What is Tarvacin™ and Peregrine Pharmaceuticals

[Preciouslife1]

This question has been posed to me by inquiries through the Private messaging function as well as form Leonid, from this scientific based
site. I will try to explain the Tarvacin(BAVITUXIMAB NOW) Platform in an easy and concise
way. First, as fate would have it, PPHM upgraded their fine website
today and made it even better, easier to navigate and user friendly.
The address is: http://www.peregrineinc.com/
When you click on the blue tabs on top, you will see that a drop down
menu appears where you can click on the subject of choice. Whether
it is the Pipeline and Clinical Programs or the Technology tab, you will see extensive data and facts on that given subject. PPHM has a broad pipeline consisting of anti cancer and anti viral platforms.
On the next few posts I will provide the information about Tarvacin and Cotara. If you want, you can access the information yourself, in your own order just by clicking on the clinical programs or the three tabs with pictures in the middle of the page. I hope this explains this unique and novel platform that is in clinical trials testing for safety and efficacy in Cancer, HCV(HepC) and anti viral with the NIAID and USAMRIID government agencies. Thank you for coming here to this site and wanting to learn more about an all encompassing drug platform that truly has the potenial to revolutionalize medicine as we know know it. Thank you, Preciouslife1.

***DISCLAIMER: This message board is not affiliated with Peregrine Pharmaceuticals. No endorsement by Peregrine Pharmaceuticals. or any other organization is implied.*****

[Preciouslife1]

http://www.peregrineinc.com/***********************************.php?mi=Mzk=
Tarvacin™ Anti-Cancer is a monoclonal antibody that binds to a basic component of the cell structure called a phospholipid that is exposed only on the surface of tumor blood vessel cells or on cells infected with certain viruses.
Tarvacin binding to the tumor blood vessel cells alerts the body’s immune system to attack the tumor and its blood supply.

This has been shown to inhibit tumor growth and development. Because in healthy cells the phospholipids are concealed inside the cell, the Tarvacin does not bind to them. This targets the Tarvacin to the malignant cells and potentially minimizes unwanted side effects. For more scientific information about Tarvacin Anti-Cancer, click here.

Solid Cancer Phase I Clinical Trial. Peregrine is currently conducting a clinical trial in patients with advanced solid tumor malignancies that have failed to respond to available treatments. As of December 2005, the trial is underway at five sites nationwide. The clinical trial is designed to accommodate up to 28 patients with advanced solid tumors who are no longer responsive to standard cancer treatments.
This is an open-label, dose escalation study. The objectives are to (1) determine the safety and tolerability of Tarvacin administered intravenously to patients with advanced cancer; (2) characterize Tarvacin’s activity in the body and; (3) define the maximum tolerated and/or maximum effective dose.

“We are committed to making cancer history by both discovering and helping to develop new cancer therapies. We look forward to working with Peregrine to further assess the potential of this innovativeapproach to treating this challenging disease.”

Nuhad K. Ibrahim, M.D.
associate professor of medicine at
M.D. Anderson Cancer Center and a
principal investigator of the
Tarvacin Anti-Cancer study

If you are a health care provider interested in referring a patient or learning more about these clinical trials, please send an email correspondence to Peregrine Pharmaceuticals at clinicalaffairs@peregrineinc.com or visit ClinicalTrials.gov.

If you are a patient interested in participating in one of these trials, please have your personal physician send an email correspondence to Peregrine.

[Preciouslife1]

Phospholipids are normal molecular structures that are present in all cells of the human body. Scientists working with Peregrine discovered that certain phospholipids normally found on the inside of cell membranes become exposed on the outside of tumor blood vessel cells making them targets for anti-cancer treatments. These phospholipids are also exposed on the outer surface of cells infected by a broad class of viruses know as enveloped viruses making them a specific target for the potential treatment of those diseases.

To take advantage of this effect, Peregrine has developed a monoclonal antibody called Tarvacin™ that preferentially binds to aminophospholipids only when they are exposed on the surfaces of virally infected or malignant cells. The drug’s binding to the phospholipids alerts the body’s immune system to attack the tumor and its blood supply, or to attack the virally infected cells while potentially minimizing unwanted side effects in healthy tissues. Tarvacin is Peregrine’s lead Anti-Phospholipid Therapy agent.

Applications: Pre-clinical studies demonstrated that Tarvacin also binds to tumor blood vessels and inhibited growth and development of multiple solid tumor types. Tarvacin Anti-Cancer is currently in Phase I clinical trial for patients with advanced refractory solid tumors. For more information on this clinical trial, click here.

• Phospholipids are normal molecular structures that are present in all cells of the human body, indicated here in green.

• Scientists working with Peregrine discovered that on tumor vasculature...

• ...certain phospholipids normally found on the inside of cell membranes become exposed on the outer urfaces of tumor blood vessels, creating a specific target for anti-cancer treatments.

• Tarvacin is a monoclonal antibody that binds specifically to these phospholipids.

• Once bound to the tumor blood vessels, Tarvacin Anti-Cancer alerts the body’s immune system to attack the tumor and its blood supply…

• ...stopping the flow of oxygen and nutrients to the tumor cells and resulting in tumor cell death.

