Photocure announces results from phase II study in acne with Visonac(TM)
Published: 28 May 2010Medical InformationProduct Announcements
(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@photocure.no
CFO Christian Fekete, + 47 916 42 938 email: cf@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
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@photocure.no
CFO Christian Fekete, + 47 916 42 938 email: cf@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)