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New Study Finds Multi-Strain Probiotic (De Simone Formulation) Aids Dietary Management of Cirrhosis Patients Posted on July 29, 2019 14:00 , 0 comments

July 29, 2019 (Rockville, Maryland) – A new study published in the peer-reviewed journal Hepatology Communications finds that the multi-strain De Simone Formulation probiotic medical food may help in the dietary management of dysbiosis associated with cirrhosis by improving cognitive function, decreasing risk of falls, and improving inflammatory response. The De Simone formulation, which has been the subject of more than 70 clinical studies, is distributed in North America by Rockville, Maryland-based ExeGi Pharma under the brand name Visbiome®.

The double-blind placebo-controlled randomized trial, which was conducted by Román, Nieto, et al., included 36 patients studied between February 2013 and March 2016 and can be accessed at this link: https://doi.org/10.1002/hep4.1325

All patients were treated with sachets containing either the De Simone Formulation or a placebo for 12 weeks and assessed throughout the study for a battery of criteria including, among others, cognitive function, risk of falls, systemic inflammatory response, and biomarkers of intestinal barrier and bacterial translocation. Although previous studies have shown that probiotics can reduce systemic inflammation and the incidence of hepatic encephalopathy, while increasing liver function, cognitive function, and health-related quality of life, the effect of probiotics on the risk of falling in patients with cirrhosis had not been evaluated.

The study found statistically significant improvements in cognitive function as measured by the Psychometric Hepatic Encephalopathy Score (PHES). It also found statistically significant decreases in the risk of falls as measured by both the Timed Up & Go (TUG) test and gait speed. In addition to reducing the risk of falls, the study also showed an impressive decline in the incidence of falls in the study population with 0% of the De Simone patients falling and 22% of the placebo group patients falling during the study. Not surprisingly, since the probiotic patients had improved cognitive function and reduced risk of falling, the study also showed a trend toward improvement in social isolation.

The study’s authors regard the measured decrease in C-reactive protein among the probiotic patients as one of the most important outcomes of the study due to its role in reducing the proinflammatory state. They note that “systemic inflammation is related to neuroinflammation, which in turn is a main factor involved in the pathophysiology of covert and overt hepatic encephalopathy.”

“We continue to be heartened with each clinical trial that demonstrates the important effects of the De Simone Formulation and Visbiome. It’s been well known for decades to aid in the dietary management of pouchitis, IBS, and IBD, but the latest research shows its effects on broader systemic functions. Additional clinical trials are currently underway evaluating Visbiome in HIV prediabetes, depression, and Autism Spectrum Disorders. We can’t wait to hear the results”, said Marc Tewey, CEO of ExeGi Pharma.

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 scientific expertise in the field of microbiome science to deliver novel, clinically-supported live biotherapeutic and probiotic treatments for a variety of unmet medical needs. ExeGi is headquartered in Rockville, MD.

ExeGi Wins Court Ruling Against VSL#3®*, Permanent Injunction Blocks False Advertising To Doctors, Consumers Posted on June 25, 2019 08:59 , 0 comments

Federal district court finds in favor of ExeGi and probiotic inventor, prohibits VSL#3 sellers from citing studies on original formulation

ROCKVILLE, Md., June 25, 2019 /PRNewswire/ -- ExeGi Pharma LLC is pleased to announce that on Friday, June 21, the United States District Court for the District of Maryland ruled in favor of a probiotic inventor and his business partner, ExeGi Pharma, LLC, in post-trial motions concerning the probiotic product VSL#3^®. The ruling concludes over four years of litigation in which the inventor of the well-studied De Simone formulation probiotic (sold until July 2016 under the name VSL#3) sought to defend his ownership rights and prevent his former business partners from claiming that a reverse-engineered imitation product was, in fact, his own formulation.

On November 2018, a federal jury unanimously found in favor of the plaintiffs, inventor Professor Claudio De Simone and ExeGi, awarding over $18 million in damages for violations including false advertising under the Lanham Act. De Simone proved that, after leaving his long-term partnership with VSL Pharmaceuticals, VSL attempted and failed to reverse-engineer his formula. De Simone's original formulation had been studied extensively and established as a "medical food" for dietary management of serious gastrointestinal issues, such as ulcerative colitis and irritable bowel syndrome (IBS). VSL launched their version of VSL#3, an untested imitation product, without informing patients or physicians of the change.

Following the jury finding, the defendants (VSL Pharmaceuticals Inc., Leadiant Biosciences, and Alfasigma USA, Inc.) filed post-trial motions against key jury findings and requested a new trial. The Court denied each motion and affirmed that the original VSL#3 product containing De Simone's formulation was materially different from the imitation. The Court also found that, in marketing their product as the original, the defendants had advertised falsely with the intent to confuse or deceive the public.