The findings were generated in the laboratory of Philip Thorpe, Ph.D., professor of pharmacology at the University of Texas Southwestern Medical Center at Dallas and a member of Peregrine's Scientific Resource Board.

The Tarvacin Anti-Cancer Concept: The rapid and disorganized growth that is the hallmark of cancer, results in the exposure of anionic phospholipids, principally phosphatidylserine (PS), to the outer surfaces of tumor blood vessel cells. Since these phospholipids are not exposed in normal tissues, they represent an abundant and unique target for therapy or diagnosis.


Peregrine tested this hypothesis by injecting the parent antibody, mouse-derived 3G4, into animals bearing various solid tumors. The antibody bound to tumor blood vessels, but not normal blood vessels, markedly inhibiting the growth of various solid tumor types including human breast tumors. Combination therapy using 3G4 and chemotherapy or radiation therapy in mouse tumor models showed even greater inhibition of both primary and ********************static cancer growth. These studies laid the basis for Peregrine’s development of Tarvacin a chimeric (mouse/human) version of 3G4 and its movement into clinical trials.

In October 2005, the U.S. Department of Defense Prostate Cancer Research Program awarded a grant totaling $582,988 to the University of Texas Southwestern Medical Center at Dallas to study the use of vascular targeting antibodies (Tarvacin) in combination with chemotherapy agents for the treatment of prostate cancer. Dr. Philip Thorpe, a member of the Peregrine Scientific Resource Board and an inventor of the technology, will be the principal investigator.

“Receipt of this peer-reviewed grant from the Department of Defense signals the growing scientific interest and acceptance of the potential therapeutic value of our vascular targeting antibodies.”

Philip Thorpe, Ph.D.

[Preciouslife1]

Tarvacin™ Anti-Viral represents a unique approach to treating viral diseases by attacking features found only on infected cells. Tarvacin is a monoclonal antibody that binds to a basic component of the cell structure called an aminophospholipid that is exposed on the surface of cells only when they are infected with certain viruses or when they are malignant.
After binding to these infected cells, the drug alerts the body’s immune system to attack the infected cells. This makes infected cells particularly susceptible to Tarvacin treatment, while potentially sparing healthy cells. Also, Tarvacin binds to the host (human) cell and not the virus, which indicates it may not be susceptible to viral drug resistance. In addition to treating an active illness, Tarvacin may also confer long-term immunity. For more scientific information about Tarvacin Anti-Viral, click here.

Hepatitis C Phase I Clinical Trial. Peregrine is currently conducting a Phase I clinical trial for the treatment of chronic hepatitis C virus (HCV) infection. According to the World Health Organization, an estimated 170 million people are chronically infected with HCV globally. HCV is a major cause of acute hepatitis and chronic liver disease and is the leading cause of liver transplantation in the United States.

The Phase I trial is a dose escalation study designed to evaluate the safety, tolerability, and biological activity (pharmacokinetics and viral load) following a single intravenous infusion of of Tarvacin Anti-Viral in up to 32 patients with chronic HCV infection. The trial is open to patients who either no longer respond to or who have failed standard therapy. The trial is underway at the largest private infectious disease practice specializing in the treatment of viral hepatitis in the United States. Initial Phase I results are anticipated in the first quarter of 2006.



In pre-clinical experiments, Peregrine continues to evaluate Tarvacin's potential for the treatment of several virus infections including influenza and HIV.

If you are a health care provider interested in referring a patient or learning more about these clinical trials, please send an email correspondence to Peregrine Pharmaceuticals at clinicalaffairs@peregrineinc.com or visit ClinicalTrials.gov.


If you are a patient interested in participating in one of these trials, please have your personal physician send an email correspondence to Peregrine.

[Preciouslife1]

Scientists working with Peregrine discovered that certain phospholipids normally found on the inside of cell membranes become exposed on the outside of tumor blood vessel cells making them targets for anti-cancer treatments. These phospholipids are also exposed on the outer surface of cells infected by a broad class of viruses know as enveloped viruses making them a specific target for the potential treatment of those diseases. To take advantage of this effect, Peregrine has developed a monoclonal antibody called Tarvacin™ that preferentially binds to aminophospholipids when they are exposed on the surfaces of virally infected or malignant cells. The drug’s binding to the phospholipids alerts the body’s immune system to attack the tumor and its blood supply, or to attack the virally infected cells while potentially minimizing unwanted side effects in healthy tissues. Tarvacin is Peregrine’s lead Anti-Phospholipid Therapy agent.

Applications: Tarvacin Anti-Viral is in Phase I clinical trial for hepatitis C virus. For more inofrmation on this clinical trial, click here.

Tarvacin has also been shown to recognize a broad spectrum of enveloped viruses, a category that includes nearly half of the viruses that cause human disease. Data developed by Peregrine demonstrate that Tarvacin binds to members of six different virus families. In addition to bovine viral diarrhea virus, a model for hepatitis C, these include influenza A and B, HIV 1 and 2, measles, respiratory syncytial virus and pichinde virus, a model for the deadly Lassa hemorrhagic fever.

