�Novavax, Inc. (NASDAQ: NVAX) announced favourable results from the second stage of the Phase I/IIa human clinical trial of its pandemic grippe virus-like speck (VLP) vaccine candidate. The vaccine, which does not contain an adjuvant, induced robust neutralizing antibody responses. Novavax's VLP candidate is directed against the H5N1 A/Indonesia/05/2005 avian influenza strain. Avian flu emerged in humans in Indonesia in 2005 and has caused 135 documented human cases, 81% of which birth been fateful.
In this study, the vaccine demonstrated strong neutralizing antibody titers across all three doses tested, exhibiting increasing antibody titers with the escalation of the dose. The study evaluated individuals world Health Organization received deuce injections of 15 micrograms (mcg), 45 mcg, 90 mcg or placebo. Among those individuals in the 15 mcg arm, 72% had a neutralizing antibody titer of 1:20 or greater (four-fold climb from baseline) against the H5N1 A/Indonesia strain as did 73% of subjects in the 45 microgram arm and 94% of subjects in the 90 mcg arm. All subjects tested negative for neutralizing antibodies to the H5N1 A/Indonesia strain before vaccination and no responses were observed among individuals wHO received a placebo. Novavax's proprietary VLPs contain the surface proteins (hemagglutinin [HA] and neuraminidase [NA]) and matrix protein (M1) of the H5N1 A/Indonesia nisus. Additional immunological responses induced by each of the components of the vaccinum are being evaluated including responses against HA, NA and the M1 proteins.
Although the safety information are noneffervescent blinded pending complete base hit follow-up, on that point have been no serious adverse events reported. An independent external Data and Safety Monitoring Board fully supported continuation of the study including expansion to the 90 mcg dose.
VLPs ar recombinant structures mimicking the size and shape of the virus but deficiency genetic real and ar therefore incapable of replication. Because they resemble actual infectious particles presenting proteins in the same conformation as on the wild-type virus, they are able to make a virile immune reply. The HA and NA are included to induce neutralizing antibody responses, whereas the M1 may induce cell-mediated immune responses that provide trade protection against drifted (i.e., mutated) strains.
Addressing the Gaps in the System
"These data ar exciting because they march that recombinant VLPs ar a valid and powerful vaccine plan of attack against flu. Combined with our advanced manufacturing approach, our VLP vaccine candidate has the potential to address an unmet need in pandemic influenza preparation efforts being planned by health regime around the world," aforesaid Dr. Rahul Singhvi, President and CEO of Novavax.
Novavax's fabrication process makes it possible to potentially produce and distribute a vaccine matched to a pandemic strain in clip to interrupt and/or halt a pandemic. Novavax's grippe VLPs are produced in insect cell culture, utilizing a fabrication process that consists exclusively of disposable, ready-to-use equipment. Current yields are 7 to 10 times higher than that of traditional egg-based or mammalian cell culture manufacture. Because the Novavax work on involves recombinant technology and does not require a live flu virus, vaccine can be manufactured within 10 to 12 weeks of identification of a pandemic form, approximately 50% of the time continuance required to manufacture egg-based vaccines. As a key fruit commercialization opening move, Novavax has collaborated with GE Healthcare, a whole of General Electric Company (NYSE: GE), to develop processes victimization disposable systems as its manufacturing approach. This fabrication approach permits rapid commission at a fraction of the toll of traditional, egg-based manufacture facilities. The VLP vaccine may be an efficient and affordable component of a pandemic solution for countries that do non currently have in-border pandemic vaccine production.
"This data milestone simon Marks good progress in the viability of Novavax's vaccine which, combined with GE Healthcare's ready-to-use bioprocessing technologies, signals the promise of a solution to problems countries face in preparing for the inevitability of pandemic influenza," said Peter Ehrenheim, President and CEO, Life Sciences, GE Healthcare.
"In the face of a global health menace, innovations are required that can render safe and effective vaccines quickly and reliably," aforesaid Robert B. Belshe, M.D., Dianna and J. Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology at the Saint Louis University School of Medicine, who served on the Data and Safety Monitoring Board for the study. "Two doses of this novel vaccinum - which is designed to keep bird grippe - gave strong immune responses.
The data ar encouraging that this unexampled vaccine approach can help oneself prevent pandemic influenza."
