Novavax Completes Enrollment of Its Seasonal Influenza VLP Vaccine Phase IIa Clinical Trial

Friday, September 19, 2008 General News
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ROCKVILLE, Md., Sept. 19 Novavax, Inc.(Nasdaq: NVAX) announced today it has completed enrollment of healthyvolunteers in a Phase IIa clinical trial of its virus-like particle (VLP)based seasonal influenza vaccine. The Phase IIa randomized, placebocontrolled clinical trial is evaluating the safety and immunogenicity ofdifferent doses of its seasonal influenza VLP vaccine. Specifically, thevaccine will be studied in approximately 300 healthy adults between the agesof 18 and 49 years, who will receive a single injection of either a placebo oran influenza vaccine at doses of 5 mcg, 15 mcg or 30 mcg. The goals of thestudy are to select a dose for evaluation in a subsequent Phase III efficacystudy and to continue the evaluation of safety of its novel influenza VLPvaccines.

VLPs are recombinant structures that mimic the size and shape of a virusbut lack genetic material and are therefore incapable of replication. Becausethey resemble actual infectious particles presenting proteins in the sameconformation as on the wild-type virus, they are able to induce potent immuneresponse. Novavax's VLP vaccine may be differentiated from other influenzavaccines in several ways. First, it includes three viral proteins importantfor inducing a broad immune response including two surface proteins,hemmaglutinin ("HA") and neuraminidase ("NA"), and a core matrix protein, M1.In contrast, most seasonal vaccines consist almost entirely of HA with littleor no NA and M1. The HA protein induces antibody that neutralizes or blocksthe growth of the virus; NA induces antibodies that prevent cell-to-celltransmission of virus down the respiratory tract, potentially reducing theseverity of influenza disease; and cell mediated immune responses to M1 maylead to destruction of cells already infected. Further, the vaccine is madein cell culture rather than eggs, which permits an exact genetic match to theflu strains causing illness since there is no requirement for adapting thevaccine to grow in eggs.

"We are pleased to complete enrollment so quickly of our seasonalinfluenza vaccine Phase IIa trial", said Dr. Rahul Singhvi, President and CEOof Novavax. "The completion of enrollment for this critical clinical trialwithin a week of its initiation should enable us to release top line data fromthis study in the fourth quarter of this year. I congratulate our team onthis accomplishment and for advancing two novel influenza vaccines into PhaseII development this year."

Novavax's novel manufacturing approach

Novavax's manufacturing process makes it possible to rapidly produce avaccine that contains strains that are an exact genetic match to the strainscirculating in the community causing influenza disease. Novavax's influenzaVLPs are produced through recombinant technology in insect cell culture,utilizing a manufacturing process that will consist entirely of disposable,ready-to-use equipment. Current yields are 7 to 10 times higher than those oftraditional egg-based or mammalian cell culture manufacturing. Because theNovavax process involves recombinant technology and does not require a liveinfluenza virus, a matched vaccine for the first seasonal influenza clinicaltrial was manufactured within 12 weeks of identification of the Centers forDisease Control and Prevention ("CDC") released seasonal strains, orapproximately half the time required to manufacture egg-based vaccines. Theability to rapidly respond to the identification of annual seasonal strainsmay be important in providing timely vaccine in advance of annual physicalsfor children before the school year.

Seasonal Influenza

The majority of individuals with influenza recover in less than two weeks;however, some may develop life-threatening complications such as pneumonia.In addition, influenza exacerbates the symptoms of chronic health conditionssuch as diabetes, asthma and congestive heart failu

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