volume move 8)
I guess that it will not get higher than 1.20 level on June 22 'cause since then there is no good news. 1.20 is the resistance for now unless people expect good news.
Many small biotechs have had a substantial raise in share price.
PPHM shows a nice stream of news and the prospects are intact.
The stock also tended to have straight rallies in the past.
Also it seems that there have been some recent insider buys.
The signals show green.
Happy trading all!
Phabrux
This looks like it wants to make a run.... ;D
Hey All, I'm impressed with some of the work that I've seen on these boards recently. Kudo's..Anyway, I hope to add something of value myself. I like PPHM. Although I'm technically knowledgeable, I put the most faith in the "2 I" method. I watch how a stock trades..lol. This one might be worth keeping an "I" on as it appears that someone is interested in buying. Back around Jan 10, it popped through a recent resistance line around .95. Then, as one would expect, immediately pulled back and held that line for a few days. It has since held strong around a $1
and today was very constructive as it seems to have moved away from that level and closed on it's highs($1.11) and above it's 200 day M/A. Also worth noting is it the good press it's gotten lately(Defense Dept. Grant) and something tells me there's more to come.
Best of luck,
Jono
whoa, that's wierd..We both posted for the same stock within 20 seconds of each other..at 2AM no less..I might have to buy some more on the open........
Post your comments here: thread already started ;)
Quote from: jfra on January 24, 2006, 02:06:53 AM
Hey All, I'm impressed with some of the work that I've seen on these boards recently. Kudo's..Anyway, I hope to add something of value myself. I like PPHM. Although I'm technically knowledgeable, I put the most faith in the "2 I" method. I watch how a stock trades..lol. This one might be worth keeping an "I" on as it appears that someone is interested in buying. Back around Jan 10, it popped through a recent resistance line around .95. Then, as one would expect, immediately pulled back and held that line for a few days. It has since held strong around a $1
and today was very constructive as it seems to have moved away from that level and closed on it's highs($1.11) and above it's 200 day M/A. Also worth noting is it the good press it's gotten lately(Defense Dept. Grant) and something tells me there's more to come.
Best of luck,
Jono
Jfra, yea that was too funny..........
Nice jump today...........
This looks like it wants to break out............ ;D
Hopefully some of you enjoyed todays move........ ;D
HG - thanks for updating. I played PPHM last Jan-Mar from ~1.25 to ~1.50. Today's volume was the highest in 2 years. The last time PPHM had volume better than this was during the time it ran from .70 to 2.00 in May-Jun 2003.
"T4" at Ragingbull has been a big touter of PPHM for a long time. I'm surprised the ol' windbag hasn't been around lately to pontificate about the current move. Here's the last T4 rant on PPHM. This post and some of his others are a quick way to get some DD on PPHM and Tarvacin: http://tinyurl.com/b8rve
HG - I took a position today at $1.30. Go PPHM and GO TARVACIN!!!!
I like my entry. Hopefully something big is brewing at PPHM. Serious volume this week.
Well, I hope some of the members agreed with my little disertation on this stock and joined me in it. ;D
Hi jfra
I've benn keeping my eye on this one to because of all the insider buying that has been going one for the past year. Here's link. Goodluck trading and welcome to 3SOF
http://www.secform4.com/insider/showhistory.php?cik=pphm
Hey, thanks for the link. I am aware of mostly "for pay" insider activity sites. I'll have to take a good look at this one over the weekend. Also, I am aware of Mr Swartz's buying, but I usually look for non-option or non stock plan type accumulation and it appears that his has been of the stock plan variety. I would welcome your opinion on this as I'm not too "corporate finance or accounting" knowledgeable.
Thanks again,
Jonathan
Hi jfra
I'm still learning a lot about trading and would not like to give advise and cause someone to loose money because of my opinoin's. When I buy stock based on insider buying I like to see at least three or more differant insiders buying that holds top positions in the company as an example, CEO, Chief Fianancial Officer, Director and so on along with lot's of shares being bought, the more the better. When I see insider buying that fits this example I'll look for some very positive news that will cause price movement of the stock to go up and check their prior earnings report to see if it's good or bad.
Don't know if this might help but it's a good thing to learn. I've read many times that Peter Lynch, a well known investor would say, " Why else would an insider buy unless he knew that the price of a stock is going to go up." Also when an insider buys, It can take anywhere from two weeks to six months for the stock to move so it can depend a lot on how long you're willing to hold if you buy because of insider buying.
Hope you the best of luck with you're venture in stock trading.
Another link to check for insider buying
http://insider-monitor.com/buy_today.html
Nice run sooooo far............ ;D
Alot brewing here, could run some more but I jumped out at the close............
PPHM is a core holding of mine from 1.26; the stock was truly on fire when jfra posted his views. However, pphm got to 1.75 and then took a HUGE tumble today to 1.45. I think the stock will resume the climb as the fundamentals point to Tarcavin data being released on Feb 27th - if the dataa is positive this stock will soar
I've been posting to a different PPHM thread but I'll start posting here instead. This from the other thread:
Quote from: Lucas Scott on January 31, 2006, 11:51:49 PM
HG - thanks for updating. I played PPHM last Jan-Mar from ~1.25 to ~1.50. Today's volume was the highest in 2 years. The last time PPHM had volume better than this was during the time it ran from .70 to 2.00 in May-Jun 2003.
"T4" at Ragingbull has been a big touter of PPHM for a long time. I'm surprised the ol' windbag hasn't been around lately to pontificate about the current move. Here's the last T4 rant on PPHM. This post and some of his others are a quick way to get some DD on PPHM and Tarvacin: http://tinyurl.com/b8rve
I'm in from 1.30 last week. I almost soiled myself on the steep pullback today, but it rebounded nicely. Very nice hammer!
A ot of people sold their shares....
from 1.78....to 1.4$....could it run up ???
We'll see :P
What's up with PPHM? No news, just sliding, sliding, sliding, like down an icy slope. The chart often precedes the news, so maybe we'll find out soon what's behind this drop.
