Oslo, Norway, March 11 2013: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces that initial three month data from the Phase 2b trial with Cevira® in patients with human papilloma virus (HPV) related disease of the cervix, will be presented today at the Society of Gynecologic Oncology’s 44th Annual Meeting on Women’s Cancer, in Los Angeles, California.
The abstract (No.975), which will be presented by Mark Einstein, MD, Montefiore Medical Center, is entitled: A double-blind randomized placebo-controlled trial of hexaminolevulinate (HAL) photodynamic therapy in patients with cervical intraepithelial neoplasia (CIN) 1&2, and will be presented in Scientific Plenary V from 7.45-9.00am today.
Initial three month results from the phase 2b study show that the optimal dose of Cevira, 5%, demonstrated a statistically significant lesion response compared to placebo in patients with precancerous CIN2 lesions, 95% vs 57% respectively, (p<0.01). This was further supported by significant clearance of HPV, including subtypes 16 and 18 which carry high oncogenic risk. The clinical benefit was underlined by a high patient acceptance with only minor local self-limiting adverse reactions.
Photocure will announce final results which include 6 month follow up data in the second quarter of 2013.
Kjetil Hestdal, President and CEO of Photocure, said: "We are delighted to have these data presented as late breaking data at this prestigious conference. We believe that Cevira is a promising new treatment option for the large number of women globally who suffer from HPV infections and related precancerous lesions of the cervix. We look forward to reporting the final results in the second quarter of 2013.”
Cervical HPV and precancerous lesions of the cervix are highly prevalent diseases affecting an estimated 260 million women across the globe, currently with no therapeutic treatment options available. Cevira is being developed as the first novel therapeutic option for this large and growing patient population. Cevira can be easily administered by gynecologists, obviating the potential morbidities associated with surgery. Clinical proof of concept has previously been demonstrated, with an excellent safety profile and no patient down time.
Photodynamic technology is the application of a photosensitizer followed by exposure to light for activation.
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: email@example.com
Mary Clark, Amber Bielecka, Hollie Vile
Tel: +44 207920 2361, Email: firstname.lastname@example.org