Citing public health and wellbeing, the Court also issued a permanent injunction preventing the defendants from linking their product with the original De Simone formulation in other ways, including by citing clinical studies that were, in fact, performed only on the De Simone formulation. To date, more than 70 human clinical trials have been conducted on the original formulation, currently sold as VISBIOME^®.

Marc Tewey, CEO of ExeGi, said: "We are very pleased with Friday's rulings. Ultimately, they will help protect the countless patients depending on VISBIOME^® from further marketplace deception. We hope this sends a message to other probiotic manufacturers and resellers that not all probiotics are the same. Quality and testing matter when it comes to products with health implications and we will go to any lengths necessary to protect patient safety."

About Claudio De Simone
Claudio De Simone, MD, PhD, is an internationally recognized scientific leader in the field of probiotics and the human gut microflora. Professor De Simone invented the formulation of the probiotic tested and currently sold under the name VISBIOME^®, which has been the subject of more than 70 clinical trials and is used for the dietary management of pouchitis, IBD and IBS. In addition, Professor De Simone has authored over 200 published scientific articles, reviews, case reports and book chapters.

*VSL#3 is a registered trademark of VSL Pharmaceuticals Inc.

Maryland Federal Jury Unanimously Finds Probiotic Sellers Liable for False Advertising and Awards Product Inventor More than $18 Million in Damages Posted on November 26, 2018 10:26 , 0 comments

Claudio De Simone, inventor of high-potency probiotic, sued pharmaceutical companies for making false advertising claims, ownership rights to the product formula and unpaid royalties

November 26, 2018 09:30 AM Eastern Standard Time

GREENBELT, Md. - A federal jury on Tuesday, Nov. 20, unanimously ruled in favor of a probiotic inventor who sued his former business partners after an international dispute concerning false advertising, ownership of a proprietary formulation and unpaid royalties. The inventor accused his former partners of attempting to make a copy of his invention and selling it to unsuspecting patients under the same brand name, even though the copy product had never been clinically tested.

The three-week trial in the U.S. District Court for the District of Maryland in Greenbelt included plaintiffs Professor Claudio De Simone and ExeGi Pharma LLC, of Rockville, Md., against defendants VSL Pharmaceuticals Inc., Leadiant Biosciences Inc. and Alfasigma USA Inc. The jury unanimously ruled that the pharmaceutical companies collectively owe the probiotic inventor, De Simone, more than $18 million in damages, including $15 million for defendant Alfasigma USA’s violation of the Lanham Act by deceiving patients, physicians and other stakeholders concerning the probiotic product they have been marketing since 2016.

De Simone successfully argued in court that VSL Pharmaceuticals had attempted to create a “knock-off” of De Simone’s product, even though they never had access to the propriety formula. They continued to call this knock-off by its original brand name, “VSL#3^®”, a trademark owned by VSL Pharmaceuticals Inc., and continued to reference the extensive clinical research on the product proving the product was efficacious and safe, even though they never fully tested the copy product. During the trial, De Simone was able to prove that the defendants’ copy product was not the same as De Simone’s original invention and had never been tested in humans to ensure that it performs the same way as the original formula. De Simone is currently partnered with co-plaintiff ExeGi Pharma to sell the formulation under the brand name Visbiome®.

Prof. De Simone and ExeGi were represented in the case by Jeremy W. Schulman of the law firm Schulman Bhattacharya, LLC.

“We are proud that we’re protecting the life’s work of a brilliant scientist, Prof. Claudio De Simone, who is responsible for helping thousands of patients worldwide to live better lives by managing their serious medical conditions through the invention of a superior, high-potency probiotic product,” Schulman said.

De Simone commented: “I am grateful that the jury saw through the falsehoods of the defendants and ruled in our favor. I created the probiotic product to help patients who had suffered for years with gastrointestinal illnesses and diseases. I never imagined that a multi-national pharmaceutical company and the other defendants would attempt to steal my invention and then pass off an inferior and fake product as mine. Now I will turn my attention to supporting patients in Europe, Asia and other parts of the world who are at risk of being similarly misled.”

