Replies to post #90257 on Avid Bioservices Inc (CDMO)

[freethemice]

Great! 5.4 months for the control MOS, that makes the MOS for the treatment arms even better in comparison.
If less than 35% treatment arm patients had died by the end of April (is that when it was unblinded)
this could go on for a while. It could get to 3X the control arm MOS. The treatment arm patients may
be on a plateau if plotted on a KM survival curve. At some point you could say their cancer is controlled,
or cured. I think the emphasis on CRs is wrong because CRs are defined by the RECIST criteria and are
measured during the treatment cycles. It is possible to have a CR, as defined by those criteria, and then
to later progress and not be a CR. CR does not mean cure. On the other hand it can go the other way too.
We are now in a place where we don't really know what is going on inside those patients still alive, all we
know is that they are still alive.

[freethemice]

The 5.4 months for the control arm also tells us that this patient group was pretty sick. King has said that
over 90% were stage 4 (metastatic disease). If you look back at my table for the second-line NSCLC phase 3 trials,
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=77206110
you can see that 5.4 months is less than all of them. That makes the current situation all the more remarkable.

[pfosse]

Is that "Less than 35% died" in the Bavi Arms a new data point? I don't remember it.

[cjgaddy]

Fri. Sept7 Chicago/Thoracic SCHD, featuring Dr. David Gerber’s late-breaker plenary talk that will update data (esp. MOS) from the ongoing randomized, ctl’d Bavi+Doce 2nd-Line NSCLC n=121 Phase IIB trial ( http://clinicaltrials.gov/ct2/show/NCT01138163 )...

1. Fri. Sept7 7:15amCT/8:15amET: ASTRO/Thoracic is putting on a 4-segment “News Briefing #2” Webcast, one segment of which is, “Adding Bavituximab To 2nd-Line Chemotherapy Doubles Response Rate in Late-Stage Lung Cancer Patients”. ***This BRIEFING #2 is not the same as today’s (Sept6) ASTRO/Thoracic Preview “Press Kit” article, ”Adding Bavituximab to 2nd-Line Chemotherapy Doubles Response Rate in Late-Stage Lung Cancer Patients”, which included Dr. Gerber’s plenary ABSTRACT, which stated that Ctl-Arm MOS is 5.4 mos. – see http://tinyurl.com/bwyxf3r . YOU MUST register in advance for the webcast here: https://www.astro.org/News-and-Media/News-Releases/2012/Ground-breaking-research-to-be-presented-at-lung-cancer-symposium.aspx - scroll down to the Sept7 webcast, and click on the GO-TO link. A REPLAY WITH SLIDES will be available after the news briefings here: https://www.astro.org/News-and-Media/Media-Resources/Press-Kits/Thoracic-2012/2012-Thoracic-Symposium-Press-Kit.aspx in the virtual press kit.

2. Fri. Sept7 Time=???: Peregrine will post a pre-recorded Audio Webcast & Slide-Deck to PPHM’s website ( http://www.peregrineinc.com ) which will be hosted by Joseph Shan (VP/Clin&RegAffairs). See http://tinyurl.com/cvr7fp4 .

3. Fri. Sept7 1:40pmCT/2:40pmET: Dr. David E. Gerber will deliver a late-breaker plenary talk at ASTRO-ASCO/Thoracic titled, “Randomized, Double-Blind, Placebo-Ctl’d Phase 2 Trial of Bavituximab + Docetaxel in Patients with Previously Treated Locally Advanced or Metastatic Non-Squamous NSCLC (Top-line Results)”. More here: http://tinyurl.com/cvr7fp4 - plus his ABSTRACT here: http://tinyurl.com/bwyxf3r .

