The study was initiated after discussions with the FDA in 2009. The agency
requested clinical data on pediatric patients including data with the new acne
full-face acne lamp.
The results from the phase 2 study will provide Photocure with important
information to improve the design of its phase 3 program for Visonac, especially
in the younger age group. The results from the phase 2 study will be presented
to the FDA prior to the commencement of the phase 3 program for Visonac.
Dr. Kjetil Hestdal, President and CEO of Photocure, commenting on today?s
announcement said ?When we began the development of Visonac we were seeking to
provide a much improved treatment option for patients with moderate to severe
acne. The interest for new acne products are clearly demonstrated by the
inclusion rate we have experienced the last months. We look forward to analyzing
the phase 2 data and for the preparation of our phase 3 program for Visonac.?
About Visonac(TM)
Visonac PDT is a photodynamic therapy that combines the Visonac cream with
controlled illumination by a red light source. 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.
About acne
Acne is a common skin condition which affects up to 85% of adolescents. 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.
Current therapies for these patients include oral antibiotics and isotretinoin,
both products that may have significant adverse effects. There is thus a clear
medical need for a safe and efficacious topical treatment for acne patients.
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.
Photocure's commercial activities includes own marketing and sales in selected
markets as well as out-licensing 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. In addition, the
company has developed a proprietary light source, which is used in combination
with the Visonac? 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?platform.
For more information about Photocure, visit our website at www.photocure.com.
Photocure®, the Photocure logo and Hexvix® are registered trademarks of
Photocure ASA.
For further information, contact:
Attn. Kjetil Hestdal (President and CEO) or Christian Fekete (CFO)
Kjetil Hestdal mobile +47 913 19 535 ? Christian Fekete mobile +47 916 42 938
E-mail: kh@photocure.no or cf@photocure.no
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1370792]
