Tumor Drug from Lexicon Pharma shows positive results Print E-mail
By M.E.Garza   
Tuesday, 09 August 2011 09:11
Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, said on Tuesday its experimental drug reduced symptoms related with tumors in small intestine, colon, appendix and lungs in a mid-stage study.   

The drug, LX1032 or telotristat etiprate, is designed to treat carcinoid syndrome -- a chronic condition caused by neuroendocrine tumors that usually originate from the gastrointestinal tract. It is characterized by severe diarrhea and flushing episodes with long-term consequences including malnutrition, heart disease, and death. Symptoms of carcinoid syndrome have been linked to excess production of serotonin by metastatic tumor cells. Telotristat etiprate is designed to reduce serotonin production.

"Telotristat etiprate is our third drug candidate to demonstrate proof of concept in patients in Phase 2," said Dr. Arthur T. Sands, Lexicon's president and CEO. "Based on the positive results of this U.S. study, as well as encouraging observations from our clinical trial in Europe, we intend to discuss a Phase 3 development plan for carcinoid syndrome with the FDA."

Excess production of serotonin -- a compound found in the pineal gland, blood platelets, the digestive tract and the brain -- may lead to carcinoid syndrome.

It is characterized by severe diarrhea and flushing episodes with long-term consequences including malnutrition, heart disease and death. Lexicon's drug is designed to reduce excess serotonin production.  

The randomized, double-blind, placebo-controlled study was conducted in the United States in 23 patients with carcinoid syndrome who were refractory to currently available therapy. Patients in the study had metastatic carcinoid disease and were experiencing an average of about six bowel movements per day at baseline. Patients received either placebo (n=5) or one of four doses of telotristat etiprate (n=18) daily for 28 days. The primary endpoint of the study was safety and tolerability. Efficacy measures included change in bowel movement frequency, relief of symptoms, and reduction in serotonin synthesis.

Adverse events in the study were usually mild to moderate with similar frequencies between the treatment and placebo groups, the company said.

"The Phase 2 data clearly show a reduction in bowel movements and symptom relief in a population that has exhausted all standard-of-care treatment options," said Dr. Pablo Lapuerta, senior vice president and chief medical officer at Lexicon. "The Phase 2 data are also consistent with preliminary results from the European study, where there appear to be some early responses and additional benefit with continued treatment. We look forward to presenting detailed results at a scientific meeting later this year."


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