Dendreon "HOP ODER TOP???" - 500 Beiträge pro Seite

[Khalif]

Was hällt ihr von dieser Aktie??? Hier ein paar Eckdaten
MK: 327 Mio US$
KGV: Verlust
Umsatz 99: 3,7 Mio US$
Umsatz 00: 6,5 Mio US$
Umsatz 01: 12,0 Mio US$ "geschätzt"
Ergebnis 99: -0,59 US$/Aktie
Ergebnis 00: -0,93 US$/Aktie
Ergebnis 01: >-1,00 US$/Aktie "geschätzt"
Cash-Burn-Rate: 15 Mio US$
Liquidität: 86 Mio US$

"www.dendreon.de".

Die Firma hat einige aussichtsreich Medikament in der Pipeline. 3xPhase I; 1XPhase II; 1XPhase III. Die meisten Medikament gegen Krebs.

Khalif

[Frau_Breule]

Dendreon and Kirin Expand Their Collaboration

SEATTLE--(BW HealthWire)--Aug. 10, 2001--Dendreon Corporation (NasdaqNDN)
announced today the expansion of its collaboration with the Pharmaceutical Division of Kirin
Brewery Co., Ltd. of Tokyo, Japan.

Under the terms of the new agreement, Dendreon will provide Kirin with extensive clinical
development and regulatory support aimed at seeking marketing approval in Asia of Dendreon`s
leading cancer vaccine candidates, Provenge(TM) and Mylovenge(TM). Kirin has also secured
a supply of key components of these products from Dendreon and has obtained an option to
license Dendreon`s proprietary manufacturing technology for Provenge.

In consideration of these new activities and commitments, Dendreon has received from Kirin a
payment of $10 million. Other economic terms of the original agreements are unaffected.

"This expanded mutual commitment clearly reflects that our relationship with Kirin, now
approaching three years old, is progressing well for both parties," said Christopher S. Henney,
Ph.D., D.Sc., chief executive officer of Dendreon. "As Provenge and Mylovenge move through
the clinical trial process, it is important to contemplate potential commercialization of these
products. Under the new agreement, Kirin is assured of a continuing source of Provenge to fill
anticipated Asian needs. We look forward together to success in our efforts to launch Dendreon
products in Asia and to the joining together of Dendreon and Kirin technologies in what we
hope will become a family of new products."

The Pharmaceutical Division of Kirin Brewery Co., Ltd. is focused on the development of new
products in areas including cancer and hematopoietic disease. Kirin is an established leader in
the development and sales of pharmaceutical products throughout Asia.

Dendreon Corporation (www.dendreon.com) is dedicated to the discovery and development of
novel products for the treatment of cancer through its innovative manipulation of the immune
system. Dendreon currently has three therapeutic cancer vaccine candidates in clinical trials --
Provenge, for the treatment of prostate cancer, in Phase III trials; Mylovenge, for the treatment
of multiple myeloma, in Phase II trials; and APC8024, for the treatment of breast, ovarian and
colon cancers, in Phase I trials.

Except for historical information contained herein, this news release contains forward-looking
statements that are subject to risks and uncertainties that may cause actual results to differ
materially from the results discussed in the forward-looking statements, particularly those
inherent in the process of discovering, developing and commercializing drugs that are safe and
effective for use as human therapeutics. Factors that may cause such a difference include risks
related to Dendreon`s limited operating history, risks associated with completing our clinical
trials and those of our collaborator, dependence on the efforts of third parties, including
collaborators, and our dependence on intellectual property. Further information on the factors
and risks that could affect Dendreon`s business, financial condition and results of operations, are
contained in Dendreon`s SEC reports, which are available at http://www.sec.gov



mfg
Breule

[Hermes007]

hi Khalif ibn eloualid!
Die Aktie ist in der Tat sehr interessant!

[Frau_Breule]

Nein ist nur eine Perle




mfg
Breule

[Frau_Breule]

[Frau_Breule]

[Frau_Breule]

Provenge™

Provenge is Dendreon`s therapeutic vaccine product for the treatment of prostate cancer.
It is currently in Phase III clinical trials for the treatment of advanced prostate cancer and
earlier stage prostate cancer. (see Clinical Trials for more information.)

Provenge involves the use of a proprietary recombinant antigen derived from prostatic
acid phosphatase - found in approximately 95 percent of prostate cancers. The target
antigen is combined with a patient`s own dendritic cells and reinfused into the patient to
stimulate an immune response.

In five Phase I/II studies, approximately 80 men with prostate cancer that is resistant to
hormone therapy have been treated with Provenge. The vaccine was found to be safe
and well tolerated. Provenge stimulated cell-mediated immunity to the prostate antigen
in every patient tested. Some patients experienced tumor shrinkage or had decreases in
PSA. About one-third of patients` cancers stabilized or improved for more than six months.









Mylovenge™

Mylovenge is Dendreon`s therapeutic vaccine product for the treatment of B-cell
malignancies, including multiple myeloma and amyloidosis. It is currently in Phase II
clinical trials at multiple sites for patients with advanced multiple myeloma and
amyloidosis (see Clinical Trials for more information.)

