Photocure announces successful Phase II results for Cevira
Photocure announced 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.
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.
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