Contact Us: 1-518-583-0095 
We’re Hiring… Join Our Team!
The FDA approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations.
Continue readingA collaborative virtual clinical trial will study the effectiveness of two digital therapeutics. Both digital therapeutics are anticipated to have an impact on mental and physical health when used adjunctively with multidisciplinary oncology care regimens.
Continue readingIn adults who had previously received a full regimen of any of three COVID-19 vaccines granted Emergency Use Authorization or approved by the FDA, an additional booster dose of any of these vaccines was safe and prompted an immune response, according to preliminary clinical trial results reported in The New England Journal of Medicine.
Continue readingThe National Institutes of Health will fund a large, randomized, placebo‑controlled Phase 3 clinical trial to test several existing prescription and over-the-counter medications for people to self-administer to treat symptoms of COVID-19.
Continue readingIntranasal administration of OMV-Spike protected against challenge with SARS-CoV-2 has significant advantages over injectables
Continue readingIn Phase 3 Clinical Trials, Biktarvy® Demonstrated High Efficacy and Zero Resistance Through 48 Weeks
The triple-combination, single-tablet therapy combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of a guideline recommended dual nucleoside reverse transcriptase inhibitor (NRTI) backbone – Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF). BIC/FTC/TAF provides a convenient once-daily dosing STR without regards to food. Furthermore, BIC/FTC/TAF’s use is not restricted by the patient’s baseline viral load, CD4 cell count or HLA-B 5701 status.
“Safety and resistance profiles are important considerations for HIV patients, as the disease requires long-term care. In addition, potent treatments with convenient dosing can potentially improve adherence and outcomes for patients,” said Dr Chan Kai Ming, Specialist in Infectious Disease, Consultant in Internal Medicine, Union Hospital, Hong Kong.
The Hong Kong Dept of Health has approved Biktarvy® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults*. Hong Kong is the first market in Asia to approve Biktarvy. BIC/FTC/TAF was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2018 and the European Commission on June 21, 2018.
The approval was based upon data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naive HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a population of 2,414 participants, and BIC/FTC/TAF met its primary efficacy objective at 48 weeks in all four studies, with no participants in any of the four BIC/FTC/TAF studies developing treatment-emergent virologic resistance. There were no cases of renal discontinuation, proximal renal tubulopathy or Fanconi syndrome in the BIC/FTC/TAF arms at 48 weeks. Additional ongoing studies not included in the marketing authorization application involve dedicated studies in women, adolescents and children.
“We welcome the timely approval of BIC/FTC/TAF in Hong Kong, a novel treatment option for people living with HIV,” said Andrew Hexter, Vice President and GM for Gilead Sciences Asia. “We are committed to serving the needs of HIV patients and medical communities in Asia, and are working with public health authorities to make the treatment available in this region.”
Reprint by permission of PRNewswire; Image courtesy of skitterphoto at Pixabay (Free Lic CC0)
Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com
Scientists have not been able to develop a vaccine against the sexually transmitted disease gonorrhea, despite working toward one for more than 100 years.? However, they may have stumbled onto something that could provide clues to advance the development of such a vaccine.
Decades ago, in the late 1990s, a strain of meningitis B was reaching epidemic proportions in New Zealand. A vaccine, MeNZB, was developed to protect young people who were at the highest risk of getting this particular type. It did not provide protection against any other strain.
Between 2004 and 2006, MeNZB was given to anyone under the age of 20. Babies and preschoolers were routinely immunized until 2008. People with a high medical risk continued to get the vaccine until 2011. Once the epidemic was over, the vaccination program was stopped.
However, scientists noticed that the meningitis vaccine also seemed to offer some protection against gonorrhea. A study published in the Lancet last month showed that one-third of the people who had received MeNZB did not get gonorrhea, compared to a control group who was not inoculated. The lead author noted that the bacteria causing both diseases share between 80 and 90 percent of their primary genetic sequences.
Dr. Steven Black, an infectious disease expert at Cincinnati Children?s Hospital, noted, ?This is the first time it?s been shown that you could have a vaccine that would protect against gonorrhea. And if these results are confirmed in another setting, that would mean that it would be very reasonable ? to go forward with developing perhaps a more targeted vaccine.? Black’s comments were published in the current issue of JAMA, the Journal of the American Medical Association.? The JAMA article concludes that ultimately, a preventive vaccine could be the only sustainable solution to a fast-changing bug that has proven adept at developing resistance.
The World Health Organization reports?that gonorrhea is becoming harder, and sometimes impossible, to treat, warning that it could become incurable in the not-too-distant future. At the moment, there no new antibiotics being developed to treat this disease.
The U.S. CDC reports that gonorrhea is the second most commonly reported notifiable disease in the United States. All known cases must be reported to the CDC, but officials there estimate that they are notified of fewer than half of the 800,000 new cases each year.
Displayed with permission from?Voice of America via RePubHub FREE LIC; Image courtesy of FREEPIK by marioluengo CC0 License
Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com
Scientists want to track them to find out.
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.
By Andrew Joseph | Displayed with permission from STAT.? Read full article online at RePubHub:
Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com
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.
In 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.
Displayed with permission from PRNewswire
Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com
A Canadian research team at the IRCM in Montr?al, led by molecular virologist ?ric 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.”
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 ?douard C?t? and Johanne Mercier from the IRCM, as well as Nick Aschman and Winfried Weissenhorn from the Universit? 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.
Displayed with permission from PR Newswire via RePubHub Free License
Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com