Replies to post #146967 on Biotech Values

[dia76ca]

There are going to be a number of of opportunities for updates on PPHM's progress on the second line NSCLC phase II study. Here are some of them.

Aug, 15: Wedbush Life Sciences Conference
Sep, 5: Stifel Nicolaus Healthcare Conference 2012
Sep, 7: 2012 Chicago Multidisciplinary Symposium in Thoracic Oncology
Sep, 21: Credit Suisse 3rd Annual Small & Mid Cap Conference

I look forward to more data being released as it becomes available. The Chicago Thoracic Oncology Conference should be of particular interest. The two Bavi plus Doce arms MOS is what I most look forward to. It may not even be reached by these dates but that alone is noteworthy.

I expect Dr. Thorpe to be making many presentations in the near future and amending both his slides and presentations as more is learned about targeting PS and PE.

[dia76ca]

To help you do your due diligence here is information that cjgaddy has organized in the PPHM IBOX.

BAVITUXIMAB CANCER TRIALS SUMMARY AS OF 8-2012 (FROM IBOX):
http://investorshub.advfn.com/boards/show_ibox.aspx?boardid=2076

BAVITUXIMAB SOLID CANCERS PHASE1+2 TRIALS: (see http://PeregrineTrials.com)
==> PR=Partial-Resp(30-99% Red.), SD=Stable-Disease(29% Red.-19% Incr.), OR=Obj-Resp(PR+CR)
7-16-12: Peregrine's Ambitious Goal for Bavi: Accelerated Approval after Phase II: http://tinyurl.com/c39428b
6-2012: FTM's charts of MOS Data from CtlArms(chemo) of Comp.Trials for 1NSCLC 2NSCLC PANCRE trials http://tinyurl.com/757plm7
6-2011 WJCO article summarizes The War on NSCLC (1st- & 2nd-Line) - lots of trial summaries: http://tinyurl.com/7jdtpto
7-2-11: Early comp. of Bavi/n=49/Ph2 vs. Avastin/n=434/E4599 in Frontline NSCLC: http://tinyurl.com/6k5uuf7
11-25-11: Comp. of Bavi+Chemo vs. Avastin & Chemo-Only in 3 completed Ph.2 single-arm trials (ABC/2 & NSCLC): http://tinyurl.com/79b3jcj
6-15-12: Table of All 16 BAVI Cancer & Viral Trials (~606 treated, ~687 targeted): http://tinyurl.com/6spf8fd
Info on Peregrine's IST Pgm. (Investigator-Sponsored Trials), init. 6-2010: http://tinyurl.com/67q5hvx (Jill Capps 714-508-6027 [e-mail])

N. 5th IST Trial (Bavi+Capecitabine+RAD) vs. Rectal Cancer (Ph1, open-label, 1arm, n=18)
Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01634685
...Note: Capecitabine (prodrug of 5-FU) = Roche/Genentech's Xeloda - see http://www.xeloda.com
...7-16-12: IST (Rectal) initiated at UTSW (PI=Jeffrey Meyer), ~18 patients - http://tinyurl.com/cr29l6k

M. Tumor Imaging & Dosimetry trial of I124-PGN650 (FH-Bavi) in Adv. Solid Tumors (Ph0, open-label, 1arm, n=12)
Protocol: http://clinicaltrials.gov/ct2/show/NCT01632696 (1 U.S. site as of 6-28-12)
..."I124-PGN650 is the Fab end of PS-targeting mab PGN635 (FH-Bavi) joined to the PET imaging radioisotope iodine-124, a new approach to imaging cancer."
...6-28-12: Trial added to Trials.gov, 1st site "recruiting" (Wash.UnivSM/St.Louis)
…4-3-12: Peregrine Launches PS-Targeting Clinical Imaging Pgm (AACR'12 #2452) http://tinyurl.com/7p7jovt & http://tinyurl.com/7yrwqm7

L. 4th IST Trial (Bavi+Cabazitaxel vs. 2nd-Line PROSTATE(CRPC) Cancer, open-label Ph.1B/IIA)
Protocol: http://clinicaltrials.gov/show/NCT01335204 (CRPC=Castration-Resistant Prostate Cancer)
...Note: Cabazitaxel = Sanofi-Aventis' Jevtana - see http://www.jevtana.com
...5-25-11: IST (Prostate) initiated at UCI (PI=M.Lilly), ~31 patients - http://tinyurl.com/3mtvdvl