Contacts

ExeGi Media:
Andrea Fetchko
202-591-4015

Michael O’Brien
202-591-4042

Visbiome® Vet probiotic to be the subject of two new clinical trials in domestic dogs Posted on September 12, 2018 07:00 , 0 comments

Visbiome^® Vet probiotic to be the subject of two new clinical trials in domestic dogs

Rockville, Md., September 12th, 2018 –ExeGi Pharma is pleased to announce two new clinical partnerships with the College of Veterinary Medicine at the University of Georgia and the University of Tennessee to study the Visbiome Vet probiotic in domestic dogs. Both studies will evaluate the probiotic’s effectiveness in managing canine gastrointestinal disorders. Visbiome Vet is an 8-strain probiotic compound with an extremely high concentration of beneficial bacteria (112.5 billion bacteria per dose). The formulation in Visbiome Vet is one of the most extensively studied probiotic products for pets, as it has been the subject of four controlled clinical trials.

The University of Georgia will research and evaluate effects of the product on diarrhea levels in dogs post-surgery. Diarrhea is a common occurrence in dogs following surgical procedures and anesthesia. This placebo-controlled study will evaluate the incidence and severity of diarrhea, as well as changes to the canine microbiome.

The second study will be conducted by the University of Tennessee Institute of Agriculture. The research will evaluate reduction of severe diarrhea in canine acute gastroenteritis after consumption of Visbiome Vet. This placebo-controlled study will compare the safety and efficacy of Visbiome Vet to dietary changes with a specifically formulated medical diet, or antibiotics (metronidazole).

Pets, like humans, are host to a complex ecological community consisting of trillions of microorganisms. This bacterial community, which is commonly referred to as the microbiome, consist of good and bad bacteria that live on and in the body. Good bacteria exist in a beneficial and symbiotic relationship with the host. In recent years, scientists have come to a better understanding of how alterations in the gut microbiome can impact certain diseases. Visbiome Vet beneficially alters the gut microbiome of companion animals by introducing a high concentration of helpful bacteria to help normalize some forms of gastrointestinal disorders. While antibiotics are commonly used today to treat diarrhea, these treatments may lead to long term antibiotics resistance.

Many researchers and doctors are now advocating for the supplementation of probiotics. Veterinarians are also supporting the use of probiotics in animals. “Gastrointestinal disorders are a common cause for pet owners to seek the medical care of a veterinarian,” said Dr Al Jergens, DVM, PhD. “Modulating the gut microbiome with high potency probiotics may prove to be a valuable tool to help these pets manage clinical signs of GI disease, including diarrhea.”

Visbiome® Vet is available exclusively through veterinarians and veterinary pharmacies.

About Visbiome^® Vet

Visbiome^® Vet is a new high potency probiotic for use in companion dogs to help support normal inflammatory responses in the gastrointestinal tract (GI tract) and to help normalize gut health.

The formulation in Visbiome Vet contains an eight-strain proprietary probiotic blend that has recently been studied in several canine GI disorders. Visbiome Vet is the identical formulation to Visbiome^®, a human medical food that has been the subject of over 60 clinical trials.

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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EXEGI PHARMA LAUNCHES HIGH POTENCY VETERINARY PROBIOTIC TO HELP MANAGE GI TRACT ILLNESSES IN DOGS Posted on March 12, 2018 10:38 , 0 comments

Clinical studies show probiotic used to manage human GI disorders can help support bowel and gut health in dogs

ROCKVILLE, MD - ExeGi Pharma LLC, a company focused on developing and commercializing live biotherapeutics and probiotic treatments, announced today that it has launched Visbiome^® Vet, a new high potency probiotic for use in companion dogs to help support normal inflammatory responses in the gastrointestinal tract (GI tract) and to help normalize gut health.

The formulation in VisbiomeVet contains an eight-strain proprietary probiotic blend that has recently been studied in several canine GI disorders, with two clinical trials published in the last 12 months. Visbiome Vet is the identical formulation to Visbiome^®, a human medical food that has been the subject of over 60 clinical trials.

“Serious gastrointestinal conditions in dogs is often linked to alterations in the GI bacterial community, commonly known as the gut microbiome,” said Dr. Jan Suchodolski, PhD, DACVM at Texas A&M University. “This formulation has been shown in a variety of trials to help normalize gut health.”

Visbiome Vet contains 112.5 billion live bacteria per dosage, a potency that far exceeds other conventional veterinary probiotics. The product, only available to veterinarians and veterinary pharmacies, is packaged conveniently for veterinary applications. Visbiome Vet is shipped and stored only under refrigerated conditions to ensure maximum product potency.

“Over the last year we have been overwhelmed by pet owners telling us about the tremendous results they were experiencing using our human Visbiome product with their pets,” said Marc Tewey, CEO of ExeGi Pharma. “We are pleased to finally bring this high potency probiotic formulation to the veterinary community with Visbiome Vet.”

