Category Archives: Infectious Disease

Are NYC Rats Disease ‘Sponges’?

Scientists want to track them to find out.

FREE PIXABAY rat-279633_1280 CC0 LIC

Photo courtesy PIXABAY CC0 Lic

Rats are commonplace in urban areas yet remain a mystery in many ways. But researchers plan to track New York City rats to get a better idea of what pathogens they may spread.

But despite how commonplace rats are in cities around the world, they remain in many ways mysterious, including in the potential threat they pose to public health, experts say.  To combat that, a trio of scientists outlined in the journal Frontiers in Public Health step-by-step recommendations for how they say public health officials should capture rats, implant them with microchips, test them for pathogens, and track their activity. The methods were developed and tested with rats in New York City.

“There’s not a lot of research being done with rodents, and because of that, we don’t have a lot of information about the pathogens they harbor,” said Michael Parsons, the report’s lead author and a chemical and behavioral ecologist.  .

Rats – and rodents more broadly – aren’t responsible for nearly as many disease cases or deaths as, say, mosquitoes. But they can transmit fevers, a type of meningitis, and, yes, plague. The diseases are spread through bites and scratches, pathogens in the animals’ feces and urine, and via fleas. (People are not susceptible to all pathogens that rats harbor.)

“Instead of sampling animals periodically, on a punctuated basis,” Parsons said, “we need to implement something on a continual basis.”  In 2015, the city’s rat budget got a $2.9 million boost and its program has about 170 people on staff, including exterminators and scientists.

The paper, which Parsons wrote with a fellow Hofstra scientist and a medical entomologist from an extermination company, outlines the steps the researchers developed to trap rats and then monitor them.  After being released, the rats were drawn back to sensors that weighed them, providing regular insights into their health. The researchers also recaptured some rats for tests to see if pathogen levels changed over time.

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New Drug Holds Promise Against Zika

MV-4 Based On Research That Unlocks Key to Breaking Down Viruses

A New York pharmaceutical company, TGV-Laboratories, says it has unlocked the key for breaking down the protective barriers of viruses, a breakthrough that it believes can be developed into antiviral drugs to treat Zika and host of life-threatening viruses, including Ebola, HIV and Bird Flu.  The company’s lead researchers, Victor and George Tetz, said lab tests show their discovery, called MV-4, can break down the protective barriers of both enveloped and non-enveloped viruses, indicating it can be developed into targeted synthetic antiviral drugs to kill a wide variety viruses.

ZIKA Virus WordleArtIn laboratory tests, the researchers said they were able to kill influenza viruses, HIV, Herpes viruses, polio and adenoviruses, and are eager to test their discovery against Zika, Ebola and Bird Flu.  In a letter to the CDC, the researchers outlined their findings, and offered their help in developing new treatments against these global health threats.

“We are very excited about our findings to date, and are eager to expand the testing of our drugs on these dangerous and highly contagious viruses,” said Victor Tetz, scientific head of TGV-Laboratories. The Zika virus is primarily a mosquito-transmitted infection. However, it was recently isolated from semen, and there is evidence it can be transmitted through sexual intercourse — opening new frontiers for global spreading and raising the need for an antiviral drug that can attack it at many levels. “The studies we have conducted to date show MV-4 can inactivate viruses in the outer environment, on human skin and at intravenous administration, so we believe discovery shows huge promise against Zika, Ebola and Bird flu.”

TGV Laboratories, along with its Institute of Human Microbiology, are finalizing a paper that details their discovery and what they believe to be its strong potential for safely treating a broad range of life-threatening and non-life threatening viruses. Currently, there are no broad-spectrum antiviral drugs.  MV-4 is the second broad-spectrum drug candidate developed by TGV Laboratories, whose Mul-1867 has shown potential for being developed into drugs that can treat an extensive range of antibiotic-resistant bacterial and fungal infections. TGVs subsidiary, TGV-Inhalonix, recently filed an application with the Food and Drug Administration seeking Orphan Drug Status for Mul-1867 to be tested on cystic fibrosis patients with life-threatening antimicrobial-resistant pulmonary infections.

