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LigoCyte Pharmaceuticals Awarded an Additional $2.3M Department of Defense Contract to Continue the Preclinical Development of Their 3rd Generation, Mucosal Anthrax Vaccine

LigoCyte Pharmaceuticals, Inc. http://www.ligocyte.com announced today that they have been awarded another contract from the Department of Defense (DOD) to continue the validation of their third generation, mucosal anthrax vaccine. The award for $2.3 million continues the DOD’s support for the preclinical development of LigoCyte’s unique, intranasal, dual-antigen vaccine.

Protection data from LigoCyte’s vaccine was recently reported in the May, 2006 journal Vaccine, one of the top peer-reviewed journals in the field. The new vaccine provided 100% protection from an inhaled anthrax challenge in an animal study at Battelle Memorial Institute. "Our vaccine not only prevented death in all of the immunized animals, but it also reduced the morbidity, preventing the sickness caused by an infection," said Dr. Susan Wimer-Mackin, LigoCyte’s Director of Molecular Biology and the lead scientist on the anthrax vaccine project.

LigoCyte’s dual-antigen vaccine includes a protein antigen to protect against a toxin released from the bacteria, and a bacterial capsule antigen to help the body fight the infection itself. This vaccine offers a number of advantages over other anthrax vaccines that are currently being evaluated by the government. LigoCyte’s dry powder formulations are stable, easy to handle and are less likely to require cold storage to be transported to remote areas. The intranasal, needle-free delivery route is less invasive and provides an opportunity for self-administration by the user. Data show the potential for this vaccine to offer protection against anthrax after only a single administration, a vast improvement over the six-dose regimen for the vaccine currently licensed by the FDA.

"Our anthrax vaccine program is quickly moving forward," said Don Beeman, LigoCyte’s CEO. "We have effectively built public-private partnerships to develop products of great importance to the nation’s biodefense. As announced last year, this program has also been awarded a peer-reviewed $4.6 million competitive grant from the National Institutes of Health (NIH), which validates and builds on the foundation established under DOD funding, and confirms the value of our vaccine programs as we move towards the clinic." LigoCyte’s dry powder, intranasal approach is also being applied to other vaccines, including LigoCyte’s vaccine against Norovirus. Norovirus outbreaks (also known as the "stomach flu" or "cruise ship disease") are a critical problem in nursing homes and hospitals, as well as military installations worldwide.

LigoCyte’s new DOD contract stems from an appropriation supported by Senator Conrad Burns (R-MT). This funding mechanism has enabled LigoCyte to develop products of high priority to the DOD while garnering the support of the NIH for developing products for broad civilian use.

About LigoCyte:

LigoCyte, established in 1998, is breaking new ground in the treatment of inflammatory and infectious diseases. The company has produced a number of novel drug compounds that stimulate or suppress immune responses. LigoCyte is advancing its proprietary products into human clinical testing, positioning the company for continued growth and success in the biotechnology industry. For additional information on LigoCyte, please visit http://www.ligocyte.com. Binding Science. Better Medicine.

The referenced work is supported by USAMRMC Contracts DAMD17-01-C-0040 & W81XWH-05-C-0150. The views, opinions and/or findings are those of LigoCyte and should not be construed as an official Department of the Army position. In conducting research using animals, the investigator(s) adhered to "Guide for the Care and Use of Laboratory Animals," prepared by the Committee on Care and Use of Laboratory Animals of the Institute of Laboratory Animal Resources, National Research Council (NIH Publication No. 86-23, Revised 1985). In conducting work involving the use of recombinant DNA the investigator(s) adhered to Guidelines for Research Involving Recombinant DNA Molecules; Notice, Federal Register, July 5, 1994, Volume 59, Number 127.

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