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"As declared by WHO on June 11th, 2009", said Dr Yotam Levin, theCompany's CEO, "the novel A H1N1 influenza has become a phase 6 globalpandemic. There is an imminent need of developing countries, as well as thatof many developed countries, for an adequate supply of pandemic flu vaccines.Since global capacity is limited and production yield is reported to be low,novel approaches for vaccine enhancement are of great need." Dr Ofer Sharon,the Company's Medical Director added, "NanoPass has proven in a randomizedclinical trial, recently published in Vaccine,[2] that it can reduce the doseof a seasonal flu vaccine by 80% while preserving its efficacy. This effectis thought to be achieved by targeting the potent specialized immune cellsthat reside in the skin. This means that health authorities can use the sameamount of vaccine they have sourced, to vaccinate at least double, if nottriple, the number of subjects, with the same vaccine purchase." NanoPass isdesigning clinical studies to demonstrate this significant effect for swineH1N1.
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The major global public threat posed by the new H1N1 flu strain demandsclose coordination among vaccine manufacturers, governments, technologydevelopers and global health authorities to manage the supply of vaccines andto ensure there are enough doses for everyone.
About NanoPass's MicronJet Device
MicronJet is a microneedle-based device for intradermal delivery ofvaccines. The device allows for consistent, reliable, and simple delivery ofthe vaccine directly into the skin. It has been shown in multiple clinicaltrials,[3,4] that injecting a seasonal influenza vaccine directly into theskin harnesses this very potent immune organ, and allows for both thereduction of the dose required for the same immune response ("dose sparing"),as well as the ability to actually potentiate this response, with the use ofequivalent doses ("increased immunogenicity").[5]
This approach is being tested for a variety of major diseases that do notyet have an effective vaccine, such as malaria, HIV and tuberculosis.
NanoPass - Transforming device innovation into global health solutions
NanoPass, founded by Dr Shuki Yeshurun, is an Israeli-based privatecompany developing an innovative delivery device for the enhancement ofvaccines and other large molecules. The Company has proven efficacy andsafety in multiple applications including seasonal flu, insulin delivery andlidocaine for local anesthesia. MicronJet is approved for marketing in the EU(please see http://www.nanopass.com for more information), and is about to beregistered in additional markets. The MicronJet is approved for use by healthcare professionals for intradermal delivery of drugs and medicinal productsthat are approved for intradermal delivery.
Contact: Yotam Levin: +972-8-9313099 or +972-523-392727 [email protected] [1]http://www.who.int/mediacentre/news/statements/2009/ h1n1_pandemic_phase6_20090611/en/index.html (Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. Remove the space if one exists.) [2] Van Damme P, Oosterhuis-Kafeja F, Van der Wielen M, Almagor Y, Sharon O and Levin Y. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine. 2009 Jan 14;27(3):454-9. [3] Belshe RB, Newman, FK et al. Serum Antibody Responses after Intradermal Vaccination against Influenza. N Engl J Med 2004;351:2286-94. [4] Kenney RT, Frech SA et al. Dose sparing with intradermal injection of influenza vaccine. N Engl J Med. 2004 Nov 25;351(22):2295-301. Epub 2004 Nov 3. [5] Holland D, Booy R et al. Intradermal influenza vaccine administered using a new microinjection system produces superior immunogenicity in elderly adults: a randomized controlled trial. JID 2008; 198:650-58.
SOURCE NanoPass Technologies LTD.
