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Mid Day PR, unheard of from PPHM they are finally learning
Peregrine Pharmaceuticals Announces Promising Bavituximab Phase I Data Published in the Peer-Reviewed Journal Cancer Medicine...
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Peregrine Pharmaceuticals Inc. (MM) (NASDAQ:PPHM)
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Today : Tuesday 31 March 2015
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- Combination of Bavituximab and Paclitaxel Achieved an 85% Objective Response-
- Design of Phase II Clinical Trial Underway -
Peregrine Pharmaceuticals (Nasdaq:PPHM) (Nasdaq:PPHMP), today announced the peer-reviewed publication of clinical data from a Phase I investigator-sponsored trial evaluating the company's lead investigational immunotherapy bavituximab plus paclitaxel therapy in patients with HER2-negative metastatic breast cancer. The manuscript details the results of the Phase I trial showing that the combination produced an objective tumor response in 85% of patients, including 15% of these patients achieving a complete response, measured in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
"The publication of these data marks an important milestone in the development of this novel therapeutic in a difficult to treat patient population," said Alison Stopeck, M.D., the principal investigator on the trial and Professor, Department of Medicine and Associate Director for Translational Research at the Stony Brook Cancer Center in Stony Brook, New York. "The regimen was very well tolerated and the clinical responses were encouraging. The data also suggest bavituximab may uniquely affect the coagulation system in a beneficial way for cancer patients. It is my belief that the combination of bavituximab with weekly paclitaxel is a feasible regimen that is associated with a promising response rate in patients with metastatic breast cancer and warrants further clinical exploration."
In the online released manuscript, researchers at the University of Arizona Medical Center led by Alison Stopeck, M.D. enrolled 14 patients with metastatic breast cancer (MBC) and while all were evaluable for toxicity, 13 were evaluable for response and progression free survival (PFS). These patients with HER2-negative MBC were treated with paclitaxel (80 mg/m2) weekly for three weeks of each four-week cycle and bavituximab (3 mg/kg) administered weekly beginning on day 15 after two weekly doses of paclitaxel. Results from 13 evaluable patients showed that 11 patients (85%) achieved an objective response, including two patients (15%) that achieved a complete response (CR), 9 patients with partial responses (PR) and 2 patients with progressive disease (PD). Median PFS for the combination of bavituximab with weekly paclitaxel was 7.3 months. In addition, the combination of bavituximab and paclitaxel was safe and well-tolerated with the majority of grade 1 or 2 adverse events being paclitaxel related. Approximately half of these patients were classified as "triple negative," a traditionally difficult-to-treat patient population. In addition, treatment with bavituximab reduced circulating PS-expressing microparticles (exosomes) which are immunosuppressive.
"These compelling results in a very difficult to treat patient population provide the foundation to move with confidence into a later stage trial," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine Pharmaceuticals. "These data build upon our historical clinical experience in the area of breast cancer and when combined with recent preclinical data demonstrating bavituximab's ability to promote antitumor immune activity, increase our understanding of the immune-stimulatory aspects of bavituximab."
These results appear in the March issue of the peer-reviewed journal, Cancer Medicine, in a manuscript titled: "A Phase I Clinical Trial of Bavituximab and Paclitaxel in Patients with HER-2 Negative Metastatic Breast Cancer."
The online article is available at: http://onlinelibrary.wiley.com/doi/10.1002/cam4.447/full
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party customers. Additional information about Peregrine can be found at www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that the company may not have or raise adequate financial resources to initiate a later stage breast cancer clinical trial and the risk that the results of a later stage breast cancer clinical trial will not be consistent with the results from this Phase I breast cancer trial. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2014 as well as any updates to these risk factors filed from time to time in the company's other filings with the Securities and Exchange Commission. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
CONTACT: Christopher Keenan
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
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WHERE'S THE DRILLING PR??? BUELLER!!!
PPHM the Rodney Dangerfield of Bio-Techs.
$PPHM The next big drug
http://stks.co/p1ln5
Still relevant.
