Avid Bioservices Inc (CDMO)

[cjgaddy]

SUNRISE #Sites from 91 to 100 a/o 7-2-14 (32/US + 68/Intl)…

• 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)

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 - 100 sites a/o 7-2-14 (USA/32 Aus/6 Bel/7 Fr/4 Ger/8 Hungary/6 Korea/7 Rom/4 Rus/6 Spain/15 Taiwan/5)
…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)
...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
...3-2014: Eur.Med.Assoc.(EMA) appears to approve Bavi/2L-NSCLC for possible future trial in Children: http://tinyurl.com/lqsjfj2
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) [e-mail]
Peregrine Pharmaceuticals’
Clinical Development Group
A.J. Leyco, RN - Associate Director, Clinical Trials
Jennifer Lai, MBA, CCRA - Manager, Clinical Research