PPHM and Tarvacin discussion

[Preciouslife1]

Peregrine Acquires Worldwide Rights to Novel Anti-Angiogenesis Technology From M. D. Anderson Cancer Center


-Naturally-Occurring Anti-Angiogenesis Protein 'Clipped' Beta 2 Glycoprotein 1 Has Been Independently Validated in Cancer Models by Researchers at M. D. Anderson and Other Institutions- -Research Reported by a Group of Authors that Included Angiogenesis Pioneer Dr. Judah Folkman Showed that Treatment with 'Clipped' Beta 2 Glycoprotein 1 Resulted in 96% Reduction in Tumor Growth-
-Peregrine and M. D. Anderson Are Collaborating to Advance Novel Clipped Beta 2 Glycoprotein 1 Compound toward Clinical Trials-

TUSTIN, Calif., July 9, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus infection, today announced that it has licensed worldwide exclusive rights to a novel anti-angiogenesis technology from The University of Texas M. D. Anderson Cancer Center. The agreement is for development and commercialization rights to all forms of "clipped" (or nicked) Beta 2 Glycoprotein 1 (B2GP1) protein, which was first characterized by Dr. Alan J. Schroit, Deputy Chairman, Department of Cancer Biology and John Q. Gaines Professor of Cancer Biology at M. D. Anderson Cancer Center. Peregrine, Dr. Schroit and M. D. Anderson will collaborate under a sponsored research agreement to conduct preclinical studies that are designed to advance B2GP1 toward human clinical trials. The anti-cancer potential of clipped B2GP1 has been independently verified in a study published in September 2006 by a group of authors that included angiogenesis pioneer Dr. Judah Folkman. They showed that clipped B2GP1 inhibited endothelial cell proliferation and tube formation and reduced tumor growth by 96% in an animal model of bladder cancer.(1)
"A growing body of studies suggests that clipped Beta 2 Glycoprotein 1 is a promising anti-angiogenic agent. We are delighted to have secured the rights to develop and market potential new therapies based on this approach," said Steven W. King, president and CEO of Peregrine. "We are particularly encouraged by the fact that we have already identified a potential clinical candidate for the B2GP1 program, and we look forward to working with Dr. Schroit and his colleagues at M. D. Anderson to complete the preclinical studies needed to move clipped B2GP1 toward clinical testing in humans."
"Clipped forms of Beta 2 Glycoprotein 1 may represent an exciting new approach for anti-angiogenesis therapies, and I am pleased to be collaborating with Peregrine to further explore its clinical utility," said Dr. Schroit. "The more we learn about this plasma protein, the more intriguing its role appears to be. The anti-angiogenic potential of B2GP1 was first identified by my laboratory in studies suggesting that it is a negative regulator of angiogenesis that can inhibit the growth of primary tumors and me.tastases. First-generation anti-angiogenesis agents have already demonstrated their value in some cancer and ophthalmology applications, and we are eager to learn more about the clinical potential of this new anti-angiogenesis approach."
(1): An Endogenous Inhibitor of Angiogenesis derived from a Transitional Cell Carcinoma: Clipped b2-Glycoprotein-I Wolf-Dietrich C. Beecken,1 Tobias Engl,1 Eva M. Ringel,1 Kevin Camphausen,2 Martin Michaelis,3 Dietger Jonas,1 Judah Folkman,4 Yuen Shing,4 and Roman A. Blaheta1 Annals of Surgical Oncology, 13(9): 1241--1251
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 in the U.S. and India with its lead product candidates bavituximab and Cotara(R). 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 http://www.peregrineinc.com.
__________________
PL1

[Preciouslife1]

***Peregrine Pharmaceuticals Initiates Bavituximab Clinical Trial in HCV Patients Co-Infected With HIV***

TUSTIN, Calif., July 10 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced initiation of patient enrolment in a study of bavituximab in patients co-infected with HCV and the human immunodeficiency virus (HIV). The multi-center trial will be initially conducted at Saint Michael's Medical Center in Newark, NJ under the direction of Dr. Stephen Smith, director of the Peter Ho Memorial Clinic, the largest HIV/AIDS treatment facility in the state.

"This is an important study for the bavituximab HCV clinical program that is designed to evaluate an extended treatment schedule in an important HCV patient population," said Steven W. King, president and CEO of Peregrine. "We believe that bavituximab's unique targeting mechanism has the potential to act on both HCV and HIV virus infections, and we look forward to working with Dr. Smith and his colleagues to assess the potential of bavituximab in this high need co-infected population."

The co-infection trial is an open-label, dose escalation safety study designed to assess the safety and pharmacokinetics of bavituximab in approximately 24 patients chronically infected with HCV and HIV. Patient cohorts will receive ascending dose levels of bavituximab weekly for up to 8 weeks. HCV and HIV viral titers and other biomarkers will be evaluated, although they are not formal study endpoints.

In the United States alone, an estimated 300,000 individuals are co-infected with HIV and HCV, representing up to 30% of all HIV-infected patients. Co-infected patients have been shown to have a lower response to current interferon/ribavirin HCV regimens and the adverse effects of these regimens can be especially problematic for some HIV patients.

