PPHM and Tarvacin discussion

[Andreea]

Hello!

First and foremost I think we should be more concerned about the success of this drug from a medical point of view and not so much on the finacial part. However it's great that you guys are bringing more people into the discussion!
Personally I would be interested more in the scientifical side of this drug rather than its "income" or monetary value on the market.

Can anyone please keep me up to date as to where are we standing with regards to the developments of this drug and its potential success in the medical field?

Thanks!

[Preciouslife1]

The science is what counts and great things are happening behind the scenes. When any news comes out I or someone else will post it here. There is CC at end of week, so we'll see what new developments mgt. has to tell us. Take care and stay tuned. PL1

[Preciouslife1]

Peregrine's Subsidiary Begins First Commercial Stage Drug Manufacturing Project
Tuesday December 6, 10:06 am ET - Avid Bioservices Is Manufacturing the Active Ingredients for Hylenex(TM), Now Approved for Marketing by the FDA -

TUSTIN, Calif., Dec. 6 /PRNewswire-FirstCall/ -- Avid Bioservices, Inc., the wholly owned manufacturing subsidiary of Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News), became a commercial stage manufacturing organization as FDA approval was announced for commercial distribution of a recombinant human enzyme Avid is manufacturing for Halozyme Therapeutics. Avid produces the active pharmaceutical ingredients (API) for the drug Hylenex(TM). The API produced by Avid will be further processed by Baxter Healthcare for final commercial distribution.

"This is a major milestone for Avid Bioservices, as we demonstrate our ability to move beyond clinical stage manufacturing into commercial production," said Steven W. King, chief executive officer of Avid. "This contract with Halozyme is an excellent example of the resources and potential Avid has to support companies during the inspection and approval processes. Having now added the capability for commercial stage production greatly enhances the opportunities available to both our partners and to Peregrine."

Avid maintains and operates a state-of-the-art cGMP manufacturing facility to produce monoclonal antibodies and recombinant proteins to diagnose and treat human diseases. The Tustin, California, manufacturing facility was expanded last year with the installation of a 1,000-liter mammalian cell culture bioreactor.

"The FDA's pre-approval inspection (PAI) is an important part of the drug approval process, and Avid has done a great job ensuring that their manufacturing processes and quality systems meet the standards for current good manufacturing practices (cGMP)," said Jonathan Lim, M.D., Halozyme's chairman and CEO. "Avid is a strong partner and we appreciate the relationship we have with them."

About Avid Bioservices

Avid Bioservices is the wholly owned manufacturing subsidiary of Peregrine Pharmaceuticals, Inc. Avid manufactures cGMP supplies for all phases of clinical trials and for commercial distribution for biotechnology and biopharmaceutical industries. The company's comprehensive range of services includes:

* cGMP cell banking and cell bank storage * Media and culture optimization for production in stirred tanks * Purification development and scale-up * cGMP manufacturing utilizing 100L, 300L and 1000L bioreactors in batch, fed-batch, and perfusion capacities * Assay development, qualification and validation * Final product filling (including labeling and packaging services) * In-process Material and Final Container testing using in-house assays and qualified contractors * In-process Material and Final Container Stability programs * Process validation * Regulatory strategy and support. For more information about Avid, please visit www.avidbio.com. About PeregrinePeregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and viral diseases. The company is pursuing three separate clinical trials in cancer and anti-viral indications with its lead product candidates Tarvacin(TM) 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.

[rootemail]

No answers ? Why ?

No one likes negative possibility, but that's part of our life as well as the market.

BTW, I've just bought 15% more and will hung here until positive Tarvacin news coming out.

[Preciouslife1]

That I don't have concrete answers to.

1) Tarvacin is in trial for HepC at Godofsky Center in Bradenton and with NIAID and several others.
When they will be finalized and data compiled is up to the company to say, and so far they haven't. The CC is this week.
2) If Tarvacin proves as efficacious in humans as guinea pigs then you have a major platform based winner here. Price???? I couldn't or can't say....
3) If Tarvacin did fail, then the major driver of future revenue dies, but there is still Cotara, patents, and Avid.
Is BK a possibility, yes. But so is it with General Motors also.
Sorry I can't be more informative, but we all have to wait on the human data to start hypothasizing about share price and the next indications. They're in Duke now and they are great with HIV. Take care and keep posts coming....PL1

[rootemail]

That's whay I like to hear. Thanks.