“Developing broad-spectrum drugs that can treat viruses and the growing list of antibiotic-resistant infections is one of the most important, but elusive, goals in infectious research today,” said George Tetz, head of research for the Institute of Human Microbiology. “With MV-4 and Mul-1867, we believe we have unlocked the key for developing the next-generation of antibiotics and anti-viral drugs.”

The drugs in TGV’s pipeline were discovered as the result of years of research by Victor and George Tetz using a new concept they developed called Pangenome, (http://www.ncbi.nlm.nih.gov/pubmed/15990697), which acts like a guide that helps mark new therapeutic targets for drugs. The Institute of Human Microbiology assisted TGV with Mul-1867’s discovery.

TGV-Laboratories Group of Companies. (http://tgv-labs.com) is a research-based pharmaceutical company headquartered in New York that provides a broad range of innovative products to treat currently untreatable infectious, autoimmune and neurodegenerative diseases. TGV operates under two divisions: the Division of Drug Discovery & Development and the Division of Medical & Industrial Microbiology.

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HIV Uses Immune System’s Own Tools to Suppress Itself

Canadian scientists make a significant discovery on HIV persistence

A Canadian research team at the IRCM in Montréal, led by molecular virologist Éric A. Cohen, PhD, made a significant discovery on how HIV escapes the body’s antiviral responses. The team uncovered how an HIV viral protein known as Vpu tricks the immune system by using its own regulatory process to evade the host’s first line of defense. The findings pave the way for future HIV prevention or cure strategies.

The study’s goal was to determine how HIV manages to compromise antiviral responses in the initial period of infection, also called the acute infection stage, during which the virus establishes itself in the body. The acute infection is considered a critical period in determining the complexity, extent and progression of the disease. It is also during this stage that HIV establishes latent infection in long-lasting cellular reservoirs. These viral reservoirs, which harbor the virus out of sight from the immune system and antiviral drugs, represent the primary barrier to a cure.

“An important component in this process is a group of proteins collectively called type 1 Interferons, which are the immune system’s first line of defense against viral infections and are known to have a beneficial role in the early stages of HIV infection,” says Dr. Cohen, Director of the Human Retrovirology research unit at the IRCM. “The problem is that HIV has developed mechanisms to suppress the Interferon response and, until now, little was known about how this was achieved.”

PHIL-18143 PubDomLic SEM HIV Particles courtesy NIAID

SEM HIV Particles courtesy NIAID PHIL-18143

Most of the Interferon is produced by a very small population of immune cells called pDCs (plasmacytoid dendritic cells), responsible for providing immediate defense against infections. PDCs patrol the body to detect invaders and, when they recognize the presence of a pathogen, they secrete Interferon. The Interferon then triggers a large array of defense mechanisms in nearby cells, creating an antiviral state that prevents the dissemination and, ultimately, the expansion of the virus.

“When pDCs encounter HIV-infected cells, the production of Interferon is regulated by a protein located on the infected cell’s surface called BST2,” explains Mariana Bego, PhD, first author of the study and research associate in Dr. Cohen’s laboratory. “BST2 has the ability to bind to and activate a receptor called ILT7, found on the surface of pDCs, which, in turns, sends a signal that suppresses the production of Interferon and halts its defensive functions. Interestingly, BST2 is also responsible for restricting HIV production by trapping the virus at the cell surface before it can exit infected cells and disseminate. However, HIV uses the viral protein Vpu to counteract BST2 antiviral activity.”

“With this study, we uncovered a unique mechanism whereby HIV exploits the regulatory process between BST2 and ILT7 to limit the body’s antiviral response, which allows the virus to spread and leads to persistent infection,” adds Dr. Bego. “We found that HIV, through Vpu, takes advantage of the role played by BST2 by maintaining its ability to activate ILT7 and limit the production of Interferon, all the while counteracting its direct antiviral activity on HIV production.”

