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Biojector(R)2000 Technology Put to the Test in CDC Flu Vaccine Study.


Trial Compares Reduced Dose ID with Needle-free versus Larger Dose IM with Needle

PORTLAND, Ore. -- Bioject Medical Technologies Inc. (Nasdaq:BJCT), a leading developer of needle-free injection therapy ("NFIT NFIT Needle-Free Injection Therapy ") systems, today announced that the Biojector([R])2000 ("B2000") needle-free system has advanced to Phase II in a clinical study sponsored by the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center.  ("CDC See Control Data, century date change and Back Orifice.

CDC - Control Data Corporation
"). The trial performed in the Dominican Republic Dominican Republic (dəmĭn`ĭkən), republic (2005 est. pop. 8,950,000), 18,700 sq mi (48,442 sq km), West Indies, on the eastern two thirds of the island of Hispaniola. The capital and largest city is Santo Domingo. , evaluates influenza vaccine influenza vaccine Flu vaccine A vaccine recommended for those at high risk for serious complications from influenza: > age 65; Pts with chronic diseases of heart, lung or kidneys, DM, immunosuppression, severe anemia, nursing home and other chronic-care  using a reduced dose delivered into the skin via an intradermal intradermal /in·tra·der·mal/ (-der´mal)
1. within the dermis.

2. intracutaneous.


in·tra·der·mal
adj.
Within or between the layers of the skin.
 ("ID") route, compared to similar and standard larger doses delivered intramuscularly in·tra·mus·cu·lar  
adj.
Within a muscle: an intramuscular injection.



in
 ("IM") by conventional needle and syringe.

The study is a prospective, phased, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, investigator and parent-blinded controlled comparison of therapeutic activity (immunogenicity immunogenicity /im·mu·no·ge·nic·i·ty/ (-je-nis´it-e) the property enabling a substance to provoke an immune response, or the degree to which a substance possesses this property. ) 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 pandemic /pan·dem·ic/ (pan-dem´ik)
1. a widespread epidemic of a disease.

2. widely epidemic.


pan·dem·ic
adj.
Epidemic over a wide geographic area.

n.
 or otherwise unaffordable un·af·ford·a·ble  
adj.
Too expensive: medical care that has become unaffordable for many.



un
 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([R]), 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 orifice /or·i·fice/ (or´i-fis)
1. the entrance or outlet of any body cavity.

2. any opening or meatus.orific´ial


aortic 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 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.

For more information about Bioject, visit www.bioject.com.
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Publication:Business Wire
Article Type:Clinical report
Date:May 27, 2008
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