Peregrine Pharmaceuticals Inc. Research Report
On June 3, 2013, Peregrine Pharmaceuticals Inc. (Peregrine Pharmaceuticals) reported final data from its randomized, double-blind, placebo-controlled Phase II trial of bavituximab in patients with second-line non-small cell lung cancer (NSCLC). An improvement in median overall survival (OS) of 11.7 months in the 3 mg/kg bavituximab plus docetaxel arm compared to 7.3 months in the combined control arm, with a persistent separation in the Kaplan Meier survival curves (HR=0.662) were seen in the final results from the Phase II trial. "Immunotherapies have shown significant promise in treating solid tumors and it is encouraging to see these latest results from bavituximab in second-line NSCLC. Bavituximab is a unique targeted immunotherapy with a novel mechanism of action that potentially synergizes well with other compounds currently being developed for oncology. I look forward to being involved in the upcoming Phase III trial and to seeing the potential of bavituximab in other indications and combinations," said Martin J. Edelman, M.D., Professor of Medicine at the University of Maryland Greenebaum Cancer Center. The Full Research Report on Peregrine Pharmaceuticals Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: 
IRVINGTON, N.Y., June 17, 2013 (GLOBE NEWSWIRE) -- MELA Sciences, Inc. (MELA), the medical device company that has developed MelaFind(R), today announced that Joseph V. Gulfo has resigned as Chairman, President, Chief Executive Officer, and member of the Board of Directors effective June 15, 2013. Robert C. Coradini, a member of the Board of Directors since December 2011, will serve as interim CEO while the board conducts a search for a new CEO. Mr. Coradini has over 20 years experience in the health care industry leading and managing businesses for Johnson & Johnson and GE Medical Systems (currently known as GE Healthcare).
While at Johnson & Johnson, Mr. Coradini held numerous senior leadership positions -- he has been President of various subsidiaries of J&J, including Lifescan, Cordis Endovascular and Cardiovations (Ethicon) and was the head of business development of the Medical Devices & Diagnostics Group. He was most recently President of New Ventures of the Johnson & Johnson Consumer Group of Companies where he was responsible for the OrthoNeutrogena division (currently known as Ortho Dermatologics), a leader in dermatology, which was acquired by Valeant International.
"We are thankful for Joseph's leadership over the past nine years as the company has undergone a successful transformation from product development, to FDA Approval, to early commercial launch of MelaFind(R) in the US and Germany," said Mr. Coradini. "The Board and I believe in the technology as a major advance for dermatologists in their fight against Melanoma. It is our intent to work closely with these physicians to succeed. We wish Joseph the best in the next phase of his career."
Upon this change, David K. Stone, who has served as Lead Independent Director, will assume the role of Chairman of the board and will lead the search for Mr. Gulfo's replacement.
ANY TIME SOON?
..."WAY Overpriced... .PPHM IS YEARS Away from making money... SERIOUS MONEY... They need infusions of Outside capital in excess of $50,000,000 to $100,000,000 to make a true difference in their PPS."
IT'S NEVER GONNA HAPPEN!
"WOULD YOU BUY THE GARBAGE THAT SOMEONE ELSE MADE"?....
(I REST MY CASE.... )
...."ARE YOU NUTS?.... OH SURE! ... 'SIERRA'!!! .... - I'D BELIEVE THEM! ... WHATEVER THEY 'SAY' IS
GOSPEL! ..... NOT!...."
SIERRA HAS ALL THE CREDIBILITY OF A DOCK STRIKE.
IF SIERRA WAS OR IS 'EVER' RIGHT... IT WOULD BE A MIRACLE.
AND IF YOU GO LONG ON THEIR BS... THEN YOU'RE A BIGGER IDIOT THEN THEY ARE!....
both here and in Europe... has tanked this much and another 10% Today!
And looks like they 'may' go BK....Let's hope that doesn't happen.
"WHEN THE BOARD OF THIS COMPANY, WAKE UP AND SEE THAT THERE'S A PROBLEM"?
(I am long but honestly can't state a 'BUY' rec on my Sentiment Disclosure... SO it's a hold, what
choice do I have? .... LOL!)
...."I think they should spare her life... LOOK at what she has to offer the inmates?... 'VALUABLE' Tee shirts that she's gonna make behind bars that says: 'SURVIVOR'! ... ???
she is truly insane! .... ('TEE SHIRTS'?.... They should spare her life so she can make the word
'SURVIVOR' on T-Shirts?.... She is nuts.)
CALL ANYONE PERTAINING TO PAID BASHING!!!!..
HOW IS IT THAT YOU 'ARE THE DUMBEST OF THE DUMB HERE?....
YOU'RE ALWAYS WRONG.... YOU'RE WORSE THAN A BASHER....
"YOU'RE A PUMPER"!!!!!!!!!
NOW JUST GET LOST CREEP!
YOU'RE A WASTE HERE!
MUST BE JOKING THAT SOMEONE... IS PAYING TO BASH A 'PIDLY-LITTLE' POS BIOTECH LIKE PPHM TO KEEP THE PRICE AT THESE LEVELS.
PLEEEEEEZE... THIS COMPANY... WHICH HAS "NO MONEY"!!!... IS THIS LOW BECAUSE THEY
HAVE NO MONEY.... NO FUTURE... AND ARE YEARS AWAY FROM MAKING ANY SERIOUS MONEY.
