Cevira® is in development as a treatment for cervical persistent oncogenic human papilloma virus (HPV) infections and precancerous lesions. Selectively targeting the diseased area, Cevira® is a treatment modality aiming to preserve the competence of the cervix, an improvement over surgical procedures frequently used today.
Cevira® may be a favourable alternative for treatment of oncogenic hpv infections and cervical precancerous lesions
Photocure is developing breakthrough technology with Cevira®; a small, convenient, intravaginal, fully integrated drug delivery device for easy use by the gynecologist. This treatment modality is based on our highly selective Photocure Technology™ combining a photosensitizer with activation by light of a specific wavelength. Cevira® is investigated as a treatment of persistent oncogenic HPV infections and a non-invasive treatment for patients with precancerous lesions.
Patients with persistent oncogenic HPV infections and mild cervical lesions (CIN1) lack available treatments and are referred to tedious gynecological examinations which has a limited detection capability for precancerous lesions. This causes patient distress due to the risk of disease progression, and Cevira® may be an excellent treatment alternative in these patients.
For patients with precancerous lesion (CIN2/3), common surgical procedures (e.g. LEEP) are associated with increased risk of undesirable side effects including bleeding, infection, scarring (stenosis), infertility and complications in later pregnancies.
Cevira® may be a favourable alternative for all these patients for several reasons:
- selective treatment of HPV infection and precancerous lesions
- preservation of normal cervical tissue
- only local, transient self-limiting side effects
- fewer monitoring visits to the gynecologist
- easy and convenient procedure for both gynecologist and patient
Cevira combines drug and light in one easy device
Cevira® treatment is administered locally to the cervix by the gynecologist, using the Cevira drug delivery device. After the application the patient may return to normal daily activities. The device includes an integrated light source that automatically starts and stops photoactivation of the drug. The device is easily removed by the patient when the treatment is completed.
The Cevira®-device applied to the cervix
Photocure has recently completed a multicenter phase IIb placebo controlled dose-finding study including 262 patients with CIN1/2 in Europe and US. The study demonstrated a high response of 95% with the preferred drug dose in patients with precancerous lesions (CIN2), versus 57% in the placebo group at 3 months follow up. The patients mainly experienced local, transient, self-limiting side effects and the device was easily handled by gynecologist and patient.
Photocure is now preparing documentation for Cevira® to be ready for initiation of the regulatory phase III trial.