Bavituximab is a monoclonal antibody in a new class of anti-phosphotidylserine (PS) immunotherapeutics that targets and binds to cellular components that are normally not present on the outside of cells, but which become exposed on certain virally infected cells and on the surface of enveloped viruses, including both HCV and HIV. Bavituximab helps stimulate the body's immune defenses to destroy both the virus particles and the infected cells. Since bavituximab's PS target comes from the host and not the virus, bavituximab is expected to be less susceptible to the development of anti-viral resistance than many other therapies. Bavituximab has successfully completed Phase la and lb clinical trials as monotherapy in patients with chronic HCV infection, which showed that the drug appears safe and well-tolerated and demonstrated encouraging signs of anti-viral activity.

Note: Dr Smith is on the Scientific Research Board(SRB) at PPHM:
Dr. Stephen M. Smith is Medical Director of the Peter Ho Memorial Clinic at Saint Michael's, the largest HIV clinic in New Jersey.

DR. STEPHEN M. SMITH, 2-8-05, UPON JOINING PEREGRINE’S SRB:
"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."


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 in the U.S. and India with its lead product candidates bavituximab and Cotara(R). 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 http://www.peregrineinc. com.

[Preciouslife1]

PR 7-11-07: FY2007 (4-30-07) Financial Results
“Peregrine Pharmaceuticals Reports Financial Results for FY 2007”

TUSTIN, CA., July 11 2006:
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced financial results for the fiscal year ended April 30, 2007. The company reported a consolidated net loss of $20,796,000, or $0.11 per basic and diluted share, compared to a consolidated net loss of $17,061,000, or $0.10 per basic and diluted share for fiscal year 2006. Total revenues for fiscal year 2007 were up 16% to $3,708,000 versus $3,193,000 in the prior year, primarily generated from Avid Bioservices, the company's wholly owned contract manufacturing subsidiary.

Total costs and expenses in fiscal year 2007 increased to $25,618,000 from $22,276,000 for the fiscal year ended April 2006. The increase in total expenses was entirely due to an increase in research and development expenses associated with the advancement of the company's clinical and preclinical product candidates. Cost of sales related to Avid Bioservices' revenues were flat despite an increase in manufacturing revenues, and overall selling, general and administrative expenses slightly decreased from the prior fiscal year.

This current year increase in research and development expenses was primarily related to the advancement of bavituximab and Cotara(R) for the treatment of solid tumors and hepatitis C virus (HCV) infection. Over the past fiscal year, the company increased its expenditures in support of 5 separate clinical trials, including a Phase I bavituximab study for the treatment of advanced solid tumors, a Phase Ib bavituximab study in combination with chemotherapy for the treatment of advanced solid tumors, a Phase Ib bavituximab repeat dose study in patients with chronic HCV infection, and two Cotara(R) clinical trials for the treatment of glioblastoma multiforme, a deadly form of brain cancer. In addition, the company supported the advancement of its preclinical programs, including studies that were presented at the Annual Meeting of the American Association for Cancer Research (AACR) in April 2007.

"This past fiscal year has been marked by significant progress in the three clinical programs that we expect to be key value drivers for Peregrine during fiscal year 2008," commented Steven W. King, president and CEO of Peregrine. "Most importantly, we successfully completed Phase lb clinical trials for our first-in-class anti-PS monoclonal antibody bavituximab for the treatment of both cancer and hepatitis C viral infection. These studies represent major milestones for the bavituximab program, with positive results in both indications showing that bavituximab appeared well-tolerated and that it demonstrated encouraging signs of anti-viral and anti-tumor activity. Successful completion of these studies has set the stage for Phase ll clinical trials."

Mr. King added, "Similarly, we laid the foundation for substantial progress in the clinical program for lead tumor necrosis therapy (TNT) agent Cotara by preparing to conduct a new trial in patients with malignant brain cancer. Our Indian clinical centers are well equipped to conduct this trial and have access to large numbers of patients with brain cancer who are eager to participate in clinical studies. We expect that positive results in this Phase ll trial would set the stage for product registration trials and eventual commercialization."

Mr. King added, "While our focus during the past fiscal year was on advancing our clinical programs, we also reported important progress in our preclinical programs. In September 2006, we reported new research showing that a fusion protein approach combining our Vascular Targeting Agent (VTA) and anti-PS technology platforms demonstrated significant potential, reducing tumor growth in animal cancer models by more than 90%. At the AACR meeting in April 2007, Peregrine's collaborators reported positive results from a number of our preclinical programs, including data indicating that bavituximab-type compounds may have potential as powerful vaccine-like agents against malignant brain cancer and also as part of immunocytokine fusion protein therapies targeted to lymphoma and other cancers. We also reported on progress in our anti-VEGF program[“2C3”], presenting data showing that our unique selective inhibitor was as effective as Avastin(R) in preclinical cancer models while having potential advantages as a result of its selectivity. Earlier in the year, a peer-reviewed publication reported that microbubbles constructed using our VTA technology can be used with widely available ultrasound systems to monitor patient response to Avastin(R), identifying at an early stage which cancer patients are actually benefiting from this treatment. These developments and others highlight the depth and diversity of our preclinical programs. We currently are pursuing some of these programs on our own and are actively seeking partners to collaborate with us on others."

