Early study success paves way for Photocure's next-gen Cevira cervical precancer treatment
This article was originally published in Scrip
A next-generation version of Photocure's Cevira photodynamic treatment for precancerous cervical lesions has shown promise in a small feasibility study, setting the scene for results from a bigger Phase II trial later this year.
The single-use disposable device is both a drug applicator and light source. It applies ointment (hexaminolevulinate) to the cervix; the light is then switched on at a predefined timepoint, activating the drug, which destroys abnormal tissue and leaves surrounding healthy tissue intact. Patients can continue with normal daily activities during the treatment, and dispose of the device themselves after therapy is completed, within 24 hours. The previous version of Cevira involved the drug being administered as a suppository followed by laser as the light source. The new device is easier to use because it allows the entire treatment to be carried out in one session.
The feasibility study, in 13 patients with low-to-moderate cervical lesions (CIN1 or 2), was designed to demonstrate the safety and tolerability of the device. Efficacy was also measured over six months.
The researchers found that Cevira was easily administered by a gynaecologist and well-tolerated by patients. The trial also found encouraging efficacy results, with 70% of patients having a complete lesion response, and 20% a partial response.
The results were presented at the American Society of Colposcopy and Cervical Pathology meeting, currently being held in San Francisco, California.
The feasibility study results increase the chances of Cevira's eventual approval, if replicated in an ongoing Phase IIb trial, which is fully accrued and due to report results in the second half of this year. The study is evaluating 240 women with CIN1 and 2; the primary endpoint is histological-confirmed response three months after treatment. Photocure started enrolling patients in the trial last June (scripintelligence.com, 20 June 2011), and completed enrolment in January.
"The results of [the Phase IIb] study will lay the ground work for Phase III," Kathleen Deardorff, Photocure's chief operating officer, told Clinica. "We will also have discussions with the FDA and EMEA on the design of the Phase III trial; we intend to carry out a global Phase III programme that will satisfy both of these regulators."
Photocure is hoping to enlist a partner to participate in the Phase III programme, and help the firm commercialise Cevira on a global scale, if approved. "We think this product would be a great fit with companies in the women's healthcare area," Ms Deardorff said, adding that Photocure has already started talks with potential partners.
"If all goes to plan, we hope to be able to have Cevira approved and commercialised in 2015-16," she said. The product will be regulated as a drug-device combination in the US and as a drug in Europe.
Photocure is already considering the thorny question of reimbursement. "We've done some market research in the US with physicians, payers and patients, looking at various reimbursement scenarios," Ms Deardorff said.
In 2010, the company reported positive results from a 70-patient Phase II trial of the earlier version of the device (www.clinica.co.uk, 6 October 2010); in the same study, Cevira continued to show a benefit at six months (scripintelligence.com, 26 January 2011).
Photocure does not plan to seek approval of the first-generation product. "Those were our proof-of-concept trials," Ms Deardorff explained. "Now we're focused exclusively on the integrated drug-delivery device, because it obviates all the obvious commercial barriers. Patients will have everything they need – both the drug and light source – combined. It makes it very easily accessiblefor gynaecologists in an office setting."
Photocure estimates that if approved, Cevira has peak sales potential of €550 million ($760 million) in the EU and US markets combined. The company believes that it could be used as a first-line therapy in patients with low-grade lesions, with non-responders and patients with high-grade lesions being referred for surgery.
The current standard of care for precancerous cervical lesions is surgery to remove the affected area of the cervix, which is associated with an increased risk of preterm labour, scarring that could impair fertility, infection and bleeding.