New publication on Hexvix demonstrating that Hexvix guided fluorescence cystoscopy reduces recurrence in patients with non-muscle invasive bladder cancer
(Thomson Reuters ONE) -
Oslo, Norway, October 5, 2010.
Photocure today announces a newly published publication in Journal of Urology on
Hexvix. This publication shows that Hexvix guided fluorescence cystoscopy
(Hexvix(®)), as an adjunct to conventional white-light cystoscopy, improves the
detection of bladder cancer and reduces the rate of early tumour recurrence,
compared with white-light cystoscopy alone.
The publication is based on Photocure's prospective, randomised study conducted
in 28 centres in Europe and North America. The study demonstrated that by using
Hexvix(®)-guided fluorescence cystoscopy Ta/T1 tumours that had not been seen
under conventional cystoscopy were detected in 47 (16%) of the patients with Ta
or T1 tumours (p=0.001). Of these tumours that were only seen using Hexvix
cystoscopy, 28 (59%) were medium-grade tumours (G2), and 19 were tumours of high
risk of recurrence and progressions (high grade or T1). Furthermore, 32% of the
patients with carcinoma in situ (CIS, a, high-grade aggressive cancer) were
identified only by Hexvix(®)-guided fluorescence cystoscopy.
The study group, led by H. Barton Grossman, Professor of Urology at MD Anderson
Cancer Center, Houston, USA, also reports a 16% relative reduction of bladder
tumours recurrence in patients with Ta /T1 tumours assessed with Hexvix(®)-
guided fluorescence cystoscopy, compared with white-light cystoscopy alone
(p=0.026). At 9 months' follow up, there was a 9% absolute decrease in
recurrence in the Hexvix(® )group, compared with white-light cystoscopy alone,
which means that only 11 patients needed to undergo the procedure to avoid one
recurrence.
The group also report reduced recurrence of aggressive/clinically significant
lesions. They found more CIS, T1 and muscle-invasive disease recurrence in the
patients who had undergone white-light cystoscopy compared to Hexvix guided
cystoscopy (24% vs 16%, respectively, p=0.17).
As the paper points out, improved tumour detection is likely to result in more
accurate tumour mapping and disease staging, and hence more complete cancer
resection. A reduced recurrence rate is an objective marker for these benefits.
Per patient, bladder cancer is the most expensive cancer to treat, in part
because of the diagnostic testing and treatment of recurrent disease. Professor
Stenzl and his co-authors explain that although the introduction of Hexvix(®)-
guided fluorescence cystoscopy involves a financial outlay, the technique is
easy to learn, and there is evidence from across Europe that the initial cost
will be offset by prolonged disease-free survival.
For further information, please contact
Photocure
President & CEO
Kjetil Hestdal
Phone: + 47 913 19 535
Email:kh(at)photocure.no
CFO Christian Fekete
Phone: + 47 916 42 938
Emaill:cf(at)photocure.no
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
Notes to editors
· The trial is reported in: Stenzl A, Burger M, Fradet Y et al.
Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients
with nonmuscle invasive bladder cancer. J Urol 2010; 184: 1907-1914
· Classification of bladder cancer includes assessment of tumour spread (T)
and grade/aggressiveness (G). Ta and T1 cancers are localised (non-muscle-
invasive [NMIBC]), but may be high grade. For example, a TaG3 tumour is within
the inner lining of the bladder, but is likely to undergo rapid spread. CIS is a
very early, high-grade bladder cancer than can occur in more than one location
on the bladder lining (http://www.cancerhelp.org.uk/type/bladder-
cancer/treatment/bladder-cancer-stage-and-grade#grade)
· NMIBC is associated with a 25-70% risk of recurrence and a 15-20% risk of
progression (Bunce C, Ayres BE, Griffiths TRL et al. The role of
hexaminolevulinate in the diagnosis and follow up of nonmuscle-invasive bladder
cancer. Br J Urol Int 2010; 105(Suppl): 2-7.)
· When treated effectively, NMIBC has an excellent prognosis, but progression
to muscle-invasive disease is associated with poor survival rates, i.e. less
that 50% at 5 years
(http://info.cancerresearchuk.org/cancerstats/types/bladder/#survival)
· Hexvix(® )is manufactured by Photocure ASA, Hoffsveien 48, NO-0377 Oslo,
Norway.
Tel: +47 2206 2210; Fax: +47 2206 2218; email: info(at)photocure.no
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1449051]
This announcement is distributed by Thomson Reuters on behalf of
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Photocure ASA via Thomson Reuters ONE
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Datum: 05.10.2010 - 08:02 Uhr
Sprache: Deutsch
News-ID 44116
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