Biojector(R)2000 Technology Put To The Test In CDC Flu Vaccine Study

Main Category: Flu / Cold / SARS
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials;  Medical Devices / Diagnostics
Article Date: 29 May 2008 - 4:00 PDT

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Bioject Medical Technologies Inc. (Nasdaq:BJCT), a leading developer of needle-free injection therapy ("NFIT") systems, announced that the Biojector®2000 ("B2000") needle-free system has advanced to Phase II in a clinical study sponsored by the Centers for Disease Control and Prevention ("CDC"). The trial performed in the Dominican Republic, evaluates influenza vaccine using a reduced dose delivered into the skin via an intradermal ("ID") route, compared to similar and standard larger doses delivered intramuscularly ("IM") by conventional needle and syringe.

The study is a prospective, phased, randomized, investigator and parent-blinded controlled comparison of therapeutic activity (immunogenicity) and safety/side effects (reactogenicity) in infants and toddlers from 6 to 23 months of age.

The ID route of vaccination is of interest for influenza and other diseases for which vaccines may be in short supply in a pandemic or otherwise unaffordable in developing countries. Prior studies found that reduced doses in the skin often work just as well as full doses injected into fat or muscle. Such "dose-sparing" might extend protection to more people than otherwise would be possible. The influenza pandemic preparedness plans of both the U.S. Government and the World Health Organization have identified such research as a priority.

ID injection by traditional needle method, however, is difficult and requires extra training and experience by health workers to perform correctly. An intradermal spacer on the B2000 injector provides a quick and simple method to deliver such doses. A needle-free system also eliminates other drawbacks of needle-syringes, including needlestick injuries, and in many countries, improper unsterile reuse and unsafe disposal of needle waste.

The CDC decided to use the B2000 because its ID spacer had the most clinical use in adult studies to justify its investigational use in children. Phase I of the still-blinded trial is now complete and its safety results were presented in poster presentation P25 at the 11th Annual Conference on Vaccine Research, in Baltimore, MD, May 2008 (http://www.nfid.org/pdf/conferences/vaccine08abstracts.pdf). An independent Data Safety Monitoring Board reviewed unblinded results from Phase I and deemed the study safe and ethical to proceed to its larger Phase II, which began in April 2008.

"We are hopeful this study will determine whether intradermal vaccination by needle-free jet-injector will be of practical use in young children, who are particularly vulnerable to influenza," said Dr. Bruce G. Weniger of CDC, U.S. principal investigator and sponsor of the study. "If it works, developing country health officials would have additional options to better protect their populations against this serious disease," Dr. Weniger added.

"This study is very well designed to carefully evaluate the safety and effectiveness of our needle-free injection device for the intradermal delivery of reduced-dose influenza vaccine," said Dr. Richard Stout, MD, Executive Vice President and Chief Medical Officer of Bioject. "We are delighted that the B2000 was selected to be included in this important CDC study which aims to benefit patients in the developing world, and look forward to results from the trial's ongoing Phase II," he continued.

The influenza vaccine studied is Vaxigrip®, manufactured by the Sanofi Pasteur in France. Participant children who receive reduced doses will afterwards get a full dose to ensure protection. All children will get a bonus dose six months later for the next influenza season.

Bioject Medical Technologies Inc., based in Portland, Oregon, is an innovative developer and manufacturer of needle-free injection therapy (NFIT) systems. Needle-free injection works 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.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such risks include that the results of clinical studies may not produce the anticipated results and that intradermal injection device may not be commercialized. Readers of this press release are referred to the Company's filings with the Securities and Exchange Commission, including the Company's reports on Form 10-K and Forms 10-Q for further discussions of factors that could affect the Company's business and its future results. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. The Company assumes no obligation to update forward-looking statements if conditions or management's estimates or opinions should change.

Bioject Medical Technologies Inc.