• Phospholipids are normal molecular structures that are present in all cells of the human body. (Here they are represented by the green line within the cell.)

• Scientists working with Peregrine discovered that certain phospholipids normally found on the inside of cell membranes become exposed on the surface of cells infected by a broad class of viruses known as enveloped viruses. When these viruses reproduce and exit the host cell, they carry along the host cell’s membrane to make their own envelope or coat. This outer shell of the virus is known as the viral envelope.

• This exposes the target phospholipid on both the surface of the host cell and the virus cells. These phospholipids are similarly exposed on the surface of tumor blood vessels.

• To take advantage of this effect, Peregrine has developed a monoclonal antibody called Tarvacinthat preferentially binds to these target phospholipids, but can reach them only when they are exposed on the surfaces of virally infected or malignant cells.

• The drug’s binding to the phospholipids alerts the body’s immune system to attack the virally infected cells, while non-targeted healthy cells are left intact. Because Tarvacin binds to a phospholipid from the infected human cell rather than from the virus, it should not be affected by virus mutations, a problem that frequently leads to viral drug resistance.

The findings were generated in the laboratory of Philip Thorpe, Ph.D., professor of pharmacology at the University of Texas Southwestern Medical Center at Dallas and a member of Peregrine's Scientific Resource Board.

Background: Pre-clinical data demonstrated that Tarvacin exhibits significant anti-viral therapy and may be effective against a broad spectrum of enveloped viruses. And because Tarvacin binds to the infected host cell rather than the virus, it should not be affected by virus mutations, a problem that frequently leads to viral drug resistance.

Highlights of pre-clinical results presented at the American Association of Immunologists annual meeting in April 2005 and the Biotechnology Industry Organization annual meeting in June 2005 include:

• 100% of animals lethally infected with mouse derived (murine) cytomegalovirus (CMV) and treated with Tarvacin survived as compared with 20% survival in control treated animals
• Animals lethally infected with Pichinde virus (a model for Lassa fever, a fatal viral hemorrhagic fever that is on the U.S. government’s biodefense Category A watch list) and then treated with Tarvacin showed a 50% survival rate as compared to zero survivors in the control treated group
• Surviving animals infected with Pichinde virus did not show any signs of viral infection several months after treatment with Tarvacin and were considered to have been disease free
• Surviving animals had long-term immunity to further infection with the Pichinde virus
• Tarvacin protected lethally infected animals whether treated at the time of viral challenge or after symptoms had developed indicating an active viral infection

[Preciouslife1]

Cotara® is an antibody attached to a radioactive molecule. Like a guided missile, the antibody is designed to target specific features at the core of a tumor to deliver a radioactive isotope to kill the tumor literally from the inside out.
Peregrine is working in collaboration with New Approaches to Brain Tumor Therapy (NABTT), a brain cancer consortium funded by the National Cancer Institute, to conduct a clinical trial designed to further evaluate safety and efficacy of a single Cotara infusion in patients with first or second recurrence of glioblastoma multiforme, a particularly deadly form of brain cancer. Cotara has been granted orphan drug status for the treatment of two very different forms of brain cancers -- glioblastoma multiforme and anaplastic astrocytoma.

The trial is designed to treat up to 28 patients, although the study may be expanded as it progresses. Patients who have had prior surgery, chemotherapy, or some forms of radiation treatment may be eligible for the trial. However, patients may be excluded if they have received radiosurgery, brachytherapy, gliadel wafers (implanted wafers containing chemotherapeutic) or other local therapies.

If you are a health care provider interested in referring a patient or learning more about these clinical trials, please send an email correspondence to Peregrine Pharmaceuticals at clinicalaffairs@peregrineinc.com or visit ClinicalTrials.gov.





If you are a patient interested in participating in these trials, please have your personal physician send an email correspondence to Peregrine.

[Preciouslife1]

Tumor Necrosis Therapy (TNT), Peregrine’s most clinically advanced technology, uses monoclonal antibodies attracted to the dead and dying cells found at the core of tumors. When these antibodies are conjugated (attached) to therapeutic agents such as radioisotopes, they carry the anti-cancer agent into the tumors to kill them from the inside out. Cotara® is the company’s lead TNT compound.
Applications: Peregrine is working in collaboration with New Approaches to Brain Tumor Therapy (NABTT), a brain cancer consortium funded by the National Cancer Institute, to conduct a clinical trial designed to further evaluate safety and efficacy of a single Cotara® infusion in patients with first or second recurrence of glioblastoma multiforme, a particularly deadly form of brain cancer. For more information on this clinical trial, click here.
Peregrine has also licensed a TNT therapeutic for the treatment of advanced lung cancer to Medipharm BioTech that is the first radio-labeled monoclonal antibody approved for cancer therapy in China. Marketing is pending approval of the manufacturing facility.

