PDT - Photodynamische Therapie: FDA geeft toestemming voor gebruik photofrin in PDT behandeling ter voorkoming van slokdarmkanker na succesvolle studie

13 april 2011: ik ben kanker-actueel aan het herzien en laat onderstaand artikel staan omdat PDT meer en meer wordt toegepast bij slokdarmkanker. O.a. in het AvL - Amsterdam en Erasmus Medisch Centrum wordt PDT toegepast soms bij hoofd- halstumoren, waaronder slokdarmkanker

d.d. 4 augustus 2003: Zie voor toestemming gebruik Photofrin ook voor behandelen van slokdarmkanker ander berichten over PDT op deze pagina.

Het bedrijf Axcan heeft van de FDA toestemming gekregen om Photofrin als fotosensitizer te gebruiken bij een PDT behandeling van een voorloper van slokdarmkanker het zogenoemde HGD - hooggradige dysplasia (Chronische ontstekingen kunnen het slijmvlies van de slokdarm beschadigen. Deze ontstekingen kunnen een veranderende samenstelling van het slijmvlies bewerkstelligen, hetgeen een - Barrett Oesofagus - genoemd wordt, naar de Engelse arts Barrett. Patiënten met dit Barrett Oesofagus hebben een duidelijk verhoogd risico op slokdarmkanker.
Erfelijke factoren spelen geen rol.). De Canadese studie is uitgevoerd bij 208 patiënten in Noord-Amerika en Europa met zogeheten Barrett's Oesofagus. 138 patiënten werden behandeld met photofrin, 70 patiënten zonder photofrin en twee jaar lang gevolgd. In de photofringroep ontwikkelde 13 procent slokdarmkanker, in de controlegroep 28 procent. Een hoog significant verschil van P>0.006. Op basis hiervan heeft de FDA nu toestemming gegeven om photofrin als middel in PDT te gebruiken bij het behandelen van dit Barrett Oesofagus een voorstadium dus van slokdarmkanker om daarmee bij veel mensen slokdarmkanker te voorkomen. Onderaan dit Engelse bericht staat een adres waar u of uw arts inlichtingen kan krijgen. Pikant detail is wel dat radachlorin, het spirulina-extract dat in een SYLT - behandeling wordt gebruikt als fotosensitizer wel 35 keer zo gevoelig is dan photofrin. Misschien zou daar eens een studie mee opgezet kunnen worden?

Over de bijwerkingen van Photofrin zijn schema's te zien op
www.rxlist.com/cgi/generic3/photofrin_ad.htm Het is bekend dat Photofrin
gemaakt wordt met als uitgangspunt bloed van varkens en koeien.

Nog meer interessante informatie op deze site van de Berkeley University op
www.ucmp.berkeley.edu/glossary/gloss3/pigments

Hier kun je verschillende publicaties over spirulina vinden:
www.earthrise.com/ERLibAbstracts3

-- PRESS RELEASE: Axcan Receives Canadian OK for PHOTOFRIN --

Axcan Receives Canadian Approval for PHOTOFRIN in the Treatment of
High-Grade Dysplasia Associated with Barrett's Esophagus

TSX SYMBOL (Toronto Stock Exchange): AXP
Nasdaq SYMBOL (Nasdaq National Market): AXCA

MONT SAINT-HILAIRE, Quebec, March 20 /PRNewswire-FirstCall/ - Axcan Pharma
Inc. ("Axcan" or the "Company") announced today that it received approval from
the Therapeutic Products Directorate of Health Canada for PHOTOFRIN in the
treatment of High-Grade Dysplasia ("HGD") associated with Barrett's Esopaghus.
"This is a very important milestone for the Company since HGD associated with
Barrett's Esophagus is a condition for which there has been no treatment,"
commented Dr. Francois Martin, Senior Vice President, Scientific Affairs of
Axcan. "In addition, long-term study results confirm that PHOTOFRIN photodynamic
therapy ("PDT") significantly reduces the probability for patients suffering
from HGD associated with Barrett's Esophagus to experience a progression to
cancer, and that PHOTOFRIN PDT can potentially prevent esophageal cancer. The
absolute risk reduction of progression to cancer of 14% outlined in our study
would suggest that the number of patients needed to be treated to prevent 1
progression to esophageal cancer is only 7," concluded Dr. Martin.
PHOTOFRIN in the treatment of HGD associated with Barrett's Esophagus will be
launched in Canada by the end of the third quarter of fiscal 2003. In 2003,
Axcan also expects to receive approval for the U.S. and European markets, where
Orphan Drug designation has been granted. The entire North American market for
PHOTOFRIN for the treatment of this indication is estimated to be U.S. $30-50
million annually. This market is estimated to be of a similar size in Europe.

ABOUT BARRETT'S ESOPHAGUS
-------------------------
Barrett's Esophagus is a condition that results from prolonged heartburn in
which the normal lining of the lower part of the esophagus is replaced, over
time, by another type of lining normally present in the stomach. Barrett's
Esophagus is clearly recognizable at endoscopy. Usually, Barrett's Esophagus
develops during the process of healing after a chronic injury to the esophageal
mucosa, such as the injury caused by the reflux of gastric juice in the
esophagus. Continued reflux may cause dysplastic changes progressing from
Low-Grade to High-Grade Dysplasia. Such dysplasia may lead to esophageal
adenocarcinoma, a life-threatening condition.
It is estimated, in North America, that 25,000 to 35,000 people suffer from
High-Grade Dysplasia associated with Barrett's Esophagus, and approximately
5,000 to 7,000 new patients in North America are diagnosed with this condition
each year.

STUDY RESULTS
-------------
The Canadian filing was based on a 208-patient study conducted in North
America and Europe. A total of 138 patients in the PHOTOFRIN PDT group and 70
patients in the comparative group were followed for a minimum of a 2-year
period. Esophageal cancer occurred in only 13% of patients treated with
PHOTOFRIN PDT compared to 28% of patients treated with omeprazole alone, a 52%
reduction that is highly-statistically significant (p less than 0.006).

Axcan is a leading specialty pharmaceutical company involved in the field of
gastroenterology. The Company markets a broad line of prescription products sold
for the treatment of symptoms in a number of gastrointestinal diseases and
disorders such as inflammatory bowel disease, irritable bowel syndrome,
cholestatic liver diseases and complications related to cystic fibrosis. Axcan's
products are marketed by its own sales force in North America and Europe. Its
common shares are listed on the Toronto Stock Exchange under the symbol "AXP"
and on the Nasdaq National Market under the symbol "AXCA".

"Safe Harbor" statement under the Private Securities Litigation Reform
Act of 1995.
----------------------------------------------------------------------
To the extent any statements made in this release contain information
that is not historical, these statements are essentially forward looking
and are subject to risks and uncertainties, including the difficulty of
predicting FDA approvals, acceptance and demand for new pharmaceutical
products, the impact of competitive products and pricing, new product
development and launch, reliance on key strategic alliances, availability
of raw materials, the regulatory environment, fluctuations in operating
results and other risks detailed from time to time in the Company's
filings with the Securities and Exchange Commission.

The name PHOTOFRIN appearing in this press release is a trademark of
Axcan Pharma Inc. and its subsidiaries.

SOURCE Axcan Pharma Inc.