InvestorsHub Logo
Followers 72
Posts 4827
Boards Moderated 0
Alias Born 01/24/2004

Re: None

Sunday, 08/30/2009 9:59:31 AM

Sunday, August 30, 2009 9:59:31 AM

Post# of 345554
PR 8-26-09: $763k NIAID Grant to Dr. Thorpe to Expand Anti-PS/VHF Studies

NIAID Awards New Grant to Expand Studies of Peregrine's Anti-PS Antibodies to Treat Viral Hemorrhagic Fevers
• Two-Year Research Grant will Support Evaluation of New Anti-PS Antibodies as Broad-Spectrum Agents to Treat Viral Hemorrhagic Fever Infections
• New NIAID-Funded Research Complements Peregrine's Ongoing TMTI Research Contract to Evaluate Bavituximab as a Potential Therapy for Viral Hemorrhagic Fevers
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=405232

TUSTIN, Aug 26, 2009: Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced that the U.S. National Institute of Allergy and Infectious Diseases (NIAID) has awarded a two-year, $763,000 grant to Philip Thorpe, Ph.D., of the University of Texas Southwestern Medical Center for research expanding its studies of anti-phosphatidylserine (anti-PS) antibodies as potential treatments for viral hemorrhagic fever (VHF) infections. Anti-PS antibodies work through a unique mechanism that allows the body's own immune system to recognize and attack virus infections. Previously published preclinical data and ongoing research support the potential of anti-PS antibodies for the treatment of VHF infections. The objective of the newly funded research is to evaluate a panel of new fully human anti-PS antibodies with different binding and functional properties as potential second-generation treatments.

The new studies complement Peregrine's ongoing research evaluating its lead anti-PS antibody bavituximab and an equivalent fully human antibody for the treatment of VHF, which is classified as a significant biodefense threat. In 2008, Peregrine was awarded a 5-year research contract worth up to $44.4 million by the Defense Threat Reduction Agency [“DTRA”] for the Transformational Medical Technologies Initiative (TMTI) [ 7-1-08 http://tinyurl.com/5dxpup ]. In previous preclinical studies funded by NIAID, bavituximab demonstrated encouraging anti-viral activity as a potential treatment for hemorrhagic fevers.

"PS is a highly specific, host-derived target that becomes exposed on cells when they are infected by a broad variety of viruses," said Dr. Thorpe, professor of pharmacology at UT Southwestern. "As a result, anti-viral approaches targeting PS have potential as broad-spectrum agents effective against a range of viral infections, including VHF and other emerging virus pathogens. This grant from NIAID will enable us to conduct studies in VHF models to assess the anti-viral potential of a panel of fully human anti-PS antibodies. We expect the results will be useful for the development of anti-PS therapies for viral hemorrhagic fevers and also will enhance our basic understanding of anti-PS mechanisms in the treatment of virus infections."

Dr. Thorpe is a pioneer in the field of anti-PS biology and its application to anti-viral and anti-cancer therapeutics. The PS-targeting technology developed by Dr. Thorpe and his colleagues at UT Southwestern is exclusively licensed to Peregrine.

"The research we are conducting under our TMTI contract to assess bavituximab and an equivalent human antibody against VHF infections is already generating promising results, and Dr. Thorpe's work under this new NIAID grant dovetails very nicely with that research," said Steven W. King, president and CEO of Peregrine. "The NIAID grant will allow our research collaborators to expand our existing VHF research to the evaluation of new PS-targeting antibodies that could extend the potential of our anti-PS platform. We expect it will result in greater understanding of the anti-viral mechanisms of our anti-PS technology platform that should be valuable for the development of new therapies against VHF as well as other serious viral infections."

Bavituximab is currently being assessed in a clinical trial in patients co-infected with hepatitis C virus (HCV) and HIV. Bavituximab and Peregrine's other PS-targeting antibodies may have anti-viral potential in a wide range of other virus infections including influenza, cytomegalovirus and biodefense targets such as Ebola, Yellow Fever and Punta Toro viruses. Peregrine's collaborators currently evaluating the anti-viral potential of its PS-targeting platform include researchers affiliated with Duke University, Harvard University, UT Southwestern, the NIH, Utah State University, the Southwest Foundation for Biomedical Research, the University of Texas Medical Branch at Galveston and other institutions. Bavituximab is also being tested in Phase II clinical trials for the treatment of advanced breast cancer and non-small cell lung cancer.

The fully human anti-PS antibodies being used in Dr. Thorpe's NIAID research were developed by Affitech A/S in collaboration with Peregrine.