Originally Posted by Preciouslife1

3) If Tarvacin did fail, then the major driver of future revenue dies, but there is still Cotara, patents, and Avid.

[rootemail]

By vettesquare in Yahoo PPHM group:

What you're missing is the government and the military are testing Tarvacin at their expense, primarily for it's anti-virus properties.

They don't have to wait on 'no stinkin' FDA approval', especially if Tarvacin is effective against bio-weapons... lassa and marburg fever... stuff like that.

and there's the animal rule, if Tarvacin looks good to them pre-clinically, and doesn't kill the critters it's injected into... then crank-up the bioreactor for millions of doses for soldiers and citizens.

You have to realize the pre-clinical data on this stuff is astounding.
And it's been accepted into trials at the top cancer and virus centers in the U.S., which is an extremely competitive process. So you have to realize those doctors already see the promise.

Further, this stock could rocket long before any FDA approval, if it looks 'juicy' in Ph-I and Ph-II trials, big pharmaceutical companies come knocking to make deals, or, as I believe will happen, buy us out.

That's what you're missing, vettesqaure.

Don't miss the ride up! It's coming!

[rootemail]

dup. sorry.

I bet PPHM goes to $ 2.00 Friday ?

[Preciouslife1]

I can't see the impetus for that unless they release some preliminary human data that infers efficacy and no adverse side effects. Every indication so far including my friend in the Godofsky trial indicates that it is very well tolerated and no apparent side effects which is great. Good HUMAN DATA will bring parabolic share price rise IMO. The platform is great and growing and the bricks are being laid daily for the future.
All in all, it looks real good for 2006 IMHO. Take care and keep it coming...PL1

[strad]

(can ya tell I'm excited about this?

2nd Annual Viral Hepatitis in Drug Discovery and Development
Monday, February 27, 2006 1:50 p.m. ET / 10:50 a.m. PT
Speakers: Joseph Shan, MPH, Senior Director, Clinical & Regulatory Affairs, Peregrine Pharmaceuticals, Inc.

Location: Hilton Boston Back Bay
Boston, MA

http://www.srinstitute.com/conf_page...ruary2720 06/

Initial Results from a Phase 1 Trial of Tarvacin™ in Patients with
Tarvacin™, a chimeric monoclonal antibody, targets an internal plasma membrane phospholipid, phoshphatidylserine (PS) that becomes externally exposed on the surface of virally-infected host cells and enveloped viruses. Preclinical studies support its potential use as a broad-spectrum antiviral therapy. Tarvacin™ has been shown to bind to viruses from six different families, including influenza A and B, HIV 1 and 2, RSV, pichinde (model for Lassa fever) and BVDV (model for HCV). Additionally, Tarvacin™ protected animals from lethal infections of cytomegalovirus or pichinde. Initial results will be presented from a phase 1 study designed to evaluate the safety, pharmacokinetics and changes in viral load in patients with chronic hepatitis C virus infection who have failed or no longer respond to pegylated interferon plus ribavirin combination therapy.





strad

[Preciouslife1]

On February 27th at the Hilton in Boston this Hepatitis Conference will take place and Joe Shan will be the speaker for PPHM @1:50 to give preliminary data for Tarvacin in anti viral:

Initial Results from a Phase 1 Trial of Tarvacin™ in Patients with Tarvacin™, a chimeric monoclonal antibody, targets an internal plasma membrane phospholipid, phoshphatidylserine (PS) that becomes externally exposed on the surface of virally-infected host cells and enveloped viruses. Preclinical studies support its potential use as a broad-spectrum antiviral therapy. Tarvacin™ has been shown to bind to viruses from six different families, including influenza A and B, HIV 1 and 2, RSV, pichinde (model for Lassa fever) and BVDV (model for HCV). Additionally, Tarvacin™ protected animals from lethal infections of cytomegalovirus or pichinde. Initial results will be presented from a phase 1 study designed to evaluate the safety, pharmacokinetics and changes in viral load in patients with chronic hepatitis C virus infection who have failed or no longer respond to pegylated interferon plus ribavirin combination therapy


.