The TNT Concept. Tumor Necrosis Therapy (TNT) acts by binding to dead and dying cells found primarily at the necrotic core of a tumor. Most solid tumors develop a core of dead or dying (necrotic) cells in the center of the tumor mass as it grows. The outer membranes of necrotic cancer cell become leaky, which exposes the DNA making it an abundant but selective target. The DNA target may also be more stable and reliable than conventional targets, since it is not believed to modulate as is commonly seen with tumor-specific cell surface antigens that are used with other antibody-based therapeutic modalities.

Because it is attracted to necrotic regions throughout the tumor, TNT can deliver a toxic payload to neighboring viable cancer cells, resulting in their death. TNT antibodies are potentially capable of carrying a variety of therapeutics agents into the interior of solid tumors including radioisotopes and chemotherapeutic agents. Peregrine’s first TNT-based product, Cotara, is an antibody conjugated to Iodine 131, a therapeutic radioisotope. The radioisotope kills adjacent cancer cells and has an additional advantage over other therapeutics, since it can be easily tracked by scanning devices to be sure it is entering the tumor and not dispersing in healthy tissues.

Cotara’s conjugated isotope has an additional advantage over other therapeutics. As demonstrated in this SPECT analysis of the cranium of a patient suffering from a type of brain cancer called glioblastoma multiforme, Cotara can be easily tracked by scanning devices to be sure it is entering the tumor as seen here, and is not dispersing in healthy tissues.

Another potential advantage is that each successive treatment with TNT potentially kills more cancer cells, expanding the necrotic area of the tumor, thus becoming more effective upon subsequent doses, contrary to conventional chemotherapy, which may lose its therapeutic effect due to increased drug resistance. The TNT targeting mechanism could be the basis for an entire class of new products effective across a wide-range of solid tumor types, including brain, lung, colon, breast, liver, prostate and pancreatic cancers.

[Preciouslife1]

Avid Bioservices is the wholly owned manufacturing subsidiary of Peregrine serving the biotechnology and biopharmaceutical industries. Avid manufactures cGMP supplies for all phases of clinical trials and for commercial distribution. Its facility was expanded last year with the installation of a 1,000-liter mammalian cell culture bioreactor. Avid manufactures research and clinical products for Peregrine and for external customers. Its 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
• 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 info...

[Preciouslife1]

Information from IHUB board and CJGaddy whose efforts have
informed and helped many to understand this unique Platform:

Tarvacin ALL SOLID CANCERS Phase1 status:
6-10-05 Trial initiated at Arizona CC: "will enroll up to 28 patients with advanced solid tumors that no longer respond to std. cancer treatments. Patients who demonstrate an objective response may be offered continued treatment on an extension protocol."
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=719219
6-10-05 Initial sites: ArizonaCC/Tucson (PI: Dr. Linda Garland) & Premiere Oncology/Scottsdale (PI: Dr. David Mendelson): http://www.azcc.arizona.edu
9-2-05 Added 3rd site: Premiere Oncology/SantaMonica (PI: Dr. Lee Rosen): http://www.premiereoncology.com
10-21-05 Added 4th site: M.D.Anderson/Houston (PI: Dr. Nuhad K. Ibrahim) http://tinyurl.com/cnytx
12-9-05 Added 5th site: Scott & White Hospital, Temple TX (PI: Dr. Lucas Wong) http://tinyurl.com/ag3am
1-27-05 Tarvacin Cancer IND Approval: http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=667441
###CANCER Trial protocol at ClinicalTrials.gov: http://www.clinicaltrials.gov/ct/show/NCT00129337

Tarvacin HEPATITIS C Phase1 status:
8-8-05 HEP-C Trial Inititates at Bach and Godofsky Infectious Diseases, Bradenton FL:
"An dose-escalation study in up to 32 patients with chronic HepC (HCV) who either no longer respond to or failed std. therapy with pegylated interferon & ribavirin combo therapy - conducted at Bach & Godofsky Infectious Diseases, the largest private infectious disease practice specializing in the treatment of viral hepatitis in the USA."
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=740477
1-18-06: HepC Trial "ahead of schedule" http://www.investorshub.com/boards/read_msg.asp?message_id=9298625
”Peregrine is now targeting completion of patient dosing in Feb2005, several months ahead of initial estimates. Top-line safety data from the study will be presented at the Viral HEP in Drug Disc. & Dev. Conf., Feb27th in Boston”
9-27-05: Sarasota Herald article on Bach&Godofsky HEP-C clinic, uniquely mentioning Tarvacin P1 http://tinyurl.com/98dr4
"Godofsky thought Tarvacin looked promising... he agreed to the trial because the drug seems to have low toxicity, and it is a novel approach."
5-31-05 HEP-C IND approved (filed 5-5-05 with FDA): http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=714919
###HEP-C Trial protocol at ClinicalTrials.gov: http://clinicaltrials.gov/ct/show/NCT00128271

