Tokai Pharmaceuticals Announces Presentation at the 2015 ASCO Annual Meeting
May 30 2015 - 2:42PM
Business Wire
Poster Highlights Protocol and Rationale for
ARMOR3-SV, a Pivotal Trial of Galeterone in Patients with AR-V7
Positive Castration-Resistant Prostate Cancer
ARMOR3-SV Remains on Track to Begin 2Q 2015,
with Topline Data Expected by End of 2016
Tokai Pharmaceuticals, Inc. (NASDAQ:TKAI), a biopharmaceutical
company focused on developing novel therapies for prostate cancer
and other hormonally driven diseases, today announced a poster
presentation outlining the design and rationale for ARMOR3-SV, the
planned pivotal Phase 3 trial of galeterone in AR-V7 positive
castration-resistant prostate cancer (CRPC) patients, at the 2015
American Society of Clinical Oncology (ASCO) Annual Meeting being
held May 29 – June 2 in Chicago, Illinois.
The poster, titled “Androgen Receptor Modulation Optimized for
Response: Splice Variant (ARMOR3-SV) -- Randomized, Open-label,
Multicenter, Controlled Study of Galeterone vs Enzalutamide in Men
with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Expressing AR-V7 Splice Variant” (Abstract Number TPS5069, Poster
Board #63a), is being presented today, Saturday, May 30, from 1:15
PM to 4:45 PM CT at the Genitourinary (Prostate) Cancer Poster
Session of the meeting, located in S Hall A.
“We believe the planned pivotal trial will support the use of
galeterone in patients expressing AR-V7, which has been linked to
poor responses to existing hormonal agents,” stated Jodie Morrison,
President and Chief Executive Officer of Tokai Pharmaceuticals. “We
are honored to have the opportunity to present the design of the
first precision medicine-based pivotal trial in prostate cancer,
together with supportive clinical data, at ASCO this year and we
look forward to initiating this Phase 3 clinical trial this
quarter.”
ARMOR3-SV is Tokai’s planned pivotal Phase 3 clinical trial that
will compare galeterone to Xtandi® (enzalutamide) in 148 metastatic
CRPC treatment-naïve patients whose prostate tumors express the
AR-V7 splice variant, which is a truncated form of the androgen
receptor (AR). These truncated ARs are missing the C-terminal end
of the receptor that contains the ligand binding domain, which is
known as C-terminal loss. The primary endpoint of ARMOR3-SV will be
radiographic progression-free survival (rPFS), measured from the
time of patient randomization to the time of radiographic evidence
of disease progression or time of death from any cause.
Tokai plans to begin ARMOR3-SV in the second quarter of 2015,
with topline data expected by the end of 2016.
In a retrospective analysis of the Phase 2 ARMOR2 trial,
galeterone was associated with clinical responses in patients
identified as having C-terminal loss, with 6 of 7 (86%) patients
achieving a 12-week PSA50 response (the one non-responder
discontinued therapy due to an adverse event unrelated to
galeterone and did not receive the full treatment regimen). It is
believed that one of galeterone’s mechanism of action, androgen
receptor degradation, does not require a functional ligand binding
domain to disrupt the activation of the pathway and tumor growth
and thus galeterone may have activity even in the presence of
C-terminal loss, such as AR-V7. In contrast, Zytiga® (abiraterone
acetate) and Xtandi, two commonly used oral therapies for
metastatic CRPC, have been associated with poor responses in
patients lacking a functioning ligand binding domain.
About Tokai Pharmaceuticals
Tokai Pharmaceuticals is a biopharmaceutical company
focused on developing novel therapies for prostate cancer and other
hormonally-driven diseases. The company’s lead drug candidate,
galeterone, is a highly selective, multi-targeted, oral small
molecule drug candidate being developed for the treatment of
patients with castration-resistant prostate cancer. The Company’s
ARDA drug discovery program is focused on the identification and
evaluation of compounds that are designed to disrupt androgen
receptor signaling through enhanced androgen receptor degradation
and are targeted to patients with androgen receptor signaling
diseases, including prostate cancer. For more information on the
company and galeterone, please visit www.tokaipharma.com.
Forward-looking Statements
Any statements in this press release about future expectations,
plans and prospects for the Company, including statements about the
Company’s strategy, future operations, intellectual property, and
other statements containing the words “believes,” “anticipates,”
“plans,” “expects,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: whether the
Company’s cash resources will be sufficient to fund the Company’s
continuing operations for the period anticipated; whether data from
early clinical trials will be indicative of the data that will be
obtained from future clinical trials; whether galeterone will
advance through the clinical trial process on the anticipated
timeline, including whether ARMOR3-SV will be initiated when
anticipated; whether a companion diagnostic can be developed
successfully and on a timely basis; whether the results of
ARMOR3-SV will warrant submission for regulatory approval of
galeterone and whether such submission will receive approval from
the United States Food and Drug Administration or equivalent
foreign regulatory agencies; whether, if galeterone obtains such
approval, it will be successfully distributed and marketed; and
other factors discussed in the “Risk Factors” section of the
Company’s quarterly report on Form 10-Q for the three months ended
March 31, 2015. In addition, the forward-looking statements
included in this press release represent the Company’s views as of
the date hereof and should not be relied upon as representing the
Company’s views as of any subsequent date. The Company anticipates
that subsequent events and developments may cause the Company’s
views to change. However, while the Company may elect to update
these forward-looking statements at some point in the future, the
Company specifically disclaims any obligation to do so.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150530005050/en/
Tokai PharmaceuticalsInvestor:Lee Kalowski, 617-225-4305Chief
Financial OfficerorArgot PartnersDavid Pitts/Maeve Conneighton,
212-600-1902david@argotpartners.commaeve@argotpartners.comorMedia:Pure
Communications, Inc.Susan Heins, 864-286-9597
Novus Therapeutics (NASDAQ:NVUS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Novus Therapeutics (NASDAQ:NVUS)
Historical Stock Chart
From Apr 2023 to Apr 2024