Skip Peregrine Pharmaceuticals For 2015
Mar. 25, 2015 2:55 PM ET | About: Peregrine Pharmaceuticals Inc. (PPHM)
Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)
Summary
Peregrine is funded for the year; unfortunately, not much is expected to happen on the clinical front.
Surprise collaborations may be the only major price movers.
Tune back in next year, when interim data for the main trials are expected.
Peregrine Pharmaceuticals (NASDAQ:PPHM) is a small biopharmaceutical company focused on a new class of antibodies that bind to phosphatidylserine (PS). PS is externalized on the outer membrane of tumor cells and vasculature, but is normally localized inside healthy blood vessel cells, making PS a specific target for anticancer therapies. Peregrine's lead PS-targeting candidate has been advanced to Phase III development. Peregrine has a market cap of $278.73 million, and on March 12, announced financial results for the third fiscal quarter (FQ3) of fiscal year (FY) 2015 that ended January 31, 2015. They have money to last the year, but few catalysts.
Lead candidate:
Bavituximab is the lead antibody being evaluated as immunotherapy (helping the body's immune system to fight infections) for several oncology indications. SUNRISE is a pivotal Phase III, multinational, double-blind, randomized, controlled trial (RCT) of bavituximab plus docetaxel versus docetaxel alone in patients with previously treated Stage IIIb/IV non-squamous non-small cell lung cancer (NSCLC). SUNRISE has two planned interim analyses. The first is a safety assessment triggered after 33% of a pre-specified number of patient deaths and the second will assess both safety and efficacy after 50% of pre-specified deaths. There is no timeline as to when these might occur.
In January, Peregrine presented updated data from a single-arm Phase II investigator sponsored trial (IST) using bavituximab and NexAVAR. NexAVAR from Bayer (OTCPK:BAYRY) is the only oral therapy FDA-approved specifically for unresectable hepatocellular carcinoma (HCC). The combination was associated with a 4-month progression-free survival (PFS) in 62% of 38 patients with advanced HCC. Two patients (5%) achieved a partial response and the median overall survival (OS) was 6.2 months. The trial is being conducted by the University of Texas Southwestern Medical Center (UTSW) and may have more analyses revealed at a later time.
The company is currently evaluating its options on how to advance bavituximab in breast cancer. Two other ISTs are ongoing in rectal adenocarcinoma and advanced melanoma. The availability of funds is the major limiting factor.
Financial position:
At January 31, 2015, Peregrine had $55.2 million in cash and equivalents. Management believes they have sufficient cash resources to fund operations through at least December 2015.
Cash flows/expenses:
Peregrine's contract manufacturing business, Avid Bioservices, produced $5.7 million in revenue in FQ3 and $17.4 million for the current nine-month period. This represents a 10% increase over the same nine-month period. The revenue guidance is $5.6-$7.6 million for FQ4, while consensus revenue is $6.42 million. These targets are very likely to be reached.
Research and development spending saw an expected increase in FQ3 to $11.3 million as SUNRISE progresses. The RCT started in 2013 and the past 3 FQ R&D costs totaled $10.0 million in FQ2, $10.2 million in FQ1, and $8.8 million in FQ4 2014. R&D expenses in future quarters are likely to be in the $11-12 million range. Selling, general and administrative spending has been consistently between $4 and $5 million for the past year and is likely to remain there.
Forward look:
There is only one scheduled catalyst for 2015. A Phase I IST by UTSW incorporates bavituximab into the standard of care treatment with capecitabine and radiation therapy of patients with rectal adenocarcinoma. UTSW is trying to identify the bavituximab's maximum tolerated dose in the combination; the trial has a primary completion date of August 2015. Another Phase I IST evaluating bavituximab in advanced melanoma is still enrolling and won't be done until 2016. UTSW may report more results/analyses for the HCC trial, but if there are no additional complete or partial responses, the data won't move the stock price. Avid Bioservices does generate income. However, analysts have this pegged down, and estimates have been spot on the past 2 quarters. FQ4 is bound to be in line once again.
