News Article | May 9, 2017
Pathways Bioscience, LLC announced today that the National Institute of Dental and Craniofacial Research (NIDCR) has awarded the Company a Small Business Innovation Research (SBIR) Phase I grant to pursue research and development of its PB201 topical formulation for use against oral mucositis, a common cancer therapy side effect that impacts hundreds of thousands of patients in the US each year. PB201 activates the Nuclear Factor, Erythroid 2 Like 2 (NFE2L2, also known as Nrf2) transcription factor pathway, which regulates the expression of a large group of cell protective and anti-inflammatory genes. “We have discovered that PB201 potently activates the Nrf2 pathway and increases the expression of a wide variety of cytoprotective genes, making it a promising agent for use in the prevention or treatment of a variety of health conditions including oral mucositis,” said Dr. Joe M. McCord, Clinical Professor of Medicine at the University of Colorado School of Medicine and cofounder of Pathways Bioscience, LLC. In the project entitled “A Topical Nrf2 Activator for Oral Mucositis,” NIH Award number R43DE026086, scientists at Pathways Bioscience will collaborate with Dr. Stephen Sonis and his team at Biomodels. “Oral mucositis remains a devastating and critically dose-limiting side effect of the most common forms of cancer therapies for which there are no effective interventions. In the upcoming preclinical study at Pathways Bioscience and Biomodels, we will evaluate the potential of the topical Nrf2 activator PB201 to mitigate the pathophysiology of oral mucositis,” said Stephen T. Sonis, DMD, DMSc, Senior Surgeon at Brigham and Women’s Hospital and the Dana-Farber Cancer Institute and Chief Scientific Officer at Biomodels, LLC. “Dysregulation of inflammation and increased oxidative stress play important roles in the pathophysiology of oral mucositis,“ said Brooks M. Hybertson, PhD, President and CEO of Pathways Bioscience and Principal Investigator on the project. “Our preliminary data with our PB201 formulation have been very encouraging, demonstrating strong Nrf2 activation and increased transcription of genes that are involved in protection against inflammation and oxidative stress. We are honored and grateful to receive this SBIR award from NIDCR to pursue the development of much-needed therapeutics that help patients avoid the devastating problem of oral mucositis.” The research reported above is supported by the National Institute of Dental and Craniofacial Research of the National Institutes of Health under Award Number R43DE026086. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Pathways Bioscience LLC is a biomedical sciences company focused on discovering and developing new agents, both small molecule drugs and dietary supplements, that influence gene expression pathways and exert beneficial effects, with particular emphasis on the Nuclear Factor, Erythroid 2 Like 2 (NFE2L2, or Nrf2) gene transcription factor, known as the master regulator of cell protection mechanisms. These activities are based on the concept that the best way to improve healthspan and overcome the health and wellness problems associated with aging is to support the body’s own defense mechanisms that allow it to protect and heal itself. The company's headquarters are in Aurora, Colorado. For further information regarding Pathways Bioscience, LLC, please visit the Company’s Website at http://www.pathwaysbio.com. The National Institute of Dental and Craniofacial Research (NIDCR) is the US federal government's lead agency for scientific research on dental, oral and craniofacial health and disease. NIDCR is one of the National Institutes of Health (NIH) in the U.S. Department of Health and Human Services. For more information about NIDCR and its programs, visit http://www.nidcr.nih.gov. NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
News Article | May 18, 2017
Long-term follow-up data indicate that the tumor resolution was enduring and, moreover, that the mortality rate in the SGX942 1.5 mg/kg treatment group was lower (p=0.08) than the placebo group over the 12 months following completion of CRT. These data further support the safety and tolerability of SGX942 in this patient population. Potential ancillary benefits of utilizing SGX942 for the treatment of oral mucositis include the reduction of infection, the accelerated tumor resolution and the decreased mortality rate. Soligenix recently announced that it has received US Food and Drug Administration (FDA) clearance to advance the pivotal Phase 3 clinical trial and released the protocol study design for SGX942, following the completion of the Phase 2 follow-up visits late last year. The Phase 3 study utilizes the patient population at highest risk of severe oral mucositis as identified in the Phase 2 study (i.e., those receiving the most aggressive CRT). While the drug effect was 67% in the Phase 2 study, a much more conservative estimate was utilized in planning the Phase 3 study, yielding a study size of