BOSTON--(BUSINESS WIRE)--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 it plans to discontinue the ARMOR3-SV clinical trial, the company’s pivotal Phase 3 study comparing galeterone to enzalutamide in treatment-naïve metastatic castration-resistant prostate cancer (mCRPC) patients whose prostate tumors express AR-V7, following the recommendation made yesterday by the trial’s independent Data Monitoring Committee (DMC).
Based on a review of all safety and efficacy data, the DMC determined that the ARMOR3-SV trial will likely not succeed in meeting its primary endpoint of demonstrating an improvement in radiographic progression-free survival (rPFS) for galeterone versus enzalutamide in AR-V7 positive mCRPC. In making its recommendation, the DMC did not cite any safety concerns with galeterone in the trial. ARMOR3-SV is the first pivotal clinical trial in mCRPC to prospectively select AR-V7 positive patients, a population with an unmet medical need and aggressive disease course. The company plans to present data from the trial in a scientific forum once fully available and analyzed.
“We are very disappointed by this outcome. An immediate priority is to analyze the unblinded study data in detail as we evaluate potential paths forward for galeterone and our pipeline,” said Jodie Morrison, President and Chief Executive Officer of Tokai. “We are deeply grateful for the support and commitment from the patients participating in the study, their caregivers, and the study investigators and their staff.”
The company intends to evaluate its ongoing ARMOR2 expansion in mCRPC patients with acquired resistance to enzalutamide, and the planned study in patients who rapidly progress on either enzalutamide or abiraterone acetate. Tokai plans to allow all patients currently enrolled in the ARMOR2 and ARMOR3-SV trials to continue on therapy following consultation with their physicians and study investigators. The appropriate health authorities and clinical study investigators are being notified that ARMOR3-SV is being discontinued.
As of June 30, 2016, Tokai had approximately $43.9M in cash and cash equivalents.
Conference Call Information
Tokai will host an update
conference call today, July 26th, at 8:30 AM E.T. The call
can be accessed by dialing (844) 243-9273 (U.S. and Canada) or (225)
283-0389 (international) and entering passcode 56339813. To access the
live audio webcast, or the subsequent archived recording, visit the
“Investors and Media – Calendar of Events” section of the Tokai website
at www.tokaipharmaceuticals.com.
The webcast will be recorded and available for replay on the company’s
website for two weeks.
About ARMOR3-SV
ARMOR3-SV was a pivotal Phase 3 trial
comparing galeterone to Xtandi® (enzalutamide) in mCRPC treatment-naïve
patients whose prostate tumors express the AR-V7 splice variant. These
truncated ARs are missing the C-terminal end of the AR that contains the
ligand-binding domain, which is known as C-terminal loss. AR-V7 is the
most common form of C-terminal loss. The trial employed a precision
medicine approach for selection of patients with the AR-V7 splice
variant by using an AR-V7 clinical trial assay successfully optimized
for global use by Qiagen. The primary endpoint of ARMOR3-SV was
radiographic progression-free survival assessed by blinded independent
central review.
About Galeterone
Galeterone is an oral small molecule that
utilizes the mechanistic pathways of current second-generation hormonal
therapies, including abiraterone and enzalutamide, while also
introducing a unique 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. 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 hormonal therapies, 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 also has a cancer
discovery program focused on compounds that potently and selectively
degrade the androgen receptor. For more information on the company,
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, if we determine to move forward with the development of
galeterone, necessary regulatory and ethics approvals to commence
additional clinical trials for galeterone can be obtained, data from
early clinical trials of galeterone will be indicative of the data that
will be obtained from future clinical trials; whether the results of
clinical trials will warrant submission for regulatory approval of
galeterone, any such submission will receive approval from the United
States Food and Drug Administration or equivalent foreign regulatory
agencies and, 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.