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The U.S. Food and Drug Administration approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated (also referred to as deep partial thickness burns).
Continue readingAOBiome Therapeutics, Inc. a clinical-stage microbiome company focusing on the research and development of therapeutics for dermatological conditions, announced the administering of its lead product candidate, B244, to the first patient in the Company’s Phase 1b clinical trial to treat pediatric patients with atopic dermatitis (eczema). Data from the First Pediatric Study are Anticipated in the Second Half of 2019.
“There is a significant medical need for new therapies to treat children with atopic dermatitis due to the high and increasing incidence of the disease and the limited number of safe and efficacious options to treat this sensitive population,” said President & CEO, Todd Krueger. In the United States, 13% of children (or 9.6 million) under the age of 18 years suffer from eczema. Of these, approximately one third have moderate to severe eczema. Additionally, many children who suffer from atopic dermatitis in their youth also go on to disproportionally suffer from certain diseases later in life, including 43% of children with severe atopic dermatitis before the age of 8 developing asthma and 45% developing allergic rhinitis according to one recent study.
The clinical trial is an open-label, multicenter, Phase 1b study of B244, a first-in-class, topical formulation of beneficial ammonia oxidizing bacteria (“AOB”), delivered as a topical spray twice daily and is designed to assess safety and tolerability in 36 pediatric patients aged 2 to 17 years with mild to moderate atopic dermatitis over a 28-day period. The AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.
“Our goal is to alleviate both the symptoms that are associated with atopic dermatitis and to utilize AOB’s nitric oxide-mediated anti-inflammatory abilities coupled with its capability to reduce levels of pathogenic bacteria as a dual-modality approach to treatment,” said CMO, Dr. Judith Ng Cashin, M.D. “Current therapies for atopic dermatitis can cause side effects such as stinging, burning, and thinning of skin, especially in pediatric patients. B244’s innovative nature represents a novel therapeutic opportunity to address the significant market need and to impact the lives of patients.”
In addition to the ongoing pediatric study, AOBiome is currently conducting a Phase 2 clinical trial investigating B244 for the treatment of adult atopic dermatitis with expected top-line data readout in 2019. See: www.clinicaltrials.gov.
Reprint by permission of PRNewswire; Image courtesy of PixaBay Free License CC0
Science continues to peel away layers of the skin microbiome to reveal its protective properties.? Researchers now report on a potential new role for some bacteria on the skin: protecting against cancer.
“We have identified a strain of Staphylococcus epidermidis, common on healthy human skin, that exerts a selective ability to inhibit the growth of some cancers,” said Richard Gallo, MD, PhD, Distinguished Professor and chair of the Department of Dermatology at UC San Diego School of Medicine. “This unique strain of skin bacteria produces a chemical that kills several types of cancer cells but does not appear to be toxic to normal cells.”
The team discovered the S. epidermidis strain produces the chemical compound 6-N-hydroxyaminopurine (6-HAP). Mice with S. epidermidis on their skin that did not make 6-HAP had many skin tumors after being exposed to cancer-causing ultraviolet rays (UV), but mice with the S. epidermidis strain producing 6-HAP did not.? 6-HAP is a molecule that impairs the creation of DNA, known as DNA synthesis, and prevents the spread of transformed tumor cells as well as the potential to suppress development of UV-induced skin tumors.
Mice that received intravenous injections of 6-HAP every 48 hours over a two-week period experienced no apparent toxic effects, but when transplanted with melanoma cells, their tumor size was suppressed by more than 50 percent compared to controls.
“There is increasing evidence that the skin microbiome is an important element of human health. In fact, we previously reported that some bacteria on our skin produce antimicrobial peptides that defend against pathogenic bacteria such as, Staph aureus,” said Gallo.
In the case of S. epidermidis, it appears to also be adding a layer of protection against some forms of cancer, said Gallo. Further studies are needed to understand how 6-HAP is produced, if it can be used for prevention of cancer or if loss of 6-HAP increases cancer risk, said Gallo.
More than 1 million cases of skin cancer are diagnosed in the United States each year. More than 95 percent of these are non-melanoma skin cancer, which is typically caused by overexposure to the sun’s UV rays. Melanoma is the most serious form of skin cancer that starts in the pigment-producing skin cells, called melanocytes.
Displayed with permission from FARS News Agency via RePubHub
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It?s as predictable as taxes in April. Every year, the Fourth of July brings patriotic displays of color, smoke, and sound ? and a slew of emergency room visits from burns and blast wounds.
Federal researchers track data on those injuries year-round using the National Electronic Injury Surveillance System, a national probability sample of about 100 hospitals in the U.S. and its territories. Fireworks injuries don?t only happen in July, but they are, unsurprisingly, far more common in that month versus the rest of the year.
Even when fireworks are sold legally, they are still prone to safety recalls.?36,100 units of TNT Red, White & Blue smoke fireworks were recalled because the fireworks may explode unexpectedly.
Fireworks law varies widely
Where fireworks laws do exist, they vary wildly from state to state, or even from county to county. In Massachusetts and New Jersey, it?s illegal to buy or sell fireworks at all. In Ohio, fireworks are available for purchase, but consumers have to sign a document stating they?ll take them out of the state within 48 hours. And in spite of known hazards here’s a surprising?fun fact: Four states (Arkansas, Mississippi, North Dakota, and Oklahoma) allow residents to legally purchase fireworks at age 12.
So who gets hurt?