Dr. David E. Gerber, MD (UTSW-MC/Dallas - Asst.Professor, Medical Oncology)

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NEWS BRIEFING #2: Friday, Sept. 7, at 7:15amCT/8:15amET
Study findings previewed:
• Crizotinib [Pfizer’s Xalkori] reduces tumor size in patients with ALK positive lung cancer
• Brain radiation after lung cancer treatment reduces risk of cancer spreading
• Standard chemo treatment provides higher survival rate than experimental regiment in late-stage lung cancer patients
• Adding bavituximab to 2nd-line chemotherapy doubles response rate in late-stage lung cancer patients
REGISTER: https://www.astro.org/News-and-Media/Media-Resources/Press-Kits/Thoracic-2012/2012-Thoracic-Symposium-Press-Kit.aspx

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9-4-12: An Audio Webcast & Slide-Deck will be posted to PPHM’s website after Dr. Gerber’s Sept7 late-breaker Plenary talk on the ongoing randomized Bavi+Doce 2nd-Line NSCLC Trial at ASCO/Thoracic/Chicago…
From today’s 9-4-12 PR:
“In conjunction with Dr. Gerber's presentation in Chicago, Peregrine will post an audio webcast and slide deck to Peregrine's website. The pre-recorded webcast will be hosted by Joseph Shan, VP of Clinical & Regulatory Affairs. Access to the audio and corresponding slides can be found on Peregrine's website.”
PR: http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=704058
Webcast => http://ir.peregrineinc.com/events.cfm

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CHICAGO SUMMARY: ( http://tinyurl.com/cvr7fp4 )
Chicago Symposium in Thoracic Oncology, Sept6-7 => 3 Bavi presentations & posters on Peregrine’s NSCLC trials (highlighted by Dr. Gerber’s Sept7 Plenary Talk on the ongoing randomized Bavi+Doce 2nd-Line NSCLC Trial), and another interesting general talk by Dr. Gerber on Tumor-Diameters vs. OS in NSCLC.
• Sept7 1:40-1:50pm Dr. David Gerber (UTSW), Late-breaker PLENARY talk on Bavi+Doce 2nd-Line NSCLC Trial
• Sept6 5:00-6:30pm Dr. K.H. Dragnev (PI, Dartmouth-Hitchcock MC), POSTER on Bavi+PC 1st-Line NSCLC Trial
• Sept6 8:00-12:00pm Dr. J.Grilley-Olson (UNC), “PUB. ONLY” on Ist#3, Bavi+Pemcarbo/1st-Line NSCLC Trial
- - - - - - - - -Non-Bavi Specific:
• Sept6 6:10-6:25pm Dr. David Gerber, Poster Discussion on Tumor-Diameters vs. OS in NSCLC

Sept6-8 2012: “2012 Chicago Multidisciplinary Symposium in Thoracic Oncology (ASCO/ASTRO)”
http://www.thoracicsymposium.org
“This meeting will bring together physician specialists from around the world for interdisciplinary discussions on the latest research and state-of-the-art care for thoracic cancers. Speakers will address a variety of strategies to treat lung and esophageal cancer, malignant mesothelioma and metastatic cancers of the chest. In addition, the symposium will highlight the translation of novel clinically significant discoveries into clinical practice. Other educational topics to be discussed include the relation of molecular diagnoses, pathology and the clinical significance of targeted therapies in molecularly defined patient subpopulations for clinical trials and clinical practice.”
Co-sponsors:
• ASCO: American Society of Clinical Oncology - http://www.asco.org
• ASTRO: American Society for Radiation Oncology - https://astro.org
• IASLC: Intl. Association for the Study of Lung Cancer - http://iaslc.org
Symposium Supporters: Genentech, Lilly, Amgen, Astellas, Pfizer
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Per Roth/Pantginis 8-9-12 update (see RRDog’s #86253), “PPHM is a ‘late breaking’ entry for presentation on Sept 7th. The implication in the report is that PPHM will discuss the Bavi 2nd line Phase II trial developments.”
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Pgm. Agenda: http://www.thoracicsymposium.org/MeetingProgram/Agenda.htm
Abstract Search: http://www.abstractsonline.com/Plan/AdvancedSearch.aspx
Late-Breaking Presentations (must be submitted by 7-12-12): http://www.thoracicsymposium.org/Abstracts/Latebreaking.htm
=> “3. Late-breaking abstract research should be limited to important new developments
=> “5. Only those abstracts that are deemed to be of high scientific priority and which merit presentation will be accepted.”
Def. Plenary Session: General assembly for all participants in a conference (during those sessions, typically all other activities are suspended, or exhibit halls closed, to allow everyone to attend the plenary talks or sessions.)
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Sept 7 12:30-2:30 Session: PLENARY SESSION (10 speakers)
Moderators:
• Pasi A. Janne, MD, PhD, Program, Chairman Dana-Farber Cancer Inst., Boston
• Fadlo R. Khuri, MD, Winship Cancer Inst., Atlanta
Late-Breaking Presentation Abstract:
Sept 7, 2012, 1:40-1:50pm #LBPL2 - David E. Gerber
Presentation: “Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients with Previously Treated [2nd-Line] Locally Advanced or Metastatic Non-Squamous NSCLC (Top-line Results)”
Category: Locally Advanced NSCLC
Authors: David E. Gerber 1, M. Joppert 2, D. R. Spigel 3, D. P. Singh 4, D. Giorgadze 5, M. Shtivelband 6, O. V. Ponomarova 7, J. Shan 8, C. P. Belani 9
1 Harold C. Simmons Cancer Center, UTSW-MC/Dallas
2 Florida Cancer Specialists, Ft. Meyers, FL
3 Sarah Cannon Research Inst./Tennessee Oncology, PLLC, Nashville, TN
4 Dept of Radiotherapy & Clinical Oncology, S.M.S. Medical College & Hospitals, Jaipur, India
5 Chemotherapy & Immunotherapy Clinic, Tbilisi, Georgia
6 Ironwood Cancer & Research Centers, Chandler, AZ
7 RE Kavetsky Institute of Experimental Pathology, Oncology & Radiobiology, Kiev, Ukraine
8 Peregrine Pharmaceuticals, Tustin, CA
9 Penn St. Hershey Cancer Inst., Hershey, PA
Disclosures:
David .E. Gerber: Research Grant; Peregrine Pharmaceuticals, Inc.
Joe Shan: Stock; Peregrine Pharmaceuticals, Leadership; Peregrine Pharmaceuticals