Visbiome Vet is available exclusively to veterinarians and veterinary pharmacies. For more information, please visit visbiomevet.com or exegipharma.com.

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 scientific expertise in the field of microbiome science to deliver novel, clinically-supported live biotherapeutic and probiotic treatments for a variety of unmet medical needs. ExeGi is headquartered in Rockville, MD.

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Visbiome Probiotic May Play a Role in Recovery of GI Functions in HIV Patients Posted on May 4, 2017 16:48 , 0 comments

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

ROCKVILLE, Md.--(BUSINESS WIRE)--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 Visbiome^TMin the United States and Vivomixx^TM 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 Visbiome^TM. 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

http://www.hivplusmag.com/treatment/2017/1/02/study-probiotic-could-help-prevent-disorders-people-hiv

By Jeannie Wraight

JANUARY 02 2017 6:20 PM EST

A new study reported in the International Journal of Molecular Sciences found that a probiotic formulation decreased inflammation in the cerebrospinal fluid, which is associated with neurocognitive disorders in people living with HIV.

Research conducted over the past decade has shown us that the tiny microbes that reside in our bodies can greatly affect our health for the better, or for the worse. Studies have found that the microbiome (colonies of microbes) of people living with HIV differ from HIV-negative individuals and that some of these differences contribute to conditions such as heart disease and neurocognitive disorders.

Approximately half of antiretroviral-treated people with HIV will experience some form of neurocognitive disorder, ranging from mild forms of HIV-associated neurocognitive disorders (HAND) to severe dementia. One major contributing factor to neurocognitive degeneration is inflammation.

Although it is still unclear as to whether there are additional sources of inflammation, studies show that an imbalance of the gut microbiome (dysbiosis) caused by HIV can create a weakening of the lining of the intestinal tract, and a disruption of the Gut-Associated Lymphoid Tissue (GALT), which allows bacteria to seep into the bloodstream.

This is called microbial translocation. The immune system’s response to these bacteria creates a constant state of inflammation which is carried throughout the body, including the brain. The persistent inflammation is believed to be a cause of neurocognitive disorders.

Recent research has identified the importance of the gut microbiome to what is called the "gut-brain axis" (GBA). The GBA consists of bidirectional communication between the central and the enteric nervous system, which links the cognitive and emotions centers of the brain with peripheral intestinal functions. Simply put, the GBA is the connection from the brain to the gut and vice versa and it’s existence is why we can get a stomach ache when we’re nervous or feel "butterflies" in our stomach when we’re in love. It may also link changes in the gut microbiome, which cause dysbiosis, to neurocognitive degeneration.

Researchers at the University of Rome hypothesized that the consumption of a probiotic formulation called Visbiome (which is made by Exegi Pharma) may alter the GALT microbiome, restoring a healthy balance of bacteria and correcting the state of dysbosis, thus eliminating or reducing neurological inflammation.

The probiotic formulation was given to 10 study participants for six months. Everyone who participated in the study was on antiretroviral therapy and was virally suppressed for a minimum of one year, and each participant had a median CD4 count of 674 cells/ml.

Researchers found that the probiotic improved the metabolism of tryptophan, an amino acid that is a necessary component to the human diet, which researchers believe had been disrupted through alterations to the microbiome. These alterations may be responsible for cytotoxic metabolites, such as quinolinic acid, which may cause some neurological inflammation in people with HIV. IDO is an enzyme involved in tryptophan metabolism. It can increase quilinic acid, and controls the synthesis of other metabolites that contribute to neural toxicity and degeneration. It is increased in people with HIV.

The use of Visbiome reduced CNS inflammation and improved the metabolism of tryptophan by reducing IDO, and stimulating the synthesis of serotonin which is formed from tryptophan and is a vital neurotransmitter-like chemical.

"The data being presented by this small but important study emphasizes how broad the implications of microbiome restoration in the context of HIV may prove to be," commented Dr. Nichole Klatt of the University of Washington, Seattle, who's lab specializes in mucosal immunity. "These results establish a connection between the gut immune system and the long term neurological implications of HIV, and suggest a possible therapeutic intervention with this probiotic."

Probiotics studies in HIV-positive people have previously yielded mixed results in determining if there was a benefit to their use. This may be because probiotics formulas vary greatly, depending on the bacterial strains utilized, the concentration of bacteria, the way these strains are processed and the quality of the strains used. The benefits shown by this probiotic warrant further research.

The probiotic used in this study, Visbiome, is a highly concentrated probiotic mix that contains seven strains of 1,800 billion live bacteria. These strains are a mix of Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus bulgaricus, Lactobacillus paracasei, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, and Streptococcus thermophiles.