There is a gap to fill between 1.20 and 1.25 that should get filled tomorrow. Hopefully we get some buyers at the gap fill point.
hi what do think about pphm
Good play? ;) Nice volume today, Strong close, breaking out from symmetrical triangle pattern :D
Today Peregrine is on fire !
+20% in premarket...
Here's the news :
Peregrine Pharmaceuticals' Bavituximab Shows Potential Activity Against Avian Flu in Initial Testing
Wednesday May 24, 7:00 am ET
- Initial Data Presented at ASM Meeting Show Complete Inhibition of Viral Replication in H5N1 In Vivo Model -
- Supported by In Vitro Data Confirming Bavituximab Binds to H5N1 Viral Particles -
Peregrine Pharmaceuticals' Bavituximab Shows Potential Activity Against Avian Flu in Initial Testing
Wednesday May 24, 7:00 am ET
- Initial Data Presented at ASM Meeting Show Complete Inhibition of Viral Replication in H5N1 In Vivo Model -
- Supported by In Vitro Data Confirming Bavituximab Binds to H5N1 Viral Particles -
TUSTIN, Calif. and ORLANDO, Fla., May 24 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News), a biopharmaceutical company with a portfolio of innovative, clinical stage product candidates for the treatment of hepatitis C virus (HCV) infection and cancer, today announced that its lead anti-viral compound bavituximab (formerly Tarvacin) completely inhibited replication of a laboratory strain of the H5N1 virus, commonly known as avian flu, in fertilized chicken eggs, an in vivo model for influenza anti- viral activity. These preliminary findings will be reported today at the 106th general meeting of The American Society for Microbiology (ASM) in Orlando, Florida by Dr. Philip Thorpe, a member of the Peregrine Scientific Resource Board and professor of pharmacology at the University of Texas Southwestern Medical Center at Dallas. Bavituximab, a monoclonal antibody with unique anti-viral and anti-cancer properties, has already demonstrated good tolerability in a Phase l trial in patients with HCV infection.
"This first set of results showing that bavituximab appears to have inhibited H5N1 viral replication in the fertilized egg model and the supportive data confirming that bavituximab binds to H5N1 viral particles are encouraging," said Dr. Thorpe. "These early data support the view that bavituximab may be active against H5N1 and other common strains of influenza."
The H5N1 studies reported by Dr. Thorpe were conducted at a number of independent research laboratories. Peregrine has also been collaborating with other researchers to evaluate the potential of bavituximab delivered by different routes of administration to treat infections caused by influenza A, the viral family that includes the H5N1 strain. Peregrine has ongoing studies to evaluate various delivery methods and treatment regimens to treat influenza in a number of in vivo models, including well-established mouse and ferret models. These studies include assessments of bavituximab delivered by nasal inhalation, a form of delivery expected to be more effective than systemic delivery alone for respiratory viruses that lodge deep in the lungs.
"These early experimental data suggesting that bavituximab may have activity against the avian flu, along with preliminary data recently generated showing signs of activity in a ferret model of influenza A infection, give us momentum and direction as we pursue a variety of preclinical initiatives to assess the anti-viral potential of bavituximab," said Steven W. King, president and CEO of Peregrine. "With a repeat dose safety study in HCV patients expected to begin next month, we should be well-positioned to initiate clinical trials for bavituximab in additional indications once we have sufficient preclinical data in hand."
Bavituximab is an antibody that attaches to specific cellular components called phospholipids found on the surface of virus particles, including influenza and certain other virus strains, as well as on the outer surface of human host cells only when they are infected with these viruses. Bavituximab helps stimulate the body's natural immune defenses to destroy both the virus particles and the infected cells, without affecting healthy cells. Bavituximab is in Phase 1 clinical trials for hepatitis C virus infections and for solid tumor cancers. A Phase 1b repeat dose study in HCV patients is expected to start in June.
Dr. Thorpe's ASM presentation, Broad-Spectrum Anti-Virals, is scheduled for May 24th at 10:00am in Room 208A as part of a symposium on Bioterrorism: Challenges and Opportunities.
PPHM is breaking out.....
Should close at the HOD...gapper tomorrow.
PPHM IS SETTING ITSELF FOR A LATE-DAY RALLY...
HUGE BIDS POPPING UP.....
BIRD FLU NEWS WILL BE ALL OVER THIS EVENING...SHOULD BE A GAPPER/RUNNER TOMORROW
Terabemo - do you just make stuff up? "Huge bids popping up"? The is no evidence of that. "Gapper/Runner tomorrow"? It was a gapper today and it ran the wrong way. A gap up tomorrow is not likely.
BIRD FLU NEWS WILL BE ALL OVER THIS EVENING...SHOULD BE A GAPPER/RUNNER TOMORROW
Quote
Here is why the bird flu stocks dropped off there morning highs.
WHO finds "no evidence" bird flu more contagious in humans, countering early concerns of potential outbreak
Long weekend comimg up...any bird flue news developing this weekend will make PPHM one of the biggest winners in this sector. PPHM is trading at pre-bird flu news prices. Besides, ASCO is coming up in June and PPHM always does good in June being a cancer paly.
PPHM LOOKING STRONG TODAY....CANCER PLAY AS WELL AS BIRD FLU PLAY....ASCO WILL FUEL RALLY
PPHM is up nicely in pre-market. Nice PM volume too. Don't know the reason(s) for it.
PPHM ---> made a breakout from 16 weeks consolidation ;)
Eric Swartz (director) has been buying tons of shares since 04-25-2005
we will probably see a breakout today...
Watch
link:
Peregrine's Bavituximab Shows Promising Anti-Viral Activity and Signs of Prolonged Anti-Viral Effect in Single Dose Monotherapy HCV Trial
PR Newswire (Wed 7:00am)
there is some activity rightnow
There's lot of activity !
link :
• Peregrine's Bavituximab Shows Good Data
AP (Wed 8:06am)
taking a position ;)
Quote from: Terliso on June 07, 2006, 01:03:22 PM
taking a position ;)
Took a position @ 1.82 ... I got limit order there & it got executed --->now GAP closed for the day.