Mr. King concluded, "Since the start of the last fiscal year, we believe that Peregrine has made exceptional progress in advancing its three lead clinical programs towards Phase II trials and reporting progress in a number of high potential earlier stage programs. As a result of our recent financing, we now have the resources to pursue these programs aggressively in the year ahead. We believe the company has set the stage for what could be a very successful 2008 fiscal year."

At April 30 2007, the company had $16,044,000 in cash and cash eq.uivalents. The company has strengthened its cash position to about $32,500,000 as of June 30, 2007, after taking into consideration the net proceeds received from a recent financing announced on June 28, 2007. The company believes it has sufficient cash on hand to progress its current clinical programs through at least fiscal year 2008 based on its current projections.

End part #1

[Preciouslife1]

Corporate Highlights Since the Start of Fiscal Year 2007

-- In July 2007, Peregrine announced that it had submitted a clinical protocol with the Drug Controller General of India for a Phase ll trial of bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC). Up to 21 NSCLC patients will be enrolled initially and the study may be expanded up to a total of 49 patients if positive results are observed in the first cohort.
The primary objective of the study is to assess overall response to the combination of bavituximab and chemotherapy; secondary objectives include time to tumor progression, duration of response, overall patient survival and safety parameters. This trial is expected to begin enrolling patients later this year.
-- In June 2007, Peregrine announced commitments to purchase $22.5 million in shares of its common stock in a registered direct offering, for net proceeds of approximately $20.9 million. The financing did not include warrants. Rodman & Renshaw acted as the exclusive placement agent.
-- In June 2007, Peregrine announced initiation of a new clinical trial designed to evaluate the safety and efficacy of its TNT agent Cotara in patients with glioblastoma multiforme, a deadly form of brain cancer.
Peregrine believes that combined positive data from this new study in India and ongoing U.S. glioblastoma trials would provide a foundation for advancing Cotara into Phase III product registration trials.
-- In May 2007, the company reported positive results in its Phase lb open label cancer trial of bavituximab in combination with chemotherapy.
This trial was designed to assess the safety and tolerability of
bavituximab in combination with common chemotherapy agents in advanced cancer patients with me.tastatic disease.
In the trial, the safety profile of bavituximab in combination with chemotherapy appeared similar to that seen in advanced cancer patients undergoing chemotherapy alone.
The combination of bavituximab and chemotherapy showed positive signs of clinical activity, achieving objective tumor response or stable disease in 50% of the patients who were evaluable for tumor response. Data from this study are being further analyzed to support the initiation of Phase II cancer trials.
-- In May 2007, Peregrine announced it had filed a new clinical trial protocol with the FDA to study bavituximab in patients co-infected with HCV and HIV, and this study was initiated in early July 2007. The multi-center open-label study designed to assess the safety and pharmacokinetics of bavituximab in approximately 24 patients will initially be conducted at Saint Michael's Medical Center under the direction of Dr. Stephen Smith. An estimated 30% of HIV patients are co-infected with HCV and these patients often do not respond well to current HCV therapies.
-- At the April 2007 AACR meeting, data from multiple studies reinforced the versatility and broad anti-cancer potential of bavituximab, provided new preclinical data confirming the potential anti-tumor efficacy of the company's selective VEGF inhibitors, provided validating data for its immunocytokine fusion proteins developed using the company's VTA technology, and highlighted the clinical potential of Peregrine's earlier stage Vasopermeation Enhancement Agent (VEA) cancer platforms.
-- In February 2007, Peregrine reported results from a Phase lb study of bavituximab in patients with chronic HCV infection. The study was designed to assess the safety, distribution and pharmacokinetic properties of four ascending dose levels of bavituximab administered as twice-weekly monotherapy. Bavituximab was generally safe and well-tolerated, with no dose limiting toxicities or serious adverse events reported. The preliminary results also indicate that bavituximab
showed positive signs of dose dependent anti-viral activity, setting the stage for HCV combination therapy trials and further dosing studies.
-- In October 2006 at the prestigious AASLD meeting, Peregrine reported final results from its Phase Ia study of bavituximab in HCV patients who had failed or relapsed after standard therapy. Bavituximab appeared generally safe and well-tolerated and there were signs of anti-viral activity at all dose levels tested.
-- In June 2006, Peregrine announced that had signed a definitive agreement for the sale of 9,285,714 shares of common stock to one institutional investor in exchange for net proceeds of $13 million.
This financing involved no warrants and no placement fees.
-- In June 2006, Peregrine reported top-line results on the effect of bavituximab on viral RNA serum titers when administered as single dose monotherapy in a Phase Ia study in patients with chronic HCV infection.
Bavituximab showed signs of anti-viral activity at all four dose levels studied and it also showed evidence of a prolonged anti-viral effect.

[Preciouslife1]

Posted by jazz on IHUB.com...

