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Visbiome Probiotic May Play a Role in Recovery of GI Functions in HIV Patients Posted on May 04, 2017 16:48 , 0 comments

http://www.businesswire.com/news/home/20170502006014/en/Multi-Strain-Probiotic-Play-Role-Recovery-Critical-Gastrointestinal

ROCKVILLE, Md.--()--A newly released study published in the Journal of Immunity, Inflammation and Disease and conducted by the Sapienza University of Rome, Italy, found a multi-strain, high concentration, probiotic formulation that helped reconstitute the physical and immunological integrity of the gastrointestinal lining in HIV-1-positive patients on antiretroviral therapy (ART).

The human gastrointestinal (GI) tract is home to trillions of organisms which form a complex bacterial community, commonly referred to as the “gut microbiome.” A key function of the GI tract is to separate these bacteria from internal organs with a single layer of intestinal cells, called epithelial cells. The epithelial cells form a physical and immunological barrier to prevent entry of gut bacteria into the bloodstream. When this barrier breaks down, or becomes compromised, it can result in a dangerous circulation of bacteria throughout the body.

In patients with HIV, this “barrier function” of the GI tract is damaged by the virus starting very early after viral acquisition. Even when the disease is treated with antiretroviral therapy, the integrity of the GI tract often remains severely compromised. This lack of a proper barrier can result in a low-grade, long-term, systemic immune activation and inflammation which is commonly associated with a variety of HIV-related comorbidities, such as cardiovascular disease, kidney disease, diabetes, and bone fracture.1, 2

Probiotic bacteria have been shown to help support this barrier function through a variety of mechanisms, including the competitive exclusion of damaging bacteria and the release of bioactive compounds, such as butyrate, which help tighten the junctions between the epithelial cells. In this longitudinal pilot study, a high potency, eight strain probiotic formulation (commercialized as VisbiomeTM in the United States and VivomixxTM in Europe) was evaluated in long-term treated HIV-positive patients on ART to determine the product’s safety and impact on gut barrier function. The investigators observed several clinical and biochemical indicators, which showed an improvement in the integrity of the gastrointestinal epithelial cell wall and an overall reduction in damaging systemic inflammation.

“We believe this is the first time a probiotic has been shown to clearly improve the integrity of the GI epithelial cell wall in HIV patients,” said Dr. Giancarlo Ceccarelli M.D., Ph.D., a clinical researcher and HIV treatment specialist at the Sapienza University of Rome who actively conducted the study. “There appear to be multiple therapeutic mechanisms at work, but the improvement in Th17 immune cells in the GI tissue was of particular interest. In the HIV population, a depletion of Th17 in the gastrointestinal tract is common and is a significant driver of the loss of intestinal barrier function.”

There were no adverse safety-related findings associated with VisbiomeTM. The investigators also cautioned against broadly translating this research to all probiotic products, noting that the clinical findings for probiotics should only be applied to the specific strains evaluated, particularly when dealing with an immunocompromised patient population.

Two large studies are currently underway in the United States and Canada to further evaluate the impact of Visbiome in HIV. A multi-center study, being conducted by the NIH funded AIDS Clinical Trials Group (ACTG), is seeking to determine if the product can reduce damaging systemic inflammation in HIV patients in comparison to placebo. Results of this study are expected in early 2018.

To learn more about these trials, please visit https://www.clinicaltrials.gov. A full copy of this study can be found at http://onlinelibrary.wiley.com/doi/10.1002/iid3.160/epdf.

For information about Visbiome in the United States, please visit www.visbiome.com. For information about Vivomixx in Europe, please visit www.vivomixx.eu.

About Visbiome™
Visbiome™ is a high potency probiotic medical food consisting of eight strains of live, freeze-dried lactic acid bacteria. Visbiome is specially formulated for the dietary management of dysbiosis associated with IBS, ulcerative colitis, pouchitis, and hepatic encephalopathy. Visbiome is a non-drug therapy that addresses distinct nutritional requirements, to promote microbial balance, in people with IBS, ulcerative colitis, pouchitis, and hepatic encephalopathy that cannot be addressed by modification of the diet alone. Visbiome is currently the subject of eight clinical trials, as a medical food, in several new disease states including HIV, autism spectrum disorders, and liver cirrhosis. Visbiome is intended to be used under the supervision of a physician.

