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Biotech / Medical : Biotech Valuation

CRSP 53.18

-3.8%

12:35 PM EST

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To: Biomaven who started this subject	4/1/2004 2:22:33 PM
From: zeta1961	of 52153

Parking SUPG's detailed #'s for reference... Investigator's Assessments of Patients' Reponses on Intent to Treat Dacogen Supportive Care P-Values (N=89) (N=81) Best response on study Complete response 9 (10%) 0 <0.001(1) Partial response 11 (12%) 0** Hematological improvement 10 (11%) 0 Stable disease 33 (37%) 34 (42%) Progressive disease 15 (17%) 20 (25%) Not assessed for response* 11 (12%) 25 (31%) Patients that withdrew from study prior to any response evaluation Two patients had a partial response to Dacogen after progressing on supportive care (1)from 2-sided Fisher exact test for equal overall response rate (CR+PR) Investigator's Assessments of Patients' Reponses Evaluable for Response Dacogen Supportive Care P-Values (N=78) (N=56) Best response Complete response 9 (12%) 0 <0.001(1) Partial response 11 (14%) 0** Hematological improvement 10 (13%) 0 Stable disease 33 (42%) 34 (61%) Progressive disease 15 (19%) 20 (36%) Patients that withdrew from study prior to any response evaluation *Two patients had a partial response to Dacogen after progressing on supportive care (1)from 2-sided Fisher exact test for equal overall response rate (CR+PR) Times to AML or Death # (Patients withdrawing consent, not receiving randomized treatment or crossing over are censored) Population Dacogen Supportive Care P-Value (N=89) (N=81) All Patients 89 81 0.042(1) Number of Events (%) 46 (52%) 46 (57%) 0.198(2) Median (days) 338 263 High Risk IPSS Patients 23 21 0.001(1) Number of Events (%) 14 (61%) 17 (81%) 0.004(2) Median (days) 275 79 Intermediate-2 IPSS 38 36 0.227(1) Patients 20 (53%) 20 (56%) 0.417(2) Number of Events (%) 340 275 Median (days) Int-2 & High Risk IPSS Patients 61 57 0.005(1) Number of Events (%) 34 (56%) 37 (65%) 0.040(2) Median (days) 334 189 Intermediate-1 IPSS Patients 28 24 0.624(1) Number of Events (%) 12 (43%) 9 (38%) 0.508(2) Median (days) 370 417 Previously Treated MDS Patients 27 19 0.340(1) Number of Events (%) 17 (63%) 9 (47%) 0.193(2) Median (days) 300 417 Treatment Naive MDS Patients 62 62 0.004(1) Number of Events (%) 29 (47%) 37 (60%) 0.030(2) Median (days) 354 189 (1)2-sided Wilcoxon Test for homogeneity of survival distributions (2)2-sided log-rank Test for homogeneity of survival distributions Baseline Characteristics Dacogen Supportive Care P-Values(1) (N=89) (N=81) Age (years) Median 70 70 0.113 IPSS Stage Intermediate-1 28 (31%) 24 (30%) 0.980 Intermediate-2 38 (43%) 36 (44%) High Risk 23 (26%) 21 (26%) Weeks Since MDS Diagnosis Median 29 35 0.990 Gender Male 59 (66%) 57 (70%) 0.622 Female 30 (34%) 24 (30%) Type of MDS De Novo 77 (87%) 70 (86%) 1.00 Secondary 12 (13%) 11 (14%) Previous MDS Therapy Yes 27 (30%) 19 (23%) 0.388 No 62 (70%) 62 (77%) (1)from 2-sided Fisher exact test

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