|View printer-friendly version|
|Tokai Pharmaceuticals Presents Updated Phase 2 Data on Galeterone in Patients with Advanced Prostate Cancer at ESMO 2014|
ARMOR2 Trial Data Continue to Demonstrate Meaningful PSA Responses in CRPC
The data were presented today at the
“Resistance to therapy is among the most important clinical challenges
we face in treating patients with advanced prostate cancer, making the
need for new treatment options a critical priority,” said Dr. Taplin.
“These updated results continue to show clinically meaningful reductions
Additional Data from ARMOR2
The ongoing ARMOR2 trial, for which enrollment is now complete, is a two-part Phase 2 study designed to confirm the dose of galeterone (Part 1) and demonstrate safety and efficacy in distinct CRPC patient cohorts (Part 2). At the conclusion of Part 1 of the study, a once-daily galeterone dose of 2550 mg was selected for Part 2 based upon review of safety, efficacy and pharmacokinetic data.
The interim results presented include data that was collected as of
Galeterone was well tolerated, with approximately 90% of reported adverse events (AEs) classified as Grade 1 or 2.
Additional Data on Treatment in Patients with C-Terminal Loss in ARMOR2
In Part 2 of ARMOR2, the company is also characterizing circulating
tumor cells for AR C-terminal loss based on preclinical data showing
galeterone activity in splice variants that cause a C-terminal deletion,
including AR-V7. As of
Of the six responders, four elected to continue into an optional
extension phase of the trial following the initial 12 week treatment
period. As of
Independent clinical data presented at ESMO on
“Based on a growing body of evidence, CRPC patients with splice variants
resulting in the loss of the C terminal appear to be resistant to
hormonal agents commonly used to treat CRPC,” said
Broadcast of Briefing with Clinical Investigators,
Galeterone is a highly selective, multi-targeted, oral small molecule
drug candidate being developed for the treatment of castration-resistant
prostate cancer that acts by actively disrupting androgen receptor (AR)
signaling, the key driver of prostate cancer growth, via multiple
mechanisms of action. Galeterone combines the mechanisms of action of
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, cash resources, financial position and projected costs, 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 interim results obtained in clinical trials such as the results in this release will be indicative of the final results obtained in the trials and 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 and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether the Company can establish companion diagnostics arrangements for its planned Phase 3 trial; 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 Registration Statement on Form S-1. In addition, the forward-looking statements included in this press release represent the Company’s views as of September 29, 2014. The Company anticipates that subsequent events and developments will 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. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to September 29, 2014.
|Print Page | E-mail Page | RSS Feeds | E-mail Alerts | IR Contacts | Financial Tear Sheet|