Replies to post #178620 on Avid Bioservices Inc (CDMO)

[patientlywaiting]

Well done CJG.......!

[Frustrated]

I guess the poster session proves in black and white that it is a fact and proves that the revised data is not as good as the data that was original reported by mgmt. The data is out there and has been out there for everybody to see. While the data may be good it is definitely not as earth shattering as the original MOS and supposedly stat significant data. Plain and simple. Price and no partner tell the story. All imo.

[cjgaddy]

SUNRISE #Sites from 73 to 88 a/o 6-19-14 (34/US + 54/Intl) – 3 more in the U.S. and 12 more internationally…

• 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)

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 - 88 sites a/o 6-19-14 (USA/34 Aus/5 Bel/6 Fr/1 Ger/6 Hungary/6 Italy/1 Korea/5 Rom/1 Rus/6 Spain/14 Taiwan/3)
…EU/EEA Registries: (pts world=582, pts/EU=345, planned EU sites=100)
• 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)
...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
Email: [e-mail]
Phone: 855-291-SUNR (7867)

[biopharm]

5-28-14 2pmET: Rolf Brekken, PhD (UTSW/PPHM-SAB), "Reactivating Your Immune System to Fight Cancer"
- - - - - OTHERS IN THE SERIES:
6-5-14: Nina Bhardwaj, MD/PhD, "Harnessing the Immune System to Treat Melanoma"
6-10-14: Sumit K. Subudhi, MD/PhD, "Immunotherapy for Prostate, Bladder, and Kidney Cancers"
6-17-14: George Coukos, MD/PhD, "Developing Effective Immunotherapies for Ovarian Cancer & Other Tumors”
6-24-14: Glenn Dranoff, MD (Dana-Farber/Harvard CC), "Immunotherapy for Lung Cancer”

Thanks CJ! .... besides Dr. Brekken very first webinar ...just happened to notice one of the other webinars from June 17 -- was George Coukos, and he is also part of theanswertocancer patient profile series: "Day#26".

Barbara was treated at the Abramson Cancer Center at University of Pennsylvania by George Coukos, M.D., Ph.D. As part of a clinical trial, Barbara received a two-step immunotherapy regimen. The first step consisted of a vaccine made from her own dendritic cells that were previously exposed to cancer cells from her tumor. These “smart” dendritic cells were then injected back into her lymph nodes where they help to stimulate her immune system to attack cancer cells in her body.

http://www.theanswertocancer.org/online-community-for-cancer-immunotherapy/stories-from-patients-and-caregivers/barbara-lisser-patient-story

Interesting that Day#24 Michael Rose... is the only patient profile that is not associated with a Doctor. All other patient profile stories have a Dr. tagged to that profile story, except Michael Rose.

http://www.theanswertocancer.org/online-community-for-cancer-immunotherapy/stories-from-patients-and-caregivers/michael-rose-patient-story

------------------------------------------------------

Now this is just a long shot... but there are 4 Dr's left, 4 days left in the month... and wonder if there is room for the remaining 4?

Time... or days will tell

[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

[cjgaddy]

SUNRISE #Sites from 100 to 108 a/o 7-9-14 (33/US + 75/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)
• 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)

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 - 108 sites a/o 7-9-14 (USA/33 Aus/6 Bel/7 Fr/7 Ger/9 Hungary/7 Korea/7 Rom/6 Rus/6 Spain/15 Taiwan/5) - Growth: http://tinyurl.com/q4y7kcc
…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
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

[cjgaddy]

SUNRISE #Sites from 108 to 115 a/o 7-23-14 (32/US + 83/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)
• 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)

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 - 115 sites a/o 7-23-14 (USA/32 Aus/6 Bel/7 Fr/9 Ger/9 Greece/5 Hungary/7 Korea/7 Rom/6 Rus/6 Spain/15 Taiwan/6) - Growth: http://tinyurl.com/pfrn7er
…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
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

[cjgaddy]

SUNRISE #Sites from 115 to 118 a/o 7-28-14 (34/US + 84/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)
• 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)

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 - 118 sites a/o 7-28-14 (USA/34 Aus/6 Bel/7 Fr/9 Ger/9 Greece/5 Hungary/7 Korea/7 Rom/6 Rus/6 Spain/15 Taiwan/7) - Growth: http://tinyurl.com/murme2l
…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
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

[cjgaddy]

SUNRISE #Sites from 118 to 121 a/o 7-31-14 (34/US + 87/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)
• 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)

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 - 121 sites a/o 7-31-14 (USA/34 Aus/6 Bel/7 Fr/9 Ger/10 Greece/6 Hungary/7 Korea/7 Rom/6 Rus/6 Spain/15 Taiwan/8) - Growth: http://tinyurl.com/mmk4uog
…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
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