Support for VLP Seasonal Influenza Vaccine Candidate
These data ar also supportive for moving forward with development of another Novavax vaccine candidate: against seasonal influenza. Seasonal influenza causes over five hundred,000 deaths worldwide and over 36,000 deaths in the U.S. each year, most of which occur in adults 65 years of age and older, a population in which currently licensed vaccines have only when modest efficaciousness. Novavax has developed a vaccine candidate against seasonal worker (human) grippe strains. While current seasonal worker vaccines consist almost whole of HA, the Novavax VLP contains HA, NA, and M1 with the potential of inducing neutralizing antibody to prevent infection and bring down the rigour of grippe illnesses. Dose ranging studies in healthy young adults and adults 65 years of age and older are scheduled to start later this year.
About Novavax
Novavax, Inc. is a clinical stage biotechnology company, creating novel vaccines to address a all-inclusive range of infectious diseases worldwide exploitation advanced proprietary virus-like subatomic particle (VLP) technology. The Company produces these VLP based, potent, recombinant vaccines utilizing new, and efficient manufacturing approaches. Additional information roughly Novavax is available at http://www.novavax.com and in the Company's various filings with the Securities and Exchange Commission. http://www.novavax.com
Forward Looking Statement
Statements herein relating to future development results and performance, conditions or strategies and other matters, including expectations regarding product and clinical developments are forward-looking statements inside the substance of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause genuine results to differ materially from the results discussed in the forward-looking statements or historic experience let in risks and uncertainties, including risks relating to the early stage of Novavax's product candidates under development; current results may not be prognosticative of next pandemic results, results of our seasonal worker influenza vaccine or any other vaccine that we may explicate; further testing is mandatory before regulative approval can buoy be applied for and the FDA may non approve the pandemic vaccinum even if further tribulation results ar similar to those disclosed herein; uncertainties relating to clinical trials; dependence on the efforts of third parties; contest for clinical resources and patient registration from drug candidates in development by other companies with greater resources and visibility; and risks that we may lack the financial resources and approach to capital to fund our operations including further l trials. Further information on the factors and risks that could regard Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov. These advanced statements speak only as of the date of this exhort release, and Novavax assumes no duty to update forward-looking statements.
http://www.novavax.com
More information
Tuesday 2 September 2008
Thursday 7 August 2008
Wednesday 25 June 2008
Terry Lee Brown Junior
Artist: Terry Lee Brown Junior
Genre(s):
House
Discography:
Karambolage
Year: 2006
Tracks: 1
Insectisuicides
Year: 2006
Tracks: 3
One in a growing host of German producers influenced by the sound of Chicago, Terry Lee Brown, Jr. is the on the job nom de guerre of Norman Feller, wHO produces from his base in a small town southward of Frankfurt. Though many Teutons have got made their careers on the sound of Detroit-influenced trance, Feller's music reveals no glimpse of its origins. His first productions appeared as Storming Norman on Influence Records, after which he connected with Tom Wax of Phuture Wax Records; recording for Phuture Wax as Watchman, he skip iI of the biggest hard house tracks of 1996, "Watchman's Theme" and "Skip the Midrange." He had already debuted his pretence Terry Lee Brown, Jr. (selected because it simply sounded like the nominate of an American house producer) on Plastic City, and recorded as Twisted Minds, Lectric Cargo and Wax Scientists as well. His debut Terry Lee Brown, Jr. album, 1996's Chum for Real, was followed by Chocolate Chords one yr later. Plastic City too released Selected Remixes in late 1998; followed iI years later with an album of remixes.
Wednesday 18 June 2008
Court hears Amy Winehouse's husband wanted Pete Doherty assaulted
The Old Bailey heard yesterday (June 16) how Blake Fielder-Civil, the imprisoned husband of Amy Winehouse, offered a man �20,000 to beat up Babyshambles' frontman Pete Doherty, who he suspected of having an affair with his wife.
News of Blake Fielder-Civil's cash-for-violence offer had previously been reported in the tabloid newspapers, but it was heard in court for the first time yesterday.
The claim was heard during the trial of Douglas Johnson and David Austin, who are alleged to have been offered �5,000 to kill Charlie Butler, a wheel clamp boss, in a case separate to Fielder-Civil's.
Giving evidence during the trial, Richard Lyttle said that while he and Fielder-Civil were in prison Fielder-Civil said "he would give �20,000 to anyone who done him [Doherty] � cause him injury," reports The Telegraph.