TARVACIN ANTI-VIRAL NEWS:
11-30-05: Flu expert Dr. Arnold Monto joins SRB: http://www.investorshub.com/boards/read_msg.asp?message_id=8680379
Dr. Monto, "TarvacinAV has a unique and intriguing mechanism of action supported by interesting science, and I look forward to helping to fully evaluate its potential as a possible new therapy for influenza. A flu pandemic is inevitable at some point, so it is essential that we be prepared with a full arsenal of preventative and therapeutic measures. Tarvacin may prove to be a promising new therapeutic option in the anti-viral arena, and I look forward to contributing to its progress."
11-16-05: Virologists Alfred Prince/HEP & Peter Barry/CMV join SRB: http://www.investorshub.com/boards/read_msg.asp?message_id=8534047
”Dr. Prince & Dr. Barry join our SRB at an exciting time for our anti-viral program. Both HCV and CMV currently lack adequate therapies and we are optimistic that TarvacinAV may have promise as an effective new therapeutic approach."
10-24-05: Peregrine Revs Up Tarvacin Avian Flu Initiative: http://tinyurl.com/a4w2y
CEO S.King, "Evaluating TarvacinAV as a potential treatment for Influenza, incl. deadly new strains, such as Avian Flu, is a high priority."
7-21-05: U.S. Army's USAMRIID to Test Tarvacin against Ebola & Marburg Viruses
"Peregrine will supply Tarvacin for animal studies directed by Dr. Thomas W. Geisbert, Chief, Dept. of Viral Pathology, USAMRIID, Fort Detrick, MD"
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=733181
6-22-05: Thorpe presents Tarvacin AV pre-clin. data at BIO2005:
“Tarvacin Binds to Viruses in 6 Diff. Virus Families: HIV 1+2, Influenza A+B, Measles, RSV, BVDV (HepC model), and Pichinde. Inhibits Repl. of Multiple Virus Types. Provides significant protection in animals CMV with 100% survival vs. 20% for control animals."
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=722805
6-15-05: CEO Steve King gives TARVACIN AV update at Rodman & Renshaw’s Sec. Conf.
"Our current collaborations with NIAID are screening against viral bio-terrorism & health threats; they indicated to us that this is one of the 1st times they've ever tested such a broad spectrum of viruses with a single agent… We have collected HepC animal data, and are continuing animal studies on HIV & Influenza, ID’ing others… In pre-clinicals, Tarvacin has shown the ability to arrest the dev. of disease even in the very late stages of infection… we believe, pending positive results of the HepC+Cancer P1 trials of course, this could be a fairly rapid route to regulatory approval for Tarvacin for the treatment of widespread viral outbreaks."
Audio replay: http://www.peregrineinc.com/video-***********************************.php?id=181
Recap: http://www.investorshub.com/boards/read_msg.asp?message_id=6722475
4-4-05: Dr. Thorpe tells AAI Conf., “Significant ANTI-VIRAL Activity of TARVACIN [3G4] in Animal Studies”:
“Surviving animals (50%) showed no signs of viral infection several months after treatment with Tarvacin and were considered disease free; they developed long-term immunity to further infection with the Pichinde virus. ...Since Tarvacin targets a basic, universal property of enveloped viruses that is host-derived & independent of the viral genome, it may be effective against a broad spectrum of enveloped viruses. This target may also be difficult for viruses to overcome via resistance mechanisms." :
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=691385
ABSTRACT: http://www.investorshub.com/boards/read_msg.asp?message_id=5923418
4-4-05: NIH's NIAID to Test TARVACIN on “Broad Spectrum of Enveloped Viruses":
NIAID's testing labs will screen Tarvacin for activity against a broad spectrum of enveloped viral pathogens of health & bioterrorism concern, including Herpes, respiratory viruses, pox viruses, HEP B/C, Papillomavirus and viruses of biodefense concern including Pichinde, Yellow Fever, West Nile and Dengue:
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=691387
2-8-05: Virologists Stephen Smith & Preston Marx added to Peregrine's SRB:
Dr. Smith, "I look forward to working with Peregrine on these novel anti-viral agents; this approach represents an entirely new way of combating infectious diseases. Instead of targeting viral proteins, Peregrine's product attacks altered, endogenous phospholipids. Therefore, drug resistance cannot develop."
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=671707

[Preciouslife1]

