GTx, Inc. (GTXI) Completes Stage 1 Milestone in Phase 2 Trial of Enobosarm in ER+/AR+ Breast Cancer
- Amazon, health stocks weigh on S&P, Nasdaq; Chevron lifts Dow
- ExxonMobil (XOM) Tops Q3 EPS by 5c; CapEx Light of Views
- Baker Hughes (BHI), General Electric (GE) in Partnership Talks, Not Merger Talks
- AbbVie (ABBV) Tops Q3 EPS by 1c; Boosts FY16 EPS Outlook
- Amazon.com (AMZN) Misses Q3 EPS by 26c, Offers Q4 Guidance
Get access to the best calls on Wall Street with StreetInsider.com's Ratings Insider Elite. Get your Free Trial here.
GTx, Inc. (Nasdaq: GTXI) today announced the achievement of the Stage 1 milestone for the 9 mg cohort of its Phase 2 clinical trial of enobosarm (GTx-024) to treat women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer. A pre-defined number of patients demonstrated clinical benefit per protocol to allow the clinical trial to advance to the second and final stage of the trial (Stage 2). GTx also expects to provide an update on Stage 1 of the second dosing cohort (18 mg) in the clinical trial once there are sufficient evaluable patients to assess clinical benefit in this cohort. The Company anticipates reporting Stage 1 data from the clinical trial in the fourth quarter of 2016.
“The demonstration of clinical benefit among a pre-defined number of evaluable patients in Stage 1 of the 9 mg cohort of our ER+/AR+ breast cancer study represents an important milestone for GTx since we have met the protocol specified success criteria to continue with enrollment in Stage 2 of this cohort,” said Robert J. Wills, Ph.D., Executive Chairman of GTx. “We believe enobosarm may provide a new hormonal approach for the treatment of estrogen receptor positive breast cancer and may delay the need for chemotherapy in these women.”
About the Phase 2 Clinical Trial in ER+/AR+ Breast Cancer
The open-label, multi-center, multinational Phase 2 clinical trial (NCT02463032) will assess the efficacy and safety of orally administered enobosarm in up to 88 evaluable patients with metastatic or locally advanced, ER+/AR+ breast cancer. Patients will receive orally-administered enobosarm (9 mg or 18 mg) daily for up to 24 months. The two cohorts in the trial will be treated independently for the purpose of assessing efficacy. The first stage of evaluation will be assessed among the first 18 evaluable patients for each cohort. If at least 3 of 18 patients achieve clinical benefit at week 24, then the trial will proceed to the second stage of enrollment for that cohort to assess clinical benefit in a total of 44 evaluable patients per arm. Clinical benefit is defined as a complete response, partial response, or stable disease, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks. The lead investigator for the trial is Dr. Beth Overmoyer from the Dana Farber Cancer Institute and the Harvard Medical School.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Corindus Vascular Robotics (CVRS) Reports FDA Clearance for Next-Gen Robotic System
- AstraZeneca (AZN) Shares Decline After Recruitment Paused in Head and Neck Cancer Trial
- Apple (AAPL) Unveils New TV App
Create E-mail Alert Related CategoriesCorporate News, FDA, Hot Corp. News, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!