approximately 190 subjects. SGX942 will be administered in conjunction with the CRT, as a treatment for oral mucositis. "The long-term follow-up data further support the safety and tolerability of SGX942, consistent with the results from the previous Phase 1 study," stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix. "The Phase 2 study also enabled a highly powered and efficient Phase 3 study to be designed, which will use duration of severe oral mucositis as the primary endpoint, while continuing to assess incidence of infection, tumor resolution status and survival as important safety endpoints. We look forward to starting the pivotal Phase 3 study this year." "The primary objective of the Phase 2 study was to demonstrate the safety and explore the efficacy of SGX942," stated Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix. "The results from the follow-up evaluations indicate that SGX942 is safe and well tolerated and may have a number of additional benefits. The consistency between the clinical findings and the earlier nonclinical studies further demonstrates the applicability of dusquetide to a human clinical population in multiple indications, including reduction of infection. Accordingly, we will continue to explore expanding the IDR technology across additional indications, including antibiotic resistant and emerging infectious disease." The Phase 2 oral mucositis clinical study was partially funded with a grant from the National Institute of Dental and Craniofacial Research Small Business Innovation Research grant #1R43 DE024032-01 (Soligenix, Inc.). Dusquetide (the active ingredient in SGX942) is an IDR, a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis, macrophage activation syndrome (MAS) and other bacterial infections. Some of these preclinical findings have been published in an article entitled "A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy," available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.03.032. SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Recently, SGX942 had positive results in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to CRT for HNC. Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099). In patients at the highest risk of developing severe oral mucositis (i.e., those receiving concomitant cisplatin chemotherapy of 80-100 mg/m2 every third week), the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04). The p-values met the prospectively defined statistical threshold of p<0.1 in the study protocol. Additional observations included an improved tumor response to CRT at the one month follow-up visit, as well as decreases in mortality and infection rate. The study results are reviewed in "Dusquetide: A Novel Innate Defense Regulator Demonstrating a Significant and Consistent Reduction in the Duration of Oral Mucositis in Preclinical Data and a Randomized, Placebo-Controlled Phase 2 Clinical Study," published online in the Journal of Biotechnology and available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.10.010. Long-term (12 month) follow-up data further indicated the safety and tolerability of SGX942 treatment, with a sustained trend towards reduced mortality and increased tumor resolution in the 1.5 mg/kg SGX942 treatment group compared to the placebo group. Opioid pain medication use was also seen to decrease over the course of CRT in the 1.5 mg/kg SGX942 treatment group at the point of highest oral mucositis risk, while it increased in the placebo group. Detailed clinical results from the Phase 2 study, as well as a review of the pathogenesis of oral mucositis and the mechanism of action of SGX942, are discussed here. The long-term follow-up results from the Phase 2 study are reviewed in, "Dusquetide: Reduction in Oral Mucositis associated with Enduring Ancillary Benefits in Tumor Resolution and Decreased Mortality in Head and Neck Cancer Patients", published online in Biotechnology Reports and available at the following link: https://doi.org/10.1016/j.btre.2017.05.002. The Phase 2 oral mucositis clinical study was partially funded with a grant from the National Institute of Dental and Craniofacial Research Small Business Innovation Research grant #1R43 DE024032-01 (Soligenix, Inc.). Drug products containing dusquetide have also received Fast Track Designations from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, and as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis. Orphan Drug Designations for use of dusquetide in the treatment of MAS as well as for the treatment of acute radiation syndrome have also been granted. In addition, dusquetide has been granted Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of severe oral mucositis in HNC patients receiving CRT. Dusquetide and related analogs have a strong intellectual property position, including composition of matter. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes. The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in HNC is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe. Oral mucositis almost always occurs in patients with HNC treated with CRT and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation. Oral mucositis in HNC remains an area of unmet medical need where there are currently no approved drug therapies. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201). Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com. This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy and the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/soligenix-announces-publication-of-its-phase-2-long-term-follow-up-results-of-sgx942-for-the-treatment-of-oral-mucositis-in-head-and-neck-cancer-patients-300459736.html
