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Photocure ASA (OSL:PHO) Studies demonstrate efficacy and safety of VisonacTM and the potential for a simplified Photodynamic Therapy (PDT) procedure for treatment of moderate to severe acne.
Oslo, Norway, 27 August 2008 - Photocure announces positive preliminary results from two Phase II studies carried out with VisonacTM its 2nd generation PDT treatment for moderate to severe acne. The first study showed that Visonac(TM) achieved similar efficacy results when compared to previous PDT approaches for the treatment of acne but was much better tolerated, while the second study confirmed that the overall Visonac(TM) procedure could be simplified. The final results from these two studies will provide Photocure with important information to design its overall Phase III VisonacTM program. The results from these studies will be presented to FDA and European regulatory agencies prior to beginning the Phase III program for Visonac.
Visonac(TM) treatment demonstrates excellent efficacy with reduced pain and redness The larger of the two Phase II studies recruited 150 patients from 14 sites in US. The primary aim of the study was to establish an effective dose of VisonacTM that was well tolerated. This study was blinded and the patients were randomized into three treatment groups: * 8% Visonac(TM) cream plus red light illumination * 4% Visonac(TM) cream plus red light illumination and * Vehicle cream (containing no Visonac(TM)) plus red light illumination
In this study red light illumination began 90 minutes after the application of the cream. Tolerability was closely monitored during and after the illumination. Importantly the study showed that side effects such as pain and redness were substantially reduced compared to previous studies where a more aggressive treatment regime has been used. A dose-response relationship was seen with respect to pain and redness, with even the highest Visonac(TM) dose being well tolerated in this study population.
In this study the efficacy of Visonac(TM) therapy was evaluated over time with the maximum efficacy being seen 6 weeks after the last of four treatments. At this visit, there was a 54% reduction in the total number of acne lesions in the 8% Visonac(TM) cream plus red light illumination group compared to a 37% reduction in acne lesions in the vehicle cream plus red light illumination group. In the 4% Visonac(TM) group, the reduction in the number of acne lesions was similar to the vehicle group. The efficacy results from this study are similar to the results shown in previous studies with a more aggressive treatment which caused more pain and redness than the 8% Visonac(TM) treatment regime.
Simplified Visonac(TM) Treatment Procedure Confirmed The second Visonac(TM) study, which was designed to evaluate whether occlusion was a necessary element of the PDT procedure, recruited a total of 44 patients at two sites in Canada. All patients received 8% Visonac(TM) cream plus red light illumination. In previous acne studies, using PDT, the areas to be treated have been covered by an occlusive dressing following application of the Visonac(TM) cream in order to facilitate the uptake of the Visonac(TM) into the skin. However, this process was regarded as time-consuming by dermatologists.
The results from this study clearly showed that the efficacy of the Visonac (TM) PDT procedure for the treatment of acne could be maintained without the use of occlusive dressing. This is an important finding as it is anticipated that this simpler procedure would be much more appealing to dermatologists making them more willing to treat moderate to severe acne patients with Visonac(TM) PDT.
Dr. Kjetil Hestdal, President and CEO of Photocure, commenting on today's announcement said "When we began the development of Visonac(TM) we were seeking to provide a much improved treatment option for patients with moderate to severe acne. The results from these two studies clearly highlight that we are well on our way to achieving this goal. The fact that we have been able to deliver good efficacy results with Visonac(TM) , while at the same time reducing pain and redness will be of major benefit to patients. The second study which has demonstrated that we can simplify the overall treatment procedure with Visonac(TM) while delivering equivalent efficacy, is expected to help increase the penetration of Visonac(TM) PDT into the overall acne market. We look forward to confirming these positive findings in our Phase III program for Visonac(TM)."
Dr. David Pariser, lead investigator for the US Phase IIb study commented: "" There is a large medical need for a new topical treatment for patients with moderate to severe acne especially in the US. This Phase IIb study provides strong clinical evidence that Visonac(TM) PDT delivers high efficacy and improved tolerability when compared to current treatment options."
About VisonacTM Visonac PDT is a photodynamic therapy that combines the Visonac cream with controlled illumination by a red light source. Visonac cream contains methyl aminolevulinate, the same active substance that is used in Metvix® cream. 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.
For further information, contact: President and CEO Kjetil Hestdal E-mail: kh@photocure.no Mobile: +47 913 19 535 Office: +47 22 06 22 10
CFO Christian Fekete E-mail: cf@photocure.no Mobile: +47 916 42 938 Office: +47 22 06 22 10 www.photocure.com
Photocure ASA is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer.
Photocure has two proprietary pharmaceutical products on the market: Metvix®, for the treatment of sun-damaged skin and certain types of skin cancer, and Hexvix®, for the diagnosis of bladder cancer. In addition, the company has developed a proprietary light source, the Aktilite® lamp, which is used in combination with the Metvix 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 and technologies.
Photocure® and Metvix® are registered trademarks of Photocure ASA.
