FDA Plays

[Guy]

GTXI - bought @1.38. They are going to present
clinical data on Enobosarm in Breast Cancer at
ASCO 2014 on June 2nd and data to assess the primary
study endpoint expected in July.

From Q1 PR:
"Enobosarm 9mg, being studied for the targeted treatment of androgen receptor and estrogen receptor positive metastatic breast cancer: GTx is conducting a Phase 2, open label clinical study evaluating an oral daily dose of 9mg enobosarm for the treatment of androgen receptor (AR) positive and estrogen receptor (ER) positive metastatic breast cancer in women who have previously responded to hormonal therapy for the treatment of their advanced breast cancer. Nine clinical study sites in the US have fully enrolled the study with 22 postmenopausal women with advanced breast cancer to assess clinical benefit response after six months of enobosarm 9mg treatment, which is defined as either those women receiving treatment who have demonstrated a complete response (disappearance of all targeted lesions), a partial response (at least a 30 percent decrease in the sum of the diameters of the targeted lesions) or stable disease (no disease progression from baseline). Enobosarm 9mg continues to be well tolerated by patients in the study.

In preclinical and clinical studies, androgens suppress breast cancer growth. Prior studies have shown that women with metastatic breast cancer who have been previously treated with tamoxifen and whose cancer has progressed have responded to non-selective androgens, with overall response rates ranging from 20 to 60 percent. Although these non-selective androgens have been used to treat breast cancer, the unwanted virilizing side effects, including facial and body hair, enlargement of voice box, acne, and edema have limited their widespread clinical use. GTx believes that a selective androgen receptor modulator, like enobosarm, by targeting the androgen receptor in metastatic breast cancer, has the potential to provide clinical benefit to women with advanced breast cancer by treating their disease while minimizing the unwanted masculinizing side-effects associated with steroidal androgens. Furthermore, unlike steroidal androgens, enobosarm cannot be converted to an estrogen that could be detrimental in breast cancer.

The Company has determined that the study will meet the pre-specified goal of demonstrating at least three clinical benefit responses in a minimum of 14 patients with AR positive metastatic breast cancer. The study is ongoing and the last study patient is expected to have her primary endpoint visit in June of this year, with data to assess the primary study endpoint expected in July 2014. Preliminary data from the study is being presented at the American Society of Clinical Oncology (ASCO) in Chicago, Illinois on June 2, 2014, in a poster presentation entitled, “Enobosarm: A targeted therapy for metastatic, androgen receptor positive breast cancer.” The Company is planning to meet with key opinion leaders and other breast cancer specialists at ASCO to evaluate data then available from the study and discuss appropriate next steps for the development of this potential treatment option for women with advanced breast cancer."

SeekingAlpha article:

http://seekingalpha.com/article/2171763-pitt-hyde-and-mason-hawkins-buy-50-percent-stake-in-gtx-ahead-of-phase-ii-results