Biotech Values

[cjgaddy]

DewD, re: PPHM - nothing to do with potentially combining Bavituximab with Ampyra for MS.

The main reason for PPHM’s move from .47 (mktcap=$48mm) on 6-22-12 to 2.75 on 8-12-12(mktcap=$288mm) is the revelation of exceptional MOS data accruing in the ongoing randomized, placebo-ctl'd Ph.II Bavi+Doce 2nd-Line NSCLC trial – Bavituximab (both high & low dose arms) is about to double the Docetaxel ctl-arm in this trial…
An UPDATE is coming on Sept7 in a Plenary Talk by Dr. David Gerber (UTSW) at The Chicago Symposium in Thoracic Oncology (see below)…

SUMMARY:
Bavi+Doce 2nd-Line Adv. NSCLC (high unmet need) Phase II (n=120, robust, gold-std, Robert Garnick, “mini Ph.III” http://clinicaltrials.gov/ct2/show/NCT01138163 ) UPDATE Coming 9-7-12 – see below…

Remember:
• Doce-CTL Arm MOS “< 6 mos” as of April’12. (announced 5-21-12 http://tinyurl.com/73aeyxj )

• Both Bavi Arms (1mg & 3mg) have not yet reached MOS => since enroll. comp. 10-6-11, that means will be min. 12mos, and maybe 13-14mos. (7-12-12/JMP & 7-16-12/CC)
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CEO Steve King 7-12-12/JMP: “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.” http://tinyurl.com/csdclwb
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VP/Regulatory Rob Garnick* 7-16-12/CC: "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." http://tinyurl.com/cs7spbz

UPDATE coming Sept7:
Sept7: Chicago Symposium in Thoracic Oncology http://tinyurl.com/9vt2vbo
… 1:40-1:50pm Dr. David Gerber (UTSW), Late-breaker PLENARY talk on Bavi+Doce 2nd-Line NSCLC Trial

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10-19-09: Dr. Robert Garnick (former DNA Exec) appointed Peregrine's Head/Reg.Affairs http://tinyurl.com/yga7z4x
...examples of Dr. Garnick's work at Genentech on Avastin (bevacizumab) approvals: http://tinyurl.com/yg7vtqa
...All of Dr. Garnick's comments (thru 6/2011) re: his new assoc. with PPHM: http://tinyurl.com/3lgoras
During his 24-year career at Genentech, he was responsible for 17 new product approvals including most of the company's top selling monoclonal antibody therapeutics such as Rituxan(R), Herceptin(R), Avastin(R) and Lucentis(R). Dr. Garnick will be responsible for overseeing Peregrine's interactions with the U.S. FDA and regulatory agencies around the world, and will lead the development of the company's regulatory strategies for advancing its novel monoclonal antibody-based treatments for cancer and infectious diseases.

Phase IIb Bavi+Doce vs. 2nd-Line NSCLC (randomized, double-blinded, placebo-controlled, n=120, 'registrational')
http://clinicaltrials.gov/ct2/show/NCT01138163
“this is very robust trial design, really meant to be part of a registration package. We worked with the FDA on this, and it has a lot the same bells & whistles you would find normally in Phase III clinical dev., in a slightly smaller study, of course. So, a very robust design: double-blinded, placebo-ctl’d, IDMC (Indep. Data Monitoring Committee), central radiology review - really meant to be a robust proof-of-principle study…” (CEO S.King, 7-12-12/JMP http://tinyurl.com/csdclwb )

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4 Links to good Bavi MOA articles added to iBox – good refreshers, as we advance towards proof in man…

BAVI MOA: 4-2010 Thrombosis Research article (Dr.Thorpe) http://tinyurl.com/9reso7s

BAVI MOA**: 5-1-12 Dr.Thorpe's 46min talk at NYAS Anti-PS Symposium http://tinyurl.com/d6vtsrr

BAVI MOA: 5-26-11 Dr.Thorpe's keynoter at Recombinant-Mabs/Barcelona http://tinyurl.com/3klpodc & Slides: http://tinyurl.com/3m33h33

BAVI MOA: See http://www.peregrineinc.com/technology/bavituximab-oncology/recent-data.html

- - - - - -**MUST HEAR:
**5-1-12 Audio replays of the NYAS Anti-PS Symposium (NYC) now at NYAS.org: http://tinyurl.com/7w3kpuc
…The 5 Speakers were: Alan Schroit, David Ucker, Ari Helenius, Chris Reutelingsperger, Philip Thorpe
=> Dr. Phil Thorpe's 46min talk: http://tinyurl.com/d6vtsrr

iBox/PPHM: http://investorshub.advfn.com/boards/show_ibox.aspx?boardid=2076