Date: 2014-11-04
Type of information: Publication of results in a medical journal
phase: 2b
Announcement: publication of results in the American Journal of Obstetrics and Gynecology.
Company: Photocure (Norway)
Product: Cevira® (hexaminolevulinate)
Action
mechanism: Cevira® is an intravaginal drug delivery device with an integrated light source, so it 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 drug application the patient may return to normal daily activities. The device includes an integrated light source that automatically starts and stops for photoactivation of the drug. The device is removed by the patient when treatment is completed.
Disease: human papilloma virus (HPV) related disease of the cervix
Therapeutic area: Infectious diseases - Cancer - Oncology
Country: Europe, USA
Trial
details: The phase 2b trial is a multicenter, randomized, double-blind placebo controlled trial in patients with histologically confirmed low to moderate grade cervical intraepithelial neoplasia (CIN1/2). The study enrolled 262 patients at 23 office or hospital based gynecology practices in the US and Europe. Patients were randomized to three different doses of hexylaminolevulinate to evaluate the optimal dose as compared to placebo. The treatment regimen consisted of up to two treatments, each three months apart. Efficacy, measured by histology, cytology and HPV DNA as well as safety, was assessed three months after the last treatment. Results after the six-nine month assessment will be presented in the first half 2013.
Latest
news: * On November 4, 2014, Photocure, a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announced the Phase 2b study of Cevira® in patients with human papilloma virus (HPV) related disease of the cervix, has been published in the American Journal of Obstetrics and Gynecology. Cevira® demonstrated significant and sustained efficacy in the eradication of oncogenic HPV infections and precancerous lesions in CIN2 patients as compared to placebo. The final study results were announced in April 2013. The Phase 2b trial was carried out in 262 patients with low to moderate grade cervical intraepithelial neoplasia (CIN1/2) caused by oncogenic Human papilloma virus (HPV) infections. It demonstrated a statistically significant and sustained lesion response compared to placebo in patients with precancerous CIN2 lesions, 95% vs 62% respectively at six months, (p<0.02). This was further supported by high clearance of the highest risk oncogenic HPV subtypes 16 and 18 in the CIN2 cohort, of 83% vs 33% at six months. Additionally, high clearance of HPV 16 and 18 was also demonstrated in the overall CIN1/2 population, 62% vs. 33% as compared to placebo. * On November 6, 2013, Photocure, a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, has announced that data will be presented on Cevira®, Photocure’s non-invasive therapy for the treatment of oncogenic human papillomavirus (HPV) and pre-cancerous cervical abnormalities at the EUROGIN Congress in Florence. Professor Peter Hillemanns, Head of Department of Gynecology and Obstetrics at the Medical University of Hannover, has presented data on a placebo-controlled Phase IIb study of Cevira (hexaminolevulinate) photodynamic therapy in patients with CIN1 and CIN2. The Phase IIb trial was carried out in 262 patients with histologically confirmed low to moderate grade cervical intraepithelial neoplasia (CIN1/2) and demonstrated a statistically significant and sustained lesion response compared to placebo in patients with precancerous CIN2 lesions, 95% vs 62% respectively at six months, (p<0.02). This was further supported by high clearance of the highest risk oncogenic HPV subtypes 16 and 18 in the CIN2 cohort, of 83% vs 33% at six months. Additionally, high clearance of HPV 16 and 18 was also demonstrated in the overall CIN1/2 population, 62% vs. 33% as compared to placebo. Cevira® was well tolerated and easy to use by both gynecologists and patients. No treatment related serious adverse events were reported in the study. Patients experienced only expected and self-limiting local events. * On December 5, 2012, Photocure has announced the initial three month results of the phase 2b study of Cevira® in patients with human papilloma virus (HPV) related disease of the cervix. Cevira®, a novel and easy to use integrated drug-delivery device, demonstrated statistically significant efficacy in eradication of oncogenic HPV infections and precancerous lesions in CIN2 patients. 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 types 16 and 18, which carry high oncogenic risk, in the CIN2 cohort of 83% vs 0%,(p<0.02). In the overall CIN1 and CIN2 study population, Cevira, at the optimal dose, showed a higher response (73% vs 60%, p=0.2) and clearance of high oncogenic risk in HPV types 16 and 18 (54% vs 11%, p=0.07) as compared to placebo.
(“A randomized study of hexaminolevulinate photodynamic therapy in patients with cervical intraepithelial neoplasia (CIN) 1/2")
Cevira® was well tolerated and easy to use by both the gynecologists and patients. No treatment related serious adverse events were reported in the study. No patients withdrew from the study due to treatment related events. In addition, patients experienced only expected benign and self-limiting events.
Photocure is now looking forward to having the final results including long term follow up in the first half next year. The product is expected to enter phase III in 2013.
