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GTx Capesaris Trials - To Stay On Hold Or Continue?


Shares of Memphis-based pharmaceutical company GTx Inc. (GTXI) have taken a hit since February of this year after the FDA placed a clinical hold on the company's phase II clinical studies for experimental prostate cancer drug Capesaris.

Capesaris is an oral nonsteriodal selective estrogen receptor alpha agonist, which was being evaluated as a potential treatment for primary (first line) androgen deprivation therapy for advanced prostate cancer and secondary (second line) hormonal treatment in phase II studies.

The clinical hold came into effect beginning February after the company reported to the FDA about an increased risk of blood clots in patients who had received high doses of Capesaris in one of the clinical trials.

Seeking to resume trials of Capesaris, GTx submitted its clinical hold response letter to the FDA on April 4, providing information requested by the regulatory agency, including its development plans for Capesaris as a secondary hormonal therapy for advanced prostate cancer at doses lower than those previously tested.

The FDA is expected to respond by May 4th, coinciding with the 30-day deadline, if it finds the company's response good enough to resolve the 'clinical hold' deficiency.

The company's lead SARM ( selective androgen receptor modulators) candidate is Enobosarm, currently under two late-stage trials for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer. The two ongoing phase III studies , dubbed POWER1 and POWER2 are placebo-controlled, double-blind clinical trials, designed to enroll 300 patients each with Stage III or IV non-small cell lung cancer. Data from the POWER1 and POWER2 phase III studies are expected in the first quarter of 2013.

GTx has one marketed product - Fareston, indicated for the treatment of advanced metastatic breast cancer in postmenopausal women. Fareston sports a boxed warning to highlight that the medication prolongs the QTc interval in a dose- and concentration-related manner. A prolonged QTc interval may increase total and cardiovascular mortality due to life-threatening ventricular arrhythmias, seizure or death.

The company slipped to a loss of $33.3 million in 2011, reversing a year-ago net income of $15.3 million. Full-year 2011 revenue was $14.7 million, down from $60.6 million in 2010. While the 2011 revenue consisted of only net sales of Fareston, the 2010 revenue consisted of net sales of Fareston, collaboration revenue from Ipsen Biopharm Ltd. and collaboration revenue from Merck & Co.

The collaboration agreement between GTx and Merck was terminated in March 2010 and in the following year - March 2011, the collaboration agreement with Ipsen was terminated.

Since February, GTXI has lost more than 43% of its value and trade around $3. The stock has thus far hit a 52-week low of $2.34 and a 52-week high of $6.86.

Prostate cancer, dubbed the silent killer of men, is the second most common cause of cancer death in American men. About 240,000 men are diagnosed with prostate cancer in the U.S. every year, and according to the American Cancer Society, over 30,000 men die of prostate cancer each year.

Several different hormonal approaches are used in treating various stages of prostate cancer. Abbott Laboratories' (ABT) Lupron Depot, Sanofi's (SNY) Eligard, AstraZeneca PLC's (AZN) Zoladex, Ferring Pharmaceuticals' Firmagon, Endo Pharmaceuticals Holdings Inc.'s (ENDP) Vantas and Watson Pharmaceuticals Inc.'s (WPI) Trelstar are some of the FDA-approved hormone therapies to treat advanced prostate cancer.

Will GTx, the developer of the selective estrogen receptor alpha agonist for prostate cancer, which is vying for a share of a large and ever growing prostate cancer drugs pie, be allowed to resume its Capesaris trials and get to play its part? Stay tuned...

by RTTNews Staff Writer

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