News Article | May 23, 2017
Oral health symptoms are associated with 90 percent of all systemic diseases, according to the Academy of General Dentistry. Studies have shown poor oral health has been linked to serious conditions, increasing the risk of heart disease by as much as 180 percent and stroke by 300 percent. For many seniors, fitness and health, like oral health, have become increasingly important. Most oral health issues associated with aging, such as decay, tooth loss and gum disease, can likely be prevented with consistent dental care and an at-home hygiene routine addressing the needs of older adults, according to the National Institute of Dental and Craniofacial Research. But without the guidance of a dentist, people may not know how to effectively combat concerns such as dry mouth, which can cause accelerated tooth decay, gum disease, oral sores and pain, and bad breath. This is often caused by common medications, like aspirin. If the medication dosage cannot be adjusted, dry mouth symptoms can be managed with help from a dental professional. Many seniors, who are on a fixed budget or not receiving the necessary dental benefits, are turning to dental savings plans as a quality, affordable alternative to dental insurance. Dental savings plans provide discounts of 10%-60% on most dental procedures at dentists nationwide. Learn more at DentalPlans.com. DentalPlans.com, founded in 1999, is a leading dental and health savings marketplace in the U.S., helping more than a million people to affordably access quality healthcare services. Our mission is to empower consumers with the tools, information, and services that they need to live happier, healthier lives. www.dentalplans.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/oral-health-and-a-lifetime-of-healthy-smiles-300462272.html
News Article | April 27, 2017
A dangerous strain may promote lung colonization by other bacteria normally found in the mouth Substances produced by a harmful bacterium in the lungs of cystic fibrosis patients may enhance the growth of other bacteria that, in turn, inhibit the harmful bacterium's biofilm, according to new research published in PLOS Pathogens. Most people with cystic fibrosis develop lung infections that involve multiple species of microbes. These microbes adhere to each other and to the walls of the airway in structures known as biofilms. A biofilm bacterium known as Pseudomonas aeruginosa can cause devastating symptoms, but recent studies suggest that other bacteria known as streptococci might inhibit P. aeruginosa and improve lung function. To better understand the role of streptococci in cystic fibrosis, Jessica Scoffield of the University of Alabama at Birmingham and colleagues grew several biofilms in dishes and in fruit flies. Each biofilm consisted of a P. aeruginosa strain and a streptococcus strain. The researchers used molecular and microscopy techniques to observe interactions between the bacteria. The scientists found that a carbohydrate substance known as alginate, produced by a particular strain of P. aeruginosa known as FRD1, promotes the biofilm of the streptococcus species Streptococcus parasanguinis. At the same time, biofilm formation by S. parasanguinis restricts biofilm formation by P. aeruginosa -- in line with previous studies. The team also found evidence that molecules known as adhesins, which are produced by S. parasanguinis, play an important role in this process. Adhesins help cells stick together in a biofilm or attach to surfaces, and they appear to be necessary for enhanced biofilm formation by S. parasanguinis in the presence of alginate. These findings suggest a potential mechanism by which S. parasanguinis, which is normally found on the surface of teeth, might colonize the lungs of a cystic fibrosis patient and inhibit P. aeruginosa. Further studies of this interaction could provide clues for the development of new treatments to combat P. aeruginosa infection. In your coverage please use this URL to provide access to the freely available article in PLOS Pathogens: http://journals. Funding: This work was supported by the National Institutes of Health/ National Institute of Dental and Craniofacial Research (NIH/NIDCR) grants R01 DE017954 (to HW) and 1K99 DE025913-01A1 (to JAS). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing Interests: The authors have declared that no competing interests exist.
