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News Article | April 17, 2017
Site: co.newswire.com

Intralytix, Inc. announced today that its latest food safety product, ShigaShield™, has received GRAS (Generally Recognized As Safe) recognition from the Food and Drug Administration (FDA). ShigaShield™ is a non-chemical antimicrobial preparation for controlling the foodborne/waterborne bacterial pathogen Shigella. The active ingredients of ShigaShield™ are naturally occurring lytic bacteriophages that selectively and specifically kill Shigella species, including strains belonging to the three major disease-causing species of Shigella: S. flexneri, S. sonnei and S. dysenteriae. "Shigella is one of the leading bacterial causes of diarrhea worldwide, causing an estimated 80-165 million cases each year," stated Dr. Alexander Sulakvelidze, Intralytix's Chief Scientist. "In the United States, Shigella is the third most common causes of gastroenteritis, with more than 500,000 cases occurring annually. ShigaShield™ can help reduce the incidence or severity of such illnesses." Dr. Sulakvelidze added, "Another important potential application is to use ShigaShield™ for improving the safety of foods for the US military and for travelers; for example, for treating fresh fruits and vegetables in high risk Shigella locations oversees where the local sanitation standards and/or quality of water are not optimal, thus creating an increased risk of Shigella contamination." Intralytix is a world leader in the development of bacteriophage-based products for food safety. The company already has three FDA/USDA approved phage-based products on the market: (1) ListShield™, effective at substantially reducing or eliminating Listeria monocytogenes in food products, (2) EcoShield™, effective at substantially reducing or eliminating E. coli O157:H7 in red meat intended for grinding, and (3) SalmoFresh™, effective at substantially reducing or eliminating Salmonella in poultry, fish, shellfish, and fresh and processed fruits and vegetables. Intralytix, Inc is a biotechnology company focused on using its core bacteriophage/phage technology platform to improve human health through the development and commercialization of innovative products for food safety, animal health and human therapeutics and probiotics. For more information, contact Mr. John Woloszyn (410-625-3813 or jwoloszyn@intralytix.com) or Dr. Alexander Sulakvelidze (410-625-2533 or asulakvelidze@intralytix.com).


News Article | July 24, 2017
Site: www.prnewswire.com

BALTIMORE, July 24, 2017 /PRNewswire/ --Intralytix, Inc. announced that it received $17.5 million in new equity funding from Lesaffre, a French family group. This investment marks the beginning of a close collaboration between both companies to develop and commercialize...


Grant
Agency: Department of Defense | Branch: Army | Program: STTR | Phase: Phase II | Award Amount: 749.97K | Year: 2011

During the studies supported by our Phase I STTR grant from the US Army, we began developing and testing a novel concept for a probiotic preparation based on naturally occurring bacteriophages as a way to condition the GI tract"s microflora gently and favorably. The preparation (tentatively designated"ShigActive") is a bacteriophage cocktail that specifically targets Shigella spp. (significant diarrhea-causing pathogens that sicken ca. 165 million people/year, ca. 1.1 million of whom die). We have succesfully isolated and rigorously characterized a large number of phages lytic for Shigella, and we have developed a murine model in which the in vivo efficacy of our phage preparation can be evaluated. During this Phase II project, we propose to perform studies required to obtain regulatory approval of ShigActive. During these studies, we will also perform metagenomic analyses of the gut microbiota (using DGGE and state-of-the-art 454-pyrosequencing of 16S rRNA genes) of mice before and after their treatment with ShigActive, in order to (i) obtain additional safety data for the FDA, and (ii) compare rigorously the effect of ShigActive and ampicillin (an antibiotic commonly used to treat shigellosis) on the intestinal microflora of mice. The proposed project"s primary goal is to submit a New Dietary Ingredient (NDI) Notification to the FDA, whose approval will enable us to commence commercial sales of ShigActive.


Patent
Intralytix, Inc. | Date: 2016-01-21

The present invention is directed to isolated bacteriophages having specificity and lytic activity against strains of Shigella species, methods of using the bacteriophages, progeny and derivatives derived therefrom, to control the growth of Shigella species in various settings (e.g., food safety, sanitation, modulating microbiome, prebiotics, probiotics).


The present invention provides a method for reducing the risk of bacterial infection or sepsis in a susceptible patient by treating the susceptible patient with a pharmaceutical composition containing bacteriophage of one or more strains which produce lytic infections in pathogenic bacteria. Preferably, treatment of the patient reduces the level of colonization with pathogenic bacteria susceptible to the bacteriophage by at least one log. In a typical embodiment, the susceptible patient is an immunocompromised patient selected from the group consisting of leukemia patients, lymphoma patients, carcinoma patients, sarcoma patients, allogeneic transplant patients, congenital or acquired immunodeficiency patients, cystic fibrosis patients, and AIDS patients. In a preferred mode, the patients treated by this method are colonized with the pathogenic bacteria subject to infection by said bacteriophage.


Patent
Intralytix, Inc. | Date: 2012-06-13

The present invention is directed to isolated bacteriophages having specificity and lytic activity against strains of Salmonella species, methods of using the bacteriophages, progeny and derivatives derived therefrom, to control the growth of Salmonella species in various settings (e.g., food safety, sanitation, probiotics).