Man this market is crazy!! I closed out my PPHM position after hours
sell-off on heavy volume :(
I know there has been a lot dilution before...and I think again...they need cash.
Press Release Source: Peregrine Pharmaceuticals, Inc.
Peregrine Receives Regulatory Approval for New Cotara(R) Brain Cancer Clinical Trial
Thursday October 12, 8:15 am ET
- Efficacy and Safety Trial Will Be Conducted at Prominent Indian Brain Cancer Centers -
- Study Expected to Enhance Ongoing U.S. Cotara Development Efforts -
TUSTIN, Calif., Oct. 12 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News), a biopharmaceutical company with a portfolio of innovative, clinical stage products for the treatment of cancer and hepatitis C virus infection, today announced that it has received regulatory approval in India for a new clinical trial of its lead tumor necrosis therapy (TNT) agent Cotara®. The trial is designed to test the safety and efficacy of Cotara in patients with glioblastoma multiforme, a deadly form of brain cancer. Cotara is currently being studied in a multi-center U.S. glioblastoma trial. Previous studies using Cotara to treat brain cancer have produced encouraging results, and Peregrine expects that positive data from this trial in combination with data from the ongoing U.S. clinical trial should provide the foundation for planning the future development and commercialization of Cotara.
The new safety and efficacy study is expected to be an integral part of Peregrine's overall Cotara brain cancer development program. It will be conducted according to internationally accepted ICH GCP guidelines at up to seven clinical centers and is expected to enroll up to 40 patients with glioblastoma who have experienced their first relapse. Patients will receive a single infusion of the drug by convection-enhanced delivery (CED), an NIH-developed technique in which the drug is slowly administered directly into the glioblastoma tumor with great precision. The primary endpoints of the trial are to confirm safety and determine median survival time and median time to progression in Cotara-treated patients. Patient enrollment in the study is expected to be completed by the end of 2007.
"We believe this new clinical trial will be a cornerstone of our future plans to develop Cotara for the treatment of this deadly form of cancer," said Steven W. King, president and CEO of Peregrine. "We are moving this program forward in India because of the high level of experience of the participating neurosurgeons with CED delivery, the state-of-the-art facilities of the medical centers involved and the fact that the contract research organization overseeing the trial is highly experienced in successfully running similar glioblastoma trials with many of the investigators who will be involved with our study."
Mr. King added, "We have previously generated encouraging results using Cotara in this lethal cancer, and this study should allow us to evaluate the potential of the drug to extend patient survival more rapidly than we had originally anticipated. The new trial aims to provide clinical data in a timely manner that can be combined with the dosimetry and safety data we will be gathering from the ongoing U.S. study to guide the further clinical and commercial development of Cotara. We believe this trial could greatly expedite our Cotara brain cancer program based on the fact that some of the cancer centers we are working with routinely treat thousands of brain cancer patients each year, while major U.S. centers typically treat at most several hundred."
Global pharmaceutical companies including Pfizer, GlaxoSmithKline, Roche and Eli Lilly have been conducting an increasing number of major clinical trials in India in recent years, taking advantage of the country's world-class clinical research facilities that leverage India's large cadre of Western-trained medical personnel and enormous pool of patients eager to participate in clinical trials.
About Cotara®
Cotara is an experimental new treatment for brain cancer that links a radioactive substance designed for medical uses -- a radioactive isotope -- to a targeted monoclonal antibody. This monoclonal antibody is designed to bind to a type of DNA that is exposed only on dead and dying cells. Solid tumors, including brain tumors, have a significant number of dead and dying cells at their center, and Cotara's targeting mechanism enables it to home in on these dying tumor cells, delivering its radioactive "payload" directly to these cells at the center of the tumor mass. Cotara thus literally destroys the tumor "from the inside out" with minimal radiation exposure to healthy tissue.
Cotara is delivered through a special method called convection-enhanced delivery (CED). CED uses a catheter to bypass the blood brain barrier and target the specific tumor site in the brain, directing Cotara to the tumor more precisely. This type of delivery has been shown to achieve up to a 10,000-fold greater concentration in local therapy exposure than conventional intravenous drug administration, while minimizing unwanted exposure.
In previous clinical studies Cotara has demonstrated encouraging results in a number of patients with advanced brain cancer. One study demonstrated a greater than 50% increase in median survival time in a group of patients suffering from late stage glioblastoma multiforme who were treated with Cotara. This was considered a promising development in this serious and deadly disease. Cotara is currently in a multi-center dosimetry and dose confirmation trial in glioblastoma patients being conducted by the New Approaches to Brain Tumor Therapy (NABTT), a consortium of leading U.S. academic brain cancer centers. Cotara has been granted orphan drug status and fast track designation by the U.S. Food and Drug Administration for the treatment of glioblastoma multiforme.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing five separate clinical trials in cancer and HCV infection with its lead product candidates bavituximab and Cotara® in the U.S. and India. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside 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 will not be able to enroll a sufficient number of patients to complete the clinical study, the risk that enrollment will be slower than expected, the risk that the results from the clinical study will not be consistent with the results from previous clinical studies of Cotara and the uncertainties associated with conducting clinical studies in, and complying with the regulatory requirements of, India. 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 the Company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2006. 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.
Contacts:
GendeLLindheim BioCom Partners
Investors Media
[email protected] Barbara Lindheim
(800) 987-8256 (212) 918-4650
--------------------------------------------------------------------------------
Source: Peregrine Pharmaceuticals, Inc.
Peregrine Pharma gets India nod for clinical trial of Cotara
Thu Oct 12, 2006 8:39am ET
Oct 12 (Reuters) - Peregrine Pharmaceuticals Inc. on Thursday said it received regulatory approval in India for a new clinical trial of its experimental drug to treat brain cancer.