News Article | January 21, 2017
As a child one is repeatedly advised by parents to chew the food properly before swallowing it. A recent study has proved that it was, is and will be a pretty good advice to lend. A new study reveals that chewing can stimulate the T helper 17 (Th17) cells, which is an immune cell and is extremely important in protecting our mouth from bacterial and fungal infections. The study was conducted by researchers from University of Manchester and National Institutes of Health in the U.S. Experts suggest that damage caused by chewing can open up the path for friendly bacteria that can act upon the Th17 or immune cells. The Th17 is present in other parts of the body like gut and skin where they get stimulated by friendly bacteria. Prior to this study, it was widely believed that the same thing is applicable for the mouth as well, but now it has been revealed that only the nutrients in food help build the immune system, how you eat it, is also important. The study points out that chewing food, which is also referred to as mastication, helps in releasing the Th17 cells in the mouth. However, the mechanism regarding its production is still not clear. Th17 cells which is a part of the adaptive immune system, uses specific antigens to fight against the potentially harmful pathogens, while enduring "friendly" bacteria which can be good for health. However, there is another side to the story. The experts have warned that excessive production of Th17 cells in the mouth may increase the chance of periodontitis or gum disease occurrence, which has been associated with several other health concerns, that includes diabetes, rheumatoid arthritis and more. The experts suggest that long-term exposure to physiological damage caused by mastication will worsen the effects of periodontitis. "Importantly, because inflammation in the mouth is linked to development of diseases all around the body, understanding the tissue-specific factors that regulate immunity at the oral barrier could eventually lead to new ways to treat multiple inflammatory conditions," says Dr Joanne Konkel, the lead researcher of the study. She added that the research showed that our mouth has a different way producing Th17 cells varied from the other barriers. Our mouth uses the activity of mastication to produce Th17 cells. In the research, the theory was proven by altering the hardness of rat food, hard food. Weaning mice were provided with soft textured food, which required less chewing for 24 weeks. After 24 weeks there was a significant decline in the amount of Th17 cell production in the rodent's mouths was noted. The team concluded that the decline was because of the reduction in mastication-induced physiological damage. The study was sponsored by the BBSRC and National Institute of Dental and Craniofacial Research and has been published in the journal Immunity. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.
News Article | December 14, 2016
Funded by the National Institute of Dental and Craniofacial Research, the study's goal is to develop improved strategies for the prevention and treatment of dental caries Dr. Rodrigo S. Lacruz, assistant professor of basic science and craniofacial biology at NYU College of Dentistry, has been awarded a five-year, $1.9M grant from the National Institute of Dental and Craniofacial Research (NIDCR) to study calcium control in dental enamel. The research seeks to gain a better understanding of the impact of calcium in enamel mineralization and of the physiological processes by which enamel crystals are formed, and ultimately to develop improved strategies for the prevention and treatment of dental caries. "Changes in the concentration of calcium (Ca2+) within the cell and the physiological mechanisms by which these changes occur can trigger a number of processes. This change in Ca2+ concentration is modulated by ORAI1 and STIM1 proteins in enamel-forming epithelial cells known as ameloblasts," explains Dr. Lacruz. "Deficiencies in the normal functioning of these mechanisms result in amelogenesis imperfecta, a term that broadly describes types of abnormalities in enamel. These abnormalities can weaken the outer enamel surface and can lead to accumulation of oral bacteria in those weak spots, resulting in caries and other dental disease, including a massive breakdown of the enamel in patients with mutations in STIM1 and ORAI1 genes." While the importance of Ca2+ influx via Ca2+ release-activated Ca2+ (CRAC) channels in ameloblasts is apparent in studies describing amelogenesis imperfecta, understanding how CRAC channels modulate enamel development and mineralization is limited, as animals lacking Stim1 and Orai1 die soon after birth. To address this challenge, Dr. Lacruz, in collaboration with Dr. Stefan