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Biojecta?s Intradermal Needle-Free Delivery System Used in World Health Organization Clinical Trial in Oman with Poliovirus Vac

^{Published on 2010-07-08 20:41:35 - Market Wire}
 

PORTLAND, Ore.--([ BUSINESS WIRE ])--Bioject Medical Technologies Inc. (OTCBB: BJCT), a leading developer of needle-free injection therapy systems, today announced that Biojecta™s needle-free injection delivery technology was used to successfully demonstrate that intradermal administration of fractional doses of inactivated poliovirus vaccine given to infants is safe and effective (using seroconversion as an indication of effectiveness), and is preferred by both health care administrators and parents over typical full-dose needle and syringe. The study results, published in the June 24, 2010, issue of The New England Journal of Medicine (NEJMVol. 362 No. 25), also demonstrated a significant cost savings in use of the fractional-dose intradermal injection as compared with a full-dose vaccination course of treatment using an auto-disable needle and syringe.

"We are pleased to have participated in this significant clinical trial and to learn about the positive results with intradermal fractional-dose injection of inactivated polio vaccine using Biojecta™s intradermal delivery technology"

The study was conducted in Oman and supported by the Ministry of Health of Oman, the Program for Appropriate Technology in Health (PATH) and the World Health Organization (WHO) as part of the Global Polio Eradication Initiative (GPEI). The randomized clinical trial of over 400 infants, of whom 373 fulfilled the entry criteria, were selected to receive either fractional-dose inactivated poliovirus vaccine (one-fifth of the full dose) or a full-dose of the same vaccine over a three course treatment during the first six months of age. The intradermal fractional-dose was given with Biojecta™s Biojector®2000 (B2000) needle-free injection delivery device and the full-dose was delivered with an auto-disable syringe and needle. The study was designed to assess the safety and efficacy of, and preference for, the needle-free intradermal fractional-dose and the potential to use a needle-free intradermal fractional-dose vaccine option with infants in order to prevent polio infection. The results of the study demonstrate that needle-free intradermal administration of fractional doses of the polio vaccine was safe, effective and lower cost than a similar course treatment with full dose needle-syringe option. In addition, both health caregivers and parents expressed a preference for the needle-free option because athe baby does not cry.a

The study was one of the research and development initiatives stemming from the GPEIa™s goal to develop affordable injectable polio vaccine options for the post-eradication era. GPEI is spearheaded by national governments, WHO, Rotary International, the US Centers for Disease Control and Prevention (CDC) and UNICEF.

aWe are pleased to have participated in this significant clinical trial and to learn about the positive results with intradermal fractional-dose injection of inactivated polio vaccine using Biojecta™s intradermal delivery technology,a said Dr. Richard Stout, Biojecta™s Executive Vice President and Chief Medical Officer. Dr. Stout added, aBased on the findings, as reported in the NEJM, we now have evidence that demonstrates potential cost savings when using intradermal needle-free injection delivery technology as compared with typical full-dose injections. In addition, we along with the parents of the treated infants are delighted to hear that the babies did not cry, leading to a significant preference for Biojecta™s needle-free injection devices. We look forward to working with other organizations around the world who are interested in leveraging the benefits of our needle-free intradermal injection delivery technology for their vaccine portfolios,a commented Dr. Stout.

Bioject Medical Technologies Inc.,based in Portland, Oregon, is an innovative developer and manufacturer of needle-free injection therapy systems (NFITS). NFITS provide an empowering technology and work by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid penetrating the skin and depositing medication in the tissue beneath. The Company is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology and veterinary companies.

For more information about Bioject, visit [ www.bioject.com ].