The company said in a statement that the trial of its lead tumor necrosis therapy agent, Cotara, will test the safety and efficacy in patients with glioblastoma multiforme, a deadly form of brain cancer.
Cotara is currently being studied in a multi-center U.S. glioblastoma trial and received encouraging results. Peregrine said it expects that positive data from the trial in India, combined with U.S. data, should help future development and commercialization of Cotara. (Reporting by Ajaya Kumar in Bangalore)
Another one with an absurd amount of threads started. >:D
I will update this one, the very first created. ;)
By the wizard himself, "EliteG" ;D
Members, Don't you get it ? ??? If a thread is old and there has not been any posting on it of late,
If you run an update to it, "The thread is alive again" ! ;D
Without the unnecessary creating of new threads... ::) "Board clutter" !
PEREGRINE PHARMA INC (NasdaqCM:PPHM) Delayed quote data
Pre-Market: 1.37 0.10 (7.87%)
Breakout now Setravis... applause ;)
Bought some @ 1.43
Peregrine Completes Patient Enrollment in Phase Ib Bavituximab Hepatitis C Trial
Tuesday October 24, 8:00 am ET
- Enrollment in Repeat Dose Study Completed Ahead of Schedule -
TUSTIN, Calif., Oct. 24 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News), a biopharmaceutical company developing targeted therapeutics for the treatment of cancer and hepatitis C virus (HCV) infection, today reported that patient enrollment has been completed for the company's Phase Ib repeat dose, dose escalation study of bavituximab in patients with chronic HCV infection. The primary objective of the study is to determine the safety, distribution and pharmacokinetic properties of bavituximab as a multiple dose monotherapy in HCV patients. Changes in viral load, measured as serum HCV RNA levels, are also being monitored.
"Completing patient enrollment in this study ahead of schedule is a positive development for Peregrine and for the momentum of the bavituximab HCV program," said Steven W. King, president and CEO of Peregrine. "We believe that bavituximab has the potential to be a significant new therapy for HCV patients, and achieving this milestone will allow us to continue advancing bavituximab through clinical development. We are already actively designing the next bavituximab HCV clinical studies, and the data we obtain from this repeat dose trial should be extremely valuable in helping us to optimize those plans."
Twenty-four patients (four cohorts of six patients each) were enrolled in the study with each cohort scheduled to receive four doses of bavituximab over a 14-day period. Subjects received bavituximab at escalating dose levels of 0.3, 1, 3 or 6 milligram per kilogram (mg/kg) of body weight. Patients in all cohorts are being followed for 12 weeks. Final data from the trial will be available when patients complete the 12 week follow-up and data analyses are complete. Initial data from the trial is expected to be available during the first quarter of 2007.
Previously Peregrine reported preliminary results from a Phase la single dose, dose escalation study of bavituximab in patients who had failed other HCV regimens, which showed that the drug was well tolerated and demonstrated encouraging signs of anti-viral activity. Final results from the Phase I single dose study will be presented at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston on October 30, 2006.
http://biz.yahoo.com/prnews/061024/nytu088.html?.v=68
9 & 200MA didn't hold ... :-\
(http://img54.imageshack.us/img54/469/pphmef1.jpg)
Update
(http://img295.imageshack.us/img295/9505/pphmur7.png)
Terliso KEEP YOUR EYE ON THIS ONE!!!!!!!
asc triangle breakout -my favorite!! ;D
Comments on the chart and story appreciated
"PPHM" Threads have been Merged.
Please use the search before starting new threads on a Stock Pick.
Chances are a thread already exist.
So why not post whatever you have to comment about on that pick to that thread.
"Simplicity" My fellow traders. ;D
All history on a stock pick in 1 thread is awesome. ;)
Just trying to get threads together,so we don't have a numerous amount floating around on the same stock. :(
Thank You....and good luck with all your trades....make some $$$ ;)
Insider buys ;)
I'm in @ .65- risky ;D
More insider buys @ .66 ;)
http://www.secform4.com/insider-trading/704562.htm
Looks like the shorts are covering, I wonder if news is about to come out?
Insider buys yesterday and today ;)
Looking good, a close above the 50 sma would be very bullish.
OK- closed HOD just above the 50 sma @ .74, traded up after hours to .77. ;D
Volume just under a million, I expect volume to increase as people begin to notice something is up and investigate further.
Looking good for a run up to a buck ;)
Insider buys:
http://www.secform4.com/insider-trading/704562.htm
Update: Sept. 1 - More buys posted last night too...
Well, what do we have here?! ;D
I wonder if this is why insiders are loading up?
http://www8.utsouthwestern.edu/utsw/cda/dept353744/files/409646.html
From the article:
"Treating the mice with bavituximab and radiation therapy together reduced tumor growth by 80 percent and was more effective than administering either treatment by itself."
More info: Look at last page for collaborations.
http://presentations.cancerconferences.com/7th_monoclonal/files/2007_0817/ws02_brekken.pdf
This may be huge!
DALLAS — Sept. 1, 2007 — Combining radiation therapy with a drug that helps destroy blood vessels nourishing malignant tumors has been shown in mice to be significantly more effective in treating lung cancer than either approach alone, researchers at UT Southwestern Medical Center have found.
The study, involving human lung-cancer cells implanted in mice, appears in the Sept. 1 issue of Clinical Cancer Research.
In the study, Dr. Philip Thorpe, professor of pharmacology at UT Southwestern, and his colleagues found that radiation generates a chemical reaction in the membranes of endothelial cells, which line the blood vessels that feed tumors. The reaction causes membrane components called anionic phospholipids to flip inside out, exposing them. In normal blood vessels, they face the interior of the cell.
Dr. Thorpe's previous research has shown that anionic phospholipids, particularly one called phosphatidylserine, are already flipped inside-out on tumor endothelial cells.
"The flipping is likely due to stress conditions present in the tumor micro-environment, and radiation increases the number of exposed phospholipids," said Dr. Thorpe.
