News 
Market Data 
Discover
Replies to post #157044 on Biotech Values
Namely, should we expect single-agent Vidaza to produce 7 CRs out of 9 patients in this patient population or is this HDAC truly adding a significant benefit here?
Study 1 was a randomized, open-label, controlled trial carried out in 53 U.S. sites compared the safety and efficacy of subcutaneous Vidaza plus supportive care with supportive care alone (“observation”) in patients with any of the five FAB subtypes of myelodysplastic syndromes (MDS): refractory anemia (RA), RA with ringed sideroblasts (RARS), RA with excess blasts (RAEB), RAEB in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). RA and RARS patients were included if they met one or more of the following criteria: required packed RBC transfusions; had platelet counts =50.0 x 109/L; required platelet transfusions; or were neutropenic (ANC <1.0 x 109/L) with infections requiring treatment with antibiotics. Patients with acute myelogenous leukemia (AML) were not intended to be included.
Of the 191 patients included in the study, independent review (adjudicated diagnosis) found that 19 had the diagnosis of AML at baseline. These patients were excluded from the primary analysis of response rate, although they were included in an intent-to-treat (ITT) analysis of all patients randomized. Approximately 55% of the patients randomized to observation crossed over to receive Vidaza treatment. The overall response rate (CR + PR) of 15.7% in Vidaza-treated patients without AML (16.2% for all Vidaza randomized patients including AML) was statistically significantly higher than the response rate of 0% in the observation group (p<0.0001)
www.drugs.com/pro/vidaza.html
