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Biotech / Medical : ADVENTRX Pharmaceuticals Inc (Anx)

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To: Keith Feral who wrote (319)	10/1/2007 6:21:38 PM
From: Keith Feral	Read Replies (1) of 418

Data summary for Cofactor, Leucovorin and a few other studies. Leucovorin bolus Time to tumor progression – 4 months 21% response rate 11.7 months median survival Infusional 5FU/ Leucovorin n = 187 (De Gramont trial) Time to tumor progression - 4.4 months 22% response rate 14.1 months median survival Infusional 5FU/Leucovorin – (Cofactor Trial) Objective response rate – 13.3% Median PFS – 6.1 months Median Survival – 14.3 months Cofactor bolus - phase 2 study US Time to tumor progression – 5.3 months 35% response rate 15.1 months survival rate No Side Effects – hematological or gastrointestinal Cofactor bolus Phase 2– Various Second Line Treatment 23.0 months median survival rate, n = 37 21.5 months Folfiri, n=109 20.6 months Folfox6, n=111 Phase 2 b Cofactor/ Infusional 5FU Objective Response rate – 10.7% Median PFS - 6.3 months Median Survival – 14.7 months Cofactor – Xeolda Studies –nude mouse study Cofactor, 5FU, Xeloda – 60 day survival Xeloda only – 38 day survival Xeloda & 5FU – 39 day survival Irinotecan & Infusional 5FU/Leucovorin n = 198 Time to tumor progression – 6.7 months 35% response rate 17.4 months median survival Eloxatin + 5FU/LV n = 267 Time to tumor progression – 8.7 months 45.2% response rate 19.4 months median survival Eloxatin + Irinotecan n = 264 Time to tumor progression – 6.5 months 34% response rate 17.6 months median survival Avastin plus IFL n = 402 Time to tumor progression - 10.6 month 44.8% response rate 20.3 months median survival ILF (leucovorin/5FU and irinotecan) Time to tumor progression - 6.4 months 34.8% response rate 15.6 months median survival FOLFOX Time to tumor progression - 8.8 months 38% response rate 18.6 months median survival Oxaliplatin & Irinotecan Time to tumor progression - 6.7 months 28% response rate 16.5 months median survival Provenge (Dendreon) 4.5 months survival vs placebo group Panitumumab - Vectibex 9% overall response rate vs 0% for Best Supported Care (BSC) Time to progression - 11.4 weeks 46% decrease in tumor progression rate vs. best supportive care Median survival time 37.6 weeks or 8 months Median duration of tumor response 17 weeks Toxicity Profile – Grade 3 & 4 Cofactor 5FU/LV 5FU/LV 5FU/LV 5FU/LV 5FU UFT UFT CPT CPT XEL n= 50 n= 394 n=195 n= 226 n=197 n= 593 Diah 0 15 11 13 6 12 Naus 0 10 9 12 6 7 Stom 0 19 16 17 3 15 Anem 0 7 4 56 2 1 Neut 2 56 31` 67 13 21 Hrub 0 8 10 8 11 5 Neur 0 nr nr nr nr nr Hand 0 0 0 0 1 1 Toxicity Profile – All Grades Cofactor 5FU/LV 5FU/LV 5FU/LV 5FU/LV 5FU UFT UFT CPT CPT XEL n= 50 n= 394 n= 195 n=226 n= 197 n=593 Diah 42 76 60 69 45 61 Naus 50 75 58 114 87 81 Stom 10 75 55 76 28 62 Anem 8 87 89 99 91 79 Neut 6 77 87` 99 48 48 Hrub 2 22 23 22 36 17 Neur 2 nr nr nr nr 4 Hand 4 5 4 nr 13 6 Cofactor Leucovorin P Value Inf 5FU Inf 5FU 1 Adverse Effect 23 10 p<0.05 Hematological 11 7 n/s Gastrointestinal 12 5 n/s Grade 3 or 4 Diarrhea 0 0.7 Nausea 0.7 0 Vomiting 0.7 1.4 Stomatis 0 1.4 Mucositis 0 0 Anemia 2.0 2.0 Neutropenia 2.7 2.0 Hyperbilirubinemia 2.7 2.0 Neuropathy 0 0 Hand Foot 0.7 0 Any Grade Diarrhea 17.0 17.6 Nausea 17.0 17.6 Vomiting 15.6 12.8 Stomatis 2.7 2.7 Mucositis 0.7 0.7 Anemia 2.0 7.4 Neutropenia 4.8 3.4 Hyper 6.1 3.4 Neuropathy 0 0.7 Hand Foot 2.7 1.4

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