Photodynamic treatment for HPV shows potential
pharmafile | March 15, 2012 | News story | Research and Development | Cancer, GE Healthcare, HPV, Photocure, ipsen, oncologly
A new photodynamic therapy treatment for human papilloma virus (HPV) associated diseases of the cervix has shown potential in a small study.
Norway-based Photocure specialises in photodynamic technologies, with a particular focus on dermatology and oncology markets. Its new product, Cevira, is designed to destroy cervical intraepithelial neoplasia (CIN).
These are pre-cancerous lesions of the cervix, usually caused by human papilloma virus infection.
A photoactive cream is applied to the affected area of the cervix using a drug delivery device with an integrated light source, which activates the drug to destroy the cells.
Most cases of CIN remain stable, or are eliminated by the body without intervention, but a small percentage of cases progress to become cervical cancer if left untreated.
Photocure says an estimated 260 million women are affected by the condition globally, and there are currently no therapeutic treatment options available.
Cevira is designed to be administered in a simple procedure by gynaecologists, meaning no surgery is necessary.
This feasibility study in 13 patients with low to moderate grade lesions (CIN1/2) was conducted at three centres in Norway and France. The study was designed to verify the safety and tolerability of administering and removing the drug-device.
Patients were followed for six months for safety and efficacy, and results showed the drug-device was easily administered by the gynecologist and well tolerated by patients. Additionally the study demonstrated encouraging early efficacy results, with 70% of patients having complete lesion response and 20% had partial response.
The results will be verified in the ongoing Phase IIb study in Europe and the US.
Kjetil Hestdal, president and chief executive of Photocure said: “This study is a landmark in the development of Cevira as the first study to investigate the safety and efficacy of integrated, single-use drug-device in patients with cervical disease. The results supported the convenience and tolerability of use for the patients and providers and the early efficacy results appear promising in treatment of cervical lesions.”
Photocure is now understood to be seeking a marketing partner for Cevira.
The company suffered a setback in September last year when GE exited a partnership to co-market Photocure’s lead product, bladder cancer imaging device Hexvix.
Global marketing rights for Hexvix, except the US and Nordic region, have now been acquired by Ipsen.
Photocure is marketing the drug in the US and its home territories itself, and is now preparing for its US launch, where it is known as Cysview.
Andrew McConaghie
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