BOSTON--(BUSINESS WIRE)--Tokai Pharmaceuticals Inc. (NASDAQ: TKAI) today provided an update on its clinical development program evaluating galeterone in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).
ARMOR3-SV Update
Tokai is enrolling patients in its
ARMOR3-SV study, a Phase 3 registration clinical trial of galeterone in
AR-V7+ mCRPC. The company now expects to complete enrollment in this
trial during the second half of 2016 and to have top-line data available
by mid-2017. This change in guidance reflects the timing for
implementation of the AR-V7 clinical trial assay as well as a delay in
initiating clinical sites in Western Europe and Australia during the
fourth quarter of 2015. The AR-V7 assay has now been implemented in all
regions. Patients are being screened at more than 85 clinical sites
globally, and the number of clinical sites is expected to exceed 100 by
the end of the first quarter. Notably, AR-V7 prevalence observed in
ARMOR3-SV to date has been consistent with the company’s expectations
and is in line with the published literature.
“With our rapidly growing number of open ARMOR3-SV clinical sites globally and the implementation of new recruitment initiatives, we believe in our ability to recruit to our revised guidance,” said Jodie Morrison, President and Chief Executive Officer of Tokai. “Interest in AR-V7 as a marker for resistance to other therapies continues to increase throughout the prostate cancer community, and we remain focused on our goal of completing ARMOR3-SV as rapidly as possible.”
2016 Galeterone Expansion Plans
With the ARMOR3-SV trial
building momentum, Tokai now plans to expand galeterone development into
broader mCRPC populations, including the initiation of two additional
studies during the first half of 2016 in patients who have shown
resistance following treatment with either abiraterone or enzalutamide.
The first of these studies is an open-label, two-part Phase 2 clinical trial designed to evaluate galeterone in men whose mCRPC rapidly progressed following treatment with either abiraterone or enzalutamide. The first part of the study will evaluate the rates of prostate-specific antigen (PSA) decline in approximately 36 patients. Following completion of the first part of the study, Tokai may then expand the study to a second, randomized phase that will compare galeterone to the next alternate androgen signaling inhibitor, with efficacy endpoints to include time to PSA progression and rPFS. Tokai plans to evaluate all patients enrolled in this open-label study for the presence of AR-V7, but AR-V7+ status is not a criterion for inclusion in the trial.
The second study is an expansion of an arm of the ongoing Phase 2 clinical trial of galeterone (ARMOR2) in mCRPC patients who have progressed following an initial response to enzalutamide. The expansion of the cohort from nine to 30 patients follows a compelling response seen in a post-enzalutamide patient. This patient did not initially show a PSA response until after seven months of galeterone treatment, at which time the patient’s PSA level rapidly dropped by over 90 percent and has remained at less than 0.1µg/L for over a year. This expanded post-enzalutamide cohort will assess reduction in PSA levels and safety.
About ARMOR3-SV
ARMOR3-SV is Tokai’s pivotal Phase 3
clinical trial of galeterone in men with metastatic castration-resistant
prostate cancer (mCRPC) whose tumor cells express the AR-V7 splice
variant, a truncated form of the androgen receptor that has been
associated with non-responsiveness to commonly-used oral therapies for
mCRPC. ARMOR3-SV is designed to evaluate whether administration of
galeterone results in a statistically significant increase in
radiographic progression free survival as compared to Xtandi®
(enzalutamide) in 148 treatment-naive mCRPC patients whose prostate
tumor cells express the AR-V7 splice variant. ARMOR3-SV is the first
pivotal trial in prostate cancer to employ a precision medicine approach
for patient selection. Top-line results from ARMOR3-SV are anticipated
by mid-2017.
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.tokaipharma.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 quarterly report on Form 10-Q for the three
months ended September 30, 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.