PS & tumor angiogenesis, Schroit / Henson / McDonald


Very important recent discoveries -



According to Schroit & Fidler, exposed PS is responsible for the endothelial cell sprouts which eventually form new blood vessels.
Exposed PS becomes the anionic target which the sprouts on endothelial cells reach out for.
http://investorshub.advfn.com/boards/read_msg.asp?message_id=21043880


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According to Peter Henson, exposed PS is responsible for stimulating VEGF production by macrophages.
http://investorshub.advfn.com/boards/read_msg.asp?message_id=21279430


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According to Pfizer, NYU etc, (and authored by Donald McDonald) After stopping VEGF inhibition therapy....

Rapid Vascular Regrowth In Tumors After Reversal Of VEGF Inhibition

'...One day after drug withdrawal, endothelial sprouts grew into empty sleeves of basement membrane. Vessel patency and connection to the bloodstream followed close behind. By 7 days, tumors were fully revascularized,...'
http://www.jci.org/cgi/reprint/116/10/2610.pdf

[Preciouslife1]

Bavituximab Repeat-Dose Trial in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus
This study is currently recruiting patients.

Verified by Peregrine Pharmaceuticals July 2007
Sponsored by:Peregrine PharmaceuticalsInformation provided by:Peregrine PharmaceuticalsClinicalTrials.gov Identifier:NCT00503347
Purpose
This trial is designed to assess the safety, tolerability, pharmacokinetics and viral kinetics after multiple infusions of bavituximab in patients co-infected with HCV and HIV.
Condition InterventionPhaseHepatitis C Virus
HIV Infections
Drug: bavituximab
Phase I

MedlinePlus related topics: AIDS

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A Phase Ib Open-Label, Escalating Repeat-Dose Trial of Bavituximab (Chimeric Anti-Phosphatidylserine Monoclonal Antibody) in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus
Further study details as provided by Peregrine Pharmaceuticals:
Primary Outcome Measures:

• • Adverse events • Laboratory evaluations • Human anti-chimeric antibody • Pharmacokinetic analysis

Secondary Outcome Measures:

• Blood levels of HCV RNA and HIV RNA (PCR)

Total Enrollment: 24
Study start: July 2007

OBJECTIVES:

• <LI style="MARGIN-TOP: 2px">To determine the safety and tolerability of bavituximab administered as multiple intravenous (IV) infusions to patients co-infected with HCV and HIV
• To characterize the pharmacokinetic profile and viral kinetics after multiple intravenous infusions of bavituximab to patients infected with HCV and HIV
• To define the maximum tolerated dose (MTD) and/or maximum effective dose (MED) of bavituximab administered as multiple infusions to patients infected with chronic HCV infection and HIV

Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:

• <LI style="MARGIN-TOP: 2px">Written informed consent has been obtained
• Adults 18 years of age or older
• HIV infection documented by detectable HIV RNA PCR
• Absolute CD4+ > 300 cells/mm3
• Chronic hepatitis C infection based on history and detectable serum HCV RNA
• Serum alanine aminotransferase (ALT) above normal limits and/or historical biopsy consistent with hepatitis C
• Complete blood counts within normal limits
• Normal renal function (serum creatinine within normal limits)
• PT/INR and aPTT within normal limits
• All patients of reproductive potential must agree to use an approved form of barrier contraception or agree not to become pregnant while taking study medications and for 30 days after study completion. Female patients must have a negative serum pregnancy test at prestudy (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)

Exclusion Criteria:

• <LI style="MARGIN-TOP: 2px">HCV or HIV antiviral therapy within 4 weeks of Day 0
• Prior exposure to any chimeric antibody
• Any other cause of liver disease other than chronic hepatitis C, such as autoimmune or alcoholic liver disease.
• Decompensated clinical liver disease, including a history of prolonged clotting times, hypoalbuminemia, encephalopathy, treatment for elevated ammonia levels, or ascites
• Any evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
• Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
• Any history of thromboembolic events [e.g., deep vein thrombosis (DVT) or pulmonary thromboembolism (PE)]. A history of including central venous catheter-related thrombosis is acceptable if there is documentation of resolution at least 12 months prior to enrollment.
• Concurrent therapy with oral or parenteral anticoagulants
• Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen)
• Investigational therapy within 4 weeks of Day 0
• Major surgery within 4 weeks of Day 0
• Pregnant or nursing women
• Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
• Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
• A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin
• A history of any condition requiring treatment (past or current) with coumarin-type agents
• Cardiac arrhythmia requiring medical therapy
• Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture)
• Requirement for chronic daily treatment with NSAIDs, antiplatelet drugs (e.g., phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), or steroids
• Cancer, autoimmune disease or any disease or concurrent therapy known to cause significant alteration in immunologic function

Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00503347

Jennifer Spallone, MBA 714-508-6097 jspallone@peregrineinc.com


United States, Florida
University of Hepatitis Center at Bach & Godofsky, Sarasota, Florida, 34243, United States; Recruiting Michelle Mays, MS, ANRP 941-684-4305
Eliot W Godofsky, MD, FACP, Principal Investigator


United States, New Jersey
Saint Michael's Medical Center, Newark, New Jersey, 07102, United States; Recruiting James Fallon 973-877-2663
Stephen M Smith, MD, Principal Investigator



Study chairs or principal investigators

Stephen M Smith, MD, Principal Investigator, Saint Michael's Medical Center
Eliot W Godofsky, MD, FACP, Principal Investigator, University Hepatitis Center at Bach & Godofsky

[Preciouslife1]

Press Release Source: Peregrine Pharmaceuticals, Inc.



