Photocure (OSE:PHO) Announces Successful Phase II Results for Cevira
Receives FDA approval for studies in US
(Oslo, January 26 2011) Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused in dermatology and cancer, announces final six month follow up results from its phase IIa study with Cevira® in patients with low-grade precancerous lesions of the cervix. The results showed a complete removal of intracervical lesions in over 50% of patients enrolled in the trial.
Photocure also announces that the US FDA has granted permission to start Phase II clinical studies in the US with Cevira in women with low-grade precancerous lesions of the cervix using the new intravaginal combination product.
Cervical HPV-induced lesions affect seven million women in Europe and the US each year. Current treatment of precancerous lesions involves invasive surgical procedures to remove the precancerous lesions, which can result in the unnecessary removal of normal cervical tissue. Besides discomfort and recovery time, this can affect the patient’s ability to carry a child full-term, impact fertility and increase the risk of post-surgical infections. For a large number of patients with persistent HPV infections and low-grade cellular abnormalities, there are no currently available non-surgical treatment alternatives, and frequent follow up visits to avoid further disease progression causes patient anxiety and adds to the burden for the health care system.
Cevira is being developed as the first non-surgical, therapeutic procedure for treating cervical HPV infection and precancerous lesions of the cervix. It has the potential to offer patients and gynaecologists an easy, safe and highly selective treatment, thus preserving normal surrounding tissue. The procedure combines hexaminolevulinate (HAL) ointment with a red light LED-source in a fully integrated disposable delivery system.
In this recently completed Phase IIa study, Cevira 5% vaginal suppositories were applied for five hours followed by a light dose of 50J/cm2 (laser) to 70 patients with low-grade cervical lesions (CIN1). At six months, HPV lesions were completely cleared in 57% of women in the treatment arm as compared to 25% in the control group (p<0.05). In the active treatment arm of the study, the HPV response rate correlated with the lesion response in 86% of the women. Cevira was well tolerated with no serious or severe side effects reported.
To date, more than 200 patients have received Cevira. A recent health economics survey among US gynaecologists and payers conducted by Photocure confirms the market need and potential opportunity for Cevira in patients with low and moderate grade cervical lesions.
"We are encouraged to see that Cevira continues to show high efficacy in patients with low-grade (CIN1) cervical disease as well as in patients with moderate-grade lesions (CIN2). Another milestone was reached when our new fully integrated device and drug recently received FDA approval to initiate studies in the USA. Photocure is now planning multicenter phase II studies in the US and EU in patients with cervical HPV infection.” said Dr. Kjetil Hestdal, President and CEO of Photocure.
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: email@example.com
Tel: + 47 916 42 938, Email: firstname.lastname@example.org
Mary Clark, Justine Lamond and Hollie Vile,
Tel: +44 (0)20 7307 5337, Email: Photocure@capitalmsl.com
Notes to editors
About HPV infection and cervical abnormalities Persistent HPV infection may cause cervical precancer with a risk of development to cancer. Screening programs are initiated to find women with cellular abnormalities who will be followed up or treated to prevent development of cervical cancer.
Standard treatment of precancer is surgery but with increased risk of side effects including preterm labour, scarring that may impair fertility, infection and bleeding, which is undesirable particularly in young women in their reproductive age. In Europe and US approximately 1 mill women are diagnosed with cervical precancer annually.
Women with mild cervical abnormalities are followed up frequently with gynaecological examinations to prevent progression to precancer. The majority of cervical lesions regress spontaneously, but treatment may be offered in the persistent conditions. In Europe and US approximately 7 mill women are diagnosed with mild cervical abnormalities annually.
HPV prophylactic vaccines have recently been introduced to young girls but will have limited short-term effects on the number of patients developing precancer. HPV tests are being introduced to the market to address patients at high risk and will most likely be included in the public screening program.
There is a medical need for a tissue preserving treatment modality in patients with cervical precancer. Patients with persistent HPV infection and mild abnormalities have a low risk of progression but all patients need frequent examinations to rule out progression to precancer. A treatment modality to eliminate the persistent HPV infection is desirable.
About Cevira Cevira® is a photodynamic therapy that combines the Cevira ointment with illumination by a red light source to treat HPV and cervical abnormalities. Cevira ointment contains HAL (hexaminolevulinate) which is applied together with the light source to the cervix. After a drug incubation time red light photoactivation starts and stops automatically, all within 10 hours. The treatment is administered by the gynaecologist but the patient may continue normal daily activities. The PDT procedure removes cervical abnormalities while preserving the normal tissue.
Photocure has patents in cervical disease until 2030.
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 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.
Justine Lamond Senior Consultant 81 Whitfield Street, London, W1T 4HG, UK T: +44 (0) 20 7307 5337 M: +44 (0)7 919 828 314 E: email@example.com
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Posted: January 2011