ABOUT PHOSPHATIDYLSERINE (PS)-TARGETING ANTI-VIRAL AGENTS
PS is a lipid molecule normally found on the inside of cell membranes that "flips" and becomes exposed on the outside of the membranes of enveloped viruses and virally infected cells. Exposed PS enables viruses to evade immune recognition and dampens the body's normal responses to infection. By masking the exposed PS, bavituximab and other PS targeting antibodies may block these effects and allow the body to develop a robust immune response. Anti-PS antibodies have been shown to help clear infectious virus from the bloodstream and to induce antibody-dependent cellular cytotoxicity, an important anti-viral immune response. Researchers have found that PS is exposed on the outer membrane of cells infected with HIV, HCV, influenza, hemorrhagic fever viruses, CMV, herpes simplex viruses, respiratory syncytial virus, measles and members of the smallpox and rabies virus families. In addition to its potent anti-viral activity in lethal viral disease models, Peregrine's PS-targeting antibody bavituximab appeared safe and well tolerated with promising signs of anti-viral activity in Phase I trials in patients with chronic HCV infection. An article by Soares et al. discussing the broad anti-viral potential of bavituximab was published in the December 2008 edition of Nature Medicine [ http://tinyurl.com/9ktvsb ]. For more information on the anti-viral mechanisms of PS-targeting agents, see the Anti-PS Technical Background--Anti-Viral at http://www.peregrineinc.com [ => http://tinyurl.com/759qyw ].

ABOUT PEREGRINE PHARMACEUTICALS
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing 3 separate clinical programs in cancer and hepatitis C virus 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 biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*
Contacts: GendeLLindheim BioCom Partners
Investors: 800-987-8256, info@peregrineinc.com
Media: Barbara Lindheim, 212-918-4650
*end*

= = = = = = = = = = = = =
“CRISP” Search Engine (Gov’t BioMedical Res. Grants): http://crisp.cit.nih.gov

8-2003 5-yr $1.68mm Grant P.Thorpe/Lassa): http://tinyurl.com/l5m6ab
. . . NIAID #5U01AI056412: ”Novel Anti-Viral Agents for Treating Lassa Fever”
. . .Project: 15-AUG-2003 - 31-JAN-2008

8-2009 2-yr $763k Expansion Grant (P.Thorpe/VHF): http://tinyurl.com/ok46lx
. . . NIAID #1U01AI077844: ”Broad Spectrum Treatment of Hemorrhagic Arenaviruses”
. . .Project: 14-AUG-2009 - 31-JUL-2011

Viral Hemorrhagic Fevers (VHFs) are a group of illnesses caused by 4 families of viruses. These include:
• Ebola Virus
• Marburg Viruses
• Lassa Fever Virus

VHFs have common features: they affect many organs, they damage the blood vessels and they affect the body's ability to regulate itself. Some VHFs cause mild disease, but some, like Ebola or Marburg, cause severe disease and death.
http://www.nlm.nih.gov/medlineplus/hemorrhagicfevers.html

Viral Hemorrhagic Fevers - by Mayo Clinic staff: http://tinyurl.com/lcczjp

= = = = = = = = = = = = = =
NIAID GRANT-RELATED BAVITUXIMAB ANTI-VIRAL INFO & NEWS:

AFFITECH-PPHM Collab: Fully-Human Mabs, Anti-PS & Anti-VEGF/2C3 http://tinyurl.com/bxyfjk
• AT001 is clearly Fully-Human 2C3 = R84 = PGN311.
• AT004 & AT005 appear to be Fully-Human BAVI= PGN635=1N11, and the Duke-PPHM-HIV candidate PGN632=11.31. It’s unclear which is which.
...7-22-09: Peregrine Licenses Anti-VEGF mabs (incl. R84) to Affitech: http://tinyurl.com/l5pl7a
...4-28-09 Affitech comments on PGN635 & PGN632 presented at AACR'09 http://tinyurl.com/cxkcb4

8-5-09: ‘New Scientist’ Article Highlights Peregrine/Thorpe/BaviAV http://tinyurl.com/mp2aku
...Dr. Thorpe, "We were doing something that was quite extraordinary. We had let the animals progress in their disease until they were heavily symptomatic, and then started treatment. It was a major accomplishment to knock that disease back."

1-6-09: New ‘Anti-PS Anti-viral Factsheet’ on the PPHM Website: http://tinyurl.com/759qyw

11-24-08: Dr.Thorpe publishes in Dec.2008 NATURE Medicine on BaviAV vs. Lassa/CMV: http://tinyurl.com/9ktvsb
...Dr. Thorpe, "This is a whole new strategy for making antiviral drugs." . . . CEO S.King, "We think it has tremendous potential."
...Dr. B.Haynes, "Targeting a host cell lipid such as PS as an anti-viral strategy is an intriguing concept that may have relevance for new therapeutic and possibly prophylactic innovations in a number of virus infections."
...7-11-09 Dr. Thorpe Interview on Bavi-AV in BMED Report: http://tinyurl.com/ltudso

