Photocure ASA: Cevira® clinical results presented at ASCCP - Initial results with fully integrated drug-device combination
cevira® clinical results Presented at ASCCP
Initial results with fully integrated drug-device combination
Oslo, Norway, 15 March 2012: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces the first clinical data for Cevira, a novel photodynamic therapy for the treatment of human papilloma virus (HPV) associated diseases of the cervix. Cevira represents a breakthrough technology that integrates the drug and light source into a compact, single-use disposable device which can be easily administered in the gynecology office setting.
This feasibility study in 13 patients with low to moderate grade lesions (CIN1/2) was conducted at three centers in Norway and France. The objective of the study was to verify the safety and tolerability of administration and removal of the drug-device. In addition, patients were followed for six months for safety and efficacy. Results showed that the single-use drug-device was easily administered by the gynecologist and well tolerated by the patients. Additionally the study demonstrated encouraging early efficacy results, with seventy percent of patients having complete lesion response and twenty percent had partial response.
These encouraging results are being presented today at the American Society of Colposcopy and Cervical Pathology (ASSCP) in San Francisco by Dr. Mark Einstein, Montefiore Medical Center, NY. The results will be verified in the on-going Phase IIb study in Europe and US.
Cervical HPV and precancerous lesions of the cervix are highly prevalent diseases affecting an estimated 260 million women across the globe. There are currently 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 gynaecologists, 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.
Commenting on the announcement, Kjetil Hestdal, President & CEO of Photocure, said: "This study is a hallmark in the development of Cevira as the first study to investigate the safety and efficacy of integrated, single-use drug-device in patients with cervical disease. The results supported the convenience and tolerability of use for the patients and providers and the early efficacy results appear promising in treatment of cervical lesions."
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
About Photocure ASA
Photocure ASA is a worldwide leader in photodynamic technology. Listed on the Oslo Stock Exchange (OSE: PHO), Photocure is focused on photodynamic technologies in dermatology and cancer. The company strives to solve unmet needs by developing new and innovative solutions based on its patented Photocure Technology(TM). Photocure markets and sells its own products in selected markets and has developed strong partnerships with leading pharmaceutical companies on a regional and global basis. Photocure's bladder cancer diagnostic product, Hexvix is approved in Europe and the US. In addition, the company markets Allumera®, a photodynamic cosmetic in the US. Setting new standards for diagnosis and treatment of several different conditions, Photocure Technology(TM) is continuously being tested for new products and applications in cancer and dermatology.
Visonac®, Allumera®, Photocure® and Hexvix®/Cysview® are registered trademarks of Photocure ASA. For more information about Photocure, visit www.photocure.com.