[May 18, 2016] |
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Tokai Announces Publication of Three Abstracts on Galeterone at the 2016 ASCO Annual Meeting
Tokai Pharmaceuticals Inc. (NASDAQ: TKAI), a biopharmaceutical company
focused on developing and commercializing innovative therapies for
prostate cancer and other hormonally driven diseases, today announced
that data related to galeterone will be presented in two posters at the
2016 American Society of Clinical Oncology (ASCO) Annual Meeting, which
will take place from June 3-7, 2016, in Chicago. Galeterone, Tokai's
lead product candidate, is being developed for the treatment of men with
metastatic castration-resistance prostate cancer.
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Title: Galeterone in treatment-naïve patients with
castration-resistant prostate cancer with C-terminal androgen receptor
loss: Results from ARMOR2
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Presenting author:
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Mary-Ellen Taplin, M.D., Associate Professor, Medicine, Harvard
Medical School, and Chair, Executive Committee for Clinical
Research, Dana-Farber Cancer Institute
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Date/time:
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Saturday, June 4, 2016, 1 - 4:30 p.m. CDT (News - Alert)
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Location:
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Hall A
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Abstract:
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5064
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Title: Randomized, open-label, multicenter, controlled study of
galeterone vs enzalutamide in men with metastatic castration-resistant
prostate cancer (mCRPC) expressing AR-V7 splice variant (ARMOR3-SV)
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Presenting author:
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Emmanuel Antonarakis, M.D., Associate Professor of Oncology and
Urology at the Johns Hopkins Sidney Kimmel Comprehensive Cancer
Center
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Date/time:
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Saturday, June 4, 2016, 1 - 4:30 p.m. CDT
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Location:
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Hall A
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Abstract:
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TPS5085
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A third abstract, "Galeterone targets proteasomal degradation of the
androgen receptor in prostate tumor cells: A novel mechanism of action
for treatment of AR-V7+ CRPC," was accepted for publication.
Additional information, including the presentation schedule and full
abstracts, may be found at abstracts.asco.org. A copy of each
presentation will be available on the "Publications & Presentations"
page of Tokai's website, www.tokaipharmaceuticals.com,
after being presented at the meeting.
About Galeterone Galeterone is an oral small molecule that
utilizes the established pathways, including CYP17 enzyme and androgen
receptor inhibition, of the current second-generation hormonal therapies
abiraterone and enzalutamide. Galeterone also introduces a distinct
third mechanism - androgen receptor degradation - that impairs the
function of androgen receptors, decreasing their sensitivity to androgen
activity and reducing tumor growth. Tokai is developing galeterone for
the treatment of patients with metastatic castration-resistant prostate
cancer (mCRPC). ARMOR3-SV, the company's pivotal Phase 3 study of
galeterone in treatment-naive mCRPC patients whose prostate tumors
express the AR-V7 splice variant, is evaluating whether administration
of galeterone results in a statistically significant increase in
radiographic progression-free survival as compared to enzalutamide.
Tokai is also evaluating galeterone in mCRPC patients who have shown
resistance following treatment with second-generation hormonal agents.
Tokai has worldwide development and commercialization rights to
galeterone.
About Tokai Pharmaceuticals Tokai Pharmaceuticals is a
biopharmaceutical company focused on developing and commercializing
innovative therapies for prostate cancer and other hormonally driven
diseases. The company's lead drug candidate, galeterone, is an oral
small molecule that utilizes the mechanistic pathways of current
second-generation anti-androgens, while also introducing a unique third
mechanism - androgen receptor degradation. Tokai is developing
galeterone for the treatment of patients with metastatic
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.tokaipharmaceuticals.com.
Forward-looking Statements Any statements in this press
release about our future expectations, plans and prospects, including
statements about our 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 our cash resources will be
sufficient to fund our continuing operations for the period anticipated;
whether necessary regulatory and ethics approvals to commence additional
clinical trials for galeterone can be obtained; whether data from early
clinical trials of galeterone 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; whether
a companion diagnostic based on an AR-V7 clinical trial assay 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 our annual report on Form 10-K for the year ended
December 31, 2015. Any forward-looking statements contained in this
press release speak only as of the date hereof and not of any future
date, and we expressly disclaim any obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160518006567/en/
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