“The hope for a definitive cure and an effective vaccine has been frustrated by HIV’s endless propensity to subvert the host’s defenses and persist in small populations of long-lasting reservoirs despite antiretroviral therapy,” describes Dr. Cohen, who also leads CanCURE, a team of leading Canadian researchers working towards an HIV cure. “Our findings can provide tools to enhance antiviral responses during the early stages of infection. By blocking Vpu’s action, we could prevent early viral expansion and dissemination, while also allowing pDCs to trigger effective antiviral responses. We believe that such interventions during primary infection have the potential to limit the establishment and complexity of viral reservoirs, a condition that seems required to achieve a sustained HIV remission.”

“The discovery by Drs. Bego and Cohen, which explains how the virus can’t be held down or wiped out during early periods of infection, will bring us closer to ending HIV/AIDS,” says Robert Reinhard, CanCURE Community Liaison. “By filling an important gap in knowledge, this new study will advance research for an HIV cure.”

About the study
The research project was funded by the Canadian Institutes of Health Research (CIHR), the Canadian HIV Cure Enterprise (CanCURE) through a partnership between CIHR, the Canadian Foundation for AIDS Research (CANFAR) and the International AIDS Society (IAS), as well as by a pilot project from the FRQS AIDS and Infectious Disease Network. The study’s authors also include Édouard Côté and Johanne Mercier from the IRCM, as well as Nick Aschman and Winfried Weissenhorn from the Université Grenoble Alpes in France. For more information on the study, please refer to the article published online by PLoS Pathogens

Findings from this study presented by Dr. Cohen on July 21 at the Vancouver Convention Centre as part of the 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention.

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A Novel Drug for Treatment of Necrotizing Soft-Tissue Infections

Criterium, Inc., a full-service CRO is proud to be the CRO of record as the supplier of services and support for this important trial.  Further study details are provided by the pharmaceutical development sponsor, AtoxBio Ltd. on ClinicalTrials.gov

Clincial Trial Results ReportA complete article detailing the trial and its current progress was highlighted in JAMA’s April 2014 issue in print and online (http://archsurg.jamanetwork.com/article.aspx?articleid=1859986).  This is a study to evaluate the safety and pharmacokinetics profile of different doses of AB-103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. The primary study hypothesis is that AB-103 can be administered safely to the patients presenting with Necrotizing Soft Tissue Infections. Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy endpoints from three outcome domains to demonstrate treatment benefit of AB-103 in comparison to placebo in patients with Necrotizing Soft Tissue Infections.

The efficacy domains Lab-Beakersare:

  1. Clinical status domain
  2. Pharmacoeconomics domain
  3. Systemic and local inflammatory biomarker domain

Criterium, with extensive experience in dermatology and infectious disease indications, particularly with wound and burn treatments, provided services for data and project management, clinical and medical monitoring, biostatistics, safety, regulatory support, and medical writing.

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Clinical Trials Monthly Case Study Analysis

Each month, we investigate a different Clinical Trial Case Study that posed us with a challenging question – this month it’s a look at INFECTIOUS DISEASE, regulatory issues and patient enrollment:

We asked ourselves: 
Scenario:
A Phase III study required by the World Map Color - NOAM-SOAMFDA for approval was stalled at its North America sites and regulatory processes in South America prevented significant contribution to these studies. There were multiple rejections because this infectious disease study required a placebo control. The study recruitment by another CRO was not met in the previous two seasons.

Criterium offered an experienced team in the Southern Hemisphere to get approval by the regulatory authorities of this placebo-controlled respiratory infection study, to extend the recruitment to 10 months of the year and to enroll at a higher rate per site than the previous seasons’ site enrollment rates.

Criterium’s team averaged more patients per site than the Northern Hemisphere at a high compliance rate for the target micro-organisms.

What If: The client could have continued recruiting patients in the Northern Hemisphere winters, thereby further extending the length of the study.

Results: Criterium managed the regulatory process to receive approval for the study on the first agency reviews and accelerated enrollment with its experienced team in South Africa and New Zealand.

Read more of our successful case studies: http://www.criteriuminc.com/case_studies.php

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