TARVACIN ANTI-CANCER NEWS:
1-18-06 2nd DOD Grant: $585k, Tarvacin/Prostate http://www.investorshub.com/boards/read_msg.asp?message_id=9307265
Dr. Ralph Mason, PI: "This new prostate cancer grant, which brings together the expertise of several disciplines at UT-SW, will employ advanced techniques such as MRI tumor oximetry to measure dynamic changes in the tumors. We expect that the findings of these studies will be directly applicable to the design of Tarvacin clin. trials for prostate cancer."
12-15-05 INTL-JRNL-CANCER article - Tarvacin+Gemzar vs. Pancreatic Cancer preclin. data: http://tinyurl.com/8h4j3
”Tarvacin+Gemcitabine demonstrated promising activity against the primary tumor itself as well as the ********************stases that cause most pancreatic cancer deaths… we plan to pursue mult. clinical trials for TarvacinAC after we successfully complete the P1 study now underway.”
11-3-05 DOD Grant: $583k to Thorpe for Tarvacin+Chemo/Prostate Cancer: http://tinyurl.com/cszda
4-20-05: Tarvacin/3G4 presented at AACR: abstracts: http://tinyurl.com/8oa5p
a. 3G4+Radiation reduces lung cancer tumor growth by 95%.
b. 3G4+Gemcitabine decreased primary tumor growth by 60% and essentially stopped ********************stasis to liver and lymph nodes.
c. Data is significant, leading to P1 trial for patients presenting with any solid tumor type.
d. Tarvacin can used to deliver a radioactive arsenic compound for tumor imaging.
e. Tarvacin also being evaluated for treatment of ocular disease, by the FFB/Wilmer Institute.
3-7-05: Tarvacin/3G4 pre-clin. data in 2-15-05 CLINICAL CANCER RES. [AACR]: http://tinyurl.com/bwkcz
a. 3G4 as a monotherapy inhibits tumor growth by up to 90% in multiple tumor models.
b. 3G4+Docetaxel reduces growth of breast cancer tumors by 93%
2004: Susan G. Komen Breast Cancer Found. awards Thorpe Lab $247k to study Tarvacin+Docetaxel combo vs. Breast Cancer:
“Since 3G4 is already chimerized [“TARVACIN”] and close to clinical trials, it should be possible to take the 3G4/Docetaxel combo rapidly into clinical trials in breast cancer patients.” http://www.investorshub.com/boards/read_msg.asp?message_id=7169616

[Preciouslife1]

About Us | Scientific Resource Board
Peregrine Pharmaceutical's Scientific Resource Board (SRB) serves as an advisory group to the company for its pre-clinical and clinical programs. Current SRB members by areas of expertise include:
CORE TECHNOLOGIES
Philip E. Thorpe, Ph.D.
Professor of Pharmacology, University of Texas Southwestern Medical Center at Dallas
Alan J. Schroit, Ph.D.
Professor of Cancer Biology, M.D. Anderson Cancer Center, Houston, Texas
ONCOLOGY Rolf A. Brekken, Ph.D.
Assistant Professor of Surgery, University of Texas Southwestern Medical Center at Dallas
Harold F. Dvorak, M.D.
Chief of the Department of Pathology at Beth Israel Deaconess Medical Center,
Mallinckrodt Professor of Pathology at Harvard Medical School
Michael S. Gordon, M.D.
Clinical Associate Professor of Medicine University of Arizona College of Medicine
Senior Investigator, Premiere Oncology of Arizona
Donald R. Senger, Ph.D.
Principal Associate in Pathology, Harvard Medical School
Research Associate, Beth Israel Deaconess Medical Center
Xianming Huang, Ph.D.
Assistant Professor, University of Texas Southwestern Medical Center at Dallas
ANTI-VIRAL – HEPATITIS C
Alfred M. Prince, M.D.
Founding Chairman, Hepatitis Research Foundation
Founding Chairman, International Consortium for Blood Safety
Head, Laboratory of Virology for The New York Blood Center
Research Professor of Pathology, New York University School of Medicine

ANTI-VIRAL - INFLUENZA
Arnold S. Monto, M.D.
Professor of Epidemiology, School of Public Health of the University of Michigan
President, American Epidemiological Society, 2004-2005

ANTI-VIRAL – HIV
Preston A. Marx, Ph.D.
Chair and Core Scientist, Division of Microbiology and Immunology at Tulane National Primate Research Center
Professor, Department of Tropical Medicine, School of Public Health and Tropical Medicine, Tulane University Health Sciences Center


Stephen M. Smith, M.D.
Chief of Infectious Diseases, St. Michael's Medical Center,
Medical Director, Peter Ho Memorial Clinic, the largest HIV clinic in New Jersey
Program Director, Infectious Diseases Fellowship at Seton Hall University

ANTI-VIRAL – CMV
Peter Barry, Ph.D.
Associate Professor, Department of Pathology and Laboratory Medicine at University of California, Davis
Core Faculty, Center for Comparative Medicine
Staff Scientist, California National Primate Research Center

[Preciouslife1]

TarvacinAV:
Researchers and scientists has seen this technology and basically said this looks like a direct re-programming of the immune system for something that would normally evade the immune system… It’s a very novel mechanism. This works with the body’s own natural defenses to fight disease, and it’s a first in class technology - we know of no other company out there developing a similar technology. It appears safe and well-tolerated; this is in extensive toxicology studies and patients treated to date… This slide shows the results of a study by our researchers at UT-SW/Dallas; this is a hemorrhagic virus, Lassa Fever – it’s just like the Marburg, Ebola viruses, which fall under this hemorrhagic fever category. These animals on day 0 were treated with 2x the lethal dose of Lassa Fever. On day 7 we began treatment, when these animals were basically on death’s doorstep, very sick animals, losing weight. And, within a few days all of the control animals died. When you look at the animals that were treated with Tarvacin, we were able to save 50% of them, and this experiment has been repeated over and over again. What’s even more amazing, though, is that these animals were re-infected on day 117 with another lethal dose of the virus, without having any other Tarvacin antibody injected, and these animals basically acquired lasting immunity. And these animals for followed for several months thereafter. So, very encouraging results. We showed this to our SRB, our scientists internally, and they basically said we should get this into the clinic as soon as practical, and that’s what we did. Based in the initial HepC study initiated in Aug2005, we are already planning add’l studies in HepC 2 more studies: the 1st one will be a Ph. 1B repeat-dose study and the 2nd one will be a Ph. I/II Combo study with std. of care, such as Ribavirin or Interferon, and we’re working with our SRB right now in developing those studies. The info & safety we gain from these studies will help expedite the broad potential of this product in other viral indications - Influenza, CMV, HIV are indications that were are currently looking at... Regarding HIV, we know that we have positive binding to both HIV1 & HIV2. There are plans underway for important collaborations in HIV, and we expect announcements during 1H-2006… [comments about Thorpe and the expanded SRB].