K. 3rd IST Trial (Bavi+PemCarbo vs. Frontline NSCLC, open-label Ph.1B)
Protocol: http://clinicaltrials.gov/ct2/show/NCT01323062
...4-2012: Clinicaltrials.gov shows 2nd site added: Univ. of Pittsburg (Pi=Liza Villaruz, MD)
...4-2-12 AACR'12: "5pts. to-date, 3 have PR's" http://tinyurl.com/7yrwqm7 (see #1744)
...3-8-11: IST (NSCLC) initiated at UNC (PI= J.Grilley-Olson), ~25 patients - http://tinyurl.com/6b926ku

J. 2nd IST Trial (Bavi+Paclitaxel vs. Her2- Met. Breast Cancer, open-label Ph.1)
Protocol: http://clinicaltrials.gov/ct2/show/NCT01288261
...4-3-12 AACR'12: "5pts. to-date, 2 CR's, 1 PR" http://tinyurl.com/7yrwqm7 (see #4404)
...1-19-11: IST (Her2- MBC) initiated at Arizona CC (PI=A.Stopeck), ~14 patients - http://tinyurl.com/5t7zomn

I. Phase II Bavi+GEM vs. Front-Line Adv. PANCREATIC (randomized, unblinded)
Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01272791 (15 U.S. + 4 Ukraine = 19 as of 6-7-2012)
...6-27-12: FTM's post showing 13 Pancreatic Trials results ('00-'11) http://tinyurl.com/bs4gprf (MOS for GEM-alone: 5.4-7.1 mos.)
……"The trial to beat is the last one using FOLFIRINOX. If Bavi+Gem can equal this trial from 2011, without the high toxicity, then it will be a candidate for the new SOC."
...6-25-12: Enrollment complete. http://tinyurl.com/72tvnfj
...6-20-12: Early data (cutoff=6/6/12 bavi=15 ctl=17) presented at AACR Pancreatic Conf. http://tinyurl.com/77m9fw2
......"Top-line results expected towards the end of 2012"
...1-5-11: U.S. Ph.2 randomized trial initiated http://tinyurl.com/26hnuzv "up to 70 front-line patients at ~10 clinical sites."

H. 1st Investigator-Sponsored (IST) Ph.I/II Trial (Bavi+Sorafenib vs. Liver Cancer/HCC, open-label)
...Note: Sorafenib = Bayer's Nexavar - see http://www.nexavar.com
Protocol: http://clinicaltrials.gov/ct2/show/NCT01264705 UTSW: http://tinyurl.com/2che4us (4 sites: 3/UTSW, 1/Parkland-Hosp.)
...4-4-12 AACR'12: Dr. Adam Yopp, "promising safety profile to-date" http://tinyurl.com/7yrwqm7 (see #5591)
...Feb/Mar'12: CEO Steve King hints of future ex-US partner-driven Bavi+Sorafenib/LIVER trial in Asia: http://tinyurl.com/77dovbl
......Articles & Data describe Liver Cancer challenges in Asian populations: http://tinyurl.com/7z7o8j9 & http://tinyurl.com/7z99cy4
...12-1-10: PPHM's 1st IST (Liver Cancer) initiated at UTSW, ~56 patients - http://tinyurl.com/3xd3e6c
…Per S.King, 5-18-10/R&R, "We've had a lot of interest in running clinical trials with the compound from investigators who have either had prior experience with the drug or would like to study the drug in various settings. Potential IST indications include all the major solid tumor types. Of particular interest is Liver Cancer, in which we have a natural tie-in with our HCV program, Ovarian Cancer and Pancreatic Cancer, also very nicely supported by the prior data."