The present invention provides a method for reducing the risk of bacterial infection or sepsis in a susceptible patient by treating the susceptible patient with a pharmaceutical composition containing bacteriophage of one or more strains which produce lytic infections in pathogenic bacteria. Preferably, treatment of the patient reduces the level of colonization with pathogenic bacteria susceptible to the bacteriophage by at least one log. In a typical embodiment, the susceptible patient is an immunocompromised patient selected from the group consisting of leukemia patients, lymphoma patients, carcinoma patients, sarcoma patients, allogeneic transplant patients, congenital or acquired immunodeficiency patients, cystic fibrosis patients, and AIDS patients. In a preferred mode, the patients treated by this method are colonized with the pathogenic bacteria subject to infection by said bacteriophage.


Grant
Agency: Department of Agriculture | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 99.99K | Year: 2013

This project aims to develop a phage-based product (VTP-100) that will contain a mixture of lytic phages effective against a variety of hatchery strains of Vibrio tubiashii. V. tubiashii is a major cause of larval shellfish mortality, which results in increased costs to the aquaculture industry and consumer. Therefore, if our V. tubiashii phage preparation is successfully commercialized, its use could have a very significant impact on reducing larval mortality in hatcheries and, potentially, on reducing the cost of producing and buying oysters. On a more general level, if the results of the studies proposed in this application support our idea that lytic phages may be effective in managing V. tubiashii-associated mortality of oyster larvae, the same platform technology could be used to develop similar phage-based products against other bacterial pathogens of concern to the aquaculture industry. The studies proposed in the present Phase I SBIR application are designed to conduct research required to obtain data critical for our subsequent development and commercialization of VTP-100. Phase I SBIR funding will be critical for conducting research with our V. tubiashii bacteriophages, which will provide a foundation for our subsequent Phase II SBIR R & D efforts and for obtaining regulatory approvals and aiding the product's commercialization.


Grant
Agency: Department of Agriculture | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 500.00K | Year: 2015

The overall objective of this Phase II project is to advance the development of our phage preparation (VTP-200) for reducing V. tubiashii- and V. coralliilyticus-associated mortality of larval oysters to the point when subsequent regulatory approvals and eventual commercialization should be feasible. If the results of the studies proposed in this application support our Phase I findings that phage biocontrol is effective in significantly reducing larval shellfish mortalities, then we will have a strong basis for moving forward with a Phase III SBIR project and product commercialization. The main thrusts of a Phase III proposal will be to further scale-up phage production for commercial distribution and to complete the process of obtaining regulatory approvals for marketing VTP-200. At the end of Phase III, it is anticipated that a new product will be commercially available to fight V. tubiashii and V. coralliilyticus contamination in hatcheries to significantly reduce shellfish mortalities. This new technological development is expected to increase productivity of the hatcheries and reduce interruptions in supply of shellfish seed for commercial shellfish growers. Ultimately, it will provide a more steady supply of shellfish to the consumer.


Grant
Agency: Department of Agriculture | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 449.87K | Year: 2012

Salmonellae continue to be one of the leading worldwide causes of foodborne bacterial diseases. They cause 1.2-1.4 million annual cases of salmonellosis in the USA, with associated costs estimated to be as high as $12.8 billion/year (in 1998 dollars). Despite continued and escalating efforts to curb diseases caused by foodborne bacterial pathogens, salmonellae continue to produce foodborne illness at an alarming and increasing rate. In this context, although the overall incidence of foodborne diseases has been declining in the United States, the 2010 report from the FoodNet indicated that the incidence of laboratory-confirmed Salmonella infections continued to increase by approximately 3%, causing 1.2 million U.S. illnesses in that year and being the most common cause of hospitalization and death tracked by the FoodNet. In fact, the incidence of Salmonella-elicited disease during 2010 was nearly 3-fold more than the 2010 national health objective target, and current outbreaks of salmonellosis continue to occur on a regular basis. Moreover, in a disturbing recent development, a Salmonella Typhimurium strain isolated from contaminated ground beef (which was implicated in a multistate outbreak during the fall of 2011) was found to be resistant to several commonly prescribed antibiotics. This is an alarming development because disease caused by such multidrug-resistant strains is associated with an increase in the risk of hospitalization or possible treatment failure in infected individuals. This finding, together with the continuing increase in the incidence of salmonellosis in the United States despite current efforts to curtail that disease, underscores the importance of developing novel intervention strategies and products capable of eliminating or significantly reducing Salmonella in various foods without promoting the emergence of antibiotic-resistant mutants. Any such products should be effective, cheap, safe, environmentally friendly, and easy to use - and there would also be potential advantages for products that target specific Salmonella serotypes; e.g., serotypes predominantly associated with human illness. We believe that a bacteriophage-based preparation/approach may be one such modality. With the partial support from the NIFA USDA Phase I grant, we developed a bacteriophage-based preparation (designated "SalmoFresh") lytic for Salmonella. During our preliminary studies, we found that SalmoFresh consistently and significantly reduced Salmonella levels in various poultry products by as much as 98%. The goals of our currently proposed Phase II project are to (i) obtain additional data concerning the efficacy of SalmoFresh treatment of various foods that are at high risk of Salmonella contamination, and (ii) obtain pertinent regulatory approvals that will enable us to make SalmoFresh available to the food industry and, thus, help to reduce foodborne contamination with Salmonella. We believe that SalmoFresh has the potential to help significantly reduce Salmonella contamination of various foods (including poultry products) and, therefore, to have a significant impact on improving food safety and public health.

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