7-1-08: PPHM Awarded 5-yr $44mm DTRA/TMTI Contract for Anti-PS vs. Hemorrhagic Fevers http://tinyurl.com/5dxpup
…DTRA funds: $5mm immediate; $22.3mm for 1st 24-mos; can extend to $44.4mm over 5-yrs.
...7-3-08 BioWorld Today article on PPHM’s DTRA Deal: http://tinyurl.com/5kr6xk
...7-23-07: DTRA Negotiations Begin: http://tinyurl.com/2t42rq ...12-18-07: Budget Cuts Halt: http://tinyurl.com/256ord
...2003-2008 Gov't Grants & Testing Collab's for Bavi-vs-VHF that led to $44mm DTRA deal: http://tinyurl.com/c53v2x
...Peregrine's $44mm award hits the DTRA website on 7-25-08 - how it ranks with others: http://tinyurl.com/6l9cec

THE DUKE/HAYNES/CAVD/GATES/NIH HIV COLLABORATION:
Duke's B.Haynes DHVI website & CAVD-Reports outline Thorpe’s Role in the CAVD-Gates HIV-Vaccine Initiative:
. . . . . http://tinyurl.com/674936 and http://tinyurl.com/5xwjk4 . . .
…”Philip Thorpe is determining the role of lipid binding of anti-HIV antibodies and anti-phosphatidylserine (PS) autoantibodies to protection from HIV infection.”
…2005-July2009: All Peregrine Public Statements on the Duke HIV Collab: http://tinyurl.com/m4aggy
…10-2008: Short profiles of ~40 Gates/NIH HIV collaborators: http://tinyurl.com/57tanp
...5-2009: Duke’s Tony Moody is CHAVI’s 'Chief Medical Officer' tinyurl.com/m3g9cu
...5-1-09: CHAVI update by Barton Haynes says paper on anti-Lipid antibodies "submitted to Nature-Med. 2009": http://tinyurl.com/d2ucmw
…..Haynes: “B Cell Discovery Team has defined a class of anti-lipid antibodies with breadth of protection in vitro PBMC assay for R5 transmitted/founder strains.”
...3-18-09: CFO Paul Lytle on the Duke-HIV Collab. at the Cowen Healthcare Conf: http://tinyurl.com/cal9br
...“We are expecting a high-profile publication, which is currently in process thru Duke Univ., to be presented within the 1st half of 2009.”
...3-17-09 CAVD 2006-2008 Recap Report – (57-pg PDF): http://tinyurl.com/d2jpm9
...““researchers in the Haynes VDC have discovered that anti-lipid antibodies in fact may play a role in HIV-1 protection. They found that anti-lipid antibodies produced in autoimmune disease have the capacity to broadly inhibit the infection of peripheral blood mononuclear cells by virtually all CCR5-dependent HIV-1 primary isolates. They are working now to translate this finding into a novel strategy of HIV-1 vaccine development.”
...10-30-08: CEO S.KING, BIO-INV. Forum (SanFran) - replay w/slides: http://tinyurl.com/664mgd
...SK on Duke/Gates/NIH HIV collab: “At AIDS-VACCINE’08, a key finding was that certain classes of Anti-Phospholipid antibodies broadly neutralize HIV infection. And, in fact, the most potent antibodies were those that were provided by Peregrine. This is a very important finding…”
...10-14-08: “The AIDS Vaccine 2008 Conference”, CapeTown, So.Africa http://tinyurl.com/7dnmpe
......Duke’s B.Haynes & T.Moody present Anti-PS data for 1st time publicly: “The most potent mAb, PGN632 [11.31], inhibited 7/7 B & C clade HIV-1 isolates & SHIV SP162P3... Studies showed the mAbs acted at host cell surfaces to inhibit HIV-1 infection."
…..Dr. Ralph Pantophlet’s summary of T.Moody’s Talk, incl. two PGN632=11.31 test data graphs: http://tinyurl.com/7w4udz.
......SK: "This data opens the door to a # of potential commercial app's incl. post-exposure prophylaxis & topical microbicides” http://tinyurl.com/cxv2st
.....1-24-09: Mojo’s Comparison Graphs of Bavi vs. 11.31(PGN632) against HIV (in-vitro): http://tinyurl.com/dkmrdp
......1-6-09: NIAID reviews CapeTown AIDS’08, commenting on the Tony Moody Anti-Lipids/PGN632 talk: http://tinyurl.com/7dnmpe
......1-15-09: JBM’s 'AIDS-Vaccine’08/Capetown Wrapup' (Anti-PS Blog): http://tinyurl.com/8cmmcs
......2-23-09 Duke article about 2F5, a ‘Rare, Potent Antibody to HIV-1’ – comp. vs. PGN632: http://tinyurl.com/aozpd2
…9-22-08: Haynes CAVD Update: ”The team has recently found that non-pathogenic anti-lipid antibodies that do not require B2GPI for lipid binding do prevent HIV-1 & SHIV-SF162P3 (and all R5 HIVs tested) from infecting PBMC in vitro..." http://tinyurl.com/3g6vbm
…2-12-08: CFO P.Lytle, BIO-CEO/INV.CONF(NYC), Replay w/slides: http://tinyurl.com/2xpzth
......PL: “On the Bavi/AV front, we’re looking at a # of potential pubs here… these s/b coming from Duke Univ. & UTSW - potentially some ground-breaking news on these 2 fronts.”
…12-2007: UCLA’s Dr. Pojen Chen (active in CHAVI/Duke HIV studies) joins PPHM’s SRB: http://tinyurl.com/2nxcm2
...7-2007: PPHM licenses "certain Anti-PS Antibodies" from UCLA - the Dr. Pojen Chen connection? http://tinyurl.com/5t8jvm
…4-24-07: GATES-FOUND. rep's lecture at U-WASH lists P.Thorpe on CAVD grants map: http://tinyurl.com/3t67gj
...3-2007: Duke’s D.Montefiori Europrise-HIV Assay paper refs. “BAVITUX” & “3G4RHD” http://tinyurl.com/448d8k
…1-27-07: Dr. Haynes (Chavi Dir.) report - pg.31 shows slide “Labeling of Microparticles by Anti-PS Antibodies”: http://tinyurl.com/289a5g
...JBM’s interesting & educational blog on Anti-PS science, esp. HIV: http://anti-ps.blogspot.com
...Haynes-BF pubs: http://tinyurl.com/3nspyw ...Moody-MA pubs: http://tinyurl.com/5yeh2e
...Duke Health News: http://www.dukehealth.org/HealthLibrary/News ...CAVD(Gates) Annual repts: http://tinyurl.com/47uhtu

