27.05.2008 13:30:00
|
Biojector(R)2000 Technology Put to the Test in CDC Flu Vaccine Study
Bioject Medical Technologies Inc. (Nasdaq:BJCT), a leading developer of
needle-free injection therapy ("NFIT”)
systems, today 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.
For more information about Bioject, visit www.bioject.com.
Der finanzen.at Ratgeber für Aktien!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Nachrichten zu Bioject Medical Technologies Inc (Oregon)Shsmehr Nachrichten
Keine Nachrichten verfügbar. |