Speaker(s)Joseph Shan, MPH
Senior Director, Clinical & Regulatory Affairs
Peregrine Pharmaceuticals

[Preciouslife1]

Anti-Phospholipid Therapy in the Treatment of Viral Diseases:

Peregrine scientists and its collaborators at the University of Texas Southwestern Medical Center at Dallas have determined that Tarvacin™ and other Anti-Phospholipid Therapy antibodies may also have applicability in the treatment of a host of serious viral diseases. Many viruses, after infecting and replicating within a host cell, envelope themselves with sections of the host cell’s membrane as they exit. However, these “enveloped” virus particles lack the mechanism to maintain normal phospholipid organization, resulting in exposure of phosphatidylserine (PS)</SPAN> and phosphatidylethanolamine (PE) on the outside of the virus particle.



Researchers at the University of Texas Southwestern Medical Center at Dallas have been carrying out studies to determine whether Tarvacin™ and other anti-aminophospholipid antibodies are useful agents for the treatment of viral diseases resulting from infection with enveloped viruses. The research has been funded by Peregrine and The National Institute of Allergy and Infectious Diseases (NIAID) which is part of the National Institutes of Health (NIH). This breakthrough research has been focused on determining if the target for Tarvacin™ is present on the surface of virally infected cells and viral particles and whether Tarvacin™ is effective at preventing or treating viral infection in Pichinde virus which is an established model for Lassa Fever, a fatal viral hemorrhagic fever that is on the U.S. government’s biodefense Category A watch list.
Peregrine researchers believe that phosphatidylserine and other anionic phospholipids provide an essential element required for viral life cycles; targeting these molecules may disrupt replication and/or viral maturation or egress. Studies in several in vitro models show that anti-phosphatidylserine antibodies bind both to enveloped virus particles and cells infected with enveloped viruses and interfere with viral replication (see table below).

Table 1. Summary of In Vitro Studies with Anti-phosphatidylserine Antibodies

Virus Family

Virus

Binds to Virus

Binds to Virus-Infected

Cells

Inhibits Virus Replication

Arenaviridae

Pichinde

P

P

P

Flaviviridae

BVDV (in vitro surrogate for hepatitis C virus)

P

nt

nt

Herpesviridae

VZV

P

nt

nt

Orthomyxoviridae

InfluenzaA & B

P

P

nt

Paramyxoviridae

Measles

P

nt

nt

RSV

P

nt

P

Poxviridae

Vaccinia (in vitro model for smallpox)

nt

P

nt

Rhabdoviridae

VSV

nt

nt

P

Retroviridae

HIV‑1 and 2

P

nt

nt

Abbreviations: Bovine viral diarrhea virus (BVDV), Varicella zoster virus (VZV), Respiratory syncitial virus (RSV), Vesicular stomatitis virus (VSV), Human immunodeficiency virus (HIV). (nt) indicates not tested for that viral system.

Together, the in vitro viral models used in these studies represent 8 different viral families (and include single and double stranded RNA and DNA viruses), suggesting that Tarvacin™ may provide broad-spectrum activity.

In addition to the in vitro data shown above, in vivo studies in 2 rodent models have shown a survival benefit for animals treated with anti-phosphatidylserine antibodies versus control animals. Anti-phosphatidylserine antibodies provided significant protection in animals infected with cytomegalovirus (CMV) with 100% of the anti- phosphatidylserine antibody‑treated animals surviving and only 20% of animals receiving control treatment surviving. Tarvacin™ provided significant protection in animals administered lethal viral loads of pichinde virus (a model of lassa fever) with 50% of the Tarvacin™ treated animals surviving and none of the animals receiving control treatment surviving. Moreover, Tarvacin™‑treated guinea pigs who survived the infection became immune to subsequent infections with the same viral strain. An interesting hypothesis still to be tested is whether treatment of one virus with APT agents confers protection against infection by other enveloped viruses.

