PPHM - Sector: Healthcare - Industry: Biotechnology & Drugs

[Se7en]

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

[Se7en]

9 & 200MA didn't hold ... 

[Se7en]

Update

[calven]

Terliso KEEP YOUR EYE ON THIS ONE!!!!!!!

asc triangle breakout -my favorite!! 

Comments on the chart and story appreciated

[setravis]

"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.                                           
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 $$$       

[boatguy]

Insider buys 

I'm in @ .65- risky

[boatguy]

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?

[boatguy]

Insider buys yesterday and today

Looking good, a close above the 50 sma would be very bullish.

[boatguy]

OK- closed HOD just above the 50 sma @ .74, traded up after hours to .77.

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...

[boatguy]

Well, what do we have here?! 

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.

[rdemp52572]

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

[la-onda]

looks good 

[boatguy]

Company PR out

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

[joet]

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

[stock-kitty]

Great Q results are out! 
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.