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AVANIR Pharmaceuticals Awarded $2 Million NIH Grant to Continue Development of Human Antibody to Anthrax Toxin.


SAN DIEGO -- AVANIR Pharmaceuticals (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:AVNR AVNR Atrioventricular Nodal Reentry ) today announced it has been awarded a $2 million grant from the National Institutes of Health/National Institute of Allergy and Infectious Disease Infectious disease

A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions.
 (NIH/NIAID) under its Cooperative Research Partnerships for Biodefense program. The NIH/NIAID grant provides funds to establish a cGMP manufacturing process and to test efficacy of the fully human monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing  treatment against inhalation anthrax inhalation anthrax Pulmonary anthrax, woolsorter's disease Pulmonology Occupational anthrax caused by inhalation of Brucella anthracis spores, affecting those exposed to aerosols during early processing of goat or other infected animal hair Clinical  in non-human primates. If successful, these pre-clinical studies can be used to support the filing of an investigational new drug application (IND) for AVANIR's potential anti-anthrax drug candidate, AVP-21D9.

"We are very pleased that the value of our human monoclonal antibody technology has been recognized by the government through the award of this significant grant," said Eric K. Brandt, President and Chief Executive Officer of AVANIR. "Given the substantial resources required to scale up this technology relative to AVANIR's size, we hope this vote of confidence from the government serves as a catalyst to attract additional funding or interest from potential partners interested in large molecule discovery and/or biodefense therapeutics."

The government grant will fund further pre-clinical development of AVP-21D9, a human monoclonal antibody that targets the Bacillus anthracis Bacillus anthracis Infectious disease A gram-positive organism which causes often fatal infections when its endospores–resistant to heat, drying, UV light, gamma radiation, and many disinfectants–enter the body and cause septicemia Military medicine  protective antigen. AVP-21D9 was discovered through the use of AVANIR's Xenerex(TM) technology and characterized with funding by prior NIH/NIAID sponsored grants. NIH/NIAID previously sponsored the evaluation of AVP-21D9 in intra-nasal anthrax challenge models in guinea pigs and rabbits through studies conducted at the University of Texas Medical Branch "UTMB" redirects here. For other system schools, see University of Texas System.
The University of Texas Medical Branch (UTMB) is a component of the University of Texas System located in Galveston, Texas, about 50 miles (80 km) southeast of downtown Houston.
 at Galveston, Texas, by Johnny W. Peterson, Ph.D. Those studies, published earlier this year in Infection and Immunity Infection and Immunity is an academic journal published by the American Society for Microbiology. The title is commonly abbreviated IAI and the ISSN is 0019-9567 for the print version, and 1098-5522 for the electronic version. , demonstrated that a single 1 mg/kg dose of AVP-21D9 was able to completely protect rabbits from lethal infection following inhalation of anthrax spores.

About Anthrax

Bacillus anthracis is a spore forming bacterium that may cause serious sickness or death. Depending on the route of pathogen entry, three distinct clinical forms of infection are described: cutaneous cutaneous /cu·ta·ne·ous/ (ku-ta´ne-us) pertaining to the skin.

cu·ta·ne·ous
adj.
Of, relating to, or affecting the skin.


Cutaneous
Pertaining to the skin.
 (skin), inhalation, and gastrointestinal anthrax infection. According to the U.S. Centers for Disease Control (CDC See Control Data, century date change and Back Orifice.

CDC - Control Data Corporation
), with appropriate antimicrobial therapy deaths are rare in cutaneous anthrax, but case-fatality is extremely high in inhalation anthrax, even with supportive antibiotic therapy. Initial symptoms of inhalation anthrax infection may resemble a common cold. B. anthracis bacteria secrete a tripartite exotoxin exotoxin /exo·tox·in/ (ek´so-tok?sin) a potent toxin formed and excreted by the bacterial cell, and free in the surrounding medium.  that primarily contributes to the pathology of the disease. One of the components, the anthrax protective antigen, is believed to be essential for the entry of lethal toxin into cells of infected individuals. AVP-21D9 is designed to target protective antigen and protect the cells from damage by the anthrax toxins.

About AVANIR

AVANIR Pharmaceuticals is focused on developing, acquiring and commercializing novel therapeutic products for the treatment of chronic diseases. AVANIR's products and product candidates address therapeutic markets that include the central nervous system, cardiovascular disorders, inflammation and infectious diseases. AVANIR currently markets FazaClo(R), the only orally-disintegrating formulation of clozapine clozapine /clo·za·pine/ (klo´zah-pen) a sedative and antipsychotic agent; used in the treatment of schizophrenia.

clo·za·pine
n.
 for the management of severely ill schizophrenic patients who fail to respond adequately to standard schizophrenic drug treatments. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenic or schizoaffective disorder Schizoaffective Disorder Definition

Schizoaffective disorder is a mental illness that shares the psychotic symptoms of schizophrenia and the mood disturbances of depression or bipolar disorder.
. For full prescribing information and important safety information regarding FazaClo, please visit www.fazaclo.com. AVANIR's lead product candidate, Neurodex(TM) for the treatment of involuntary emotional expression disorder, is the subject of a New Drug Application under priority review with the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
. Additionally, AVANIR has initiated a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  with Neurodex as a potential treatment for patients with painful diabetic neuropathy. AVANIR has active collaborations with two international pharmaceutical companies: Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease and AstraZeneca for the treatment of cardiovascular disease. The Company's first commercialized product, abreva(R), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.

FORWARD-LOOKING STATEMENT

Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate", "anticipate", "believe", "plan", or "expect", or similar statements, are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. AVANIR's monoclonal antibody technology competes with several technologies used by large pharmaceutical and biotechnology companies and is subject to a number of uncertainties, including risks associated with the success of pre-clinical and clinical trials, the progress of research and product development programs, the regulatory approval process, competitive products, future capital requirements, the continuing availability of research grants, and commercialization risks, particularly with drug candidates being developed for the U.S. federal government. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance, or that even if such regulatory clearance were received, that such products would ultimately achieve commercial success. Risks and uncertainties also include the risks set forth in AVANIR's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and from time-to-time in other publicly available information regarding the Company. Copies of this information are available from AVANIR upon request. AVANIR disclaims any intent or obligation to update these forward-looking statements.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Jun 30, 2006
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