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VOL. 127 | NO. 154 | Wednesday, August 8, 2012

GTx Narrows Q2 Loss

By Aisling Maki

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GTx Inc. Wednesday, Aug. 8, reported a net loss of $10.4 million for the second quarter, compared to a net loss of $10.7 million for the same period in 2011.

The Memphis-based biopharmaceutical company at 175 Toyota Plaza focuses on the discovery, development and commercialization of small molecules for the treatment of cancer and other serious medical conditions.

For the quarter ended June 30, GTx reported revenue of $1.6 million, which consisted of net sales of Fareston 60 mg, a drug approved for the treatment of metastatic breast cancer in postmenopausal women.

Research and development expenses for Q2 totaled $9.2 million compared to $7.6 million for the same period in 2011, while general and administrative expenses for Q2 were $2.6 million compared to $4.5 million for the same period in 2011.

GTx at the close of Q2 had cash and short-term investments of $55.9 million.

One of the company’s drugs is enobosarm, created for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.

GTx is currently enrolling subjects with advanced non-small cell lung cancer in two pivotal Phase III clinical trials called Power 1 and Power 2. These international studies are being conducted at clinical sites in the United States, Europe and South America.

Each of the placebo-controlled, double-blind clinical trials involves 300 patients with Stage III or IV non-small cell lung cancer who are receiving oral daily doses of placebo or enobosarm 3 mg at the time they begin first-line standard chemotherapy.

The studies are evaluating the response rates of enobosarm versus placebo on maintaining or improving total lean body mass.

Enrollment is expected to be completed in Q4 and top-line results are expected to be released during the second quarter of 2013.

Also in the pike is Capesaris,, a secondary hormonal therapy for advanced prostate cancer. GTx is initiating an open-label clinical study of 75 men with metastatic castration- resistant prostate cancer to test three lower doses of Capesaris sequentially, in cohorts of 25 patients each.

This Phase II 712 clinical trial is designed to assess the effect of Capesaris on serum prostate specific antigen response and prostate cancer progression.

The study is expected to provide confirmation of the drug’s effect on lowering serum-free testosterone levels in castrated men who failed primary androgen deprivation therapy.

The safety and tolerability of lower doses of Capesaris will also be evaluated in these subjects.

“We continue to make progress on our late stage clinical programs,” Dr. Mitchell Steiner, co-founder and CEO of GTx, said in a statement. “We are enrolling our two pivotal Phase III clinical trials evaluating enobosarm for the prevention and treatment of muscle wasting in non-small cell lung cancer patients. We expect to receive top line data from these studies during the second quarter of 2013. In addition, we will begin screening patients this month for our Phase II clinical study of Capesaris as secondary hormonal therapy in men with metastatic castration resistant prostate cancer.”

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