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GelVac(TM) Nasal Powder H5N1 (Bird Flu) Influenza Vaccine Passes Preclinical Toxicology Studies
Carrington
Laboratories, Inc. (OTC Bulletin Board: CARN) announced that its
wholly owned DelSite Biotechnologies, Inc. subsidiary has successfully
completed preclinical toxicology studies of its GelVac(TM) nasal powder
influenza vaccine under FDA-reviewed protocols. Successful toxicology
studies in two animal models using the H5N1 (bird flu) antigen were
required in order to proceed with a planned Phase I clinical trial later
this year. The bird flu antigen used in these preclinical studies was from
a non-egg-based source.
This vaccine candidate is believed to be the only nasal powder vaccine
under development that, if approved, could be shipped without refrigeration
to peoples' homes and self-administered in the event of a pandemic outbreak
of avian bird flu.
The toxicology studies were conducted at Charles River Laboratories,
Preclinical Services, Wilmington, MA, a contract research organization well
known for its work in preclinical studies of viral antigens. After
administering one or two doses to test subjects at the highest dose tested,
testing results showed the vaccine is safe and nontoxic and thus
established the base for moving into the Phase I clinical study of the
vaccine in humans subject to normal FDA regulatory procedures.
Separately, DelSite successfully completed its second pre-IND meeting
with the FDA last November, which was held at the request of the FDA to
discuss and clarify protocols related to the use of the H5N1 antigen.
Previously, a Phase I human safety study on the GelVac(TM) platform
(without an antigen) showed the delivery platform was safe and well
tolerated. The GelVac(TM) nasal powder formulation with the H5N1 vaccine
antigen is planned to enter a Phase I study in 2008.
"The successful completion of these preclinical toxicology studies is a
major milestone in developing this H5N1 vaccine based on our GelVac(TM)
nasal powder technology," stated Carlton E. Turner, PhD, president and CEO
of Carrington. "In addition, the completion of the second pre-IND meeting
has clearly laid out the development path toward clinical studies. These
developments further demonstrate the feasibility of the GelVac(TM) nasal
powder platform technology which can greatly expand the availability and
coverage of vaccines with its distinct advantages over current liquid
needle-based and nasal mist formulation technologies."
Dr. Turner added, "There is a true paradigm shift underway in vaccines
from the classical needle delivery to a more user-friendly application.
FluMist(R) by MedImmune started the shift, and I believe our nasal powder
technology will complete the shift to a patient-friendly vaccination
formulation and will open up markets that cannot be served by current
vaccines systems."
Dr. Yawei Ni, chief scientific officer of DelSite, added, "Our nasal
powder vaccine platform has been shown to work with many antigens, is
stable at room temperature, requires no needles, no preservatives, and no
cold storage, and can be shipped free of the restrictive cold chain
distribution systems associated with vaccines. Moreover, our system is
particularly well suited for influenza pandemic preparedness, bio-defense
applications, and vaccine coverage in areas lacking basic infrastructures."
GelVac(TM) powder platform possesses other distinct, practical
features. The GelSite(R) polymer used in the formulation is derived from a
natural source and is stable over four years at room temperature. The
polymer binds to and stabilized proteins and peptides. An influenza vaccine
incorporating a, non-egg based, H1N1 antigen in the GelVac(TM) formulation
has been stable at ambient room temperature for 36 months.
The nasal cavity is increasingly recognized as the ideal immunization
route since most infectious diseases enter the body through mucosal
surfaces such as those found in the nasal cavity, the lungs, and the
intestines. Nasal immunization not only induces a systemic response, but
also induces mucosal response, providing protection at the entry point.
GelVac(TM) is a novel in- situ gelling powder formulation for nasal
delivery. The GelSite(R) polymer enables in-situ gelling of the vaccine
powder, which changes into gel particles upon exposure to nasal fluids
present in the nasal passage. This gel adheres to the mucosal lining and
provides prolonged residence time and sustained antigen release that, in
turn, increase antigen delivery.
About DelSite
Carrington's wholly owned subsidiary DelSite Biotechnologies, Inc. is
developing its proprietary GelSite(R) technology designed to provide
controlled release of peptide and protein-based drugs and vaccines. DelSite
is currently developing a nasal powder vaccine using its GelVac(TM) formula
with the H5N1 avian flu antigen. This work is partially funded by two
grants from NIAID (National Institute of Allergy and Infectious Diseases)
of NIH (National Institutes of Health) under the Department of Health and
Human Services.
A Drug Master File (DMF) has been filed with the FDA for GelSite(R)
polymer which may be made in kilogram quantities under cGMP guidelines in
an ISO-certified facility.
About Carrington
Carrington Laboratories, Inc. is an ISO 9001-certified, research-based,
biopharmaceutical and consumer products company currently utilizing
naturally-occurring complex carbohydrates to manufacture and market
products for mucositis, radiation dermatitis, wound and oral care, as well
as to manufacture and market the nutraceutical raw material Manapol(R) and
cosmetic raw material Hydrapol(TM). Carrington also manufactures and
markets consumer products and manufactures quality products for other
companies. Manufacturing operations comply with cGMP standards.
Carrington's DelSite Biotechnologies subsidiary is developing its
proprietary GelSite(R) technology designed to provide controlled release of
peptide and protein-based drugs. Carrington's technology is protected by
more than 130 patents in 26 countries. Select products carry the CE mark,
recognized by more than 20 countries around the world. For more
information, visit http://www.carringtonlabs.com.
Certain statements in this release concerning Carrington may be
forward-looking. Actual events will be dependent upon a number of factors
and risks including, but not limited to: subsequent changes in plans by the
Company's management; delays or problems in formulation, manufacturing,
distribution, production and/or launch of new finished products; changes in
the regulatory process; changes in market trends; and a number of other
factors and risks described from time to time in the Company's filings with
the Securities & Exchange Commission.
Carrington Laboratories, Inc.
http://www.carringtonlabs.com
View drug information on Carrington patch; FluMist.
GelVac (TM) nazale Pulbere H5N1 (gripa aviara) Gripa Vaccin Permise Studii preclinice de Toxicologie - GelVac(TM) Nasal Powder H5N1 (Bird Flu) Influenza Vaccine Passes Preclinical Toxicology Studies - articole medicale engleza - startsanatate