Once they induced more flipping with radiation, the researchers administered bavituximab, a monoclonal antibody that homes in on tumor vessels by selectively binding to the inside out phospholipids. The binding signals white blood cells from the immune system to attack and destroy the vessels feeding the tumor.
In their study of mice, the researchers found that radiation increased the percentage of phospholipids that flip inside out from 4 percent to 26 percent. Treating the mice with bavituximab and radiation therapy together reduced tumor growth by 80 percent and was more effective than administering either treatment by itself.
"About 30 percent of all lung-cancer patients receive radiation and, in this animal model of lung cancer, we found that this monoclonal anitbody improves the efficacy of radiation therapy without the toxicity seen in other chemotherapeutic drugs," said Dr. Thorpe. "It's a win-win."
Bavituximab was created in Dr. Thorpe's lab is currently being tested in clinical trials in the U.S. and India for its effectiveness against solid-tumor cancers.
Peregrine Pharmaceuticals Inc. has exclusively licensed bavituximab from UT Southwestern and has a sponsored research agreement to further explore clinical uses of the drug. Dr. Thorpe is a consultant to and has an equity interest in the company.
Lung cancer is the leading cause of cancer death in the U.S. About 213,000 cases of lung cancer will be diagnosed this year and 160,000 people are expected to die from the disease, according to the National Cancer Institute.
"Although there are current therapies, the five-year survival rate for lung-cancer patients remains at only 15 percent," Dr. Thorpe said. "This tells us that there is an urgent need to develop new treatment strategies."
Vascular targeting agents such as bavituximab kill tumors without causing damage to surrounding healthy tissue. They cause fewer side effects than conventional cancer drugs that kill rapidly dividing normal cells along with the cancer cells.
Because Peregrine is already testing bavituximab in cancer patients, Dr. Thorpe said he expects new clinical trials using a combination of bavituximab and radiation therapy to start soon.
Other UT Southwestern scientists involved in the study were Drs. Jin He and Troy Luster, both postdoctoral researchers in pharmacology.
The research was funded by Gillson Longenbaugh Foundation, Peregrine and the American Cancer Society.
This morning should be a good day for Peregrine Pharmaceuticals with this UT Southwestern Medical Center news release:
http://www.utsouthwestern.edu/utsw/cda/dept353744/files/409646.html
Hopefully this is what they needed to get them out of the basement. Looks like all the insiders have been loading up as well:
http://www.insidercow.com/history/company.jsp?company=pphm
looks good >:D
Company PR out ;D
Study Published in Clinical Cancer Research Confirms Potential Of Peregrine's Bavituximab Combined With Radiation In Lung Cancer
Tuesday September 4, 8:30 am ET
- Bavituximab Equivalent Combined With Radiation Reduced Tumor Growth by 80% in Preclinical Lung Cancer Model -
- Findings Confirm Key Aspects of Bavituximab's Mechanism of Action in Combination with Radiation Therapy -
- Results Further Support Future Clinical Trials Testing Bavituximab in Combination With Radiation Therapy -
http://biz.yahoo.com/prnews/070904/aqtu096.html?.v=18
Update 1 pm: Gap filled! Time to move up, resistance at .76
I am going with the insiders, hope that the sellers dry up soon!!
Pharmas are heating up, wonder if it will last? ADLR is one to watch as well!
Cheers joe
Great Q results are out! ;D
The company is strenghtening their financial position and they are good things in the pipeline.
financial results for the first quarter of fiscal year 2008 ended July 31, 2007. The company reported a consolidated net loss of $4,656,000, or $0.02 per basic and diluted share, compared to a consolidated net loss of $5,457,000 or $0.03 per basic and diluted share for the same prior year period.
Total revenues for the current quarter increased 286% to $1,625,000 versus $421,000 for the comparable quarter last year. Avid Bioservices, the company's wholly-owned contract manufacturing subsidiary, contributed $1,621,000 in contract manufacturing revenue versus $398,000 recorded in the similar prior year period.
"The first quarter has set the foundation for what we expect to be a year of solid achievement," said Steven W. King, president and CEO of Peregrine. "We made continued progress in each of our three key clinical programs, including reporting positive top-line results in our first cancer study of bavituximab in combination with chemotherapy; initiating new clinical trials in our bavituximab HCV and Cotara® brain cancer programs; submitting a new bavituximab Phase II clinical trial protocol and achieving significant revenue growth at our Avid subsidiary. With these outstanding accomplishments in the quarter, plus the anticipated submission of at least three more clinical trial protocols by the end of the calendar year, we are well positioned to continue our positive momentum."
Mr. King continued, "We further strengthened the company's financial position during the quarter with the infusion of approximately $20.9 million in net proceeds in a registered direct offering with several institutional investors. These capital resources will enable us to continue to generate data from our three current clinical programs, which give us multiple opportunities for success in our key value driving programs during fiscal year 2008."
Mr. King concluded, "Another important development during the quarter was the announcement that our proposal to investigate the utility of bavituximab along with other anti-phosphotidylserine antibodies as a treatment for hemorrhagic fever virus was selected for negotiation of a 5-year contract award by the Defense Threat Reduction Agency of the U.S. Department of Defense, potentially valued at up to $44.5 million. We consider this a significant third party validation of the broad anti-viral potential of our technology and contract negotiations are proceeding."
Total costs and expenses slightly increased by 5% to $6,513,000 for the quarter ended July 31, 2007 from $6,212,000 for the same quarter last year. The increase in total expenses was primarily due to an increase in cost of contract manufacturing related to higher reported revenue during the quarter, as well as a small increase in selling, general and administrative expenses. These current quarter increases were offset by a decrease in research and development expenses of $417,000 during the current quarter ended July 31, 2007 primarily due to the timing of initiating new clinical studies.
Interest and other income decreased $110,000 during the current quarter compared to the same prior year quarter. At July 31, 2007, the company had $30,635,000 in cash and cash equivalents, compared to $16,044,000 at fiscal year end April 30, 2007.