Lyttle also said that Fielder-Civil had claimed that there had been threats that Winehouse would be abducted.
Fielder-Civil is currently awaiting sentencing for assault and perverting the course of justice, accusations he has pleaded guilty to.
News of Blake Fielder-Civil's cash-for-violence offer had previously been reported in the tabloid newspapers, but it was heard in court for the first time yesterday.
The claim was heard during the trial of Douglas Johnson and David Austin, who are alleged to have been offered �5,000 to kill Charlie Butler, a wheel clamp boss, in a case separate to Fielder-Civil's.
Giving evidence during the trial, Richard Lyttle said that while he and Fielder-Civil were in prison Fielder-Civil said "he would give �20,000 to anyone who done him [Doherty] � cause him injury," reports The Telegraph.
Lyttle also said that Fielder-Civil had claimed that there had been threats that Winehouse would be abducted.
Fielder-Civil is currently awaiting sentencing for assault and perverting the course of justice, accusations he has pleaded guilty to.
Tuesday 3 June 2008
Murphy joins Juno star in thriller
Cillian Murphy is to star opposite Oscar nominee Ellen Page in a new psychological thriller called 'Peacock'.
Variety reports that the film tells the story of a man (Murphy) with a split personality who fools the residents of Peacock, Nebraska into believing his alter-egos are man and wife.
Page, currently on Irish screens in 'Juno', plays a young mother who holds the key to the man's past.
The film, directed by first-time director Michael Lander, will begin shooting in May.
Read the review of 'Juno' here.
Variety reports that the film tells the story of a man (Murphy) with a split personality who fools the residents of Peacock, Nebraska into believing his alter-egos are man and wife.
Page, currently on Irish screens in 'Juno', plays a young mother who holds the key to the man's past.
The film, directed by first-time director Michael Lander, will begin shooting in May.
Read the review of 'Juno' here.
Tuesday 27 May 2008
Porn Theatre Ushers
Artist: Porn Theatre Ushers
Genre(s):
Other
Discography:
Taxachusetts
Year: 2004
Tracks: 25
Influenced by production denizens DJ Premier and Large Professor as well as funky upbeat lyricists such as Ultramagnetic MC's, De La Soul, and Organized Konfusion, the white duet Porn Theatre Ushers exploded out of the vibrant late-1990s Boston underground rap scene passionate about the music merely disappointed in its growing deficiency of humour. With that in creative thinker, they set out to contribute the playfulness back to pat music, marrying wittily irreverent and clever lyrics with idiosyncratic, frequently capricious production.
Nabo Rawk and Mister Jason low met in 1997 when comrade Boston doorknocker Esoteric introduced the two. Both were already involved in the local scene, merely as it so happened, Nabo was looking for for a DJ and Mister Jason for individual to produce for. They immediately smitten up a friendship, and shortly thereafter a partnership. Their break came the following year when Nabo Rawk even for first gear in the Biscuithead Battle, a freestyle consequence, and DJ Bruno offered to put out a 12" single on his Biscuithead Recordings, a fledgeling local label. Over the next couple years, the couple released singles like "Me & Him" and "My Imagination" to underground applaud and created a small buzz in the strike community, spell Mister Jason became an coveted producer for other local MCs as substantially. The couple in the end released their first-class honours degree definitive statement in 2000 with the intimately LP-length EP Sloppy Seconds, which included their earlier singles and collaborations with Cage and K-No Supreme as substantially as new recordings.
Chemlab
Sunday 11 May 2008
Amy Winehouse Arrested Again
Amy Winehouse Arrested Again
Amy Winehouse turned herself in to a London police station on Wednesday (May 7) and was arrested regarding a television that regime obtained earlier this year.Footage of Winehouse allegedly doing drugs constitute it's way to the U.K. tabloids in January this year and made headlines worldwide. The 24-year-old's voice released a statement expression, "Amy Winehouse voluntarily attended a Greater London law station today by appointment. She was arrested in order to be interviewed and is cooperating in full with inquiries. The interview relates to a video handed to law sooner this yr." This pick up is the latest in a serial publication of run-ins with the law as the isaac Merrit Singer continues to struggle her addictions while her hubby, Blake Fielder-Civil, is currently in poky.Exposure courtesy of Universal.
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