Memphis-based biopharmaceutical company GTx Inc. on Tuesday, May 8, reported an $11.1 million net loss for the first quarter, compared to a net loss of $2.6 million for the same period in 2011.
(Daily News File Photo)
Revenue for the quarter ended March 31 was $1.8 million compared to $9.3 million for the same period in 2011.
Q1 revenue consisted of net sales of Fareston, a drug approved for the treatment of metastatic breast cancer in postmenopausal women.
Q1 2011 revenue included Fareston net sales of $1.2 million and $8.1 million in collaboration revenue resulting from the termination of the company’s license and collaboration agreement with Ipsen Biopharm Ltd.
Research and development expenses – the company’s main focus – for Q1 totaled $9.8 million, compared to $7.3 million for the same period in 2011. General and administrative expenses for Q1 totaled $2.8 million, compared to $4.7 million for the same period in 2011.
As of the end of Q1, GTx had cash, cash equivalents and short-term investments of $64 million.
GTx Tuesday also said the Food and Drug Administration removed its full clinical hold on the company’s Investigational New Drug application for Capesaris – a drug for secondary hormonal therapy of advanced prostate cancer – following the FDA’s review of the company’s complete response and its new Phase II clinical protocol.
During the third quarter, GTx plans to start an open-label clinical study of 75 men with metastatic castration-resistant prostate cancer to test three lower doses of Capesaris in three groups consisting of 25 patients each.
The Phase II study is designed to assess the drug’s effect on serum prostate specific antigen response and prostate cancer progression.
The study is also designed to provide confirmation of the mechanism of drug action for Capesaris on lowering serum-free testosterone levels by increasing serum SHBG.
The safety and tolerability of lower doses of Capesaris will also be evaluated in these subjects.
“Our team successfully addressed FDA’s concerns about Capesaris, and we expect to initiate our Phase II clinical study of Capesaris as secondary hormonal therapy in men with metastatic castration resistant prostate cancer during the third quarter,” Dr. Mitchell S. Steiner, CEO of GTx, said in a statement. “We believe Capesaris can provide a unique treatment for a large number of men who are failing their primary hormonal treatment for advanced prostate cancer.”
Looking at Enobosarm – a drug for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer – GTx is currently enrolling subjects in two pivotal Phase III clinical trials involving patients with advanced non-small cell lung cancer.
After a pre-specified safety review in subjects currently enrolled in the two studies, the independent Data Safety Monitoring Board determined that the studies can continue as planned.
These international studies are being conducted in clinical sites in the United States, Europe and South America.
In each of the placebo-controlled, double-blind clinical trials, 300 patients with Stage III or IV non-small cell lung cancer are being randomized to oral daily doses of placebo or enobosarm as they begin first-line chemotherapy.
The studies are evaluating the effect of enobosarm versus placebo on maintaining or improving total muscle and improving physical function.
GTx expects data from the Phase III clinical studies during the first half of 2013.