PPHM DOES NOT NEED TO PAY SOMEONE TO BASH A COMPANY !!!
THERE ARE NO SUCH THINGS AS PAID BASHERS!
WHO'S GONNA PAY THEM?
'IF' THERE WERE SOME FOOL....WHO WANTED TO WASTE HIS MONEY... TO PAY SOMEONE TO
GO ON TO AN ANONYMOUS MESSAGE BOARD... TO MAKE SOME 'INANE' COMMENTS ABOUT A COMPANY... TO CAUSE 'FEAR' IN THE LONGS ON THOSE BOARDS HOPING THEY SELL
....IS AS DUMB AS THE 'SUPPOSED' PAID BASHERS THEMSELVES!
AND THIS 'SUPPOSED' GUY WHO PAYS THE 'SUPPOSED' BASHERS ... KNOWS FULL WELL,
THAT A STAUNCH LONG... WILL NOT SELL NO MATTER WHAT A BASHER SAYS!
NO ONE BUYS WHAT THESE BASHERS ARE SAYING ANYWAY... SO WHY WOULD THE FOOL
WHO 'SUPPOSEDLY' PAYS THESE BASHERS.
YES... THERE ARE BASHERS... "BUT NO ONE IS PAYING THEM A DIME"!
WAKE UP PEOPLE!
NOTHING IS GONNA HAPPEN BUT DOWN HERE!!!
STOP WITH THE LIES... YOU'RE WORSE THAN A SHORT.
Sentiment: Strong Sell
do you DO CRACK SIR?.... THIS COMPANY IS DONE... "PUT A FORK IN IT"....
NO OTHER BIO WOULD DARE TAKE CHANCE AND GIVE PPHM 'ANY' MONEY FOR
P3.... NO ONE.
Loser of a company... They are years and years away from making some major cash.
the stock is toxic.... Do not buy!
Sentiment: Strong Sell
AMOUNTED TO ANYTHING!!!
DON'T BUY IF YOU HAVEN'T YET... IF YOU HAVE PPHM SHARES?.... 'SELL 'EM'!
THIS COMPANY AND IT'S BOARD ARE FOS.... YOU'LL JUST KEEP LOSING MONEY.
Sentiment: Strong Sell
Biotech company Peregrine Pharmaceuticals (NASDAQ: PPHM ) was up as much as 33% today after announcing that it's starting a phase 3 trial for bavituximab in non-small-cell lung cancer.
You read that right. Not up 33% because its phase 3 trial was a success. Up 33% because it's starting a phase 3 trial.
Now granted, Peregrine is a small biotech company. The bump in share price only represents about a $70 million increase in Peregrine's value. But I'm not sure the news is worth even that much.
My best guess is that investors take the start of the trial as some sort of endorsement by the Food and Drug Administration. Peregrine even mentions the agency in the headline of the press release, highlighting that the company "has reached agreement with the FDA." If the agency agreed to allow Peregrine to run the trial, it must think the trial will work right?
Sorry, it doesn't really work that way.
The FDA is pretty open to biotech companies running clinical trials to test their experimental drugs, as long as there isn't a reason to think the drug will harm patients. If a biotech company can find patients willing to enter a clinical trial, the FDA is usually fine with a company running the trial. After all, that's the only way to definitively determine whether a drug works.
Examples abound where running another phase 2 trial would have made things a lot clearer, but the FDA "agreed" to allow biotech companies to run a phase 3 trial. Aeterna Zentaris (NASDAQ: AEZS ) and Keryx Biopharmaceuticals (NASDAQ: KERX ) took their colorectal cancer drug, perifosine, into a phase 3 trial based on a subset of the phase 2 data, which didn't turn out so well. Outside of cancer, Elan's (NYSE: ELN ) Alzheimer's drug bapineuzumab is a good example of the FDA's indifference to biotech companies running phase 3 trials; Elan and its partner Wyeth started phase 3 trials for bapineuzumab before the phase 2 data was even complete.
Peregrine's investors are desperate for some validation because the bavituximab phase 2 data in lung cancer are a mess; the company doesn't know which patients got the low dose of the drug and which got the placebo.
Peregrine combined the two arms of the study and compared them to the higher dose of bavituximab, which showed an increase in overall survival of 4.4 months. Assuming the low dose was doing something, the high dose might even extend survival by more than that, but the current results aren't statistically significant.
The only way to know for sure is to run another trial. Peregrine could have run another cheaper phase 2 trial to confirm the tantalizing-but-very-dirty data from the first phase 2 trial, or it could roll the dice and jump into an expensive phase 3 trial. Don't for a second think that was the FDA's decision to make. It's Peregrine's money to spend.
Speaking of money, that seems to be the main motivator here. At the end of January, Peregrine had about $26 million in cash and equivalents. Pausing to run a second phase 2 trial would have eaten up much of that. Pressing into phase 3 trials has investors excited, which will allow the company to raise more cash at a higher valuation.
I'm not saying that bavituximab is guaranteed to fail its phase 3 trial in lung cancer. But without any definitive data, it's a #$%$ shoot, like most phase 2 trials run by biotech companies.