Peregrine Enters Contract Negotiations With U.S. DTRA for Hemorrhagic Fevers

Monday July 23, 3:00 pm ET
- U.S. Department of Defense Agency Has Selected Peregrine for a Multi-Year Award That Could Total $44.5 Million Pending Successful Contract Negotiations



TUSTIN, Calif., July 23 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that the company's proposal to investigate its antiviral agent bavituximab and other anti-phosphotidylserine (anti-PS) antibodies as potential therapies for hemorrhagic fever virus (HFV) infections has been selected for a contract award by the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense (DOD), pending negotiation of a final contract. In its notification announcing the selection of Peregrine's proposal, DTRA stated that its goal is to finalize the contract award within the next few months.



Peregrine outlined a five-year program in its proposal to the DTRA's 2007 Transformational Medical Technologies Initiative to assess the utility of its clinical stage anti-PS product candidate bavituximab and other anti-PS antibodies as potential therapies for HFV infections. Bavituximab is a monoclonal antibody that in preclinical studies has demonstrated encouraging activity against diverse viruses, including a hemorrhagic fever virus. Peregrine is developing bavituximab for the treatment of chronic hepatitis C virus infections and has completed two HCV clinical studies showing a positive safety profile and promising signs of antiviral activity. This proposal includes funding for preclinical studies designed to confirm its antiviral activity against HFV infections, manufacturing and product scale-up and initiation of clinical trials.

In the proposal submitted to the DTRA, Peregrine has sought funding of approximately $44.5 million over the five years of the proposed project. The DTRA accepted Peregrine's full proposal as the basis for contract negotiations. The final scope of the contract award will be negotiated as part of this process.

"We are very pleased that our proposal to the DTRA has been selected for a contract award pending successful negotiation of a final contract," said Steven W. King, president and CEO of Peregrine. "The submitted proposal represents an excellent opportunity to move our programs forward in an area of antiviral research that we likely would not pursue without outside funding. The hemorrhagic fever viruses include deadly species that are believed to present significant threats as potential bio-weapons, and we therefore welcome the opportunity to obtain federal government support to help assess the potential of our anti-PS technology in the treatment of these dreaded diseases. The DTRA has indicated it hopes to conclude contract negotiations in a timely manner, and we look forward to being able to report on the outcome of these negotiations in the near future."

[Preciouslife1]

About Bavituximab and Anti-PS Immunotherapeutics

Bavituximab is the first investigational agent in a new class of anti-phosphotidylserine (anti-PS) monoclonal antibodies that targets and binds to cellular components that are normally not present on the outside of cells, but that become exposed on certain virally infected cells and on the surface of enveloped viruses. It is thought that anti-PS agents help stimulate the body's immune defenses to destroy both the virus particles and the infected cells. In preclinical studies, anti-PS antibodies have demonstrated their ability to bind to a wide range of enveloped viruses, as well as showing promising activity in animal models of serious viral diseases. Bavituximab was well tolerated and showed encouraging signs of antiviral activity in Phase l trials in patients with chronic hepatitis C viral infection. A clinical trial in patients co-infected with HCV and HIV is currently underway. Similar to the proposed antiviral mechanism, anti-PS agents also bind to phospholipids exposed on tumor blood vessels in all solid cancers tested to date. Bavituximab has demonstrated positive signs of anti-tumor activity in a Phase l trial in combination with chemotherapy in late stage cancer patients and a Phase II protocol has recently been submitted to treat lung cancer patients in combination with chemotherapy.

About the Defense Threat Reduction Agency

The Defense Threat Reduction Agency (DTRA) was founded in 1998 to integrate and focus the capabilities of the Department of Defense that address the weapons of mass destruction (WMD) threat. The mission of the DTRA is to safeguard America and its allies from WMD (chemical, biological, radiological, nuclear, and high yield explosives) by providing capabilities to reduce, eliminate, and counter the threat, and mitigate its effects. Under DTRA, Department of Defense resources, expertise and capabilities are combined to ensure the United States remains ready and able to address the present and future WMD threat.

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 in the U.S. and India 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 http://www.peregrineinc.com.