5-2007: Thorpe/Soares IMMUNOLOGY’07 Bavi/AV Poster: http://tinyurl.com/2tf8df & http://tinyurl.com/3cxk2d
”We show that Bavi is able to cure overt disease in g.pigs lethally infected with Pichinde virus [Lassa Model].”

NIAID-related Presentations of Bavi by Soares & Thorpe:
…3-29-06: M.Soares at NIAID Mabs Workshop: http://tinyurl.com/grflf ***28-pg PDF: http://tinyurl.com/eu8mk
…5-24-06: P.Thorpe on Kurilla’s ”Bioterrorism: Challenges and Opportunities” panel at ASM2006: http://tinyurl.com/ndcak

7-21-05: U.S. Army's USAMRIID to Test Tarvacin against Ebola & Marburg Viruses http://tinyurl.com/dd4yc
"Peregrine will supply Tarvacin for animal studies directed by Dr. Thomas W. Geisbert, Chief, Dept. of Viral Pathology, USAMRIID, Fort Detrick, MD"

6-22-05: Thorpe presents TarvacinAV pre-clin. data at BIO2005: http://tinyurl.com/avt4y
“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."

4-4-05: NIH's NIAID to Test TARVACIN on “Broad Spectrum of Enveloped Viruses": http://tinyurl.com/9u7n6
"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."

Thorpe’s Aug03-Jan08 $1.68mm NIH/NIAID Grant for research using PPHM’s APTs (Anti-PS/3G4) as “Novel Anti-Viral Agents for Treating Lassa Fever”:
Thorpe: “We are developing drugs to use against Lassa fever that operate on a new principle in virology. They exploit the fact that viruses coat themselves with an outer membrane where some of the lipids are inside-out. The drugs direct our immune responses to the inside-out components of the viral membrane, or envelope. These drugs potentially could be effective against numerous viruses that have similar outer membranes… We have raised mabs to PS and other anionic phospholipids that block the spread of several viruses to uninfected cells in vitro, essentially completely. The phospholipids that they recognize have the same structure & cellular distribution in different mammalian species, simplifying the transition from experimental animals into humans. The antibodies are not toxic to mice, even when administered in high doses for prolonged periods of time.”
GRANT LINK: http://tinyurl.com/5ntcm . . .11-3-03 Grant PR: http://tinyurl.com/5aulds

The Inventor of the Anti-PS mabs is DR. PHILIP E. THORPE of UTSW-MC/Dallas.
BIO: http://www.utsouthwestern.edu/findfac/research/0,2357,17308,00.html
...Thorpe's LAB TEAM: http://tinyurl.com/yuxemu
DR. THORPE'S PATENTS:
GRANTED: http://tinyurl.com/m232k PENDING: http://tinyurl.com/845p2
ARTICLES: http://tinyurl.com/csjsl
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent CDMO News