About ExeGi Pharma
ExeGi Pharma, LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi's team leverages the growing advances in the field of microbiome science to deliver novel clinically supported live biotherapeutic and probiotic treatments for a wide variety of unmet medical needs.

1 Guaraldi G, Orlando G, Zona S, et al. Premature age-related comorbidities among HIV-infected persons compared with the general population. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2011; 53(11):1120–1126.

2 Marchetti G, Tincati C, Silvestri G. Microbial translocation in the pathogenesis of HIV infection and AIDS. Clinical Microbiology Reviews. 2013; 26(1):2–18.

Contacts

ExeGi Pharma, LLC
Vanita Patel, 240-428-6891
vanita.patel@exegipharma.com


HIV PLUS Magazine Reports on New Visbiome Study Posted on January 11, 2017 09:30 , 0 comments


ExeGi Pharma Recognizes World AIDS Day Posted on December 01, 2016 10:00 , 0 comments

Visbiome is a medical food which is currently the subject of two ongoing, publically sponsored, clinical trials, in the United States and Canada, evaluating the safety, tolerability, and effect of Visbiome on the gut microbiome and immune activation markers in people living with HIV who are currently on suppressive antiretroviral therapy (ART).

World AIDS Day, the first ever global health day, was originally designated by the World Health Organization and recognized by the United Nations on December 1st in 1988. Each year on World AIDS Day, people around the planet promote HIV awareness and education, remember those who have lost their lives to AIDS, and support those currently living with HIV, through the organization and participation of events, rallies, vigils, educational events, and other gatherings in recognition of the day.

Since its discovery in 1981, AIDS-related illnesses have claimed the lives of 35 million people worldwide. Currently there are 36.7 million people living with HIV globally and 1.2 million residing in the United States. Approximately 2.1 million people were diagnosed with HIV in 2015.

A growing body of data has established a correlation between dysbiosis, a state of imbalance of the gut microbiome, and the pathogenesis of HIV. Visbiome has shown promise as a therapeutic approach to addressing dysbiosis associated with HIV infection and the resulting inflammation. This consistent state of inflammation, which is common in people living with HIV, is believed to contribute to non-AIDS-related conditions such as cardiovascular disease, cognitive dysfunction, and some cancers. A report in the October issue of the International Journal of Molecular Sciences found Visbiome decreased inflammation in the cerebrospinal fluid, which is associated with neurocognitive disorders in HIV-positive people.

“World AIDS Day 2016 is significant for efforts to end HIV as a global health threat by 2030” said Dr. Gary Blick M.D., AAHIVS., co-founder of the CIRCLE CARE HIV treatment center in Norwalk, CT and founder of BEAT AIDS Project Zimbabwe. Dr. Blick continued, “To achieve this lofty goal, we need to accomplish the UNAIDS 90-90-90 Initiative, that is, by 2020, we must get 90% of people HIV tested and aware of their status, start 90% of those HIV-positive on HIV medications, and fully suppress HIV in 90% of those on medication. Full HIV suppression prevents HIV transmission. One serious barrier to achieving full HIV suppression globally is that HIV diarrhea and enteropathy is found in up to 60% of people living with HIV (PLWHIV), which results in poor absorption of HIV medications. Thankfully, ExeGi recognizes the need to rebalance the gastrointestinal tract of people with HIV, and their probiotic, Visbiome, has shown early benefit in not only improving HIV diarrhea, but also reducing chronic HIV inflammation in the gut and the brain. Since 60% of PLWHIV also experience some degree of neurocognitive dysfunction, Visbiome holds promise to reduce this devastating HIV complication.”

