Friday, August 15, 2014 10:46:12 AM
• 5-2-14: 25 (All USA)
• 5-29-14: 62 (USA/29 Aus/3 Fr/1 Ger/6 Hungary/4 Korea/4 Spain/13 Taiwan/2)
• 6-9-14: 73 (USA/31 Aus/5 Fr/1 Ger/6 Hungary/4 Korea/4 Rus/7 Spain/13 Taiwan/2)
• 6-19-14: 88 (USA/34 Aus/5 Bel/6 Fr/1 Ger/6 Hungary/6 Italy/1 Korea/5 Rom/1 Rus/6 Spain/14 Taiwan/3)
• 6-25-14: 91 (USA/34 Aus/5 Bel/7 Fr/1 Ger/6 Hungary/6 Italy/0 Korea/7 Rom/1 Rus/6 Spain/14 Taiwan/4)
• 7-2-14: 100 (USA/32 Aus/6 Bel/7 Fr/4 Ger/8 Hungary/6 Korea/7 Rom/4 Rus/6 Spain/15 Taiwan/5)
• 7-9-14: 108 (USA/33 Aus/6 Bel/7 Fr/7 Ger/9 Hungary/7 Korea/7 Rom/6 Rus/6 Spain/15 Taiwan/5)
• 7-23-14: 115 (USA/32 Aus/6 Bel/7 Fr/9 Ger/9 Greece/5 Hungary/7 Korea/7 Rom/6 Rus/6 Spain/15 Taiwan/6)
• 7-28-14: 118 (USA/34 Aus/6 Bel/7 Fr/9 Ger/9 Greece/5 Hungary/7 Korea/7 Rom/6 Rus/6 Spain/15 Taiwan/7)
• 7-31-14: 121 (USA/34 Aus/6 Bel/7 Fr/9 Ger/10 Greece/6 Hungary/7 Korea/7 Rom/6 Rus/6 Spain/15 Taiwan/8)
• 8-7-14: 124 (USA/34 Aus/7 Bel/7 Fr/9 Ger/11 Greece/6 Hungary/7 Korea/7 Rom/6 Rus/6 Spain/16 Taiwan/8)
• 8-13-14: 128 (USA/34 Aus/7 Bel/7 Fr/10 Ger/12 Greece/6 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/6 Spain/16 Taiwan/8)
BAVITUXIMAB PHASE III TRIAL: (see http://PeregrineTrials.com => http://www.SunriseTrial.com )
A. Phase III Bavi+Doce vs. 2nd-Line NSCLC "SUNRISE" (randomized, double-blind, placebo-ctl'd, n=582) (Start=Dec’13 Est PrimaryComp=Dec’16)
USA Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01999673 - 128 sites a/o 8-13-14 (USA/34 Aus/7 Bel/7 Fr/10 Ger/12 Greece/6 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/6 Spain/16 Taiwan/8) - Growth: http://tinyurl.com/ny5qyrn
…EU/EEA Registries: (pts world=582, pts/EU=345, planned EU sites=100) http://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-003953-13
• GER: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/DE (planned sites=14, pts=43)
• SPAIN: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/ES (planned sites=16, pts=100)
• HUNGARY: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/HU (planned sites=9, pts=28)
• GREECE: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/GR (planned sites=9, pts=120)
• ITALY: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/IT (planned pts=55)
...EU= European Union (29 countries – see http://www.gov.uk/eu-eea ), EEA=European Economic Area (all the EU, plus Iceland, Liechtenstein, Norway)
…Regions where sites are planned: Australia, Belgium, France, Germany, Greece, Hungary, Italy, Korea, Romania, Russia., Spain, Taiwan, Ukraine, USA
1-6-14: FDA grants FAST TRACK status to Bavi in 2ndLine NSCLC http://tinyurl.com/l799ukk
12-30-13: Pivotal Ph.3 ‘SUNRISE’ NSCLC Trial Initiated (n=~600, sites=~100) http://tinyurl.com/kdjb9qz
5-20-13: FDA Approves Bavituximab Ph.III Design for 2L/NSCLC; 600-pt trial to begin by y/e’13 http://tinyurl.com/n3dxtm6
...S.King: “We will now focus on starting the Ph.III trial while continuing ongoing partnering discussions.”
…R.Garnick: “This was a highly collaborative effort with the FDA; this trial, when combined with Bavi’s supporting data to date, could be sufficient to support a future BLA submission."
Contact: Jennifer Lai, MBA 1-855-291-SUNR (7867) lungcancertrial@peregrineinc.com
Peregrine Pharmaceuticals’ Clinical Development Group
• A.J. Leyco, RN - Associate Director, Clinical Trials
• Jennifer Lai, MBA, CCRA - Manager, Clinical Research
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