[cjgaddy]

SUNRISE #Sites from 121 to 123 a/o 8-4-14 (34/US + 89/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)
• 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)
• 8-4-14: 123 (USA/34 Aus/6 Bel/7 Fr/9 Ger/11 Greece/6 Hungary/7 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 - 123 sites a/o 8-4-14 (USA/34 Aus/6 Bel/7 Fr/9 Ger/11 Greece/6 Hungary/7 Korea/7 Rom/6 Rus/6 Spain/16 Taiwan/8) - Growth: http://tinyurl.com/mekvene
…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
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

[cjgaddy]

SUNRISE #Sites from 123 to 124 a/o 8-7-14 (34/US + 90/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)
• 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)

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 - 124 sites a/o 8-7-14 (USA/34 Aus/7 Bel/7 Fr/9 Ger/11 Greece/6 Hungary/7 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)
...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) [e-mail]
Peregrine Pharmaceuticals’ Clinical Development Group
• A.J. Leyco, RN - Associate Director, Clinical Trials
• Jennifer Lai, MBA, CCRA - Manager, Clinical Research

[cjgaddy]

SUNRISE #Sites 124=>128 a/o 8-13-14 (34/US + 94/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)
• 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) [e-mail]
Peregrine Pharmaceuticals’ Clinical Development Group
• A.J. Leyco, RN - Associate Director, Clinical Trials
• Jennifer Lai, MBA, CCRA - Manager, Clinical Research

[cjgaddy]

SUNRISE #Sites from 128 to 131 a/o 8-20-14 (35/US + 96/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)
• 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)
• 8-20-14: 131 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9)

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 - 131 sites a/o 8-20-14 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9) - Growth: http://tinyurl.com/qzfo56c
…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) [e-mail]
Peregrine Pharmaceuticals’ Clinical Development Group
• A.J. Leyco, RN - Associate Director, Clinical Trials
• Jennifer Lai, MBA, CCRA - Manager, Clinical Research

[cjgaddy]

Ph.3/NSCLC SUNRISE #Sites 131=>133 a/o 8-26-14 (36US+97Intl)

• 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)
• 8-20-14: 131 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9)
• 8-26-14: 133 (USA/36 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)

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 - 133 sites a/o 8-26-14 (USA/36 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10) - Growth: http://tinyurl.com/ov5ggwe
…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) [e-mail]
Peregrine Pharmaceuticals’ Clinical Development Group
• A.J. Leyco, RN - Associate Director, Clinical Trials
• Jennifer Lai, MBA, CCRA - Manager, Clinical Researc

[cjgaddy]

Ph.3/NSCLC SUNRISE #Sites 133=>135 a/o 9-4-14 (37US+98Intl)

• 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)
• 8-20-14: 131 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9)
• 8-26-14: 133 (USA/36 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-4-14: 135 (USA/37 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)

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 - 135 sites a/o 9-4-14 (USA/37 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10) - Growth: http://tinyurl.com/mx55t49
…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) [e-mail]
Peregrine Pharmaceuticals’ Clinical Development Group
• A.J. Leyco, RN - Associate Director, Clinical Trials
• Jennifer Lai, MBA, CCRA - Manager, Clinical Research

[cjgaddy]

Ph.3/NSCLC SUNRISE #Sites 135=>138 a/o 9-17-14 (37US+101Intl)

• 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)
• 8-20-14: 131 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9)
• 8-26-14: 133 (USA/36 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-4-14: 135 (USA/37 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-17-14: 138 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/2)

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 - 138 sites a/o 9-17-14 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/2) - Growth: http://tinyurl.com/qhgojlv
…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) [e-mail]
Peregrine Pharmaceuticals’ Clinical Development Group
• A.J. Leyco, RN - Associate Director, Clinical Trials
• Jennifer Lai, MBA, CCRA - Manager, Clinical Research

[cjgaddy]

Ph.3/NSCLC SUNRISE #Sites 138=>141 a/o 9-23-14 (37US+104Intl)

• 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)
• 8-20-14: 131 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9)
• 8-26-14: 133 (USA/36 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-4-14: 135 (USA/37 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-17-14: 138 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/2)
• 9-23-14: 141 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/4)

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 - 141 sites a/o 9-23-14 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/4) - Growth: http://tinyurl.com/nwk8a3q
…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)
• BELGIUM: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/BE (planned sites=7 pts=31)
...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) [e-mail]
Peregrine Pharmaceuticals’ Clinical Development Group
• A.J. Leyco, RN - Associate Director, Clinical Trials
• Jennifer Lai, MBA, CCRA - Manager, Clinical Research

