LAVAL, Quebec, Feb. 25, 2015 /PRNewswire/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX) (TSX:
VRX) today announced the presentation of new long-term,
preliminary results from the Phase II STAND trial demonstrating a
robust immune response with PROVENGE® (sipuleucel-T)
that continues two years after completing treatment in men with
biochemically-recurrent prostate cancer (BRPC). The findings, along
with valuable data from the ongoing Phase IV registry, PROCEED,
related to increasing enrollment of African Americans in prostate
cancer trials, are being presented at the 2015 Genitourinary
Cancers Symposium (ASCO GU) February
26-28 in Orlando,
Florida.
The STAND study is a randomized, Phase II trial that consisted
of two patient study groups. One group completed PROVENGE two weeks
before initiation of androgen deprivation therapy (ADT) and the
second received PROVENGE three months after the start of ADT.
PROVENGE is not indicated for use in patients with BRPC.
Preliminary results from STAND indicate that immune responses were
observed in both study arms and suggest there may be a greater
cellular immune response in patients who received PROVENGE prior to
ADT compared with those who received PROVENGE following three
months of ADT. Humoral immune responses were observed and
similar between both treatment arms.
"It is very encouraging to observe that PROVENGE provides an
immune response in men with biochemical-recurrent prostate cancer
long after the course of androgen deprivation therapy has ended,"
said Neal Shore, M.D., medical
director at the Carolina Urologic Research Center. "This study may
also provide guidance on the optimal sequencing of immunotherapy
and ADT in biochemical-recurrent prostate cancer."
PROVENGE, the first personalized immunotherapy, stimulates a
patient's own immune system to fight cancer. It is approved in the
U.S. and the European Union as a treatment for asymptomatic or
minimally symptomatic metastatic castrate-resistant prostate
cancer.
"These are very encouraging preliminary data and the longest
duration of immune responses observed following PROVENGE completion
in men with this particular type of prostate cancer," said
Andrew S. Sandler, M.D., chief
medical officer at Dendreon. "Dendreon and Valeant remains
committed to exploring the use of PROVENGE in different prostate
cancer treatment settings to provide important clinical information
to practicing oncologists."
In 2012, an exploratory analysis of African American patients
from the PROVENGE Phase III trials suggested a positive treatment
effect in this population. Building on this observation, another
abstract being presented at ASCO GU highlights successful efforts
that nearly doubled enrollment of African American men in the
ongoing PROCEED registry. Through tactics such as utilizing
research sites in racially and ethnically diverse communities,
conducting focus groups with African Americans for insight on
recruitment materials and study plans, and educating research staff
on enrollment goals, enrollment in this population was 11.7
percent, a rate comparable to the U.S. African American population,
versus 5.8 percent in the PROVENGE Phase III registration trials.
Overall, African American men are underrepresented in randomized
clinical trials for prostate cancer, yet they have the highest
incidence rate for prostate cancer in the
United States and are more than twice as likely as white men
to die of the disease.i
Important Safety Information for PROVENGE
PROVENGE® (sipuleucel-T) is an autologous
cellular immunotherapy indicated for the treatment of asymptomatic
or minimally symptomatic metastatic castrate-resistant
(hormone-refractory) prostate cancer.
Before getting PROVENGE, tell your doctor if you:
- Have heart problems
- Have lung problems
- Have a history of stroke
- Take any other medicines including prescription and
nonprescription drugs, vitamins, and dietary supplements.
What are the possible side effects of PROVENGE?
PROVENGE infusion can cause serious reactions.
Tell your doctor right away if you:
- Have breathing problems, chest pains, racing heart or irregular
heartbeats, high or low blood pressure, dizziness, fainting,
nausea, or vomiting after getting PROVENGE. Any of these may be
signs of heart or lung problems.
- Develop numbness or weakness on one side of the body, decreased
vision in one eye or difficulty speaking. Any of these may be signs
of a stroke.
- Develop symptoms of thrombosis which may include pain and/or
swelling of an arm or leg with warmth over the affected area,
discoloration of an arm or leg, unexplained shortness of breath or
chest pain that worsens on deep breathing.
- Get a fever over 100°F, or redness or pain at the infusion or
collection sites. Any of these may be signs of infection.
The most common side effects of PROVENGE include chills,
fatigue, fever, back pain, nausea, joint ache, and headache.
These are not all the possible side effects of PROVENGE
treatment. For more information, talk with your doctor.
Call your doctor for medical advice about side effects. You may
report side effects to the FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
For more information on PROVENGE, please see the Full
Prescribing Information or call 1-877-336-3736.
About Valeant
Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a
multinational specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical products
primarily in the areas of dermatology, eye health, neurology and
branded generics. More information about Valeant can be found at
www.valeant.com. On February
23, 2015, Valeant acquired the worldwide rights to PROVENGE,
as well as certain other assets, from Dendreon Corporation.
About Dendreon
Dendreon's first product, PROVENGE® (sipuleucel-T),
was approved by the U.S. Food and Drug Administration (FDA) in
April 2010. Dendreon is exploring the
application of additional ACI product candidates and small
molecules for the potential treatment of a variety of cancers.
For more information about the Company and its programs,
visit http://www.dendreon.com/.
Forward-looking Statements
This press release may contain forward-looking statements,
including, but not limited to, the results of and the observations
from the STAND study and the impact thereof, the guidance provided
from such study, and the plans for PROVENGE in different treatment
settings. Forward-looking statements may generally be
identified by the use of the words "anticipates," "expects,"
"intends," "plans," "should," "could," "would," "may," "will,"
"believes," "estimates," "potential," "target," or "continue" and
variations or similar expressions. These statements are based upon
the current expectations and beliefs of management and are subject
to certain risks and uncertainties that could cause actual results
to differ materially from those described in the forward-looking
statements. These risks and uncertainties include, but are not
limited to, risks and uncertainties discussed in the Company's most
recent annual or quarterly report and detailed from time to time in
Valeant's other filings with the Securities and Exchange Commission
and the Canadian Securities Administrators, which factors are
incorporated herein by reference. Readers are cautioned not to
place undue reliance on any of these forward-looking statements.
These forward-looking statements speak only as of the date hereof.
Valeant undertakes no obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date of this press release or to reflect actual outcomes,
except as required by law.
Contact Information:
Laurie
W. Little
949-461-6002
laurie.little@valeant.com
References
1. Ferlay, EJC 49 (2013). 1374-1403
i National Cancer Institute. Cancer health
disparities. Available at:
http://www.cancer.gov/cancertopics/factsheet/disparities/cancer-health-disparities.
Accessed February 11, 2015.
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SOURCE Valeant Pharmaceuticals International, Inc.