G. Phase IIb Bavi+PC vs. Front-Line NSCLC (randomized, unblinded, 'confirmatory', n=86)
Protocol: http://clinicaltrials.gov/ct2/show/NCT01160601 (17 U.S. + 9 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 40 as of 8-12-11)
...Also listed in: India's CTRI registry ctri.in#2190 and WHO's registry who.int#1402
...3-9-12: Topline ORR & PFS Data (Bavi+PC vs.PC-only) http://tinyurl.com/7m9r6ya
…...LOCAL reads: ORR/32%-31% PFS/5.8-4.6mos , CENTRAL reads: ORR/25%-23% PFS/6.7-6.4mos
...12-6-11 Prelim. Data (n=86, 100% Stage IV's) => ORR=39%, PC/alone=25%: http://tinyurl.com/7ph4tty
......Comp. vs. Avastin+PC/Ph3/n=417(74% Stage IV's): ORR=35% (Sandler/E4599/2006 http://www.nejm.org/doi/pdf/10.1056/NEJMoa061884 )
...9-8-11: Enrollment complete. http://tinyurl.com/3vv9zfx
...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to 30+ sites, expect enroll. comp. "in coming weeks", interim data by Yr-end'11. http://tinyurl.com/6k6y2as
…7-14-10/CC, J.Shan (VP/Clin+RegAffairs): "This trial is intended to confirm in a randomized setting the results from our Ph.2 signal-seeking NSCLC trial which showed 43% ORR, more than double the generally accepted chemo ORR of under 20% in numerous publications. Favorable results could then lead to an end of Ph.2 meeting with the FDA, with possibly a pivotal Ph/3 trial for front-line lung cancer, our 2nd potential regulatory pathway for bavituximab."
...7-14-10: U.S. Ph.2b randomized trial initiated http://tinyurl.com/27kxksl
……up to 86 front-line patients at ~20 clinical sites; goal: enrollment comp. by mid'11.

F. Phase IIb Bavi+Doce vs. 2nd-Line NSCLC (randomized, double-blinded, placebo-controlled, n=120, 'registrational')
Protocol: http://clinicaltrials.gov/ct2/show/NCT01138163 (24 U.S. + 15 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 53 as of 8-12-11)
...Also listed in: India's CTRI registry ctri.in#2191 (12 sites a/o 3-20-11)
6-2011 WJCO article lists 2ndLine NSCLC hist. results (Doce/Tarceva/Pemetrexed) http://tinyurl.com/7jdtpto
. . . . .see pg.266, 2ndLine comparator results: ORR=6.7-9.1%, PFS=2.2-6.0mo, MOS=5.7-8.3mo
…7-16-12 QTLY. CONF. CALL - COMMENTS ON 2ND-LINE NSCLC PROGRAM... ( http://tinyurl.com/cs7spbz )
……Steve King 7-16-12: "The strength of this data (esp. MOS trends) in this large area of high unmet medical need has also sparked a surge in partnering discussions that has included over 15 in-person partnering meetings since that time with major players in oncology, with all discussions ongoing and addl. parties showing interest. Our goal for the program is to position ourselves, along with a potential partner, to initiate Ph3 by mid-2013, which means an EOP2 meeting by yr-end'12. It would be ideal to have a partner on board to participate in the EOP2 meeting, and we have communicated this to interested parties and they agree."
……Rob Garnick 7-16-12: "We've been working very hard and very actively on the next steps in our Bavi 2nd-Line NSCLC pgm, given the favorable data that we've seen. As you can imagine, with data like this, there are many things that we need to consider. One consideration is that, should the data continue to trend the way it is, particularly in survival, this opens a door for potential discussions around a pathway for Accelerated Approval. At this point, all options are being considered, with Peregrine working towards the most efficient path forward from a regulatory standpoint." Q&A: "…all in all, I think the data is extremely compelling and I think it makes a really good case. Certainly, I think, I've seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I've ever seen. So, I'm very comfortable proposing a meeting with the FDA for Q4'12."
…7-12-12 CEO Steve King, JMP-Conf/NYC ( http://tinyurl.com/csdclwb )
……Steve King 7-12-12: "Re: 2nd-Line/NSCLC trial, the most thrilling thing is the fact that, even though we'd reached MOS for the ctl-arm(Doce) at end of Apr'12 of LESS THAN 6MOS, the majority of patients are still alive (today) in both Bavi arms, and we expect that to continue for some period of time still. Ph3 planning is underway already; our goal is to start this Ph3 by mid'13, meaning an EOP2 meeting with the FDA in Q4'12; our goal is to bring a partner on board, ideally in time for that EOP2 meeting, certainly before the beg. of the Ph3 trial."
…5-21-12: TopLine data n=117 for Bavi/3mg+Doce arm: ORR=17.9%/PFS=4.5mos (vs. CTL 7.9%/3mos) http://tinyurl.com/73aeyxj
......Importantly, MOS for CTL-arm "< 6 mos", but not yet reached in both Bavi arms.
...10-6-11: Enrollment complete. http://tinyurl.com/3m9re39
...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to ~45 sites, expect enroll. comp. "early in Q4/2011", data unblinding 1H'12. http://tinyurl.com/6k6y2as
…3-17-10/Roth, CEO S.King: "We refer to this trial as a Registrational Phase II Study, because we believe that if we have results anywhere near approaching what we saw in the earlier [India] study, it could be a conduit for Accelerated Approval."
...6-4-10: Ph.2b randomized reg. trial Open for enrollment: http://tinyurl.com/25v22qk
……"up to 120 refractory patients at ~30 clinical sites; goal: fully-enroll by mid'11, topline data by y/e'11."