An ongoing study in the AIDS Clinical Trails Group is currently enrolling to further research the benefits of Visbiome. The study should provide additional information regarding this probiotics effect on microbial translocation and inflammation.

A conference dedicated to research in HIV on the microbiome was held recently in Maryland on the National Institutes of Health campus. The 2nd International Workshop on Microbiome in HIV Pathogenesis, Prevention, and Treatment offered an opportunity for researchers and activists to discuss current HIV microbiome research and its implications. Dr. Alan Landay, Professor and Chairman of the Department of Immunology/Microbiology at Rush University Medical Center, is a member of the conference's organizing committee.

"This is an exciting time in studying the microbiome," he said. "We’re learning a large amount from the trials where the various fields intersect. There has been tremendous interest in all aspects including HIV and co-morbidities. With the HIV Microbiome Workshop taking place on the NIH campus in Bethesda, it would be great to see the discussion stimulate more NIH-sponsored research on HIV and the microbiome."

As researchers learn more about the effect the microbiome has on HIV, as well as other aspects of health, interventions to alter the imbalances in the microbiome caused by HIV infection, appear to be important for managing a variety of HIV-related comorbidities. Research on the microbiome itself has gained much momentum, however at this point, strategies to restore the microbiome other than probiotics, are limited.

Conditions, other than HIV, that are associated with microbiome disruption include cardiovascular disease, auto immune diseases, Clostridium difficile (C. Diff.), colorectal carcinoma, diabetes, inflammatory bowel disease, irritable bowel syndrome, and colitis. More research into these disease states, as with HIV, will help scientists to better understand their connections and how to restore a healthy microbiome ecology. There are a small number of interventions in addition to probiotics being developed to modify, augment, or restore the microbiome.

Numerous studies have focused on a procedure called fecal microbiota transplantation (FMT), where the stool of a healthy individual is transplanted into the gastrointestinal tract of a person with a disrupted microbiome, in hopes of restoring a balanced gut microbiome. This method has thus far been shown to be safe through human studies and shows promise in C. Diff, ulcerative colitis, and Crohns disease. However, it’s large-scale implementation is limited.

Similar to FMT is a new class of drugs in development called Ecobiotic drugs (in development by Seres Therapeutics). Ecobiotic drugs target the dysbiosis in unhealthy microbiome by assisting new microbiome ecologies to flourish.

Ecobiotic drugs works by seeking out functional deficiencies in a disrupted microbiome and facilitate the repopulation of the microbiome to restore it to a healthy state. As this occurs, the damage caused by the disrupted microbiome is expected to lessen or cease. These drugs are individually designed to treat a specific disease or several related diseases.

The genetic information of microbiomes existing in a dysbiosis state due to a specific disease are compared to those from human donors with healthy, balanced microbiomes. This data is then analyzed to ascertain key differences and identify “keystone organisms.” A drug is then designed to provide bacterial spores that will facilitate the growth of healthy microbes to restore a balanced state. The spores utilized are donated from the stool of healthy individuals and are treated with ethanol to eliminate pathogens. Ecobiotic drugs differ from probiotics as they contain a wide diversity of the organisms that naturally reside in the gut whereas probiotics contain a small number.

Currently there are studies on several Ecobiotic drugs in people with reoccurring C. Diff (Phase II and II), ulcerative colitis (Phase I and preclinical), drug-resistant bacteria (Pre-clinical), metabolic diseases, liver disease and non-insulin-dependent type II diabetes (discovery).

Research into better understanding the microbiome such as that conducted by the Human Microbiome Project, and in relation to disease, as well as interventions such as probiotics, Ecobiotic drugs and FMT, appear to hold potential of unlocking an entirely new field of medicine.

With microbes outnumbering human cells in the body, their effects on HIV, health, and the importance of their presence to human disease and survival, may be much greater than we previously anticipated.

ExeGi Pharma Recognizes World AIDS Day Posted on December 1, 2016 10:00 , 0 comments

ROCKVILLE, MD., Dec. 1, 2016– December 1^st marks the observation of the 28^th World AIDS Day, a day dedicated to the fight against HIV, those who have lost their lives to AIDS, and those currently living with HIV. ExeGi Pharma recognizes World AIDS Day and reaffirms its commitment to the research of Visbiome, a high potency multi-strain probiotic, in restoring the microbiome of people living with HIV.

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 1^st 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 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 8, 2016 10:00 , 0 comments

Widely-studied De Simone Formulation proven to help patients with gastrointestinal conditions manage their symptoms

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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