You gotta love this PR because big pharma is on the prowl and things like this will catch a few eyes:
"...Total revenues for the current quarter increased 286% to $1,625,000 versus $421,000 for the comparable quarter last year. Avid Bioservices, the company's wholly-owned contract manufacturing subsidiary, contributed $1,621,000 in contract manufacturing revenue versus $398,000 recorded in the similar prior year period..."
We're looking mighty cheap here with all this good news lately and should see a POP soon!
Picked up some more ;)
Peregrine Pharmaceuticals May Be On To Something-Seeking Alpha
http://seekingalpha.com/article/47860-peregrine-pharmaceuticals-may-be-on-to-something?source=yahoo
Breakout ;D
News
- Immunocytokine Combining Peregrine's Anti-PS Antibodies and IL-2 Protected 80% of Animals From a Lethal Challenge With a Highly Aggressive Form of Cancer
http://biz.yahoo.com/prnews/071005/laf038a.html?.v=1
ANNOUNCES FIRST PATIENT DOSED IN TRIAL: Peregrine Pharmaceuticals (PPHM) announced
that the first patient has been dosed in a clinical trial designed to evaluate the safety
and pharmacokinetics of bavituximab in patients co-infected with HCV and the human immunodeficiency
virus (HIV). This open-label, dose escalation study will be conducted in approximately
24 patients chronically infected with HCV and HIV.
I am with you guys on this one also. GLTA
Cheers
Well I was wrong on this one ;D
I let my gain turn into a loss and bailed at .59.
Still watching though and just saw that someone has some hilarious vids on youtube.
Enjoy!
http://www.youtube.com/watch?v=-Dw2iH79IGg&feature=user
http://www.youtube.com/watch?v=xeSfmjjWaMA
Press Release Source: Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals' Bavituximab Achieves Primary Endpoint in First Stage of Phase II Lung Cancer Study
Wednesday February 4, 8:00 am ET
-Preliminary Data Show Seven of 17 Evaluable Patients Achieved an Objective Tumor Response by End of Four Treatment Cycles-
TUSTIN, Calif., Feb. 4 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News) today reported that its lead product candidate bavituximab achieved the primary efficacy endpoint in the first stage of its ongoing Phase II clinical trial in patients with non-small cell lung cancer (NSCLC). The open-label, Simon two-stage study is designed to evaluate the safety and efficacy of the combination of bavituximab with the chemotherapy drugs carboplatin and paclitaxel in NSCLC patients. Seventeen of the 21 patients enrolled in Stage A were deemed evaluable for tumor response by the end of four treatment cycles, with six patients achieving partial tumor responses and one patient achieving a complete tumor response, according to RECIST criteria. These preliminary results exceed the pre-specified benchmark criteria established for enrolling an additional 28 patients in Stage B of this trial, up to a total of 49 patients.
"We are very pleased with the promising early results from this pilot Phase II lung cancer trial and will now move forward to initiate the second stage of the study," said Steven W. King, president and CEO of Peregrine. "We are encouraged by the number of tumor responses seen at this early time point of approximately 12 weeks in patients with NSCLC, a leading cause of cancer deaths that responds poorly to current treatments. As these patients continue on treatment, we will be assessing them for further signs of anti-tumor activity, and we look forward to sharing more data from this study as patient treatment and follow-up progress."
The primary objective of the multi-center Phase II clinical trial in patients with previously untreated locally advanced or metastatic NSCLC is to assess the overall tumor response rate. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. All tumor responses in the trial are being evaluated using RECIST criteria. Patients may continue to receive bavituximab alone after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable. The trial is being conducted in India according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.
Lung cancer is a major cause of cancer deaths worldwide. According to the American Cancer Society, in the U.S. lung cancer is the second most commonly diagnosed cancer in men and women and is the leading cause of cancer deaths. It estimates that in the U.S. in 2008, there were approximately 215,020 new cases of lung cancer and an estimated 161,840 lung cancer deaths. NSCLC is the most common type of lung cancer, accounting for approximately 85-90% of lung cancer cases.
Bavituximab is a monoclonal antibody that binds to the cellular membrane component phosphatidylserine (PS) that is usually located inside cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. By binding to PS, bavituximab is believed to help mobilize the body's immune system to destroy the tumor and the tumor blood vessels. Bavituximab currently is in two separate Phase II combination therapy trials for the treatment of advanced breast cancer and a Phase II combination therapy trial for the treatment of non-small cell lung cancer. A Phase I bavituximab monotherapy trial in advanced solid cancers is also continuing.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside 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 will experience delays or difficulties in enrolling patients in the study, the risk that the standard carboplatin and paclitaxel response rate will not be improved as a result of the combination therapy and the risk that the results of the subsequent stage for this trial will not be consistent with the results of the first stage. 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 the company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2008 and the quarterly report on Form 10-Q for the quarter ended October 31, 2008. 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.
Contacts:
GendeLLindheim BioCom Partners
Investors Media
[email protected] Barbara Lindheim
(800) 987-8256 (212) 918-4650
--------------------------------------------------------------------------------
Source: Peregrine Pharmaceuticals, Inc.
updated chart look...
Press Release Source: Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals Reports Progress in Cotara(R) Brain Cancer Clinical Program
On Thursday May 28, 2009, 7:59 am EDT
Data from Ongoing Glioblastoma Dosimetry Trial Accepted for Oral Presentation at 2009 Society of Nuclear Medicine Annual Meeting --
--Over 65 Recurrent GBM Patients in Phase I and Phase II Clinical Trials Have Received Cotara to Date, with a Good Safety Profile and Longer-Term Survivors Seen in All Studies--
TUSTIN, Calif., May 28 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and serious virus infections, today provided an update on progress in the company's clinical program for Cotara®, a targeted monoclonal antibody-based therapy being tested in a Phase II trial as a potential new treatment for recurrent glioblastoma multiforme (GBM), a deadly form of brain cancer. The company also reported that patient enrollment in the final cohort of a second Cotara GBM trial, a dose confirmation and dosimetry study, is nearing completion and that interim data from this trial has been accepted for an oral presentation at the Society of Nuclear Medicine Annual Meeting to be held June 13-18, 2009.
