Medivation Announces European Initiation of Phase 3 Clinical Trial of MDV3100 in Advanced Prostate Cancer
By Medivation Inc., PRNEMonday, January 11, 2010
SAN FRANCISCO, January 12 - Medivation, Inc. today announced treatment of the first European patient
in a Phase 3 clinical trial of the investigational drug MDV3100 in advanced
prostate cancer. The trial, known as AFFIRM, will evaluate the novel androgen
receptor antagonist MDV3100 in men with castration-resistant prostate cancer
who were previously treated with docetaxel-based chemotherapy.
"Late stage prostate cancer remains an obvious and large unmet clinical
need," said Professor Johann de Bono, Medical Oncologist, Royal Marsden
Hospital, UK, and Principal European investigator for the AFFIRM trial. "This
study will provide an opportunity to test MDV3100, a promising developmental
drug candidate for those men with the most advanced prostate cancer and in
great need of a new therapeutic option."
Prostate cancer is the third leading cause of cancer deaths in men across
Europe, with more than 300,000 cases being diagnosed each year and accounting
for almost 25% of all cases of cancer in men living in Europe.1,2
The randomized, placebo-controlled, double-blind, multi-national AFFIRM
trial is expected to enroll approximately 1,200 patients at sites in Europe,
the United States, Canada, South America, Australia and South Africa. The
primary endpoint of the trial is overall survival; secondary endpoints
include progression-free survival, safety and tolerability. This trial will
evaluate MDV3100 at a dose of 160 mg taken orally once daily versus placebo.
For more information about the AFFIRM trial please go to
www.medivation.com . Medivation, Inc. recently announced a global
agreement with Astellas Pharma Inc. to develop and commercialize MDV3100.The
companies will collaborate on a comprehensive development programme that will
include additional studies to develop MDV3100 for both early- and late-stage
prostate cancer.
Notes to Editor
About MDV3100
MDV3100 is an investigational therapy in clinical development for the
treatment of advanced prostate cancer. The first triple-acting, oral
anti-androgen, MDV3100 has been shown in preclinical studies to provide more
compIete suppression of the androgen receptor pathway than bicalutamide, the
most commonly used anti-androgen. MDV3100 slows growth and induces cell death
in bicalutamide-resistant cancers via three complementary actions - MDV3100
blocks testosterone binding to the androgen receptor, impedes movement of the
androgen receptor to the nucleus of prostate cancer cells (nuclear
translocation), and inhibits binding to DNA. Preclinical data published in
Science earlier this year demonstrated that MDV3100 is superior to
bicalutamide in each of these three actions.
Medivation previously announced interim safety and efficacy results from
an ongoing Phase 1-2 clinical trial of MDV3100. The interim results showed
that MDV3100 was associated with anti-tumor activity in patients who had
become resistant to bicalutamide or other standard anti-androgen treatments,
including both patients who had failed prior chemotherapy and patients who
were chemotherapy naive. Anti-tumor activity was demonstrated by reductions
in prostate-specific antigen levels, improvement or stabilization in tumors
that had spread to soft tissue or bone, and a decrease in circulating tumor
cells, which has been associated in published literature with improved
survival in patients with castration-resistant prostate cancer. MDV3100 was
generally well tolerated in this trial at doses up to and including 240
mg/day, with fatigue being the most frequently reported adverse event.
About Prostate Cancer
Prostate tumors that have stopped responding to, or are growing despite
the use of, active hormone treatment strategies are characterized as
castration-resistant. Patients with castration-resistant prostate cancer have
a poor prognosis and few treatment options.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid
development of novel small molecule drugs to treat serious diseases for which
there are limited treatment options. Medivation aims to transform the
treatment of these diseases and offer hope to critically ill patients and
their caregivers. In September 2008, Medivation announced a global agreement
with Pfizer, Inc to develop and commercialize dimebon (latrepirdine) for the
treatment of Alzheimer's and Huntington diseases. With Pfizer, Medivation is
conducting a broad dimebon clinical development program that includes several
Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in
combination with other Alzheimer's medications in patients with mild,
moderate and severe Alzheimer's disease. The companies are also conducting a
Phase 3 trial of dimebon in Huntington disease. In October 2009, Medivation
entered a global agreement with Astellas Pharma Inc. to develop and
commercialize MDV3100 for prostate cancer. The first Phase 3 clinical trial
in the MDV3100 development program, known as the AFFIRM trial, is under way
in patients with castration-resistant prostate cancer who have previously
been treated with docetaxel-based chemotherapy. For more information, please
visit us at www.medivation.com.
About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical
company dedicated to improving the health of people around the world through
the provision of innovative and reliable pharmaceuticals. Astellas has
approximately 15,000 employees worldwide. The organization is committed to
becoming a global category leader in Urology, Immunology & Infectious
Diseases, Neuroscience, DM complications & Metabolic Diseases and Oncology.
For more information on Astellas Pharma Inc., please visit our website at
www.astellas.com/en
References: 1. www.europa-uomo.org/ (last accessed 17 November 2009) 2. info.cancerresearchuk.org/cancerstats/types/prostate/incidence/ (last accessed 17November 2009)
This press release contains forward-looking statements, including
statements regarding the potential clinical benefits of MDV3100 in various
patient populations, and development plans and goals for MDV3100, which are
made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Any statements contained in this press release
that are not statements of historical fact may be deemed to be forward-
looking statements. Forward-looking statements involve risks and
uncertainties that could cause Medivation's actual results to differ
significantly from those projected, including, without limitation, risks
related to the progress, timing and results of Medivation's clinical trials,
including the risk that positive results in earlier clinical trials may not
be repeated in subsequent clinical trials and the risk that interim results
from ongoing clinical trials may not be predictive of the final results of
any such trial, difficulties or delays in obtaining regulatory approval,
enrollment of patients in Medivation's clinical trials, partnering of
Medivation's product candidates, manufacturing of Medivation's product
candidates, competition with Medivation's product candidates should they
receive marketing approval, the adequacy of Medivation's financial resources,
unanticipated expenditures or liabilities, intellectual property matters, and
other risks detailed in Medivation's filings with the Securities and Exchange
Commission, including its quarterly report on Form 10-Q for the quarter ended
September 30, 2009, filed November 4, 2009, with the SEC. You are cautioned
not to place undue reliance on the forward-looking statements, which speak
only as of the date of this release. Medivation disclaims any obligation or
undertaking to update or revise any forward-looking statements contained in
this press release.
Contacts: Medivation, Inc. Patrick Machado, Chief Business Officer +1-415-829-4101 WeissComm Partners Wendy Gerber +44(0)7818-533-084
Contacts: Medivation, Inc., Patrick Machado, Chief Business Officer, +1-415-829-4101; WeissComm Partners, Wendy Gerber, +44(0)7818-533-084.
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