Aldara - Imiquimod zalf werkt uitstekend als medicijn tegen vormen van niet-melanome huidkankers blijkt uit de resultaten uit twee gerandomiseerde dubbelblinde studies

13 maart 2012: zie ook recentere berichtgeving over Aldarazalf - Imiquimod in linkerkolom.

11 juni 2003: Bron: DOW newswire.

Voor niet melanome huidkankers - ook wel basecell cancers - basaalcel carcinoma's - genoemd - heeft het bedrijf 3M toestemming gevraagd bij de FDA om hun zalf Aldara (Imiquimod) als medicijn in Amerika en Europa te mogen verkopen. Deze toestemming is gebaseerd op twee gerandomiseerde dubbelblinde studies bij 724 patiënten. We hebben geen tijd nu dit allemaal te vertalen maar nu al wel dit persbericht geplaatst. In dit bericht ook adressen voor nadere informatie verwerkt.

-- PRESS RELEASE: 3M Files sNDA For Aldara Cream 5% >MMM -- ST. PAUL, Minn.--(BUSINESS WIRE)--June 11, 2003--
- First Immune Response Modifier to Seek Indication to Treat Common Non-Melanoma Skin Cancer -

3M announced today that the company has submitted a supplemental new drug
application (sNDA) with the U.S. Food and Drug Administration to market Aldara
(imiquimod) Cream, 5%, an immune response modifier (IRM), for the treatment of
superficial basal cell carcinoma (sBCC), a common form of non-melanoma skin
cancer. Approximately 1.3 million new cases of non-melanoma skin cancer occur in
the United States each year. Of these, almost 1 million are basal cell
carcinomas (BCCs). Aldara cream, currently the leading prescription treatment
for external genital and perianal warts, is the first IRM application submitted
for the sBCC indication. Additionally, 3M submitted a sNDA last month for Aldara
cream for the treatment of actinic keratosis, a common precursor to skin cancer.
"This submission is a significant milestone in our efforts to bring Aldara
cream to market for sBCC," said Barry Labinger, division vice president,
Pharmaceuticals Division. "Aldara cream will represent an important new option
for dermatologists and other physicians who are treating patients with this
common form of non-melanoma skin cancer," he concluded. Labinger confirmed that
3M remains on track to receive an anticipated marketing approval in mid-2004 for
this indication. 3M continues to build a pipeline for new IRM molecules for a
broad range of indications.
The Aldara cream sNDA is based on positive results from two double-blind,
randomized, placebo-controlled clinical trials involving 724 patients with
sBCCs, confirmed by biopsy. Patients were treated with Aldara cream or placebo
once daily, five or seven times per week, for six weeks. The clinical studies
showed the optimal dosing to be five times per week, with a histological
clearance rate of 82 percent in patients treated with Aldara cream compared to
only 3 percent in the placebo group. Patients treated with Aldara cream seven
times per week showed a histological clearance rate of 79 percent compared to 3
percent in the placebo group.
In these clinical studies, the most frequently reported adverse reactions were
local skin and application site reactions, including flaking/scaling,
induration, edema, erythema, scabbing/crusting and ulceration. These reactions
were generally mild to moderate ranging to severe in nature.
BCC is the most common form of non-melanoma cancer worldwide. In the vast
majority of cases, it is thought to be caused by exposure to the harmful
ultraviolet rays of the sun. According to the American Cancer Society, 35
percent to 50 percent of people diagnosed with one BCC will develop a new skin
cancer within five years of the first diagnosis. Common treatments for BCC
include excisional surgery, cryosurgery, MOHS micrographic surgery, curettage
and electrodesiccation.
3M Pharmaceuticals launched Aldara cream in 1997 for the treatment of external
genital and perianal warts. Aldara cream is 3M's first IRM and works by
stimulating the immune system to recognize and respond to virus infections and
tumors in the skin. IRMs stimulate the body to produce specific cytokines, such
as interferon-alpha, which are naturally occurring proteins used by cells of the
immune system to communicate with each other. Cytokines induced by IRMs enhance
cell-mediated immunity, a natural process by which the body controls or
eliminates virus-infected cells and tumor cells.
Aldara cream is the first and only patient-applied IRM and is available by
prescription only. In the treatment of external genital and perianal warts,
clinical studies showed most local skin reactions were mild to moderate, and
included erythema, erosion, flaking, edema, scabbing and induration at the wart
site. Most common application-site reactions were itching (26 percent), burning
(16 percent) and pain (4 percent) at the wart site. Application-site
pigmentation changes have also been reported.
New warts may develop during treatment for external genital and perianal
warts. The effect of Aldara cream on the transmission of genital warts is
unknown. Aldara cream may weaken condoms and diaphragms. Sexual contact should
be avoided while the cream is on the skin.

Forward-Looking Statements

This press release contains forward-looking statements about the potential of
imiquimod for the treatment of actinic keratosis and sBCC that reflect the
current beliefs of 3M. However, as with any pharmaceutical under development,
there are substantial risks and uncertainties in the process of development and
regulatory review. There are no guarantees that the product will receive
regulatory approvals or prove to be commercially successful. For further
discussion of these and other risks and uncertainties, see 3M's filings with the
United States Securities and Exchange Commission. 3M undertakes no duty to
update forward-looking statements.

About 3M

3M is a $16 billion diversified technology company with leading positions in
consumer and office; display and graphics; electronics and telecommunications;
health care; industrial; safety, security and protection services;
transportation and other businesses. Headquartered in St. Paul, Minnesota, the
company has operations in more than 60 countries and serves customers in nearly
200 countries. 3M is one of the 30 stocks that make up the Dow Jones Industrial
Average and also is a component of the Standard & Poor's 500 Index. For more
information about 3M, go to www.3M.com/profile/pressbox/index.jhtml
Health Care Business is one of seven major 3M businesses, serving medical,
dental, pharmaceutical and personal care markets. Pharmaceuticals, a division of
Health Care, develops, manufactures and sells branded prescription drug products
related to dermatology, women's health, sexual health, cardiology and
respiratory medicine. Additional information is available at www.3M.com/pharma