More than 65 patients with recurrent GBM have received Cotara in the current and previous clinical studies. Localization and accumulation of the drug to the tumor have been excellent and longer-term survivors (greater than one year from the time of Cotara treatment) have been observed in all of the trials, with some GBM patients from early clinical studies now alive more than 8.5 years after treatment with Cotara. Expected survival for patients with GBM is approximately six months from time of disease recurrence.
In the ongoing Phase II safety and efficacy trial, over half of the 40 planned GBM patients have been dosed with Cotara and patient follow-up is continuing. Screening for the anticipated final patient in the dose confirmation and dosimetry trial is underway and patient follow-up in that trial also is continuing. Data from this trial continues to support the superior targeting properties of Cotara and the resulting accumulation of high doses of radiation specifically in the tumor.
"We are encouraged at the continuing progress in the Cotara clinical program, with screening for the anticipated final patient in the dosing and dosimetry trial now underway, more than half of the planned GBM patients enrolled in the Phase II trial, and acceptance of our oral presentation at the upcoming Society of Nuclear Medicine Annual Meeting," said Steven W. King, president and CEO of Peregrine. "Patients have tolerated the Cotara regimen well and we continue to see longer-term survivors among the treated patients, consistent with our experience in previous Cotara clinical studies."
Overall, Cotara has been administered to a total of more than 115 patients with brain, colon or liver cancer. Promising data from these studies support Cotara's ability to specifically target solid tumors and its anti-tumor activity, as well as its acceptable safety profile.
Mr. King added, "We continue to actively explore partnering opportunities and options for expanding the accessibility of Cotara to GBM patients in the U.S. and other territories, to ensure continued development of this drug candidate that we believe may offer a positive treatment option for patients with this devastating disease."
The primary objective of the open label, multi-center Phase II trial is to confirm the maximum tolerated dose of Cotara in GBM patients at first relapse. Secondary objectives include estimates of overall patient survival, progression free survival and the proportion of patients alive at six months. Patients in the trial are receiving a single infusion of Cotara by convection-enhanced delivery (CED), a technique that delivers the agent to the tumor with great precision. Brain scans are administered at eight-week intervals post-treatment. Cotara has been generally well tolerated with an acceptable safety profile in clinical studies completed to date.
The main objectives of the open label Phase I dosing and dosimetry study at U.S. brain cancer centers are to confirm the maximum tolerated dose, to determine radiation dosimetry and to assess overall patient survival, progression free survival and the proportion of patients alive at six months following Cotara administration. Dosimetry data presented at the 2008 ASCO Annual Meeting showed that Cotara delivered 100-fold more radiation to the tumor as compared to other organs. Expanded data from this study has been accepted for an oral presentation at the Society of Nuclear Medicine Annual Meeting on June 16, 2009 in Toronto, Canada.
Cotara Presentation Details:
Reference #: 150240
Publication No.: 445
Abstract Title: Dosimetry of phase I interstitial 131I-chTNT-1/B MAb (Cotara) for the treatment of recurrent glioma
Accepted to: ISRTRD Integrated Session (Oral)
Session Info: Dosimetry/Radiobiology IV: Targeted, Diagnostic and Therapeutic Agents
Tuesday, June 16
12:30 PM - 2:00 PM
Room 701B
About Cotara®
Cotara is an experimental treatment for brain cancer that links a radioactive isotope to a targeted monoclonal antibody designed to bind to the DNA histone complex that is exposed by dead and dying cells found at the center of solid tumors. Cotara's targeting mechanism enables it to bind to the dying tumor cells, delivering its radioactive payload to the adjacent living tumor cells and essentially destroying the tumor from the inside out, with minimal radiation exposure to healthy tissue. Cotara is delivered using convection-enhanced delivery (CED), an NIH-developed method that targets the specific tumor site in the brain. In a previous clinical study, a subset of patients with recurrent glioblastoma treated with Cotara achieved a median survival of 38 weeks, a 58% increase over the historical median survival time of 24 weeks for patients treated with standard of care therapy. In this study, 25% of 28 recurrent patients survived for more than a year post-treatment and 10% of patients survived for more than three years. These data are considered a promising development in this deadly disease. Cotara has been granted orphan drug status and fast track designation for the treatment of glioblastoma multiforme and anaplastic astrocytoma by the U.S. Food and Drug Administration. A Phase I dosimetry trial in GBM patients in the U.S. has completed patient enrollment and a Phase II safety and efficacy trial in GBM patients in India is ongoing. For more information on the trials, visit www.clinicaltrials.gov.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and serious virus infections. The company is pursuing three separate clinical programs in cancer and hepatitis C virus (HCV) infection with its lead product candidates bavituximab and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com/), which provides development and bio-manufacturing services for both Peregrine and outside 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 will experience delays or difficulties in enrolling patients in the study and the risk that the survival results from future trials will not be consistent with historical survival results. 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 or otherwise adversely impact the company's ability to obtain regulatory approval for its product candidates 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 the company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2008 and the quarterly report on Form 10-Q for the quarter ended January 31, 2009. 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.
Contacts:
GendeLLindheim BioCom Partners
Investors Media
[email protected] Barbara Lindheim
(800) 987-8256 (212) 918-4650
Small Caps Wave Systems, Biodel: Small-Cap Winners
01/13/11 - 12:37 PM EST
NEW YORK (TheStreet) -- Shares of biotech company Biodel(BIOD) were topping the small-cap space on Thursday, jumping 27% to $2.49.
Biodel, a development stage biopharmaceutical company is focused on the diabetes market. The company will be presenting an update at the J.P.Morgan Heatlhcare Conference at 9:30 a.m PST. The update will include information about the development of new follow-on formulations of its lead product, Linjeta including milestones and timelines, according to its press release.