Legal fireworks or not, children are much more likely than adults to get hurt ? 12-year-olds sustain more fireworks injuries than any other age group. But age isn?t the only factor playing into fireworks injuries: Men are more likely to be hurt than women.? So what about trends in the data? If you look at injury rates over the last two decades, you see that injuries to teenagers and children have dropped since 2005, but injuries among 20-40-year-olds are creeping up.? And what goes wrong most often? The most common type of injury is thermal burns. Sparklers are an unassuming culprit in the hands of any child.
The injuries span a wide range ? from a 2-year-old boy who sustained a burn to his eye after his brother accidentally hit him with a sparkler to a 23-year-old who had a bottle rocket explode in his hands and needed a finger amputated.? Some of the data points are indirect injuries: One patient suffered bites after fireworks spooked a nearby dog. And a 10-year-old girl put two pieces of bathroom tissue in her ear to drown out the noise of fireworks.
See a full set of data graphs for this article?at: STAT NEWS
Source: By Natalia Bronshtein, Displayed with permission courtesy of STAT News via Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.
Customized creams guarded five patients with a kind of itchy eczema against risky bacteria that were gathering on their cracked skin.
Bacteria live on everyone’s skin, and new research shows some friendly germs produce natural antibiotics that ward off their disease-causing cousins. Now scientists are mixing the good bugs into lotions in hopes of spreading protection. In one early test, those customized creams guarded five patients with a kind of itchy eczema against risky bacteria that were gathering on their cracked skin, researchers reported.
“It’s boosting the body’s overall immune defenses,” said Dr. Richard Gallo, dermatology chairman at the University of California, San Diego, who is leading the work.
We share our bodies with trillions of microbes that live on our skin, in our noses, in the gut. This community? – what scientists call the microbiome? – plays critical roles in whether we stay healthy or become more vulnerable to various diseases. Learning what makes a healthy microbiome is a huge field of research, and already scientists are altering gut bacteria to fight diarrhea-causing infections.? The research sheds new light on the skin’s microbiome, suggesting that one day it may be possible to restore the right balance of good bugs to treat skin disorders, too.
Healthy skin harbors a different mix of bacteria than skin damaged by disorders such as atopic dermatitis, the most common form of eczema. Those patches of dry, red, itchy skin are at increased risk of infections, particularly from a worrisome germ known as Staphylococcus aureus.
Gallo’s team took a closer look at how microbes in healthy skin might be keeping that bad staph in check.? They discovered certain strains of some protective bacteria secrete two “antimicrobial peptides,” a type of natural antibiotic. In lab tests and on the surface of animal skin, those substances could selectively kill Staph aureus, and even a drug-resistant strain known as MRSA, without killing neighboring bacteria like regular antibiotics do, the team reported in the journal Science Translational Medicine.
But those good bugs are rare in the skin of people with atopic dermatitis, Gallo said.? “People with this type of eczema, for some reason that’s not quite known yet, have a lot of bacteria on the skin but it’s the wrong type of bacteria. They’re not producing the antimicrobials they need,” he explained. Would replenishing the good bugs help? “They’re normal skin bacteria, so we knew they would be safe,” Gallo noted.
His team tested five volunteers with atopic dermatitis who had Staph aureus growing on their skin’s surface? – what’s called colonization, but didn’t have an infection. Researchers culled some of the rare protective bacteria from the volunteers’ skin, grew a larger supply and mixed a dose into an over-the-counter moisturizer. Volunteers had the doctored lotion slathered onto one arm and regular moisturizer on the other.
A day later, much of the staph on the treated arms was killed – and in two cases, it was wiped out, compared to the untreated arms, Gallo said.? “We’re encouraged that we see the Staph aureus, which we know makes the disease worse, go away,” he said.
The study couldn’t address the bigger question of whether exposure to the right mix of protective bacteria might improve atopic dermatitis itself, cautioned Mount Sinai’s Guttman-Yassky. Next-step clinical trials are underway to start testing effects of longer-term use.
Source: By Lauran Neergaard, AP,?Displayed with permission from STAT via RePubHub
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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
A 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 
are:
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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SEPTEMBER Monthly Case Study Analysis:
Each month, we look at a different Clinical Trial Case Study ? this month it?s a look inside a Phase II Dose Ranging Dermatology trial that focused on Regulatory Environment issues.
The Scenario: A Phase II NDA trial with 4 expert sites, in 4 countries enrolled 80 patients, in less than four months with outstanding clinical results.
We asked ourselves: What if the deadline for this product became critical? In principal, they needed to finish the study for their development partner before they completed the preclinical safety dossier.
The client decided to conduct this study outside of the US so they would not need to submit the study to the IND.? Our international field, data accession, and consultant team selected and managed 1 site each in Ecuador, New Zealand, South Africa and Sweden. The team enrolled the required number of patients in just 16 weeks. The data were transmitted in real time to Saratoga Springs, NY, where the database was closed within two weeks. This information was provided to our statistical group, which completed the analysis and final CSR (clinical study report) ahead of schedule.
Our Answer: Criterium saved more than three months and met the client?s deadline for corporate evaluation of the product.
Preparing clinical trials from financial issues upfront is always the ideal, but extension dates and changing timelines are variables that have to be accounted for in planning.? When we look at trial bids, we look at all the factors that surround the potential issues facing a trial ? location & timing can be tools to keep trials running smooth, not just challenges to overcome.
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Claire WyntersWed, 19 Sep 2012 20:51:00 GMTf1397696-738c-4295-afcd-943feb885714:222699