Medivation and Astellas Initiate Phase 2 Study of Enzalutamide in Breast Cancer
SAN FRANCISCO, CA and TOKYO -- (Marketwired) -- 06/26/13 --
Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503)
today announced enrollment of the first patient in a global Phase 2
clinical trial evaluating enzalutamide as a single agent for the
treatment of advanced, androgen receptor (AR)-positive,
triple-negative breast cancer (TNBC). Medivation is conducting this
study under its agreement with Astellas.
"The initiation of this Phase 2 study marks an important milestone as
we expand our enzalutamide development program beyond prostate cancer
to explore the clinical efficacy of enzalutamide in triple-negative
breast cancer, where there is a significant unmet medical need," said
David Hung, M.D., president and chief executive officer of
Medivation, Inc. "We plan to present the results from the Phase 1
study in breast cancer at an upcoming scientific conference."
The Phase 2 open label, single-arm, multicenter trial plans to enroll
approximately 80 patients with AR-positive, TNBC at sites in the
United States, Canada and Europe. The primary endpoint of the trial
is clinical benefit rate, defined as the proportion of patients with
a best response of complete response, partial response or stable
disease at ≥ 16 weeks. All patients will receive enzalutamide
at a dose of 160 mg to be taken orally once daily. Information about
patient eligibility and enrollment can be obtained by calling
800-888-7704 ext. 5473 or e-mailing email@example.com.
TNBC is a type of cancer which does not express any of the three most
commonly targeted receptors in breast cancer: estrogen, progesterone
and HER2. TNBC remains an area of significant unmet medical need.
Currently, there are no approved targeted therapies for these
patients, who are typically treated with multiple regimens of
chemotherapy. AR-positive breast cancer is a recently-identified
subtype of TNBC that can express high levels of the androgen
Enzalutamide is an androgen receptor inhibitor
that acts on different steps in the androgen receptor signaling
pathway. Enzalutamide has been shown to competitively inhibit
androgen binding to androgen receptors, and inhibit androgen receptor
nuclear translocation and interaction with DNA.
Please visit www.XtandiHCP.com for full Prescribing Information for
XTANDI(R) (enzalutamide) capsules.
About XTANDI(R) (enzalutamide) capsules
XTANDI is indicated for the
treatment of patients with metastatic castration-resistant prostate
cancer (mCRPC) who have previously received docetaxel.
Important Safety Information for XTANDI
can cause fetal harm when administered to a pregnant woman based on
its mechanism of action. XTANDI is not indicated for use in women.
XTANDI is contraindicated in women who are or may become pregnant.
Warnings and Precautions- In the randomized clinical trial, seizure
occurred in 0.9% of patients on XTANDI. No patients on the placebo
arm experienced seizure. Patients experiencing a seizure were
permanently discontinued from therapy. All seizures resolved.
Patients with a history of seizure, taking medications known to
decrease the seizure threshold, or with other risk factors for
seizure were excluded from the clinical trial. Because of the risk of
seizure associated with XTANDI use, patients should be advised of the
risk of engaging in any activity where sudden loss of consciousness
could cause serious harm to themselves or others.
Adverse Reactions- The most common adverse drug reactions ( ≥
5%) reported in patients receiving XTANDI in the randomized clinical
trial were asthenia/fatigue, back pain, diarrhea, arthralgia, hot
flush, peripheral edema, musculoskeletal pain, headache, upper
respiratory infection, muscular weakness, dizziness, insomnia, lower
respiratory infection, spinal cord compression and cauda equina
syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade
1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and
in 6% on placebo (no Grade 3-4). Grade 1-4 elevations in bilirubin
occurred in 3% of XTANDI patients and 2% on placebo. One percent of
XTANDI patients compared to 0.3% on placebo died from infections or
sepsis. Falls or injuries related to falls occurred in 4.6% of XTANDI
patients vs 1.3% on placebo. Falls were not associated with loss of
consciousness or seizure. Fall-related injuries were more severe in
XTANDI patients and included non-pathologic fractures, joint
injuries, and hematomas. Grade 1 or 2 hallucinations occurred in 1.6%
of XTANDI patients and 0.3% on placebo, with the majority on
opioid-containing medications at the time of the event.
Drug Interactions- Effect of Other Drugs on XTANDI: Administration of
strong CYP2C8 inhibitors can increase the plasma exposure to XTANDI.
