DUBLIN, January 29, 2014 /PRNewswire/ --
Research and Markets (http://www.researchandmarkets.com/research/q8l6jf/lexicons) has announced the addition of the "Lexicon's telotristat - A new approach to carcinoid syndrome" report to their offering.
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Lexicon is developing telotristat as therapy for carcinoid syndrome, an orphan' disease that occurs when carcinoid tumors spill excess serotonin into the systemic circulation.
The episodes of flushing, diarrhea, and other symptoms that result from this excess production of serotonin severely impact quality of life. Telotristat works by inhibiting a key enzyme in the production of serotonin.
To date, Lexicon has produced data from two small phase II studies and has begun a modestly sized phase III trial of use in conjunction with Sandostatin, the current first-line therapy. Thus, the key questions that this report addresses are whether those early data are adequate to predict success from all of the relevant perspectives: efficacy, safety, regulatory approval, and market acceptance.
Key Topics Covered:
1. Neuroendocrine tumors, carcinoid tumors, and carcinoid syndrome (CS)
- What are they?
- Clinical presentation
1. The rationale for the use of telotristat: serotonin in gastrointestinal diseases
2. Clinical data
- US Phase II dose finding study (Kulke MH et al; NANETS 2011)
- UK/German study (Pavel M et al; ENETS 2012 and company presentation)
3. Phase III
4. Ulcerative colitis program
CLINICAL AND REGULATORY DISCUSSION
1. Probability of phase III trial success
2. Data do not allow an adequate assessment of safety and concerns remain
- Serotonin and the brain
- Serotonin and the gastrointestinal tract
- In summary
3. Fast Track and Orphan Status
4. Regulatory precedents
5. Ulcerative colitis
6. In summary, what are the implications for telotristat?
2. Sandostatin as proxy
3. Epidemiology provides some insight
4. The ulcerative colitis market
5. In summary
6. Other current and pipeline carcinoid syndrome therapies
APPENDIX 1. Integration of Various Neuroendocrine Tumor Classification Systems
APPENDIX 2. Emergent Adverse Events in the EU Trial: N (%)
APPENDIX 3. Serotonin Receptors
- Dr Ellen Brady
- Dr Ilana Fogelman
For more information visit http://www.researchandmarkets.com/research/q8l6jf/lexicons
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