[cjgaddy]

Ph.3/NSCLC SUNRISE #Sites 141=>143 a/o 10-1-14 (37US+106Intl)

• 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)
• 8-20-14: 131 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9)
• 8-26-14: 133 (USA/36 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-4-14: 135 (USA/37 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-17-14: 138 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/2)
• 9-23-14: 141 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/4)
• 10-1-14: 143 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/4 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/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 - 143 sites a/o 10-1-14 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/4 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/5) - Growth: http://tinyurl.com/k6njks6
…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)
• BELGIUM: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/BE (planned sites=7 pts=31)
...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) [e-mail]
Peregrine Pharmaceuticals’ Clinical Development Group
• A.J. Leyco, RN - Associate Director, Clinical Trials
• Jennifer Lai, MBA, CCRA - Manager, Clinical Research

[cjgaddy]

Ph.3/NSCLC SUNRISE #Sites 143=>145 a/o 10-17-14 (37US+108Intl)

• 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)
• 8-20-14: 131 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9)
• 8-26-14: 133 (USA/36 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-4-14: 135 (USA/37 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-17-14: 138 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/2)
• 9-23-14: 141 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/4)
• 10-1-14: 143 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/4 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/5)
• 10-17-14: 145 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/5 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)

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 - 145 sites a/o 10-17-14 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/5 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/osghtkk
…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)
• BELGIUM: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/BE (planned sites=7 pts=31)
...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) [e-mail]
Peregrine Pharmaceuticals’ Clinical Development Group
• A.J. Leyco, RN - Associate Director, Clinical Trials
• Jennifer Lai, MBA, CCRA - Manager, Clinical Research

[cjgaddy]

Ph.3/NSCLC SUNRISE #Sites 145=>148 a/o 11-7-14 (37US+111Intl)

• 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)
• 8-20-14: 131 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9)
• 8-26-14: 133 (USA/36 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-4-14: 135 (USA/37 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-17-14: 138 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/2)
• 9-23-14: 141 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/4)
• 10-1-14: 143 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/4 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/5)
• 10-17-14: 145 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/5 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 11-7-14: 148 (USA/37 Aus/8 Bel/7 Fr/9 Ger/13 Greece/8 Hungary/7 Italy/7 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)

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 - 148 sites a/o 11-7-14 (USA/37 Aus/8 Bel/7 Fr/9 Ger/13 Greece/8 Hungary/7 Italy/7 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/kzhyoxa
…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)
• BELGIUM: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/BE (planned sites=7 pts=31)
...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) [e-mail]
Peregrine Pharmaceuticals’ Clinical Development Group
• A.J. Leyco, RN - Associate Director, Clinical Trials
• Jennifer Lai, MBA, CCRA - Manager, Clinical Research

[cjgaddy]

Ph.3/NSCLC SUNRISE #Sites 150=>152 a/o 12-19-14 (38US+114Intl)

• 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)
• 8-20-14: 131 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9)
• 8-26-14: 133 (USA/36 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-4-14: 135 (USA/37 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-17-14: 138 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/2)
• 9-23-14: 141 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/4)
• 10-1-14: 143 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/4 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/5)
• 10-17-14: 145 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/5 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 11-7-14: 148 (USA/37 Aus/8 Bel/7 Fr/9 Ger/13 Greece/8 Hungary/7 Italy/7 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 12-1-14: 150 (USA/37 Aus/8 Bel/7 Fr/9 Ger/14 Greece/8 Hungary/7 Italy/8 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 12-19-14: 152 (USA/38 Aus/8 Bel/7 Fr/9 Ger/14 Greece/9 Hungary/7 Italy/8 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)

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 - 152 sites a/o 12-19-14 (USA/38 Aus/8 Bel/7 Fr/9 Ger/14 Greece/9 Hungary/7 Italy/8 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/kuz6emo
…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)
• BELGIUM: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/BE (planned sites=7 pts=31)
...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) [e-mail]
Peregrine Pharmaceuticals’ Clinical Development Group
• A.J. Leyco, RN - Associate Director, Clinical Trials
• Jennifer Lai, MBA, CCRA - Manager, Clinical Research

[cjgaddy]

Ph.3/NSCLC SUNRISE #Sites 152=>154 a/o 2-17-15 (38US+116Intl)