Feske, associate professor of pathology at the NYU School of Medicine, and Dr. David I. Yule, professor of pharmacology and physiology at the University of Rochester Medical Center, has developed and is studying several mouse models in which the genes Stim1 and Orai1 have been removed from a number of tissues of interest such as ameloblasts, sweat glands, and salivary glands. This localized deletion, known as conditional deletion, enables researchers to analyze the specific function of CRAC channels in these tissues without harming the remainder of the body's organs. "Animal models enable us to look at the cells at different times and in different ways to assess the changes that occur when cells are deprived of calcium. In our case, we are interested in understanding what occurs when the enamel crystals themselves are also deprived of calcium," says Dr. Lacruz. He also plans to utilize animal models to understand the enamel problems experienced by Down syndrome (DS) patients, as they often present with a host of enamel deficiencies such as abnormal mineralization and thinner enamel. Of particular interest for his upcoming research is the protein-coding gene known as regulator of calcineurin (RCAN1), which is elevated in tissues including the brain, heart, and muscle of patients with DS, where its function in enamel is unknown. The research undertaken by Dr. Lacruz and his team has the potential to significantly impact scientific understanding of how calcium contributes to enamel formation. Dental caries prevention relies heavily on knowing how enamel is formed so that clinical techniques can be developed to replicate these processes. According to Dr. Lacruz, "It is our hope that the data we obtain will motivate physicians to involve dental practitioners early on in the treatment of patient with DS or patients with mutations to CRAC channels genes because we have established links between these diseases and deficiencies in enamel." This work was funded by the National Institute of Dental & Craniofacial Research of the National Institutes of Health under award number R01DE025639. ABOUT THE NYU COLLEGE OF DENTISTRY New York University College of Dentistry (NYU Dentistry) is the third oldest and the largest dental school in the US, educating 8 percent of all dentists. NYU Dentistry has a significant global reach and provides a level of national and international diversity among its students that is unmatched by any other dental school. http://www.
News Article | February 23, 2017
Tooth decay is the most common chronic childhood disease: U.S. Surgeon General It’s the top childhood chronic illness in America, according to the U.S. Surgeon General. 51 million school hours missed each year. More than 40 percent of children are affected by the time they reach kindergarten. This widespread ailment is tooth decay. It affects children five times more often than asthma and is seven times more common than hay fever. And, sadly, many kids are without access to professional dental care. Therefore, Solstice Benefits, Inc., a dental insurer headquartered in South Florida, recognizes February as National Children’s Dental Health Month (NCDHM). Sponsored each year by the American Dental Association, the campaign is aimed to promote the benefits of good oral health habits in children. “Good dental health practices start early,” advises Dr. Leonard Weiss, dentist and Solstice Chief Executive Officer. “The sooner children learn brushing and attention to oral hygiene, the better. Parents can brush baby teeth twice a day as soon as they erupt.” The American Academy of Pediatric Dentistry recommends that children see a dentist within six months of when the first tooth appears, or no later than the child’s first birthday—whichever happens first. While young children might feel nervous, some great ways to prepare include a reassuring talk beforehand and reading children’s books about visiting the dentist. Dental insurance is a great way to reduce costs for visiting the dentist and preventive care. Families without dental insurance can also consider dental discount plans, which generally offer discounted rates at the dentist for a low and affordable monthly membership fee. Founded in 1998, Solstice provides dental, vision and other coverage to more than 700,000 members nationally, and has built the current No. 1 largest DHMO/EPO provider networks in both Florida and New York. In 2013, Solstice created an innovative private health exchange—the Solstice Marketplace. The award-winning platform offers a customizable portal for business management, as well as group enrollment. In 2016, Solstice was ranked the No. 16 insurance company and No. 1,408 overall on Inc. magazine’s 35th annual Inc. 5000, the most prestigious ranking of the nation's fastest-growing private companies. This was the insurer’s fifth consecutive year on the Inc. 5000 list. Headquartered in Plantation, Fla., Solstice and its subsidiaries also offer Third Party Administration (TPA) services in the Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Maryland, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas and Virginia markets—and are in the process of expanding nationwide. For information on Solstice, contact 1.877.760.2247 or visit www.SolsticeBenefits.com and www.SolsticeMarketplace.com.  