What is Tarvacin™ and Peregrine Pharmaceuticals

[Preciouslife1]

Market Review: Review in Progress for Peregrine Pharmaceuticals, Inc

http://new.quote.com/news/story.action?id=MTO042u6956

Monday February 11, 2008 04:28:56 EST
Feb 11, 2008 (M2 PRESSWIRE via COMTEX News Network)
Streetinvesting.com has now resumed our progressive review of Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM), after it traded up 4% Friday, early in the afternoon with above average volume. Based on the Company's most recent news release, we will be progressively reviewing the impact of the markets and the effects of their developments.

Our research resources have been aimed towards the US Large Caps and the various prospective companies therein Peregrine Pharmaceuticals, Inc was among those that we have been closely examining due to their recent news and trading patterns.

Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM), reported on February 8, 2008 that clinical data on its anti-phosphatidylserine (anti-PS) monoclonal antibody bavituximab was discussed at the 10th Annual International Symposium on Anti-Angiogenic Agents (Angio 2008) in La Jolla, CA.

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara.
Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers.

Streetinvesting.com will continue to follow the progress of this company following their most recent news announcement. Visit www.streetinvesting.com and signup free for our financial market services.

[Preciouslife1]

Peregrine Pharmaceuticals Doses First Patient in Phase II Clinical Trial of Bavituximab in Patients With Advanced Breast Cancer

http://ih.advfn.com/p.php?pid=nmona&cb=1202823532&article=24700672&sym bol=N%5EPPHM

TUSTIN, Calif., Feb 12, 2008 /PRNewswire-FirstCall via COMTEX/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing targeted therapies for the treatment of cancer and hepatitis C virus infection (HCV), today announced that patient dosing has begun in its clinical trial designed to evaluate the safety and efficacy of bavituximab in combination with chemotherapy in patients with advanced breast cancer. The primary objective of the study is to assess the overall response rate to the combination of bavituximab with docetaxel, a chemotherapy drug commonly used in breast cancer. The multicenter clinical trial is being conducted in the Republic of Georgia.

"We are now seeing good overall momentum in our bavituximab Phase II cancer program, and we are very pleased that our clinical colleagues in Europe have been so efficient in rapidly moving from protocol approval to trial initiation to patient dosing," said Steven W. King, president and CEO of Peregrine. "We are optimistic that all three bavituximab Phase II cancer trials will proceed well in the coming months and we look forward to reporting on our progress later this year."

In the trial's two-stage design, up to 15 patients with advanced breast cancer will be enrolled initially. The study will then be expanded up to a total of 46 patients if promising results are observed. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive bavituximab alone after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable.

"Bavituximab represents a novel strategy for the treatment of cancer that has demonstrated encouraging potential in initial clinical studies," said David Tabagari, M.D., Ph.D., the head of Medulla Immunotherapy and Chemotherapy Clinic and principal investigator of the bavituximab breast cancer trial being conducted in the Republic of Georgia. "We are pleased to have the opportunity to conduct the first Phase II trial of this potentially valuable new approach to treating cancer."

Tumor response in this study will be evaluated 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) standards.

The National Cancer Institute estimates that approximately 178,480 U.S. women were diagnosed with cancer of the breast in 2007 and about 40,460 women died of the disease. According to the World Health Organization, 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.

Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is usually 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 pilot 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. Peregrine has recently received regulatory approval to conduct three Phase II trials to study the anti-tumor effects of bavituximab in combination with chemotherapy. These include two breast cancer protocols and a non-small cell lung cancer protocol testing bavituximab in combination with chemotherapy. The first bavituximab breast cancer trial is now underway and the two other trials are expected to begin soon. Bavituximab is in clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara(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 Reports Studies Published in 'Science' Highlight Key Role of Phosphatidylserine (PS) in Viral Infections

http://ir.peregrineinc.com/releaseDe...leaseID=310036

[u]- Two New Studies Provide Further Evidence that PS Plays a Critical Role in Some Viral Infections -
- Peregrine's Anti-PS Antibody Bavituximab is Currently Being Assessed in a Clinical Trial in HCV Patients Co-Infected with HIV -

TUSTIN, Calif., May 13, 2008 /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 reported that two independent studies recently published in the journal Science (1,2) highlight the critical importance of the cellular membrane lipid phosphatidylserine (PS) in the ability of some enveloped viruses to infect cells. Peregrine is a leader in the development of anti-PS therapies. Its lead anti-PS antibody bavituximab has successfully completed two Phase I trials in HCV patients and is currently in a clinical trial in patients co-infected with HCV and HIV. Bavituximab is also being assessed in a Phase I single agent cancer study and in Phase II cancer trials in combination with chemotherapy.