Co-administration of XTANDI with strong CYP2C8 inhibitors should be
avoided if possible. If co-administration of XTANDI cannot be
avoided, reduce the dose of XTANDI. Co-administration of XTANDI with
strong or moderate CYP3A4 and CYP2C8 inducers can alter the plasma
exposure of XTANDI and should be avoided if possible.
Effect of XTANDI on Other Drugs: XTANDI is a strong CYP3A4 inducer
and a moderate CYP2C9 and CYP2C19 inducer in humans. Avoid CYP3A4,
CYP2C9 and CYP2C19 substrates with a narrow therapeutic index, as
XTANDI may decrease the plasma exposures of these drugs. If XTANDI is
co-administered with warfarin (CYP2C9 substrate), conduct additional
For Full Prescribing Information, please visit www.XtandiHCP.com.
Medivation, Inc. is a biopharmaceutical company
focused on the rapid development of novel therapies 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 families. For more information,
please visit us at www.medivation.com.
About Astellas Pharma Inc.
Astellas Pharma Inc. is a pharmaceutical
company dedicated to improving the health of people around the world
through provision of innovative and reliable pharmaceuticals. The
organization is committed to becoming a global category leader in
Oncology, and has several oncology compounds in development in
addition to enzalutamide. For more information on Astellas Pharma
Inc., please visit our website at www.astellas.com/en.
Note Regarding Forward-Looking Statement - Medivation
release contains forward-looking statements, including statements
regarding the continued clinical development of enzalutamide and
potential future progress related thereto, the therapeutic potential
of enzalutamide in breast cancer, our strategy, and the continued
effectiveness of, and continuing collaborative activities and
benefits under, Medivation's collaboration agreement with Astellas,
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 timing and results of
Medivation's clinical trials, including the risk that adverse
clinical trial results could alone or together with other factors
result in the delay or discontinuation of some or all of Medivation's
product development activities, the risk that positive results seen
in our clinical trials may not be predictive of the results of our
ongoing or planned clinical trials, difficulties or delays in
enrolling and retaining patients in Medivation's clinical trials,
Medivation's dependence on the efforts of and funding by Astellas for
the development of enzalutamide, the achievement of development,
regulatory and commercial milestones under Medivation's collaboration
agreement with Astellas, the manufacturing of Medivation's product
candidates, the industry and competitive market, the adequacy of
Medivation's financial resources, unanticipated expenditures or
liabilities, Medivation's outstanding convertible senior notes,
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
March 31, 2013, filed with the SEC on May 10, 2013. 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.
Note Regarding Forward Looking Statement - Astellas
release includes forward-looking statements based on assumptions and
beliefs in light of the information currently available to management
and subject to significant risks and uncertainties. Forward-looking
statements include all statements other than statements of historical
fact, including plans, strategies and expectations for the future,
statements regarding the expected timing of filings and approvals
relating to the transaction, the expected timing of the completion of
the transaction, the ability to complete the transaction or to
satisfy the various closing conditions, future revenues and
profitability from or growth or any assumptions underlying any of the
foregoing. Statements made in the future tense, and words such as
"anticipate," "expect," "project," "continue," "believe," "plan,"
"estimate," "pro forma," "intend," "potential," "target," "forecast,"
"guidance," "outlook," "seek," "assume," "will," "may," "should," and
similar expressions are intended to qualify as forward-looking
statements. Forward-looking statements are based on estimates and
assumptions made by management that are believed to be reasonable,
though they are inherently uncertain and difficult to predict.
Investors and security holders are cautioned not to place undue
reliance on these forward-looking statements. Actual financial
results may differ materially depending on a number of factors
including adverse economic conditions, currency exchange rate
fluctuations, adverse legislative and regulatory developments, delays
in new product launch, pricing and product initiatives of
competitors, the inability of the company to market existing and new
products effectively, interruptions in production, infringements of
the company's intellectual property rights and the adverse outcome of
material litigation. This press release contains information on
pharmaceuticals (including compounds under development), but this
information is not intended to make any representations or
advertisements regarding the efficacy or effectiveness of these
pharmaceuticals nor provide medical advice of any kind.
Chief Business & Financial Officer
Senior Director, Investor Relations
Sam Brown, Inc (media for both companies)
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