US Department of Health and Human Services. Oral Health in America: A Report of the Surgeon General-- Executive Summary . Rockville, MD: US Department of Health and Human Services, National Institute of Dental and Craniofacial Research, National Institutes of Health, 2000.  Ranked by NetMinder, the industry standard for dental network data
News Article | December 7, 2016
Proove Launches the Only Commercially Available Genetic Analysis Offering Personalized Medical Treatment Recommendations for TMD Sufferers and Insights Into Contributing Causes of Orofacial Pain IRVINE, CA--(Marketwired - Dec 7, 2016) - Proove Biosciences, Inc., the Healthcare Decision Company™, is pleased to announce the introduction of its unprecedented Proove TMD Profile test, designed to assist clinicians help treat patients with the difficult-to-treat, painful condition known as of temporomandibular joint disorder (TMD) -- which currently affects millions of Americans. This latest news marks Proove Biosciences' next stride forward in using evidence-based and scientifically proven solutions to improve outcomes for patients, providers and insurers alike. "With such an abundance of Americans suffering from the painful symptoms of TMD, dentists, pain physicians and oral surgeons are lacking ways of diagnosing and treating suffering patients," says Brian Meshkin, founder and CEO of Proove Biosciences. "Building off of the incredible work done by patient advocates, academic researchers, and the largest NIH-funded prospective study in chronic pain, we are honored to partner with these experts to launch Proove TMD Profile, which will undoubtedly aid patients and clinicians by analyzing DNA markers and recommending the most appropriate treatment based on scientific evidence." Proove TMD Profile helps clinicians understand the underlying mechanisms involved in TMD pain, including genetic variants in the adrenergic and serotonergic pathways, as well as patient self-reported stress and tender points to provide personalized insights into the pathways involved in each individual patient's case. Meanwhile, it also offers clinicians the ability to pinpoint individualized treatment solutions. According to the National Institute of Dental and Craniofacial Research, temporomandibular joint disorder affects 10 million Americans. While the exact causes of TMD are still unknown, the major symptom of TMD is pain and, as such, it tends to co-occur with other pain conditions, including fibromyalgia and chronic fatigue syndrome. "A couple months ago, Proove presented data and product details at the annual scientific meeting of the TMJ Association. It was exciting to see the translational clock ring in its final hour, as all of the efforts which started with patient advocates, and leading researchers, now materializes in a commercially-available precision medicine profile supported by published evidence to help patients get the treatment they need," explains Dr. Ashley Brenton, Associate Director of Research & Development with Proove. In a recent report published in the Journal of the American Medical Association, Harvard researchers discovered that dentists are among the leading prescribers of opioid analgesics, particularly for surgical tooth extractions. The most revealing aspect of the study was that the highest number of opioid painkiller prescriptions went to teenagers aged 14 to 17 years old, closely followed by young adults 18 to 24 years. TMJ disorder and other forms of orofacial pain are often treated by dentists, orthodontists, and oral maxillofacial surgeons. Yet, without knowing or understanding certain genetic factors, such as predispositions to addiction, many professionals are unfortunately putting their patients at risk for abuse. In fact, the American Dental Association reported that dentistry is responsible for prescribing 12 percent of all instant-release opioids that contribute to the nationwide epidemic. But thanks to the recent advancements in the world of genetic testing, personalized medicine, and bioinformatics technology, this is a problem that dentistry can finally address. Equipped with the commercial license to resulting data of the National Institute of Health's largest prospective clinical studies on TMD (OPPERA), Proove Biosciences