Photocure announces successful Phase II results for Cevira(TM)
Oslo, Norway, 4 October, 2010; Photocure (OSE: PHO), a Norwegian specialty
pharmaceutical company focused in dermatology and cancer, announces today
promising initial results in a Phase II study of Cevira(TM) in treatment of
patients with mild cervical abnormalities.
Photocure is developing Cevira(TM) for the non-surgical treatment of cervical
HPV infection and precancerous lesions of the cervix. Cevira(TM) is a
photodynamic therapy that combines a drug formulation with a medical device and
offers the potential for an easy, quick and safe treatment procedure for
patients with mild cervical abnormalities.
The preliminary results from a multi-centre placebo controlled Phase II study of
70 patients with mild cervical abnormalities showed a three month response rate
of 71% for Cevira(TM) versus 43% in the control group. No serious side effects
were reported. Cevira(TM) was administered as a vaginal suppository for five
hours followed by photoactivation of 50J/cm(2) using a laser system. These
results support the efficacy/clinical benefit of Cevira(TM) in patients with
low-grade cervical lesions as the first therapeutic product in this field. The
final six months follow up data will be made available Q1 2011.
Standard treatment of precancerous lesions is surgery and is associated with an
increased risk of side effects including preterm labour, scarring that may
impair fertility, infection and bleeding, which is undesirable particularly in
young women in their reproductive age. Women with mild cervical abnormalities
are followed up frequently with gynaecological examinations to prevent
progression to precancerous lesions. A majority of cervical lesions regress
spontaneously, but treatment may be offered in the persistent conditions. In
Europe and US approximately 7 million women per annum are diagnosed with mild
cervical abnormalities, with a million women diagnosed with precancerous
cervical lesions.
A new Cevira(TM) medical device, treatment procedure and clinical development
plan was presented to FDA last week. The outcome of this meeting was positive
and Photocure plans to test the new device and procedure in clinical trials by
the end of 2010. The new device will provide both gynaecologists and patients
with a user-friendly and single-use treatment.
"Cevira(TM) will be an excellent alternative to invasive and costly follow up
visits known to cause notable patient anxiety, and a potential therapeutic for
non-compliant patients with a risk of not returning for gynaecological check-
ups. These results are an encouragement to continue product development in this
indication and patient population." says Dr. Kjetil Hestdal, President and CEO
of Photocure.
-ends-
For further information, please contact
Photocure
President & CEO
Kjetil Hestdal
Phone: + 47 913 19 535
Email: kh@photocure.no
CFO Christian Fekete
Phone: + 47 916 42 938
Emaill: cf@photocure.no
Media Enquiries
Capital MS&L
Mary Clark, Justine Lamond and Hollie Vile
Ph: +44 (0)20 7307 5337
Email: Photocure@capitalmsl.com
About HPV infection and cervical abnormalities
Persistent HPV infection may cause cervical precancer with a risk of development
to cancer. Screening programs are initiated to find women with cellular
abnormalities who will be followed up or treated to prevent development of
cervical cancer.
Standard treatment of precancer is surgery but with increased risk of side
effects including preterm labour, scarring that may impair fertility, infection
and bleeding, which is undesirable particularly in young women in their
reproductive age. In Europe and US approximately 1 million women are diagnosed
with cervical precancer annually.
Women with mild cervical abnormalities are followed up frequently with
gynaecological examinations to prevent progression to precancer. The majority of
cervical lesions regress spontaneously, but treatment may be offered in the
persistent conditions. In Europe and US approximately 7 million women are
diagnosed with mild cervical abnormalities annually.
HPV prophylactic vaccines have recently been introduced to young girls but will
have limited short-term effects on the number of patients developing precancer.
HPV tests are being introduced to the market to address patients at high risk
and will most likely be included in the public screening program.
There is a medical need for a tissue preserving treatment modality in patients
with cervical precancer. Patients with persistent HPV infection and mild
abnormalities have a low risk of progression but all patients need frequent
examinations to rule out progression to precancer. A treatment modality to
eliminate the persistent HPV infection is desirable.
About Cevira(TM)
Cevira(TM) is a photodynamic therapy that combines application of a drug with
illumination by a red light source to treat HPV and cervical abnormalities. The
drug contains HAL (hexaminolevulinate) which is applied together with the light
source to the cervix. After a drug incubation time red light photoactivation
starts and stops automatically, all within 10 hours. The treatment is
administered by the gynaecologist and the patient may continue normal daily
activities. The PDT procedure removes cervical abnormalities while preserving
the normal tissue.
Photocure has patents in cervical disease until 2030.
About Photocure
Photocure is a Norwegian pharmaceutical company listed on the Oslo Stock
Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical
devices for the photodynamic treatment and diagnosis of cancer and dermatology
indications.
Photocures commercial activities includes own marketing and sales in selected
markets as well as out-licensing to leading pharmaceutical companies on a
regional or global basis prior to phase III.
Photocure has one proprietary pharmaceutical product on the market: Hexvix®, for
the diagnosis of bladder cancer. Hexvix is approved in EU and in the US. In
addition, the company has developed a proprietary light source, which is used in
combination with the Visonac(TM) cream. Through worldwide studies, Photocure is
continuously testing its products for new indications, and the aim is to develop
a pipeline of follow-on products based on the Photocure Technology(TM) platform.
Photocure® and Hexvix® are registered trademarks of Photocure ASA.
For more information about Photocure, visit our website at www.photocure.com.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
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