"These two excellent studies from independent groups of researchers exemplify the growing interest in the scientific community in the role of PS in viral infectivity and important aspects of immunity," said Steven W. King, president and CEO of Peregrine. "In particular, we believe that the paper discussing the vaccinia virus(1) independently confirms some of the key mechanisms underlying the anti-viral potential of our anti-PS antibodies. It shows that PS is essential to the ability of the virus to infect cells, and that when PS is blocked, infection cannot occur. The study also discusses how PS helps the virus to evade immune system recognition and destruction, a key secondary mechanism we believe is operative in both the anti-viral and anti-cancer applications of our anti-PS technology."

In a separate Science Perspective article discussing the studies(3), the commentators note that the essential role of PS may not be limited to vaccinia infections, but may also play a role in HIV infection. Vaccinia and HIV are both enveloped viruses, and as the articles discuss, PS becomes exposed on the surface of enveloped viruses and the cells they infect.
This is consistent with findings by Peregrine researchers showing that its anti-PS antibodies bind to every enveloped virus tested. The company's anti-PS antibodies have also demonstrated promising anti-viral activity against a number of enveloped viruses in preclinical tests, as well as in clinical trials in patients infected with HCV, which is an enveloped virus. In addition to the ongoing clinical trial in HCV patients co-infected with HIV, Peregrine's anti-PS antibodies are currently being studied in animal models of HIV.

Peregrine's anti-PS technology is exclusively licensed from the University of Texas Southwestern Medical Center at Dallas, where Dr. Philip Thorpe has been a pioneer in investigating the role of anti-phosphatidylserine therapies in viral infections and cancer for more than a decade.

"It is gratifying to see the growing momentum of scientific interest and inquiry in the unique role of PS in immune system function and dysfunction," said Dr. Thorpe. "Our extensive work in the potential of anti-PS therapies for treating virus infections and cancer has been predicated on the same types of mechanisms that are elucidated and discussed in these first-rate studies, and we welcome the independent corroboration and additional insights that this new research is providing to the field."

About Peregrine's Anti-PS Antibody Bavituximab

Peregrine's clinical stage monoclonal antibody bavituximab is in development for the treatment of certain viral diseases and cancer. It is the first in a new class of targeted anti-PS immunotherapeutics that binds to phosphatidylserine, a specific component of certain cellular membranes. PS is normally present only on the inside of cell membranes, but becomes exposed on the external surface of enveloped viruses and the cells they infect. Enveloped viruses are responsible for about half of all human viral diseases, including HCV, influenza, HIV, cytomegalovirus and other virus strains. Scientists believe that bavituximab helps block the ability of viruses to infect cells and also helps stimulate the body's natural immune defenses to destroy both the virus particles and infected cells. Since the PS targeted by bavituximab is primarily exposed on diseased cells, healthy cells should not be affected.

In preclinical studies, bavituximab has demonstrated the ability to bind to a wide range of enveloped viruses and virally infected cells and has shown promising activity in animal models of serious viral diseases. Bavituximab appeared well tolerated with no dose limiting adverse events and showed encouraging signs of antiviral activity as monotherapy in two Phase I trials in patients with chronic hepatitis C viral infection. A clinical trial in patients co-infected with HCV and HIV is now underway, and additional studies in HCV patients are planned. Similar to their proposed anti-viral mechanism, anti-PS antibodies also bind to phosphatidylserine exposed on tumor blood vessels in all solid cancers tested to date. Bavituximab demonstrated promising signs of anti-tumor activity in a Phase l trial in combination with chemotherapy in patients with advanced solid tumors, and Phase II cancer trials are underway.

1. Vaccinia Virus Uses Macropinocytosis and Apoptotic Mimicry to Enter Host Cells, Jason Mercer and Ari Helenius* Science 25 April 2008: Vol. 320. no. 5875, pp. 531 - 535

2. Role of C. elegans TAT-1 Protein in Maintaining Plasma Membrane Phosphatidylserine Asymmetry, Monica Darland-Ransom, Xiaochen Wang,* Chun-Ling Sun,* James Mapes, Keiko Gengyo-Ando, Shohei Mitani, Ding Xue, Science 25 April 2008: Vol. 320. no. 5875, pp. 528 - 531

3. CELL BIOLOGY: A One-Sided Signal, Gregory D. Fairn and Sergio Grinstein (25 April 2008)Science 320 (5875), 458.

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara(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 www.peregrineinc.com.

