Biotech Values

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OCRX (RePost From Wednesday):
Ocera Announces Preliminary Topline Results From Phase 2a Investigator-Sponsored Study of OCR-002

http://finance.yahoo.com/news/ocera-announces-preliminary-topline-results-210500913.html

The data show that OCR-002 resulted in greater absolute and relative reductions in median plasma ammonia versus placebo at 12 hours after baseline (-19.35 microM/L and -19.62% versus -2.0 microM/L and -3.25%, respectively). These observations corresponded to an hourly decline in plasma ammonia over the first 24 hours of infusion of -0.85 microM/L in the OCR-002 group versus -0.24 microM/L in the placebo group. The differences in plasma ammonia levels between treatment arms did not reach statistical significance, which was due in part to the higher than expected variability in plasma ammonia levels. However, there were statistically significant differences in urinary excretion of ammonia, as expressed by a key metabolite phenylacetyl glutamine (PAGN), which the Company believes demonstrates the ability of OCR-002 to reduce ammonia levels.

As discussed yesterday this trial is different from the 2B sponsored by the company with data expected in the second half of 'this year, an interim analysis to check for futility and sample size adjustment is anticipated shortly.

Below is a slide of the primary/secondary endpoints and the powering assumption.


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