Mylovenge uses a patient-specific antigen, called M protein, a unique antibody produced
by a patient`s tumor and easily isolated from the blood. The antigen is combined with a
patient`s own dendritic cells and then reinfused into the patient to stimulate an immune
response.

Results of Phase I/II clinical trials indicate that Mylovenge for the treatment of multiple
myeloma is safe, well tolerated and may cause tumor regression. This vaccine candidate
appears to be of particular benefit in patients who have received treatment to reduce
tumor load.







APC8024

APC8024 is Dendreon`s therapeutic vaccine for the treatment of breast, ovarian and colon
cancers. It is currently in Phase I clinical trials (See Clinical Trials for more information.)

APC8024 is Dendreon`s first cancer vaccine that recognizes antigen found on more than
one tumor type to reach clinical trials.

APC8024 targets tumors that have increased levels of a protein called Her2-neu on their
surface. Many cancers, including the most malignant forms of breast, ovarian/uterine,
pancreatic and colorectal cancers, have Her2-neu on their surfaces.






Other Vaccine Candidates

Dendreon has developed other vaccine candidates:

APC80NY targets the NY-ESO1 antigen that is present on many cancers, including
breast, prostate, lung, ovarian/uterine and bladder. Dendreon has licensed NY-ESO1
Antigen from the Ludwig Cancer Institute.

APC80TR targets the trp-p8 antigen that is present on cancers of the lung, breast, colon
and prostate. The trp-p8 antigen was discovered at Dendreon.

Dendreon vaccines address multiple cancers

By identifying novel antigens that are associated with a broad population of cancers,
Dendreon develops single therapeutic vaccine candidates that may be effective for the
treatment of several different tumors.

[Frau_Breule]

[Frau_Breule]

Wir fahren gleich los

[puhvogel]

Da habe ich ja wieder mal mehr Glück als Verstand gehabt, denn ich hatte mit der sehr stark geflirtet.
Vorbörslich -16 %
Dendreon Receives Interim Analysis of First Phase III Clinical Trial of Provenge for Advanced Prostate Cancer

SEATTLE--(BW HealthWire)--Jan. 11, 2002--Dendreon Corporation today announced that it has received an interim analysis of its first Phase III clinical trial of Provenge(TM), Dendreon`s therapeutic vaccine for the treatment of prostate cancer.
A conference call will be held today, Friday, January 11, 2002 at 10 a.m. Pacific Standard Time to discuss this analysis. Conference call information is provided below. An independent, third party provider of statistical analyses reported its estimate relating to the probability of a treatment difference in the primary endpoint of time to disease progression in this clinical trial in men with hormone resistant prostate cancer, an advanced form of the disease.
``This preliminary analysis is inconclusive and does not provide a sufficient basis upon which to make definitive business decisions relating to the ongoing development of Provenge, as had been the purpose of the interim analysis. It does indicate to us that it is possible, but not probable, that the primary endpoint of the study will be achieved,`` said Christopher S. Henney, Ph.D., D.Sc., chief executive officer of Dendreon. ``We look forward to a more detailed final analysis, which is anticipated to be conducted in mid-2002 when availability of the additional data required for the final analysis is expected.``
``On the clinical front, we will of course continue our three ongoing Provenge Phase III clinical trials, which include two trials for the treatment of hormone resistant prostate cancer as well as an additional trial in men with hormone sensitive prostate cancer, an earlier stage of disease,`` said Henney.
The interim analysis addressed data in the first of two identical clinical trials of Provenge in hormone resistant prostate cancer and did not address a secondary endpoint of delay in the onset of disease related pain. Dendreon noted that as it prepares to seek marketing approval for Provenge, additional trials may be required to supplement the ongoing Phase III development program.

[puhvogel]

-30 %
Ich denke, das geht noch weiter runter.

[puhvogel]

Heute kamen die vorläufigen endergebnisse raus: Die Ergebnisse sind nicht so schlecht wie gedacht, für eine Zulassung wird es aber nicht reichen:
Dendreon Announces Preliminary Analysis of its First Phase III Provenge Trial;


Results Support New Approach in Fighting Prostate Cancer

SEATTLE--(BW HealthWire)--Aug. 9, 2002--Dendreon Corporation
(Nasdaq: DNDN) today announced preliminary results from its analysis of
what it believes is the first randomized, double blind placebo
controlled Phase III study of a cancer vaccine.
The product, Provenge(TM) (APC 8015), is Dendreon`s
investigational vaccine for the treatment of hormone resistant
prostate cancer. The investigational drug evaluates a new biologic
approach, using the body`s own immune system to treat men suffering
from late-stage prostate cancer. The study shows that men with hormone
resistant prostate cancer who have a Gleason score of 7 or less, which
accounts for approximately 75 percent of hormone resistant patients,
significantly benefited from Provenge treatment. Dendreon will be
hosting a conference call and slide presentation at 6:00 a.m. Pacific
Daylight Time today to discuss these results. Call in information is
listed below.