TarvacinAC:
…When you see this phospholipid flipping, you have a very specific target for our antibody… you see this huge influx, or macrophage invasion, after you give Tarvacin – the immune system comes in, there is a call-to-arms to the immune system, which shuts off the oxygen & nutrients to the tumor, causing tumor cell death.(( Again, TarvacinAC has a very broad potential, blockbuster potential.)) The target is present on all solid tumor models, about 10 diff. solid tumor models we’ve tested to date. It’s a novel mechanism, just like the antiviral; it works with the body’s own natural defenses to fight disease – first in class technology. We have very promising anti-tumor properties as a single agent, but more importantly we have compelling combo therapy data with no added toxicity. As cells become stressed out, such as with Chemo & Radiation, it actually up-regulates the target, we get greater binding of the antibody to the target, a greater immune response, and we’ve seen some great data come out of the combo therapy. The drug also appears safe and well-tolerated; again, in extensive toxicology studies and patients treated to date... Most people don’t die of the primary tumor itself, they die from ********************stases to the liver – we have more exciting data… When you combine Tarvacin & Gemcitabine, there are no detectible ********************stases to the liver… When you combine Tarvacin & Docetaxel, there are no tumor colonies within in those lungs… The current P1 All-Solid-Cancers single and repeat-dose escalation study was designed with success in mind. We have brought on experts in the field, Michael Gordon and 2 others that were involved with the initial Avastin studies, to help design the study for success.

Comments on Mkt. Potential on PPHM’s products: compare to Avastin’s $1+bb/yr. AV: Hep, Influenza, HIV – could do well over $1bb/year for each.

[Preciouslife1]

[Preciouslife1]

Tarvacin HEPATITIS C Phase1 status:
8-8-05 HEP-C Trial Inititates at Bach & Godofsky Infectious Diseases, Bradenton FL: http://tinyurl.com/cltum
"An dose-escalation study in up to 32 patients with chronic HepC (HCV) who either no longer respond to or failed std. therapy with pegylated interferon & ribavirin combo therapy - conducted at Bach & Godofsky Infectious Diseases, the largest private infectious disease practice specializing in the treatment of viral hepatitis in the USA."
1-18-06: HepC Trial "ahead of schedule" http://www.investorshub.com/boards/read_msg.asp?message_id=9298625
”Peregrine is now targeting completion of patient dosing in Feb2005, several months ahead of initial estimates. Top-line safety data from the study will be presented at the Viral HEP in Drug Disc. & Dev. Conf., Feb27th in Boston”
9-27-05: Sarasota Herald article on Bach&Godofsky HEP-C clinic, uniquely
mentioning Tarvacin P1 http://tinyurl.com/98dr4
"Godofsky thought Tarvacin looked promising... he agreed to the trial because the drug seems to have low toxicity, and it is a novel approach."
5-31-05 HEP-C IND approved (filed 5-5-05 with FDA): http://www.investorshub.com/boards/read_msg.asp?message_id=6520178
###HEP-C Trial protocol at ClinicalTrials.gov: http://clinicaltrials.gov/ct/show/NCT00128271

The toll of HCV from a Duke U. study:

Hepatitis C Patients Taxing Medical System
FRIDAY, Dec. 30 (HealthDay News) -- The use of health-care resources by hepatitis C patients in the United States has been increasing by 25 percent to 30 percent a year, says a Duke University study in the December issue of Hepatology.

About 3 million people in the United States have chronic hepatitis C virus (HCV), and many of them contracted it in the 1970s, before testing and safe needle-sharing practices became widespread. Health experts have been predicting an increasing impact on the health system as these people grow older.

The Duke researchers analyzed HCV patient hospitalization trends from 1994 to 2001, HCV-related doctors' visits from 1996 to 2002, and prescription drug data for HCV patients from 1998 to 2000.

The study found that HCV-related hospitalizations, hospital days, total charges and deaths increased by more than 20 percent per year. That's three times higher than all-cause hospitalizations. The largest increases were seen in patients in their 40s and 50s, who spent more time in a hospital, incurred greater costs, and died more often than HCV patients in other age groups.

The study also found that doctor office visits by HCV patients increased by 36 percent a year, and spending on HCV drug therapy rose from $78 per $100,000 of new prescriptions in 1998 to $259 per $100,000 in 2000.