[Preciouslife1]

Peregrine Pharmaceuticals Adds Pharmaceutical Executive as Head of Business Development for Asia and Europe


-Brings Two Decades of Hands-On Global Experience at Leading Firms to Business Development Team-

TUSTIN, Calif., July 26, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced the appointment of Mary J. Boyd, Ph.D. as head of business development for Asia and Europe. Dr. Boyd has more than 20 years of international pharmaceutical and biotechnology business development experience with large pharmaceutical companies including GlaxoSmithKline, Novartis and Roche. She will focus on identifying potential partners and negotiating agreements for Peregrine's extensive clinical and preclinical assets in Asian and European markets. "Mary is a significant addition to the Peregrine business development team, which should benefit from her on-the-ground experience in Asian and European markets where she identified and negotiated international contracts for R&D and clinical stage collaborations, as well as intellectual property licenses," said Steven W. King, president and CEO of Peregrine. "We believe that Mary's involvement will reinforce and extend our current activities, helping to increase Peregrine's global visibility and advancing our efforts to form partnerships that leverage our rich preclinical pipeline and multiple ongoing clinical programs."
Dr. Boyd was previously director, Asia, worldwide business development, R&D for GlaxoSmithKline; head of business development and licensing for Japan for Novartis; and head, licensing and patent group for Roche in Japan. In these positions, she identified new opportunities, negotiated global agreements and maintained productive relationships with other companies. Dr. Boyd holds a Ph.D. in Developmental Genetics from the University of Cambridge, UK and a B.Sc in Biochemistry from the University of Sussex, UK.
"Peregrine has a diverse portfolio of novel clinical, preclinical and intellectual property assets available for a variety of collaborative arrangements," said Dr. Boyd. "I look forward to working with Peregrine's management team and drawing on my two decades of experience in Asia and Europe to help the company achieve mutually rewarding relationships with other firms."
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 in the U.S. and India with its lead product candidates bavituximab and Cotara(R). 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 http://www.peregrineinc.com.

[Preciouslife1]

Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India


- Access to Large Population of Glioblastoma Patients Expected to Support Rapid Enrollment in Phase ll Study of Promising New Approach -

TUSTIN, Calif., Aug 02, 2007 /PRNewswire-FirstCall via COMTEX News Network/
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing targeted monoclonal antibodies for the treatment of cancer and hepatitis C virus infection, today announced that the first patient has been administered Cotara(R) in a new clinical trial designed to evaluate the safety and efficacy of this novel tumor necrosis therapy being developed for the treatment of glioblastoma multiforme (GBM), a deadly form of brain cancer.
"We are delighted that patient treatment has begun in this important Phase II clinical trial that was designed to further confirm the encouraging signs of anti-tumor activity seen in earlier Cotara brain cancer studies," said Steven W. King, president and CEO of Peregrine. "Given the high level of interest at participating clinical sites, we are optimistic that patient enrollment and dosing will proceed at a brisk pace."
This multi-center open label Phase ll safety and efficacy study is designed to enroll up to 40 glioblastoma patients who have experienced a first relapse. The study's primary objective is to confirm the maximum tolerated dose of Cotara in these GBM patients. 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), an NIH-developed technique that delivers the agent to the tumor with great precision, achieving up to a 10,000-fold greater concentration in local therapy exposure than conventional intravenous drug administration, while minimizing unwanted exposure to healthy tissue. This delivery method is expected to further enhance the tumor-killing potential of Cotara.
The new Cotara study is being conducted according to internationally accepted ICH GCP guidelines.

About Cotara(R)
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 the center of the tumor mass. Cotara thus 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), which directs Cotara to the tumor by using a catheter to bypass the blood brain barrier and target the specific tumor site in the brain.
In a previous study, a subset of patients with recurrent glioblastoma treated with Cotara achieved a median survival of 38 weeks, a 58% increase over the 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 serious and deadly disease, which kills half of its victims within 14 months of diagnosis. Peregrine believes that combined positive data from this new study in India and ongoing U.S. glioblastoma trials would provide a foundation for advancing Cotara into Phase lll trials. In addition to the trial now underway in India, Cotara is currently in a dosimetry and dose confirmation trial in glioblastoma patients at leading U.S. academic brain cancer centers. 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.

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 in the U.S. and India with its lead product candidates bavituximab and Cotara(R). 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 http://www.peregrineinc.com.

[Preciouslife1]

Final Data from Repeat Dose Trial to Be Presented at The Liver Meeting, the Premier Event in the Science and Practice of Hepatology.

TUSTIN, Calif., Aug. 7 /PRNewswire-FirstCall/
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing targeted monoclonal antibodies for the treatment of cancer and hepatitis C virus infection, today announced that final data from its Phase Ib study of bavituximab in patients with chronic hepatitis C viral (HCV) infection has been accepted for an oral presentation at The Liver Meeting(R) 2007, the premier event in the science and practice of hepatology hosted by the American Association for the Study of Liver Diseases (AASLD).

"We are extremely pleased that clinical data from our bavituximab HCV program has been selected for an oral presentation at the prestigious AASLD annual meeting for a second straight year," said Steven W. King, president and CEO of Peregrine. "We believe that bavituximab represents a unique approach with significant clinical promise for treating chronic hepatitis C virus infections. The oral presentation offers us a unique opportunity to share final data from the Phase Ib HCV clinical trial completed earlier this year with a large audience of liver experts from around the globe."

Over 6,000 hepatologists and hepatology health professionals will meet at the 58th Annual Meeting & Postgraduate Course of AASLD--The Liver Meeting at the John B. Hynes Convention Center in Boston, Massachusetts from November 2 - 6, 2007. The bavituximab HCV data presentation is scheduled for November 4, 2007 at 5:45 PM ET in the main auditorium.