[Preciouslife1]

Peregrine Pharmaceuticals Presents Promising Phase I Data at ASCO and Provides Clinical Update on Its Phase II Bavituximab Breast Cancer Study

- 50% of All Evaluable Patients in Phase I Study Receiving Combination of Bavituximab Plus Chemotherapy Achieved Objective Tumor Response or Stable Disease -
- 100% of Evaluable Patients to Date in Ongoing Phase II Breast Cancer Study Showing Objective Tumor Response or Stable Disease -

CHICAGO and TUSTIN, Calif., June 2, 2008 /PRNewswire-FirstCall via COMTEX News Network/

Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced that results from a Phase I clinical trial of its lead anti-phosphatidylserine (anti-PS) antibody bavituximab in combination with chemotherapy in patients with advanced cancer were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. The Phase I data indicated that half of evaluable patients in the trial achieved objective tumor response or stable disease after eight weeks of dosing.
The Phase I study results also showed that the safety profile of bavituximab and chemotherapy appeared consistent with chemotherapy alone and that the pharmacokinetic properties of bavituximab were not impacted by co- administration with conventional chemotherapies.

Separately, Peregrine reported an update from its ongoing Phase II trial evaluating bavituximab plus docetaxel in advanced breast cancer. Enrollment of an initial group of 15 patients in the two-stage Phase II study was recently completed.
Of the 11 evaluable patients to date, none have experienced any measureable tumor growth or disease progression, with five of the 11 evaluable patients achieving a partial tumor response. All enrolled patients are continuing to receive treatment and are being evaluated regularly for tumor response according to RECIST criteria. The primary objective of the multi-center, open label study is to assess overall tumor response rate, and the study may be expanded to a total of 46 subjects following complete evaluation of data from the first 15 patients.

"Bavituximab represents a completely novel approach to treating cancer that helps mobilize the body's own immune system to attack tumors and the blood vessels supporting tumor growth and spread," said Dr. Raghunadharao Digumarti, professor of medical oncology at the Nizams Institute of Medical Sciences in Hyderabad, India, and a principal investigator of the Phase I clinical trial presented at ASCO. "We believe these encouraging study results support the upcoming Phase II safety and efficacy trials of bavituximab in breast and lung cancers that we look forward to participating in."

The open label, multi-center Phase I study was conducted in patients with refractory advanced solid tumors. The study objectives were to assess the safety and tolerability of bavituximab and to characterize its pharmacokinetic profile when used in combination with standard chemotherapy.
Patients received up to eight weekly doses of bavituximab in combination with docetaxel, gemcitabine or paclitaxel plus carboplatin.

"The opportunity to share the positive results of the Phase I clinical study at ASCO provides us with a great platform to inform the broader oncology community about the potential of bavituximab and our anti-PS technology," said Steven W. King, president and CEO of Peregrine. "The promising anti-tumor activity of bavituximab in combination with chemotherapy seen in the Phase I and Phase II studies to date are encouraging, and we look forward to reporting additional results in the coming months."

Bavituximab is a monoclonal antibody that binds to the cellular membrane component PS that is usually located inside cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. By binding to PS, bavituximab is believed to help mobilize the body's immune system to destroy the tumor and the tumor blood vessels. Bavituximab currently is in a Phase II combination therapy trial for the treatment of advanced breast cancer and additional Phase II trials in non-small cell lung cancer (NSCLC) and breast cancer are expected to begin soon. A Phase I bavituximab monotherapy trial in advanced solid cancers is continuing.

Poster Number: 15G, Abstract No: 3038: R. Digumarti, P.P. Bapsy, J.S. Shan, "A phase Ib safety and pharmacokinetic study of bavituximab plus chemotherapy in patients with refractory advanced solid tumor malignancies." Sunday, June 1, 2008, 2:00 PM - 6:00 PM CDT.

