New 7-11-11 ‘Nature Biotech.’ HCV article includes Bavituximab in table of 18 “Selected HCV Drugs In Development”, and quotes Dr. Philip Thorpe in a paragraph discussing Peregrine’s efforts to “dispense with IFN-A by subverting a mechanism that enables viruses to evade the immune response.”
Note: these 5 people were quoted in the article: • Frank Duff, Genentech, VP of Virology Development • Eliav Barr, Merck, VP, Infectious Diseases Project Leadership & Mgt. • Ron Long, Medivir, CEO (dev. alliance with J&J) • Philip Thorpe, prof. of pharmacology at UTSW-MC/Dallas, scientific founder of Tustin, California–based Peregrine Pharmaceuticals • Doug Manion, Bristol-Myers Squibb, VP of Global Clinical Development
These 5 people were quoted in the article: - Frank Duff, Genentech, VP of Virology Development - Eliav Barr, Merck, VP, Infectious Diseases Project Leadership & Mgt. - Ron Long, Medivir, CEO (dev. alliance with J&J) - Philip Thorpe, prof. of pharmacology at UTSW-MC/Dallas, scientific founder of Tustin, California–based Peregrine Pharmaceuticals - Doug Manion, NMS, VP of Global Clinical Development
ARTICLE EXTRACTS: The recent, near-simultaneous US FDA approvals of the viral protease inhibitors Victrelis (boceprevir) and Incivek (telaprevir = VX-950) developed, respectively, by Merck & Vertex, for treating hepatitis C virus (HCV) infection, represent genuine progress in an area poorly served by existing therapy. But these new therapies, approved in May, are not likely to remain in pole position for very long. Numerous other molecules in development based on various other mechanisms (Table 1) offer more tolerable alternatives. . . But the newly approved drugs also have major shortcomings, adding an extra safety & toxicity burden to a treatment that is already difficult to take. . . . Eliminating IFN-A [interferon-alpha] altogether from triple treatments is another major theme. “It is quite a toxic treatment, and people suffer under that drug,” says Philip Thorpe, professor of pharmacology at the Univ. of Texas Southwestern Medical Center, in Dallas, who is also scientific founder of Tustin, California–based Peregrine Pharmaceuticals. Peregrine is trying to dispense with IFN-A by subverting a mechanism that enables viruses to evade the immune response. The company uses bavituximab, a humanized monoclonal antibody that targets phosphatidylserine, an immunosuppressive phospholipid found on the interior of mammalian cell membranes, whose normal function is to allow apoptosis to proceed without provoking an immune response. Phosphatidylserine is ‘flipped’ to the exterior of cells that become virally infected, however, and it is also embedded on the surface envelopes of budding viruses. When thus exposed it exerts an immunosuppressive effect. “We’re hoping that if we break the apoptotic mimicry of the HCV, we’ll enhance its immunogenicity.” . . . TABLE 1 - SELECTED HCV DRUGS IN DEVELOPMENT [Nature Biotechnology, 7-11-2011] Company Molecule Mechanism Stage 1. Merck Victrelis (boceprevir) NS3/4A protease inhibitor Approved 2. Vertex/J&J Incivek (telaprevir = VX-750) NS3/4A protease inhibitor Approved 3. Boehringer Ingelheim BI 201335 NS3/4A protease inhibitor Phase 3 4. Boehringer Ingelheim BI 207127 NS5B RNA-dep. polymerase inhibitor Ph.2 5. Medivir/J&J TMC435 NS3/4A protease inhibitor Phase 3 6. Anadys Setrobuvir Nonnucleoside inhibitor of NS5B RNA-dep. polymerase Ph.2b 7. Biolex Locteron Controlled-release formulation of IFN-a2b Ph.2b 8. Pharmasset/Roche RG7128 Prodrug/cytidine nucleoside mericitabine… PSI-6130 Ph.2b 9. Pharmasset PSI-7977 Pyrimidine nucleotide polymerase inhibitor Ph.2b 10. Pharmasset PSI-938 Guanine nucleotide polymerase inhibitor Phase 1 11. BMS PEG-IFN-A Type III IFN with greater tissue selectivity than IFN-B Ph.2b 12. BMS BMS-790052 NS5A replication complex inhibitor Phase 2 13. BMS BMS-650032 NS3/4A protease inhibitor Phase 2 14. Abbott/Enanta ABT-450/r Protease inhibitor + low-dose ritonavir Phase 2 15. Peregrine Pharmaceuticals Bavituximab Targets phosphatidylserine exposed on surface of infected cells Phase 2 16. Roche/Intermune a Danoprevir NS3/4A serine protease inhibitor Phase 2 17. Santaris Pharma (Denmark) Miravirsen (SPC3649) Locked nucleic acid (DNA phosphorothioate… Ph.2a 18. iTherX (San Diego) ITX-5061 HCV entry inhibitor Phase 1b
= = = = = = = = = = = = = = = = = = = = = = = = = = BAVITUXIMAB HEP-C PHASE1+2 TRIALS: (see http://PeregrineTrials.com) 7-2011: Nature Biotechnology article quotes Dr. Thorpe on Bavi’s goal to elim. IFN-A http://tinyurl.com/3n8qluq 6-2011: Flying Publisher 'Guide to HepC Treatment' highlights Bavituximab: http://tinyurl.com/3srbzl5 D. Phase II Bavi+Riba vs. Frontline-HEPC (randomized, open-label): Protocol (init=1-2011): http://clinicaltrials.gov/ct2/show/NCT01273948 1-13-11: Info&Quotes on Bavi's positioning as potential Interferon replacement in HCV cocktails: http://tinyurl.com/6zq5q69 1-10-11: Bavi+Ribavirin/HepC Ph.2 trial initiated http://tinyurl.com/4uz97tv ......"~66 patients with previously untreated genotype-1 chronic HCV, 1 of 3 arms (.3Bavi+R / 3.0Bavi+R / PEGIFN+R) for 12 wks, testing for safety & antiviral activity." C. PHASE 1B HCV-HIV CO-INFECTED'S MONO REPEAT-DOSE TRIAL: Protocol (init=7-2007): http://clinicaltrials.gov/ct/show/NCT00503347 …4-2-11: Ph.1B trial data presented at EASL-2011/Berlin on 4-2-11 http://tinyurl.com/3mmwy5d …1-31-11: Enrollment Complete in HCV-HIV trial http://tinyurl.com/4tagpz2 ...7-10-07: Enrollment begins at St.Michaels (Peter Ho Mem. Clinic, NJ) http://tinyurl.com/2g7rdp ......Ascending dose levels of Bavi weekly for 8 wks; ~24 pts; designed to assess Safety & PK, but "HCV & HIV viral titers & other biomarkers will be evaluated". ...5-17-07: New Clinical Protocol filed with FDA: http://tinyurl.com/2lpacm - - - - - - - - - - These 2 completed Ph.1 Bavituximab Hep-C Trials archived to: http://tinyurl.com/27f58fc 1. Phase 1A Bavi/Mono Single-Dose HCV Trial: (init=8-2005 comp=2-2006 n=30) 2. Phase 1B Bavi/Mono Repeat-Dose HCV Trial: (init=6-2006 comp=1-2007 n=24)
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