Biotech Values

[cjgaddy]

PCrutch (or do you prefer PSlice84 or MEGarza – sorry, I’m confused), re: your #146814 of 8-9-12…

By PCRUTCH iHub-BVAL #146814 8-9-12
“Well I am expecting triple failure of all their [Peregrine’s Bavituximab] trials this fall (NSCLC 1st & 2nd line, Pancreatic). I WILL BE SMILING THEN.”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=78376986

I’m having trouble figuring out your problem…

Here we have Peregrine Pharm. running a robustly-designed n=120 Ph2B clinical trial [ http://clinicaltrials.gov/ct2/show/NCT01138163 ] in 2nd-Line NSCLC (a very high unmet medical need), which, per PPHM VP/ClinAffairs Joe Shan (7-16-12/CC http://tinyurl.com/cs7spbz ):
“included all the known design features for minimizing bias in a trial - treatment was randomly assigned; procedure & examination schedules were identical for patients in all 3 arms; the trial was blinded to all parties involved, whether they were patients who participated, investigators who administered treatment and follow-up, central radiology reviewers who evaluated scans, or a company like ours who oversaw the entire trial – a "gold-std. design" typically reserved for Phase III development.”

…whose trial design was overseen by ROBERT GARNICK Peregrine Head/Regulatory since Oct’09, a 24-yr ex-Genentech veteran, who while Senior VP of Regulatory, Quality & Compliance at Genentech oversaw, from a regulatory standpoint, the development of most of the major antibodies that are on the market today [17 approvals, incl. Rituxan, Herceptin, Avastin, Lucentis – see 10-19-09 PPHM PR http://tinyurl.com/yga7z4x ].

And this ongoing 2nd-Line NSCLC trial, whose “All-comers except Squamous” n=121 enrollment was completed 10-6-11, after being unblinded in May’12, is trending towards MOS in BOTH BAVITUXIMAB+DOCE ARMS (1mg & 3mg) at 12 MOS. OR MORE, vs. the Doce Ctl-Arm, whose MOS was reached ~Feb12 at “less than 6 mos.”.

…A gold-std. trial in which Peregrine’s Bavituximab is going to AT LEAST DOUBLE **MOS** in 2nd-Line NSCLC = > **MOS** being ULTIMATE ENDPOINT that matters in NSCLC.

…An n=120 patient pop. of 90% STAGE IV’s - per CEO Steve King 7-12-12 (JMP/NYC Q&A http://tinyurl.com/csdclwb ) “The majority were Stage IV; I believe a little OVER 90% of the patients in each of the arms were STAGE IV.”

…a drug, Bavituximab, whose SAFETY & SIDE FEECTS are far superior to those of Avastin & Tarceva etal.
=> CEO Steve King, 8-15-12/Wedbush ( http://tinyurl.com/8mhrtld ) “One more point on slide13, this [ongoing 2nd-Line NSCLC trial] is also a great opportunity to really take a look at the safety profile of the drug, in which the safety events are being looked at without knowing what the patients are receiving. Importantly, the IDMC found no differences between either of the Bavi arms and the placebo arm, so WE’RE NOT ADDING TO THE TOXICITY SEEN WITH THE CHEMO ITSELF.”
==> Do a Google on “Side Effects Avastin” or “Side Effects Tarceva” if you want to compare Bavi to some not-so-nice side effects.

Bottom line:
Bavituximab is going to DOUBLE MOS IN A GOLD-STD., N=120 2ND-Line NSCLC Trial who Pts are 90+% STAGE4 patients, and do it with no addl. safety issue or side effects beyond Chemo-Only.

BUT, instead of cheering for this anti-cancer advancement, and feeling bad for the 40 pts that randomized into the Doce-Only arm who on avg. are going to less half as long, you, PSLICE84, are worried about HAZARD RATIOS and KRAS-POSITIVE and God-only-knows what else you’re yapping about on SeekingApha and on B-Values.

These two posts by you on BV’s clearly bare your true feelings & motives for all to see:

By PCRUTCH iHub-BVAL #146814 8-9-12
“Well I am expecting triple failure of all their trials this fall (NSCLC 1st & 2nd line, Pancreatic). I WILL BE SMILING THEN.”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=78376986

By PCRUTCH iHub-BVAL #146826 8-9-12 5:53PM (post removed)
“…I THINK IT'S CRIMINAL PPHM IS STILL GIVING THEIR DRUG TO PATIENTS.”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=783835 25 (post removed – so embarrassed you asked IH-Admin to remove it, PSlice?)

Well, PCrutch, you’re not going to get that big SMILE ON YOUR FACE you were so confident about on Aug. 9, 2012…

This ongoing Bavi 2nd-Line NSCLC Trial is NOT GOING TO FAIL – quite the total opposite. And the same for the ongoing randomized FRONT-LINE NSCLC n=86 Ph2.B Trial (http://clinicaltrials.gov/ct2/show/NCT01160601 ) and the ongoing randomized FRONT-LINE PANCREATIC n=70 Ph2.B Trial ( http://www.clinicaltrials.gov/ct2/show/NCT01272791 ).

BOTTOM LINE, PCrutch: It is NOT CRIMINAL that Peregrine is running these trials (ask the patients that are living twice as long with no addl. side effects), and you’re not going to get that BIG SMILES on your face when the final results of these trials are announced. ( I’d lay low on Sept 7th if I were you: 9-7-12, Chicago Symposium in Thoracic Oncology ASCO/ASTRO, 1:40-1:50pm Dr. David Gerber (UTSW), Late-breaker PLENARY talk on the Bavi+Doce 2nd-Line NSCLC Trial http://tinyurl.com/9vt2vbo => MOS to be updated.)

One final thing, PCrutch => What chgd. in your thinking about Peregrine since you posted this little ‘article’ on BiomedReports.com back in Jan. 2011?
1-11-11: “PEREGRINE SEEMS POISED FOR GROWTH IN 2011”
by Patrick Crutcher
http://biomedreports.com/2011011162299/peregrine-poised-for-growth-in-2011.html
Back then you said you were LONG on PPHM, and you wrote,
“Bavituximab is an extremely interesting molecule which has created a lot of buzz over the past 2 years; not just in oncology but also as a potent anti-viral. . . PPHM entered into an ATM with MLV to the tune of $75 million. WE VIEW THIS DEAL POSITIVELY, since it allows them to raise capital as share price increases and it is not selling them at a discount to a fund. THEY HAVE ONE OF THE BEST UNPARTNERED PIPELINES AMONGST SMALL-CAP BIOTECHS AND WE ARE EXCITED ABOUT THE POTENTIAL OVER AT PEREGRINE.”

But now, as Bavi is about to DOUBLE MOS in adv. Lung Cancer in a gold-std. trial, Peregrine’s trials are all “CRIMINAL” to you and you’re “expecting” Peregrine’s NSCLC & Pancreatic trials to fail so you can put a “BIG SMILE” on your face.

You are a piece of work, PCrutch/PSlice84/MeGarza - you, The Big Man that’s hoping for A Big Smile.

= = = = = = = = = = =NSCLC:
6-2011 WJCO article summarizes The War on NSCLC (1st- & 2nd-Line) - lots of trial summaries:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=73403906