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HINTS OF WHAT's COMING SEPT 7th in Chicago (from S.King, 8-15-12 Wedbush/NYC http://tinyurl.com/8mhrtld )

"With this (2nd-Line NSCLC) data in hand, we now have a number of events to look forward to… We have 2 Late-Breaking presentations coming up… Our goal in the Sept. 7th Chicago data presentation ( http://tinyurl.com/9vt2vbo ) is to be able to talk a little bit more about the (2nd-Line NSCLC) MOS and where we're at evaluating that in both Bavi arms. Even though we haven't reached MOS, and certainly may not have reached it by then, we still will be able to talk a little bit more about where we're at in that process. we'll also be able to talk more about how the statistics in the trial are trending, and how we put those kinds of events together into our thinking about a Phase III trial design. Our goal is to get the data out there, but we're already beginning our EOP2 meeting preparations. We're working actively on a Ph.3 trial design; our goal is to have the EOP2 meeting before the end of the year, which will put us on track for initiating a Ph.3 trial by the middle of 2013. . ."we have a number of key value-drivers coming up. The 2nd-Line NSCLC study is obviously continuing to be the focus, as we have what we believe to be a clear pathway to move that program forward. MOS data, again this is a time-to event and we haven't reached it yet, but at some point in all likelihood we will. We have the upcoming oral presentation at the ASCO Chicago Symposium (9-7-12), as well as at ESMO (9-29-12/Vienna), which gives us a great opportunity to talk about the clinical data and to describe to people why we're so excited about the potential of this trial, and why, not just ourselves, but key opinion leaders that are active in the pgm, as well as potential partners, believe this is a clear path into Phase III and to move the pgm forward... The data cut at the end of April already showed that we had clearly reached MOS in the ctl-arm. As we sit here now today, several months later, we still haven't reached that min. # of events for either of the Bavi arms to be there (MOS). It's not quite as simple as a 1-to-1, ie, 1 month doesn't mean it's 1 month addl. in OS, but what we can say is, it [2nd-Line NSCLC MOS] is going to be a very positive result, it's just a matter now of magnitude. Importantly, because we often get this question, potential partners do not need to reach MOS to make a decision on partnering. We do not need to reach MOS in the Bavi arms at this point to plan what the pivotal trial will potentially look like. At this point, we have data, and I think we'll be able to make it clearer when we present the full package on Sept. 7th in Chicago. Basically, the longer, the better, obviously - it's not just great for the program, it's great for the patients, because, again, we do have patients that are out and still even on treatments as we speak."