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Biotech / Medical : IMNR - Immune Response
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To: Emec who wrote (1224)12/21/1998 9:26:00 AM
From: poodle  Read Replies (2) of 1510
 
David,
not so easy to comment. As any PR, it's perfectly obscure.

"The company
believes that the results suggest a favorable treatment effect according to the American
College of Rheumatology criteria for improvement (ACR 20 criteria) with statistical
significance at one time point after the third injection"

Sounds interesting, but there is no any number.

"and was consistent with and expanded upon the results shown in the previous phase II trial."

In Phase II 90 mg dose results were considered as statistically significant, 300 mg was close to placebo. Phase IIb was designed to solve this controversy and to determine optimal dose. 10 mg should be tested. Consistent with 90 mg results or 300 mg results?

"Although the treatment effect was not maintained throughout the trial in the entire
patient population, " sounds not very promising.

"when patients receiving more than physiological doses (>7.5
mg/day) of prednisone (a corticosteroid used to suppress inflammation) were excluded"
In Phase II patients were not eligible to enter the study if they had received variable dosages of corticosteroids for previous 2 months and/or dosages averaging >10mg/day of prednisone or equivalent. Again, exact patient selection strategy for IIb and the reason for patients with >7.5 mg dose exclusion for statistical analysis is necessary to understabd the results.

No statistical data presented.

"these results MAY support the Company's BELIEF that the TCR peptide therapeutic vaccine is a useful approach for the treatment of rheumatoid arthritis."
Almost anything may support someone's belief.
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