has effectively pioneered a technological upgrade to genetic testing and personalized medicine in the world of orofacial pain. By using evidence-based and patent-protected healthcare decision tools, Proove Biosciences provides clinicians the much-needed ability to evaluate pain perception, assess opioid use disorder risk before treatment, and identify personalized treatment options to those suffering from TMD. Tackling opioid abuse through preventative measures represents a truly innovative step forward in addressing our national epidemic. To learn more about Proove Biosciences, visit www.proove.com. With media inquiries, please contact Leslie Licano at email@example.com or (949)-733-8679. About Proove Biosciences: Proove Biosciences -- the Healthcare Decision Company™ -- is the commercial and educational leader in the research, investigation and development of patent-protected tests that combine genetic and clinical data into reports to help physicians to individualize -- and optimize -- medicine selection and dosing. Supported by leading medical experts and institutions across the globe, the reports facilitate objective decision-making to improve outcomes for patients, providers and insurers. Backed by science and driven by data, Proove is revolutionizing individualized medicine. With a patented bioinformatics platform that delivers therapy-defining information that allows prescribers to evaluate pain tolerance, assess patient drug metabolism, predict response and immunity to opioid and non-opioid pain medication, and identify risk for dependence and addiction, Proove provides the most technologically advanced solutions to enable accurate and evidence-based medical decision-making rather than "trial-and-error" approaches. Proove helps reduce the risk of treatment failure, decrease costs to insurers and relieve society of the emotional and financial burdens associated with addiction and other avoidable consequences. For more information, please visit www.proove.com or call toll free 855-PROOVE-BIO (855-776-6832).
News Article | October 29, 2016
The next time you brush your teeth, consider capturing the action on your cell phone -- and sharing it with your dentist. The results might provide you with a better shine and fewer cavities by helping you learn to brush more effectively. This was the initial finding from a pilot study to investigate tooth-brushing behavior and to see how it may change after training. Inventors have been intrigued by devices to measure toothbrushing for years, but only now with the wide availability of smartphones, sensors and other wireless technologies have they had the opportunity to measure the behavior in real-time and in the real-world, where it counts. An expert in health tracking technology, University of Rhode Island Associate Professor of Psychology Theodore Walls was asked to participate in the study, particularly to assist with the behavioral data analysis. In partnership with the Case Western Reserve University, School of Dental Medicine, the study was facilitated by the National Institute of Dental and Craniofacial Research and conducted in India. With his combined background in statistics, movement and behavior, Walls said: "By tracking people's health behaviors, we have the opportunity to detect important patterns with statistics and, in turn, intervene to help people with technology or other interventions." For this study, participants used stands to hold their smartphones and film themselves as they brushed their teeth. Even though the period of time for which the participants brushed did not change, the data suggested some improvement in their skill after the images were shown to dentists. The brush strokes were noted to be more accurate and increased in number. The study was published in the Indian Journal of Dental Research, July 2016. "We've used similar techniques to track smoking behaviors -- using tools that indicate when someone is smoking and how much, and where to set up early warning systems to prevent a behavior. Although the selfie concept is being used in a variety of health applications, we think this is the first time it's been put to use to assess how people are brushing their teeth," said Walls. "People recording themselves as they brush might help to improve dental hygiene." So open wide, and take out your cell phone as you brush!
Lumelsky N.,National Institute of Dental and Craniofacial Research
Cell Metabolism | Year: 2014
Obtaining large numbers of functional pancreatic islets via direct cellular reprogramming is an important clinically relevant goal. In a recent issue of Cell Stem Cell, Li et al. (2014) report a new step-wise protocol for generating islet cells from mouse embryonic fibroblasts using a combination of soluble molecules. © 2014 Elsevier Inc.