|GTXI I think that they will release positive results but this thing has a ton of warrants thats currently in the money at 8.50$ for like over 6 Million shares but and the book value is only like 50 cents a share or something they have very little cash but there biggest shareholders keep lending them money blah i think its good for a day trade buy today sell tomorrow on the news but risky i think that they will get positive results out tomorrow tho its phase 2 and they had a ton of success and its only 7 people |
-- Additional data from ongoing SUI clinical trial to be released in conjunction with podium presentation at International Continence Society meeting in September 2017 --
GTx, Inc. (Nasdaq: GTXI) today reported financial results for the second quarter of 2017 and highlighted recent accomplishments and upcoming milestones.
During the quarter, GTx announced positive preliminary clinical data from an ongoing, open-label, Phase 2 proof-of-concept clinical trial of enobosarm in postmenopausal women with stress urinary incontinence (SUI). The Company also has continued to advance two additional R&D programs which are outlined below.
"We are impressed with the positive results in the first seven patients dosed in the SUI study. Stress urinary incontinence is a serious and often embarrassing condition which can have a significant negative impact on a patient's quality of life. We are focused on potentially addressing this prevalent condition with a first-in-class, orally-administered therapy," said Robert J. Wills, Ph.D., Executive Chairman of GTx.
Corporate Highlights and Anticipated Milestones
Enobosarm in Stress Urinary Incontinence: The Company has an ongoing Phase 2 proof-of-concept clinical trial of enobosarm 3 mg in postmenopausal women with SUI. This open-label, non-placebo controlled proof-of-concept clinical trial is the first of its kind to evaluate an orally-administered selective androgen receptor modulator (SARM) for SUI.
-- In June 2017, the Company announced preliminary results from the first seven women in the ongoing trial, in which all of the women treated with enobosarm showed a clinically significant reduction (50 percent or greater) in incontinence episodes per day, as measured by mean stress leaks from baseline to week 12 of the trial.
-- Mean stress leaks decreased by 80.9 percent overall; stress leaks dropped from 5.7 to 1.1 leaks per day.
-- These results, as well as data from additional patients, will be presented at the International Continence Society (ICS) annual meeting in September 2017. The results from the first seven patients can be found here.
-- Encouraged by the results to date from its SUI proof-of-concept clinical trial, the Company is planning to initiate in the second half of 2017 a randomized, double-blinded Phase 2 clinical trial to assess the efficacy and safety of two doses of enobosarm (3 mg and 1 mg) per day against placebo with the expectation that top-line data from this trial will be available by the end of 2018.
Enobosarm in Breast Cancer:
The Company has an ongoing Phase 2 clinical trial of enobosarm in estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer.
-- The Company reported in November 2016 that the pre-specified threshold for success of the trial was already attained in the 9 mg cohort, with nine patients achieving a clinical benefit response (CBR) at 24 weeks among the first 22 evaluable patients in that cohort.
-- CBR is defined as a complete response, partial response or stable disease, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks of treatment.
-- The Phase 2 clinical trial is fully enrolled with at least 44 evaluable patients enrolled in each of the 9 mg and 18 mg cohorts of the trial, and the Company expects to report top-line results in the third quarter of 2017.
-- The independent Safety Monitoring Committee established to monitor the safety of this clinical trial met on August 11, 2017, and recommended that the trial continue as planned.
The Company's Phase 2 clinical trial of enobosarm in AR+ triple negative breast cancer completed the first stage of the two stage trial. Since there was insufficient CBR demonstrated among patients enrolled in the first stage of the trial, the Company has determined that the second and final stage of the trial will not continue.
-- One patient who achieved stable disease remains on study for approximately 10 months from the initiation of treatment.
This is purely a trade based on news coming out tomorrow and it being positive