• 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)
• 8-20-14: 131 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9)
• 8-26-14: 133 (USA/36 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-4-14: 135 (USA/37 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-17-14: 138 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/2)
• 9-23-14: 141 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/4)
• 10-1-14: 143 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/4 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/5)
• 10-17-14: 145 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/5 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 11-7-14: 148 (USA/37 Aus/8 Bel/7 Fr/9 Ger/13 Greece/8 Hungary/7 Italy/7 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 12-1-14: 150 (USA/37 Aus/8 Bel/7 Fr/9 Ger/14 Greece/8 Hungary/7 Italy/8 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 12-19-14: 152 (USA/38 Aus/8 Bel/7 Fr/9 Ger/14 Greece/9 Hungary/7 Italy/8 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 2-17-15: 154 (USA/38 Aus/8 Bel/7 Fr/9 Ger/14 Greece/9 Hungary/7 Italy/10 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)

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 - 154 sites a/o 2-17-15 (USA/38 Aus/8 Bel/7 Fr/9 Ger/14 Greece/9 Hungary/7 Italy/10 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/njdonrl
…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)
• BELGIUM: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/BE (planned sites=7 pts=31)
...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
- - - - - -
5-31-14 ASCO’14: David Gerber/Joe Shan Poster on Ph3/SUNRISE Trial (#TPS8129) http://tinyurl.com/nv4jloo
3-7-14: PR & Conf-Call: "first patients enrolled and dosed." http://tinyurl.com/kh9cnrg
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

[cjgaddy]

Ph.3/NSCLC SUNRISE #Sites 154=>156 a/o 3-23-15 (38US+118Intl)

• 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)
• 8-20-14: 131 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9)
• 8-26-14: 133 (USA/36 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-4-14: 135 (USA/37 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-17-14: 138 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/2)
• 9-23-14: 141 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/4)
• 10-1-14: 143 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/4 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/5)
• 10-17-14: 145 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/5 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 11-7-14: 148 (USA/37 Aus/8 Bel/7 Fr/9 Ger/13 Greece/8 Hungary/7 Italy/7 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 12-1-14: 150 (USA/37 Aus/8 Bel/7 Fr/9 Ger/14 Greece/8 Hungary/7 Italy/8 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 12-19-14: 152 (USA/38 Aus/8 Bel/7 Fr/9 Ger/14 Greece/9 Hungary/7 Italy/8 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 2-17-15: 154 (USA/38 Aus/8 Bel/7 Fr/9 Ger/14 Greece/9 Hungary/7 Italy/10 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 3-23-15: 156 (USA/38 Aus/8 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)

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 - 156 sites a/o 3-23-15 (USA/38 Aus/8 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/qxb8ww9
…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)
• BELGIUM: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/BE (planned sites=7 pts=31)
...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
- - - - - -
5-31-14 ASCO’14: David Gerber/Joe Shan Poster on Ph3/SUNRISE Trial (#TPS8129) http://tinyurl.com/nv4jloo
3-7-14: PR & Conf-Call: "first patients enrolled and dosed." http://tinyurl.com/kh9cnrg
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

[cjgaddy]

Ph.3/NSCLC SUNRISE #Sites 156=>158 a/o 3-31-15 (38US+120Intl)

• 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)
• 8-20-14: 131 (USA/35 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/9)
• 8-26-14: 133 (USA/36 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/2 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-4-14: 135 (USA/37 Aus/7 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10)
• 9-17-14: 138 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/7 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/2)
• 9-23-14: 141 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/3 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/4)
• 10-1-14: 143 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/4 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/5)
• 10-17-14: 145 (USA/37 Aus/8 Bel/7 Fr/9 Ger/12 Greece/8 Hungary/7 Italy/5 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 11-7-14: 148 (USA/37 Aus/8 Bel/7 Fr/9 Ger/13 Greece/8 Hungary/7 Italy/7 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 12-1-14: 150 (USA/37 Aus/8 Bel/7 Fr/9 Ger/14 Greece/8 Hungary/7 Italy/8 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 12-19-14: 152 (USA/38 Aus/8 Bel/7 Fr/9 Ger/14 Greece/9 Hungary/7 Italy/8 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 2-17-15: 154 (USA/38 Aus/8 Bel/7 Fr/9 Ger/14 Greece/9 Hungary/7 Italy/10 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 3-23-15: 156 (USA/38 Aus/8 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/7 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)
• 3-31-15: 158 (USA/38 Aus/8 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/9 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6)

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 - 158 sites a/o 3-31-15 (USA/38 Aus/8 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/9 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/nrpbqhl
…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)
• BELGIUM: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/BE (planned sites=7 pts=31)
...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
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5-31-14 ASCO’14: David Gerber/Joe Shan Poster on Ph3/SUNRISE Trial (#TPS8129) http://tinyurl.com/nv4jloo
3-7-14: PR & Conf-Call: "first patients enrolled and dosed." http://tinyurl.com/kh9cnrg
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