Bavituximab is the first investigational agent in a new class of anti-phosphotidylserine (anti-PS) monoclonal antibodies that targets and binds to cellular components that are normally not present on the outside of cells, but that become exposed on certain virally infected cells and on the surface of enveloped viruses. It is thought that anti-PS agents help stimulate the body's immune defenses to destroy both the virus particles and the infected cells. In preclinical studies, anti-PS antibodies have demonstrated their ability to bind to a wide range of enveloped viruses, as well as showing promising activity in animal models of serious viral diseases. Bavituximab was well tolerated and showed encouraging signs of antiviral activity in Phase la and Phase lb trials in patients with chronic hepatitis C viral infection. A clinical trial in patients co-infected with HCV and HIV is expected to begin enrolling patients shortly.

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 in the U.S. and India with its lead product candidates bavituximab and Cotara(R). 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 http://www.peregrineinc.com.

[Preciouslife1]

Posted by: jazzbeerman
Date:8/16/2007 9:18:04 AM
Post #of 16355
picture worth a thousand words -



Haynes slide from Interim Scientific Update of January CHAVI admin meeting -



http://www.chavi.org/wysiwyg/downloads/Haynes_Admin_meeting_January_25,_2007.pdf



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PAPER BELOW NOT DIRECTLY RELATED TO PICTURE ABOVE.....


(But it's out of Duke Rheumatology & Immunology, - from AUGUST 2007)


j



...."In the rheumatic conditions such as rheumatoid arthritis and systemic lupus erythematosus, MP are potentially important markers of disease activity and have an increasingly recognized role in immunopathogenesis."


..."Further research will hopefully lead to interventions targeting MP release and function."



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Scand J Immunol. 2007 Aug

The role of microparticles in inflammation and thrombosis.

Ardoin SP, Shanahan JC, Pisetsky DS.

Division of Rheumatology and Immunology, Duke University Medical Center, Medical Research Service, Durham VA Hospital, Durham, NC, USA.

Microparticles (MP) are small membrane-bound vesicles that circulate in the peripheral blood and play active roles in thrombosis, inflammation and vascular reactivity. While MP can be released from nearly every cell type, most investigation has focused on MP of platelet, leucocyte and endothelial cell origin. Cells can release MP during activation or death. Flow cytometry is the usual method to quantify MP; the small size of these structures and lack of standardization in methodology complicate measurement. As MP contain surface and cytoplasmic ***********************************s of the parent cells and bear phosphatidylserine, antibodies to specific cell surface markers and annexin V can be used for identification. Through various mechanisms, MP participate in haemostasis and have procoagulant potential in disease. MP contribute to inflammation via their influence on cell-cell interactions and cytokine release, and MP also function in mediating vascular tone. In several disease states characterized by inflammation and vascular dysfunction, MP subpopulations are elevated, correlate with clinical events, and may have important roles in pathogenesis. In the rheumatic conditions such as rheumatoid arthritis and systemic lupus erythematosus, MP are potentially important markers of disease activity and have an increasingly recognized role in immunopathogenesis. It is clear that MP play an important role in atherosclerosis, and study of these structures may provide insight into the link between chronic inflammatory conditions and accelerated atherosclerosis. As biomarkers, MP allow access to usually inaccessible tissues such as the endothelium. Further research will hopefully lead to interventions targeting MP release and function.

[Preciouslife1]

Radiation and drug combo helps boost efficacy of lung cancer treatment Public release date: 1-Sep-2007


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.

[Preciouslife1]

PR 9-10-07: Q1-FY’08 (q/e 7-31-07) Fin. Results

”Peregrine Pharmaceuticals Reports First Quarter Fiscal Year 2008 Financial Results”
http://www.peregrineinc.com/

TUSTIN, CA., Sept. 10 2007: Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced 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 3 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(R) 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 3 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 3 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 [ DTRA http://tinyurl.com/2t42rq ] of the U.S. Dept. 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 eq.uivalents, compared to $16,044,000 at fiscal year end April 30, 2007.

CONFERENCE CALL:
The company will host a live conference call and webcast on Monday, Sept.10, 2007 at 11:30 a.m. EDT/8:30 a.m. PDT to discuss its first quarter results.

To listen to a live broadcast of the call over the Internet or to review the archived webcast, please visit: http://www.peregrineinc.com. The webcast will be archived on Peregrine's website for 30 days.

To listen to the call via telephone, please call the following number approximately 10 minutes prior to the scheduled time of the conference call: 1-800-860-2442 and request to join the Peregrine Pharmaceuticals conference call. A telephonic replay of the conference call will be available one hour after the conclusion of the call through Sept. 17, 2007 by calling 877-344-7529, passcode 382933#.

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 in the U.S. and India with its lead product candidates bavituximab and Cotara(R). 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 http://www.peregrineinc.com.


PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS

July 31, April 30,
2007 2007
Unaudited

ASSETS

CURRENT ASSETS:
Cash and cash equ.ivalents $30,635,000 $16,044,000
Trade and other receivables 1,514,000 750,000
Inventories, net 2,363,000 1,916,000
Prepaid expenses and other current assets 1,172,000 1,188,000

Total current assets 35,684,000 19,898,000

PROPERTY:
Leasehold improvements 655,000 646,000
Laboratory equipment 3,587,000 3,533,000
Furniture, fixtures and office equipment 886,000 873,000

5,128,000 5,052,000
Less accumulated depreciation and
amortization (3,332,000) (3,212,000)

Property, net 1,796,000 1,840,000

Other assets 1,188,000 1,259,000

TOTAL ASSETS $38,668,000 $22,997,000



July 31, April 30,
2007 2007
Unaudited
LIABILITIES AND STOCKHOLDERS' EQUITY

CURRENT LIABILITIES:
Accounts payable $1,366,000 $1,683,000
Accrued clinical trial site fees 113,000 228,000
Accrued legal and accounting fees 281,000 392,000
Accrued royalties and license fees 107,000 337,000
Accrued payroll and related costs 664,000 874,000
Notes payable, current portion 317,000 379,000
Capital lease obligation, current portion 17,000 17,000
Deferred revenue 1,820,000 1,060,000
Other current liabilities 427,000 885,000

Total current liabilities 5,112,000 5,855,000

Notes payable, less current portion 69,000 119,000
Capital lease obligation, less current portion 26,000 30,000
Deferred license revenue - 4,000
Commitments and contingencies

STOCKHOLDERS' EQUITY:
Preferred stock-$.001 par value; authorized
5,000,000 shares; non-voting; nil shares
outstanding - -
Common stock-$.001 par value; authorized
250,000,000 shares; outstanding
-- 226,210,617 and 196,112,201, respectively 226,000 196,000
Additional paid-in capital 245,551,000 224,453,000
Accumulated deficit (212,316,000) (207,660,000)

Total stockholders' equity 33,461,000 16,989,000

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $38,668,000 $22,997,000

THREE MONTHS ENDED
July 31, 2007 July 31, 2006
Unaudited Unaudited

REVENUES:
Contract manufacturing revenue $1,621,000 $ 398,000
License revenue 4,000 23,000
Total revenues 1,625,000 421,000

COSTS AND EXPENSES:
Cost of contract manufacturing 1,181,000 530,000
Research and development 3,624,000 4,041,000
Selling, general and administrative 1,708,000 1,641,000
Total costs and expenses 6,513,000 6,212,000

LOSS FROM OPERATIONS (4,888,000) (5,791,000)

OTHER INCOME (EXPENSE):
Interest and other income 239,000 349,000
Interest and other expense (7,000) (15,000)

NET LOSS $(4,656,000) $(5,457,000)

WEIGHTED AVERAGE COMMON SHARES OUTSTANDING 206,071,568 184,108,083

BASIC AND DILUTED LOSS PER COMMON SHARE $(0.02) $(0.03)

Contacts: GendeLLindheim BioCom Partners
Investors: 800-987-8256, info@peregrineinc.com
Media: Barbara Lindheim, 212-918-4650

[Preciouslife1]

Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Me.tastatic Breast

Cancer 09:30 a.m. 09/10/2007 Provided byTUSTIN, Calif.,

Sept 10, 2007 /PRNewswire-FirstCall via COMTEX/ -- Peregrine Pharmaceuticals, Inc. (PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that it has submitted a clinical protocol with the Drug Controller General of India (DCGI) for an open label Phase II safety and efficacy trial of bavituximab in combination with the chemotherapy drugs paclitaxel and carboplatin in patients with me.tastatic breast cancer. The multi-center trial is expected to begin enrolling patients pending regulatory and ethics committee approvals.

The trial has a two-stage design. Up to 15 patients with me.tastatic breast cancer will be enrolled initially and the study will be expanded up to a total of 46 patients if promising results are observed in the first cohort. The primary objective is to assess the overall response rate to the combination of bavituximab with doses of paclitaxel and carboplatin. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive weekly administration of bavituximab with weekly doses of paclitaxel and carboplatin as long as their cancer does not progress, unless side effects require earlier cessation of therapy."The filing of this second cancer clinical protocol reflects our strategy of fielding a number of targeted Phase II combination studies in specific cancer indications," said Steven W. King, president and CEO of Peregrine. "Despite advances in treatment, breast cancer remains a major source of mortality among women. We designed this study using data generated from our recently completed Phase Ib cancer study, which showed that the combination of bavituximab with paclitaxel and carboplatin might be especially promising in breast cancer patients. We look forward to assessing bavituximab's potential in this larger trial in women battling me.tastatic breast cancer.

"Tumor response will be evaluated every other month using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.According to the World Health Organization, me.tastatic breast cancer is the most commonly diagnosed cancer in women, and is second only to lung cancer as a leading cause of female cancer deaths. The National Cancer Institute estimates that 178,480 U.S. women will be diagnosed with cancer of the breast in 2007 and 40,460 women will die of the disease.

Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is normally located inside normal 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. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumor growth and spread. In a Phase lb trial in advanced cancer patients, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50% of the evaluable patients. A protocol for a Phase ll trial of bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC) is currently undergoing regulatory review in India. Bavituximab is also in clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.