Clinical Trial Design and Data

The trial (D9901) involved 127 men with late stage, metastatic,
hormone resistant prostate cancer, 82 of whom received Provenge.
Patients were randomized to receive three vaccinations of Provenge or
placebo over a four-week period. The primary endpoint for the study
was the time to objective disease progression. Comparison of the
Provenge treated group to the placebo group using the Kaplan-Meier
method revealed a clinical benefit in the Provenge treated patients
(p-value = 0.085) that approached but did not achieve the
pre-specified primary endpoint of the study (p-value = 0.05). The
Kaplan-Meier plots of disease progression against time identified a
clear difference between the treated versus untreated groups from
three months post randomization and continuing throughout the study.
Analysis of the data for pre-specified variables revealed that the
single most important predictor of responders to Provenge was a
patient`s Gleason score, the accepted measure of the aggressiveness of
a patient`s tumor. In patients with a Gleason score less than or equal
to 7 (the most prevalent category in prostate cancer patients), the
placebo group had a median time to disease progression of 9.0 weeks
compared to 16.0 weeks in the Provenge treated group, with a highly
significant p-value of 0.002 and a treatment effect of 78 percent. In
addition, those patients receiving Provenge whose disease had not
progressed six months after randomization, had a greater than
eight-fold advantage in progression-free survival compared to those
patients who received placebo (34.7 percent versus 4 percent). In
contrast, the benefits of Provenge therapy were not seen in patients
with a Gleason score of 8 or higher.
Overall, Provenge was well tolerated by patients, with the most
common side effects being chills and fever, which were most often
infusion-related. Analysis of the safety data is ongoing and, when
complete, will be submitted to the Food and Drug Administration (FDA)
as part of Dendreon`s registration process.
"We believe this is the most stringent testing of a cancer vaccine
that has ever been performed, and we are very encouraged by the
results of this study," said Christopher S. Henney, Ph.D., chief
executive officer of Dendreon. "In this study, the data demonstrate
that the anti-cancer activity of our therapeutic cancer vaccine,
Provenge, resulted in a significant delay in the time to disease
progression in study patients who have prostate cancer with a Gleason
score of 7 or below. This study contained a disproportionately high
number of men with a Gleason score of 8 or above, which contributed to
the results we saw with our interim analysis in January. After
adjustment for these patients, the study yielded a significant
therapeutic effect for Provenge."
"We are preparing these data for discussion with the FDA to
determine what steps we should take to support an application for
product approval with an aim, as soon as is feasible, to make Provenge
available to patients for which there is no effective available
therapy," said Henney.
"Gleason grade is the most powerful prognostic factor driving
virtually all algorithms for pathologic outcome and clinical
prognosis," said Paul Schellhammer, M.D., professor and chief of
urology at Eastern Virginia Medical School. "The majority of patients
newly diagnosed with hormone resistant prostate cancer are graded in
the 6 or 7 category. That Provenge provided a statistically
significant benefit for this cohort is a very encouraging finding."
"These data are provocative in that they suggest that for those
patients with hormone resistant prostate cancer, whose disease is not
rapidly progressive, Provenge appears to slow the tempo of the
disease. This is particularly important in light of the minimal side
effects seen," said Eric J. Small, M.D., professor of medicine and
urology at the University of California San Francisco.
Dendreon will work with the clinical trial investigators to
prepare and submit data from this trial for presentation at upcoming
scientific meetings and for publication in a peer-reviewed medical
journal.
"We believe this is a significant advance in the potential
treatment of men with hormone resistant prostate cancer and in
conjunction with the FDA we will develop a strategy for registration
that reflects today`s exciting results. In addition, we will be
evaluating internally whether to continue alone with Provenge
development in the U.S. and Europe, or to seek the commercialization
strength of a collaborator," said Mitchell H. Gold, M.D., chief
business officer at Dendreon.

About Prostate Cancer

Prostate cancer is the leading cancer diagnosed among men in the
United States. More than one million men in the United States have
prostate cancer, with 200,000 cases diagnosed and 31,500 deaths in
2001. There is currently no available treatment for hormone resistant
prostate cancer.

About Gleason Score

The Gleason Scale is the most commonly used prostate cancer
scoring system and is considered one of the most important prognostic
indicators for prostate cancer. The score is based on tissue findings
throughout the prostate that correlate with the aggressiveness of a
tumor. High Gleason scores are indicative of aggressive cancers and
are not associated with a favorable prognosis. In the hormone
refractory patient population approximately 75 percent of the patients
have a Gleason score of 7 or less.

About Provenge

Provenge is an investigational therapeutic cancer vaccine designed
to jumpstart a person`s natural defenses against prostate cancer. It
is developed through Dendreon`s proprietary Antigen Delivery
Cassette(TM) technology, which utilizes a recombinant form of an
antigen found in 95 percent of prostate cancers, prostatic acid
phosphatase (PAP).