[Preciouslife1]

In addition to the in vitro data shown above, in vivo studies in 2 rodent models have shown a survival benefit for animals treated with anti-phosphatidylserine antibodies versus control animals. Anti-phosphatidylserine antibodies provided significant protection in animals infected with cytomegalovirus (CMV) with 100% of the anti- phosphatidylserine antibody‑treated animals surviving and only 20% of animals receiving control treatment surviving. Tarvacin™ provided significant protection in animals administered lethal viral loads of pichinde virus (a model of lassa fever) with 50% of the Tarvacin™ treated animals surviving and none of the animals receiving control treatment surviving. Moreover, Tarvacin™‑treated guinea pigs who survived the infection became immune to subsequent infections with the same viral strain. An interesting hypothesis still to be tested is whether treatment of one virus with APT agents confers protection against infection by other enveloped viruses.

What is particularly exciting about these initial findings is that the recognition of viral particles by Tarvacin™ is dependent on a structural component believed to be universal to all enveloped viruses, giving it the potential to be a broad-spectrum treatment. It is also a property that is determined by host physiology, not the viral genome, making viral resistance much more difficult to achieve.

Selected Families and Examples of Enveloped Viruses

• Coronaviruses (SARS)
• Orthomyxoviruses (Influenza)
• Paramyxoviruses (Respiratory Syncytial Virus)
• Poxviruses (Smallpox)
• Retroviruses (HIV)
• Viral Hemorrhagic Fevers
  

  • Arenaviruses (Lassa Fever)
  • Bunyaviruses (Hantavirus)
  • Filoviruses (Ebola Fever)
  • Flaviviruses (yellow fever; dengue fever; hepatitis C; West Nile)

Based on the strength of this data and the potential for Anti-Phospholipid Therapy to be active against a broad spectrum of clinically significant viruses, NIAID and Peregrine have entered into a collaboration to screen APT agents for activity both in vitro and in vivo against a wide range of enveloped pathogens including Hepatitis B and C, influenza, SARS and hemorrhagic viruses. The NIAID biodefense program is particularly interested in finding treatments for viral hemorrhagic fevers (VHFs), which pose a grave risk from intentional exposure because, with very few exceptions, no vaccines or proven treatments exist, and many VHFs are highly fatal and highly transmissible.

To date, pre-clinical studies using Tarvacin and other Anti-Phospholipid Therapy antibodies for treatment of viral disease have yielded extremely promising results. A Tarvacin™ phase 1 study in patients with chronic hepatitis C virus infection is underway.

[Preciouslife1]

Tustin Company Thinks New Drug Could Target Cancer and Multiple Viruses
SourceURL:http://www.rednova.com
http://www.hcvadvocate.org/news/newsRev/2005/NewsRev-109.html#11 click on Tustin link at bottom fo links......

Jul. 16--What if someone told you they had a drug that could fight cancer and nearly every human virus from HIV to hepatitis C, and from Ebola to the common flu?

You might be a little surprised, a little curious, a little excited -- and more than a little incredulous.

But Peregrine Pharmaceuticals, a small Tustin company, is making a big bet on a new drug that it says could be just such a panacea.

The drug, Tarvacin, is in the early testing stages. So far, it has shown promising results against cancer in mice and against at least two viruses, including one that causes a kind of hemorrhagic fever related to the deadly Ebola.

Peregrine recently received federal approval to begin initial testing of Tarvacin in humans for solid tumors and for hepatitis C. It's also being tested at lower trial levels -- not on humans -- against the HIV virus, which causes AIDS, and many others.

A government agency recently asked Peregrine for permission to test the drug against some 30 viruses considered to be potential agents of bioterror. The company hopes those tests could lead to early approval of Tarvacin for use in the case of a bioterror attack -- a move that would make the drug an earner before it got formal approval from the U.S. Food and Drug Administration for wider distribution.

