Bioject Announces Results of Intradermal Dose Sparing Influenza Study Conducted by the Centers for Disease Control and Prevention
PORTLAND, Ore.--(BUSINESS WIRE)--Apr 29, 2010 - Bioject Medical Technologies Inc. (OTCBB:BJCT), a leading developer of needle-free injection therapy systems (NFITS), today announced that the Centers for Disease Control and Prevention (CDC) and its collaborating institutions presented the latest results of its clinical trial of the Biojector® 2000 at the 13th Annual Conference on Vaccine Research, sponsored by the National Foundation for Infectious Diseases and held in Bethesda, Maryland April 26 - 28, 2010. The study involved administering influenza vaccine intradermally in reduced “dose-sparing” amounts into the skin by jet injection, increasing the speed and avoiding the risks and discomfort of the traditional “Mantoux” needle method commonly used for tuberculosis skin testing.
The threat of pandemic influenza and other diseases will likely require mass campaigns in which a limited number of healthcare workers would need to rapidly vaccinate large populations. The intradermal route takes advantage of the high immune responsiveness of the skin to reduce the amount of vaccine needed for influenza and some other vaccines. Intradermal delivery may extend protection to larger numbers than would full doses of expensive or scarce vaccines. The traditional intradermal method by needle-syringe is difficult and tedious. Jet injectors can vaccinate into the skin more quickly and also eliminate many of the dangers and drawbacks of using needle-syringe delivery, such as intentional or inadvertent unsterile reuse, needle-stick injuries to healthcare workers, and improper disposal of sharps waste.
The trial was conducted in a dedicated study center at the Hospital Infantil Dr Robert Reid Cabral, a public, tertiary-care, pediatric teaching hospital in the Dominican Republic capital, with study oversight and involvement by the CDC, the World Health Organization, and PATH.
The study enrolled 450 participants, ages ranging from 6 to 24 months. Each participant received two doses, four weeks apart, of influenza vaccine randomized into three groups: One-third of the children received 0.1 mL intradermally with the Biojector® 2000; one-third 0.1 mL intramuscularly by needle/syringe, and one-third the conventional full-dose of 0.25 mL intramuscularly by needle/syringe. Overall local adverse events were mild and tolerable, and immune responses were generally good. Definitive assessment awaits unblinded analysis by group of all participants. Details about the study are publicly available at: http://www.clinicaltrials.gov/ct2/show/NCT00386542.
“We are very pleased to have participated in this study evaluating influenza vaccine given intradermally with a dose sparing regimen. The intradermal delivery of reduced doses of vaccine could help countries with limited resources vaccinate a larger percentage of their population while eliminating the hazards of needle-syringe delivery,” said Dr. Richard Stout, Bioject's Executive Vice President and Chief Medical Officer.
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 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. Bioject is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies.
For more information about Bioject, visit www.bioject.com.
This press release contains a forward-looking statement within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future clinical results that may or may not lead to commercialization. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Bioject, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such risks, uncertainties and other factors include, without limitation, the risk that the product will not be accepted by the market. Readers of this press release are referred to Bioject'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 Bioject'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. Bioject assumes no obligation to update forward-looking statements if conditions or management's estimates or opinions should change.
Contact: Bioject Medical Technologies Inc.
Ralph Makar, President and CEO, 503-692-8001 ext. 4137
Dr. Richard Stout, EVP and Chief Medical Officer, 503-692-8001 ext. 4130
Posted: April 2010