About Visbiome™
Visbiome™ is a high potency probiotic medical food consisting of eight strains of live, freeze-dried lactic acid bacteria.  Visbiome is specially formulated for the dietary management of dysbiosis associated with IBS, ulcerative colitis, pouchitis, and hepatic encephalopathy. Visbiome is a non-drug therapy that addresses distinct nutritional requirements, to promote microbial balance, in people with IBS, ulcerative colitis, pouchitis, and hepatic encephalopathy that cannot be addressed by modification of the diet alone. Visbiome is currently the subject of eight clinical trials, as a medical food, in several new disease states including HIV, autism spectrum disorders, and liver cirrhosis. Visbiome is intended to be used under the supervision of a physician.

About ExeGi Pharma
ExeGi Pharma, LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi’s team leverages the growing advances in the field of microbiome science to deliver novel, clinically supported live biotherapeutic and probiotic treatments for a wide variety of unmet medical needs.


Additional Contact Information:
ExeGi Customer Service
info@exegipharma.com

 


ExeGi Pharma Announces Visbiome™ Probiotic Now Available in Canada Posted on September 08, 2016 10:00 , 0 comments

ROCKVILLE, Md., Sept. 8, 2016 /CNW/ — ExeGi Pharma, LLC, announced today that Visbiome™, a high potency probiotic, is now available in Canada. Visbiome contains a proprietary blend of eight strains of live beneficial bacteria and is available in concentrations of 450 billion colony forming units (CFUs) bacteria per sachet. The innovative formulation in Visbiome (the “De Simone Formulation”) was originally invented by Professor Claudio De Simone, MD, more than 20 years ago and has been subject to extensive research in 60 studies and more than 170 scientific publications.

Visbiome is a probiotic that delivers probiotic bacteria in high concentrations, which helps normalize the gut flora in pouchitis patients. Visbiome is also used to reduce the risk of relapse in pouchitis patients. In conjunction with mesalamine, it can also help reduce the Ulcerative Colitis Disease Activity Index (UCDAI) by half within six weeks in patients with mild to moderate active ulcerative colitis.

Visbiome is currently undergoing additional clinical studies in a variety of conditions, including two large trials designed to evaluate Visbiome’s potential in reducing damaging systemic inflammation of HIV positive patients. One of these studies is funded by the Ontario HIV Treatment Network and the Canadian Institutes of Health Research (CIHR) Canadian HIV Trials Network and is currently recruiting patients in two sites in Toronto.

“Visbiome has a proven track record of helping patients successfully treat and manage challenging gastroenterological conditions,” said Marc Tewey, chief executive officer of ExeGi Pharma. “Now that Visbiome is available to patients inCanada, healthcare professionals have an important new tool to help their patients stabilize their conditions.”

“The availability of Visbiome in Canada is a great asset for patients looking to successfully manage their pouchitis and ulcerative colitis symptoms,” said Karen Madsen, PhD, professor of Medicine in the Division of Gastroenterology, University of Alberta and director of the Centre of Excellence for Gastrointestinal Inflammation and Immunity Research. “From my experience studying the impact of the De Simone Formulation, I have seen the benefits that it can have for patients looking for a sustained solution.”

Visbiome’s Regular and Unflavoured sachets are now available in Canada through the website, www.visbiome.ca. For more information, please visit www.visbiome.ca or call 844-GUT-HEAL (844-488-4325).

About Visbiome™

Visbiome™ is a probiotic consisting of eight strains of live, freeze-dried lactic acid bacteria. Data show that the De Simone Formulation, found in Visbiome, helps maintain the appropriate balance of beneficial bacteria in the bowel of pouchitis patients and reduces the risk of relapse in pouchitis. The formulation that makes up Visbiome is currently being investigated in more than 20 trials around the globe. Patients should consult with a physician before taking Visbiome. Natural Product Number: NPN 80061901.

About ExeGi Pharma

ExeGi Pharma, LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi’s team leverages the growing advances in the field of microbiome science to deliver novel clinically supported live biotherapeutic and probiotic treatments for a wide variety of unmet medical needs.

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