Executives at Peregrine know it's still early. But they think -- and hope -- that they might just be on to something big. When they ponder the best-case scenario, they get stars in their eyes -- and more than a few dollar signs.

"This could be the biggest science discovery of my lifetime if it works against all these viruses and cancer at the same time," says Paul Lytle, Peregrine's chief financial officer. "If you went out and tried to develop vaccines for all these viruses, it could take hundreds of years." When Lytle and his colleagues think of role models, they point to Genentech Inc. in South San Francisco, whose pioneering anti-cancer drug Avastin has posted sales of $640 million since its approval early last year.

"You want to model yourself on the people who have been successful," says Steven King, Peregrine's chief executive officer. If the early claims about Tarvacin are borne out, he sees no reason Peregrine couldn't be catapulted from money-losing research mode into the pharmaceutical big leagues.

"I see that as a way the market has actually responded to a product such as the one we're developing," King says. "I think Tarvacin represents what could be termed a blockbuster type drug." Scientists who are working on the drug with Peregrine are also excited, but they urge caution. They warn that hypotheses often crumble in the laboratory for reasons that weren't even imagined beforehand -- and that tests in humans don't always turn out the way they did in animals.

"There are no guarantees, but it's an interesting idea and it looks promising," says Preston A. Marx, a virologist at the Tulane University Primate Center in Covington, La., who's working as a paid consultant to Peregrine. "There's a lot of additional work until you realize this." Philip E. Thorpe, a professor of pharmacology at the University of Texas Southwestern Medical Center in Dallas and a paid Peregrine consultant -- whom executives at the company call "the father" of Tarvacin -- notes that recent tests of the drug in mice have shown almost complete abolition of cancer growth and ********************stasis. But "we need to demonstrate efficacy in humans," he says.

The reason Tarvacin appears to have such a broad range of uses is that it targets not any specific cancer or virus, but rather a substance found in the membranes of all cells. When cells become malignant, or are infected by a virus, the substance -- known as a phospholipid -- moves from the inside of the membrane to the outer surface, allowing Tarvacin to bind with it.

The binding marks the cell, raising a red flag that alerts the immune system to the presence of a foreign body. With viral infections, the body's white blood cells attack the viruses. With cancer, the immune system appears to destroy the blood vessels of a tumor, depriving it of the nutrients it needs to grow.

"The concept is almost so simple it's hard to believe no one picked up on it before," says King, the CEO.

In cancer, Tarvacin might prove particularly effective in combination with chemotherapy and radiation, Thorpe says. That's because those more traditional treatments appear to enhance the movement of phospholipids to the surface of the membrane, giving Tarvacin a bigger target.

Scientists say Tarvacin could have an advantage over other anti-viral drugs, because viruses probably won't be able to evade it by mutating.

"Mutation won't affect it because it's targeting a substance which is not intrinsic to the virus itself but to the host cell -- so that substance will be there no matter what new form the virus takes," says Stephen M. Smith, a paid Peregrine consultant and chief of infectious diseases at the Seton Hall school of Graduate Medical Education in New South Orange, Jersey.

Peregrine executives say that even if Tarvacin doesn't pan out, there are still other lines of business that could help make the company profitable.

They are fairly far along with testing of Cotara, a drug that has shown some effectiveness against a certain type of brain tumor. And they receive royalties from the licensing of intellectual property to other, more established drug firms.

In addition, Peregrine's wholly owned manufacturing subsidiary, Avid Bioservices, has a contract to produce an eye drug for another company -- a deal that could mean significant new revenue.

But clearly, Tarvacin is the 800 pound gorilla in Peregrine's board room these days. And while company executives soak in the headiness of a potentially revolutionary new discovery, the scientists are whispering in their ears a mix of excitement, caution and good old-fashion scientific curiosity.

"I don't know where it's going to lead us, but the approach is clearly unique," says Seton Hall's Smith. "As I tell my fellows, empiricism rules.

But from a theoretical point of view, it's really fun to think about."

PEREGRINE PHARMACEUTICALS INC.