Nearly 5 million shares were changing hands on Thursday afternoon against an average trading volume of 900,000.
Wave Systems(WAVX) was also riding on heavy volumes, soaring 14% to $5.03. Over 4 million shares were changing hands on Thursday. The Obama Administration is working on a cybersecurity ID program that would allow users to log onto different sites without having to remember different passwords for each one. That has led to a pop in the shares of Wave Systems, which offers software that enables hardware encryption and the ability to do away with multiple passwords
Canada'sEXFO (EXFO) which provides services for the telecommunications industry, was soaring after it reported higher-than-expected profits .
The company earned $14.1 million, or 23 cents a share, for the three months ended Nov. 30 with total sales rising almost 50% year-over-year to $67.6 million. EXFO's outlook called for
earnings of 17 to 21 cents a share and sales ranging from $61 million to $66 million. Earnings growth was helped by the sale of the Life Sciences and Industrial Division for $23 million in cash.
EXFO forecast earnings of 3 to 7 cents a share and sales of between $70 million and $75 million. Shares were gaining 21% to $9.14 on volume of over 2 million on Thursday's trading, much higher than its average trading volume of 28,000.
Other stocks rising on higher volumes include TTM Technologies(TTMI), Peregrine Pharmaceuticals(PPHM) and China Media Express(CCME).
Among the losers, SemiLEDS(LEDS) was shedding about a third of its value Thursday after it issued a weak revenue outlook for the next quarter. The LED market player went public in December and has risen 25% since its IPO.
Shares of Canadian communications equipment maker DragonWave (DRWI) tumbled 16% to $8.75 after it reported a loss for the latest quarter and forecast a steeper sequential drop on the topline.
Trial News Make Peregrine Pharmaceuticals Worth Watching...
Day's Range: 2.73 - 3.09
52wk Range: 1.25 - 4.30
Volume: 2,580,748
Avg Vol (3m): 779,128
Market Cap: 190.52M
P/E (ttm): N/A
EPS (ttm): -0.46
Div & Yield: N/A (N/A)
Technicals
Percentage Gainer
Last Price Quote is:
20.45%above 13-day EMA
48.25%above 50-day EMA
RS Rating: 97
Trial News Make Peregrine Pharmaceuticals Worth Watchingat Seeking Alpha(Tue, Jan 11)
Recently, Peregrine Pharmaceuticals, Inc. (PPHM) announced that it has initiated several trials in oncology and viral infections. They seem poised to garner attention from the Street over the coming months.
Yesterday, we just got news they started another trial, this one is a Phase II clinical trial in patients with previously untreated genotype-1 hepatitis C virus (HCV) infection. Just days earlier, PPHM announced that it has initiated a randomized Phase 2 trial in patients with previously untreated stage IV pancreatic cancer. This is the second trial that PPHM has started since December, the other being a Phase I/II in advanced liver cancer. We like their approach and diversification. We believe this could be a top stock to follow in 2011.
Bavituximab is an extremely interesting molecule which has created a lot of buzz over the past two years; not just in oncology but also as a potent anti-viral. As PPHM's novel anti-phosphatidylserine (anti-PS) antibody candidate, bavituximab has shown considerable promise in preclinical animal models showing it can cure lethal virus infections. It is a broad-spectrum drug, which means it could potentially be used to treat many different viruses. This is because it improves the cell's defense against all viruses rather than attacking a specific type of virus directly.
Today's trial news builds on this antiviral research. This open-label Phase 2 trial will determine the early virologic response rate of patients after 12 weeks of therapy with Bavituximab, in combination with the antiviral drug ribavirin versus standard of care, pegylated interferon alpha 2a and ribavirin. PPHM also announced they expect to complete enrollment soon in an ongoing Phase Ib HCV trial and report data by mid-year.
Both trials in liver and pancreatic cancer are being conducted in combination with other chemotherapy agents in hopes of synergistic activity between the two to produce better results. This trial is being conducted in combination with the chemotherapeutic agent gemcitabine versus gemcitabine monotherapy. Prior research has shown that "combining the PS-targeting antibody bavituximab with gemcitabine (shown to increase PS exposure on tumor blood vessels) enhances anti-tumor effects and controls metastatic growth without added toxicity over gemcitabine alone in animal models of pancreatic cancer." In the liver cancer trial, they are hopeful that the "growth-blocking mechanisms of sorafenib with the vascular-targeting and immune-reactivation mechanisms of bavituximab offers additive anti-tumor effects for patients with HCC."
They are also investigating bavituximab in 2 Phase IIb clinical trials in non-small cell lung cancer (NSCLC), one of which is looking at the front-line setting with interim data expected sometime in mid-2011. Recently, they also announced that the last patient had been treated in their Phase 2 trial using Cotara in brain cancer (GBM). Cotara has been granted orphan drug status and fast track designation for the treatment of GBM and anaplastic astrocytoma by the U.S. Food and Drug Administration.
Joseph S. Shan, VP of clinical and regulatory affairs at Peregrine said, "We expect top-line data to be available by mid-year 2011 and plan to meet with the FDA to define the optimal registration pathway for Cotara." To us, it sounds like PPHM will have something in store for investors at ASCO 2011, on both the GBM and NSCLC fronts.
We also like their other business venture into bioprocessing, in which they just recently secured a development agreement for in the biosimilars arena. They also have a government contract to evaluate its phosphatidylserine-targeting antibodies for viral hemorrhagic fever which "provides up to $24.7 million in funding for the base period ending March 2011 for a total of up to $36.3 million in funding during the five-year potential duration of the contract," according to the company. Peregrine seems to have a highly diversified pipeline that is utilising external funding sources to help validate and explore some of their clinical candidates.
Roth Capital has high expectations for PPHM in 2011, with several upcoming data releases (Cotara and NSCLC Phase 2 results) as catalysts for partnering talks. Roth has them rated as a "BUY" with a $10 price target. At the end of 2010, PPHM entered into an At Market Issuance Agreement 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.