Separately, on Saturday, May 31, 2008 Peregrine issued a press release reporting on its brain cancer drug Cotara(R).
The release reviewed dosimetry trial data presented at ASCO confirming a key attribute of Cotara--that it specifically concentrates in brain tumors, leaving healthy tissue in the body largely unaffected. The release also reported that all of the GBM patients treated to date in the Cotara Phase II safety and efficacy trial have survived past the expected median survival time for relapsed GBM patients, an early but encouraging result. The press release can be found at http://ir.peregrineinc.com/releases.cfm

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara(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 July 1/08: PPHM Awarded DTRA Contract, up to $44mm


“Peregrine Pharmaceuticals Awarded DTRA Contract Worth up to $44.4 Million to Develop Bavituximab for Viral Hemorrhagic Fevers - Five-Year Defense Threat Reduction Agency Contract Will Support Development of Bavituximab and Fully Human eq.uivalent as Potential Broad-Spectrum Anti-Viral Agents”

http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=319086

TUSTIN, July 1, 2008: 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 it has entered into a 5-year contract worth up to $44.4 million to test and develop bavituximab and an eq.uivalent fully human antibody as potential broad-spectrum treatments for viral hemorrhagic fever infections. The initial contract was awarded through the Transformational Medical Technologies Initiative (TMTI) of the U.S. Department of Defense's Defense Threat Reduction Agency (DTRA).

Bavituximab is Peregrine's lead anti-phosphatidylserine (anti-PS) monoclonal antibody and is currently in clinical trials for the treatment of HCV infections and cancer. In preclinical animal models, bavituximab has demonstrated encouraging anti-viral activity as a potential treatment for viral hemorrhagic fevers. Peregrine's fully human anti-PS antibody, which will also be assessed under this contract, is currently in preclinical development.

Under the terms of the contact, DTRA funds are available to cover testing and development efforts totaling up to $22.3 million over a 24-month base period, with $5 million appropriated immediately for the current federal fiscal year ending September 30, 2008. The remainder of the $22.3 million in funding is expected to be appropriated over the remainder of the 2-year base period ending June 29, 2010. The contract can be extended beyond the base period to cover up to $44.4 million in funding over the 5-year contract period. Work and funding under this contract are expected to begin immediately.

"This substantial 5-year contract award is especially timely in view of recent scientific publications highlighting the broad anti-viral potential of our anti-PS agents such as bavituximab," said Steven W. King, president and CEO of Peregrine. "We are pleased that DTRA has recognized bavituximab's safety profile to date and its promising anti-viral activity, which have been demonstrated in proof of concept models of hemorrhagic fever infection and in two successful clinical trials in patients with chronic HCV infection."

Mr. King continued, "We welcome the opportunity to contribute to the anti-bioterrorism mission of the Defense Threat Reduction Agency, and we also believe that some of the work performed under this contract can be leveraged to support common development tasks applicable to our ongoing bavituximab clinical programs for the treatment of HCV and cancer. The non-dilutive capital provided by this government contract will enable us to further assess the potential of bavituximab to combat the threat of viral hemorrhagic fevers and to help advance the overall bavituximab clinical program."

The DTRA biodefense contract award has the potential to create long-term value for Peregrine, including generating future potential revenues from government stockpiling to combat bioterrorism threats. In the near-term, funding from this initiative will also allow Peregrine to use data and experience obtained from the development and scale-up of bavituximab to support its ongoing clinical development programs.

"We look forward to a close partnership with the DTRA during the performance of this program," said Ronald T. Aimes, Ph.D., associate director of research & development at Peregrine and principal investigator on the contract. "This is an exciting opportunity for Peregrine to contribute to the country's defenses while also achieving important synergies with our development programs for bavituximab and our earlier stage anti-PS technologies."

ABOUT BAVITUXIMAB
Peregrine's monoclonal antibody bavituximab is the first in a new class of targeted immunotherapeutics that binds to phosphatidylserine (PS), a specific component of certain cellular membranes. PS is normally present only on the inside of cell membranes, but becomes exposed on the external surface of enveloped viruses and the cells they infect. Enveloped viruses are responsible for about half of all human viral diseases, including HCV, influenza, HIV, cytomegalovirus and hemorrhagic fevers. Scientists believe that bavituximab helps block the ability of viruses to infect cells and also helps stimulate the body's natural immune defenses to destroy the virus particles and infected cells. In preclinical studies, bavituximab has demonstrated the ability to bind to a wide range of enveloped viruses and virally infected cells, and it has shown promising activity in animal models of serious viral diseases. In two Phase I monotherapy trials in patients with chronic HCV infection, bavituximab demonstrated encouraging signs of anti-viral activity and appeared safe and well tolerated, with no dose-limiting adverse events. A clinical trial of bavituximab for the treatment of HCV patients co-infected with HIV is ongoing. Bavituximab is also in multiple Phase II trials for the treatment of solid cancers.

ABOUT THE DEFENSE THREAT REDUCTION AGENCY
The Defense Threat Reduction Agency (DTRA) [ http://www.dtra.mil ] 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 (e.g. 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 threats.

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 3 separate clinical programs in cancer and HCV infection 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.
__________________