"The study documents accelerating use of health-care resources by patients with HCV, indicating that the future burden of HCV infection will match and may exceed analysts' forecasts," the study authors wrote.

This is why Tarvacin has the real potential to big blockbuster in HCV.

Reply to me by CJ Gaddy, a great backer of PPHM's platforms:

PL1, re: HCV-HIV co-infections, I'd be willing to bet our Dr. Godofsky is working PPHM SRB'ers Drs. Marx (HIV), Smith (HIV), and Prince (HVC), [and the SIDS people at DUKE??!!] on how to best position Tarvacin to help that large class of co-sufferers. More from 2000 - note Dr. Godofsky's comments:

"Expert Perspectives: Strategies for the Management of HIV/HCV Coinfection"

INTRODUCTION:
Hepatitis C virus (HCV) is one of the most important causes of chronic liver disease in the United States. Overall, there may be 300,000 persons coinfected with HCV and HIV in the U.S., representing about 33% of the estimated 1mm persons infected with HIV. HIV coinfection is an important factor in HCV disease progression. Coinfection with HIV is associated with a higher HCV RNA viral load and a more rapid progression of HCV-related liver disease, leading to an increased risk of cirrhosis, decompensated liver disease, hepatocellular carcinoma, and death. Thus, chronic HCV infection acts as an opportunistic pathogen in HIV-infected persons, since both the incidence and the severity of HCV disease are increased. The use of highly active antiretroviral therapies (HAART) and prophylactic agents for the prevention of opportunistic pathogens has dramatically increased the survival rate among HIV-infected patients. HCV-associated disease will become an increasingly significant cause of morbidity and mortality in this patient population. Strategies to prevent primary HCV infection and modify HCV disease progression are urgently needed for HIV-infected individuals.

HAART IN THE CONTEXT OF HCV INFECTION:
While it is clear that HIV has a negative impact on the natural history of HCV, Dr. Eliot Godofsky emphasized that even complete control of HIV using HAART does not affect HCV viral titers. The potential for hepatotoxicity of antiviral medications in patients infected with chronic viral hepatitis has been a concern. When significant hepatotoxicity does develop in coinfected patients, the following issues should be considered: (1) the potential cause(s) of the abnormality; (2) the possibility of changing antiviral medications in an effort to decrease toxicity while maintaining antiretroviral effect; (3) the prevention of additional hepatotoxicity from other sources; and (4) the necessity of treating the underlying viral hepatitis. Thus, the optimal treatment of viral hepatitis concurrent with HIV is a major challenge to address. The pace of both diseases must be considered, and the priority of treatment must be critically evaluated...
http://www.projectsinknowledge.com/Init/ID/1474/1474devmtg.html

[Preciouslife1]

Peregrine Pharmaceutical's Scientific Resource Board (SRB) serves as an advisory group to the company for its pre-clinical and clinical programs. Current SRB members by areas of expertise include:
CORE TECHNOLOGIES Philip E. Thorpe, Ph.D.
Professor of Pharmacology, University of Texas Southwestern Medical Center at Dallas
Alan J. Schroit, Ph.D.
Professor of Cancer Biology, M.D. Anderson Cancer Center, Houston, Texas
ONCOLOGY
Rolf A. Brekken, Ph.D.
Assistant Professor of Surgery, University of Texas Southwestern Medical Center at Dallas
Harold F. Dvorak, M.D.
Chief of the Department of Pathology at Beth Israel Deaconess Medical Center,
Mallinckrodt Professor of Pathology at Harvard Medical School
Michael S. Gordon, M.D.
Clinical Associate Professor of Medicine University of Arizona College of Medicine
Senior Investigator, Premiere Oncology of Arizona
Donald R. Senger, Ph.D.
Principal Associate in Pathology, Harvard Medical School
Research Associate, Beth Israel Deaconess Medical Center
Xianming Huang, Ph.D.
Assistant Professor, University of Texas Southwestern Medical Center at Dallas
ANTI-VIRAL – HEPATITIS C
John G. McHutchinson, M.D.
Director, GI and Hepatology Research, Duke Clinical Research Institute, Duke University Medical Center


ANTI-VIRAL - INFLUENZA Arnold S. Monto, M.D.
Professor of Epidemiology, School of Public Health of the University of Michigan
President, American Epidemiological Society, 2004-2005

ANTI-VIRAL – HIV Preston A. Marx, Ph.D.
Chair and Core Scientist, Division of Microbiology and Immunology at Tulane National Primate Research Center
Professor, Department of Tropical Medicine, School of Public Health and Tropical Medicine, Tulane University Health Sciences Center
Stephen M. Smith, M.D.
Chief of Infectious Diseases, St. Michael's Medical Center,
Medical Director, Peter Ho Memorial Clinic, the largest HIV clinic in New Jersey
Program Director, Infectious Diseases Fellowship at Seton Hall University

ANTI-VIRAL – CMV Peter Barry, Ph.D.
Associate Professor, Department of Pathology and Laboratory Medicine at University of California, Davis
Core Faculty, Center for Comparative Medicine
Staff Scientist, California National Primate Research Center