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New Study First to Confirm Sandostatin LAR(R) Depot Controls Tumor Growth in Patients With Rare Gastrointestinal Tumors
Date:1/13/2009

- Data show significant 66% reduction in risk of disease progression versus placebo

- Sandostatin LAR more than doubled time without tumor growth for a median of 14 months compared to six months on placebo

- Results support Sandostatin LAR as first treatment after surgery in certain patients with newly diagnosed neuroendocrine tumors (NETs)

EAST HANOVER, N.J., Jan. 13 /PRNewswire/ -- Sandostatin LAR(R) Depot (octreotide acetate suspension for injection) demonstrated antitumor benefit in patients with metastatic neuroendocrine tumors (NETs) of the midgut, according to interim data presented today at the 2009 Gastrointestinal Cancer Symposium of the American Society of Clinical Oncology.

After six months of treatment, patients receiving Sandostatin LAR had a 66% reduction in risk of disease progression compared to patients taking placebo (P=0.000072). This reduction is based on findings that Sandostatin LAR halted tumor growth in 69% of patients, compared with 39% of patients receiving placebo. Patients who took Sandostatin LAR had no tumor progression for a median of 14.3 months, compared to six months for patients on placebo. This beneficial effect was seen in patients with either functioning (hormone secreting) or non-functioning (non-secreting) NETs.

The findings are from a Phase IIIb, multicenter, prospective, randomized, placebo-controlled, double-blind, study called PROMID (Placebo-controlled prospective Randomized study on the antiproliferative efficacy of Octreotide LAR in patients with metastatic neuroendocrine MIDgut tumors).

"Sandostatin LAR has a proven track record of treating the severe diarrhea and flushing associated with neuroendocrine tumors and now this study demonstrates that Sandostatin LAR also helps control tumor growth in patients with metastatic neuroendocrine tumors of the midgut," said PROMID
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SOURCE Novartis Pharmaceuticals Corporation
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