In conclusion, there isn't much happening with this stock this year. 2016 will be more exciting; however, to get there, Peregrine may have to dilute again. The only probable surprises during the year are additional agreements for ISTs. It does take time for investigators to write grant requests, and more time for the government (the most frequent source of past grants) to review and approve them. Longs holding out for SUNRISE have a good chance of success, based on the botched Phase II NSCLC trial results in 2013, which still delivered significant dose-dependent survival benefits. For prospective investors, other biotech stocks may be more attractive.
Source: Skip Peregrine Pharmaceuticals For 2015
Will never go to trial. Will be settled imo
Yea that makes a whole lot of sense. Complete BS
Do it.
Wrong. It can be sold at a discount like a bond.
Yeah. Both he and AF want everything to fail.
And please tell md1225 that DD is making fun of him on Twitter
@DewDiligence: More $PPHM comic relief—read it b4 it gets deleted: http://t.co/el5SITQ27y
Since I'm limited to one post per day over there
@SierraEquity: $PPHM Buyout Negotiations Happening Now In Tustin As Peregrine Pharmaceuticals (PPHM) Joins....Ventures Sierra Equity
http://t.co/wbYJm9FahD
GOOD THING IR MONITORS IHUB TO CORRECT THEIR ERRORS. UNREAL.
Yea I don't get it. He finds satisfaction in bashing trials of CEOs and company's he doesn't like
He's a scumbag. If he doesn't get his paola from the company he trashes it.
$1.65. WTF. KEEP ON ROLLING.
What a joke today's trading was. Can't even close above the open. And still nothing from the company. Silence must say everything which is nothing.
What a joke today's trading was. Can't even close above the open. And still nothing from the company. Silence must say everything which is nothing.
AF tweets: @adamfeuerstein: Maybe not as funny as the llama, but this Seeking Alpha article on $PPHM comes close http://t.co/aKCmyZySBf
The market averages go up and PPHM goes down. Typical. Sell the company kinger.
Mgmt needs to sell the company asap
How about the shares make it to $2. This is BS. Lack of transparency and integrity of the BOD. Makes absolutely no sense to dollar cost average this pos. Next will be a fluff pr about some bs.
If they are reading it they obviously don't care. That is very obvious. Lack of info from Tustin is business as usual.
THAT BIATCH SIERRA WAS RIGHT, THIS REALLY IS A POS
NO CREDIBILITY AT ALL
ARE WE GONNA SET A NEW 52 WEEK LOW
SELL THE FRICKIN COMPANY ALREADY
ANOTHER BUYING OPPORTUNITY FOR THE FAITHFULL
STENCH IN TUSTIN HAS REACHED ALL PARTS OF THE WORLD
Haha. They released news at 930am
IF ONLY PPHM CAN PUT TOGETHER A DEAL LIKE ZIOP JUST DID TODAY AFTER THE CLOSE. AND THEY DID IT WITH MD ANDERSON PPHMs HOSPITAL OF CHOICE. ZIOP UP OVER 30% AFTER HOURS.
Lets hope not. Hopefully they sell this pos sooner than later
You need to add $PPHM to your tweets so when people search they can find your tweets about PPHM. Otherwise they will be lost with the other millions of tweets.
SOUNDS VERY PLAUSIBLE. THIS COULD BE THE FINAL OUTCOME.
MOST ON THIS BOARD JUST PUMP AND PUMP WITHOUT A SENSE OF REALITY OR THE LIKELIHOOD OF AN EXPLANATION. WOOK THIS UP.
corrected. @SierraEquity: $PPHM Window Of Opportunity_Peregrine (PPHM) And Pfizer (PFE) To Delay Buyout Announcement Until May Predicts Sierra
http://t.co/xNDXtzlhAv
What BS..SierraEquity @SierraEquity $PPHM Peregrine Pharmaceuticals (PPHM) PT And Rating Issued 12/03/2014 By Sierra ~ SELL ~ 5 Day Price Target: $1.27
I'm still celebrating. Gonna be an all night affair.
Exciting day for PPHM
Nope they sure can't. Dumb a$$es
Yep. Let them "steal" my share for $5 per share.
I saw he was banned. What he do to get sent to exile island
Haha pumpers
Idiots there. Bunch of relentless pampers. What happened to that shill ATONEWITHpphm. Hasn't posted in 2 weeks