COMPLETED BAVI CANCER TRIALS:
These 5 completed Ph.1 & Ph.2 Bavituximab Cancer Trials archived to: http://tinyurl.com/72dnkfg
1. Ph.1A Bavi/Mono vs. Solid Cancers (USA n=26, 6/2005-6/2009)
2. Ph.1B Bavi+Chemo vs. Solid Cancers (India n=12, 11/2006-5/2007)
3. Ph.2 Bavi+Doce/BREAST/Refractory (RepGA n=46, 1/2008-5/2009): ORR=61%(Her2+=86%), PFS=7.4mos, MOS=20.7mos *
4. Ph.2 Bavi+PC/BREAST/Frontline (India n=46, 8/2008-9/2009): ORR=74%(Her2+=100%), PFS=6.9mos, MOS=23.2mos %
5. Ph.2 Bavi+PC/NSCLC/Frontline (India n=49, 6/2008-10/2009): ORR=43%, PFS=6.1mos, MOS=12.4mos #
......* BAVI+DOCE/Refract-MBC N=46: Compare *MOS=20.7mos to 11.4mos for Doce/alone (Nabholtz/JCO1999 Ph3/n=203 http://tinyurl.com/3rxqqtk )
......% BAVI+PC/FrontLine-MBC N=46: Compare %MOS=23.2mos to 16.0mos for P+C/alone (Loesch/JCO2002 Ph2/n=95 http://tinyurl.com/6wazs9p )
......# BAVI+PC/Frontline-NSCLC N=49: Compare #MOS=12.4mos to P+C/alone=10.3, Avastin+PC=12.3 (E4599/n=434), achieved using less Chemo (175-v-200 & AUC5-v-AUC6), treating 16% (8/49) more-difficult Squamous in Bavi trial (excluded totally from E4599), and treating higher % of sicker ECOG1 patients than in E4599 (96%-v-60%). See 6-15-11/PR http://tinyurl.com/3fcz5ok , ASCO'10 http://tinyurl.com/2g5cqof , and a discussion of differentiating factors between patient demographics and baselines treated in the 2 trials: http://tinyurl.com/6k5uuf7 .

= = = = = = = = =
MORE ARTICLES & PAPERS ON BAVITUXIMAB’S MOB:
See: http://www.peregrineinc.com/technology/bavituximab-oncology/recent-data.html

AND:
5-1-12 NYAS Anti-PS Symposium (Schroit Ucker Helenius Reutelingsperger Thorpe): http://tinyurl.com/7w3kpuc
…*MUST HEAR* Dr. Philip Thorpe 46min. Talk on Bavituximab's MOA => http://tinyurl.com/d6vtsrr
…"Targeting Tumor Vasculature and Reactivating Tumor Immunity with Bavituximab"

ALSO:
5-26-11: Dr. Philip Thorpe Keynotes Bavi/PS MOA at Recombinant-Antibodies Conf. in Barcelona http://tinyurl.com/3klpodc
…Dr. Thorpe, "What is especially exciting is that administration of PS-targeting antibodies like bavituximab breaks the grip of the tumor on the immune system."
...A few of the more illustrative slides from Dr. Thorpe's 5-26-11 talk: http://tinyurl.com/3m33h33

[biomaven0]

disconcerting that several of the slides have been taken away from the presentation as apparently requested by the speaker

I'm guessing he didn't want to jeopardize a potential publication in one of the journals that care about previous presentation of materials.

Peter