University of Hawaii System

WEDNESDAY, July 24, 2024 -- Arizona health officials are reporting an increase in hantavirus infections, which are spread by rodents and can cause severe respiratory illness. In a recent health alert , the Arizona Department of Health Services announced there have been seven confirmed cases and three deaths in that state in the past six months. While most hantavirus cases are reported in the Western and Southwestern United States, Arizona has one of highest numbers of reported infections in the country, according to the U.S. Centers for Disease Control and Prevention. From 2016-2022, there have been 11 hantavirus cases in Arizona , according to state health officials. “Hantavirus is a rare but important cause of serious, even fatal respiratory infection,” Dr. Aaron Glatt , chief of infectious diseases at Mount Sinai South Nassau Hospital in New York, told NBC News . “It is transmitted by various rodents, especially the deer mouse, and can cause mild disease, but it does cause fatal illness in a significant percentage of people who acquire this illness," he noted. Between 1993 and 2021, the CDC has reported a total of 850 hantavirus cases, or roughly 30 cases a year. Trish Lees, public information officer at Coconino County Health and Human Services in Arizona, told NBC News that the increase in hantavirus cases may be due to shifts in rodent populations. However, cases do tend to occur more in the summer because of increased rodent activity and people coming into contact with rodents more often, Lees explained. Climate change, such as the extreme heat waves that have been sweeping across the county this summer, may also be partly to blame, experts theorized. Dr. Camilo Mora , a professor in the department of geography and environment at the University of Hawaii at Mānoa, noted that people aren’t the only ones who seek shelter when it gets really wet or hot outside. “Many carrying-disease species get on the move with climate change -- so while for any specific case it is difficult to conclude the role of climate change, climate change has all the attributes to cause outbreaks of vector-borne diseases,” he told NBC News . The hot weather may have also worsened the illnesses after people were infected because of dehydration or other factors, Glatt added. Exactly how does hantavirus spread? Particles containing the virus get into the air when urine, saliva or poop from deer mice are stirred up. Once a person is infected, the virus can trigger hantavirus pulmonary syndrome (HPS) . The syndrome was first recognized in 1993 after a mysterious illness infected members of a Navajo tribe who lived on the border of New Mexico and Arizona. Approximately 80% of people who were infected died at the time. Symptoms can appear one to eight weeks after exposure and include: Left untreated, the illness can infect the lungs and cause fluid to “leak” through blood vessels and fill up the respiratory tract. That, in turn, causes shortness of breath, chest tightness and cough, according to the American Lung Association . Approximately 38% of people who develop lung symptoms may die from the disease. What can be done to guard against infection? “The best way to prevent infection with this illness is by carefully disinfecting and cleaning up any waste products from the rodents and by not coming into contact with them,” Glatt said. When entering a place that’s been closed up for a long time, take care to air out the space for 30 minutes, the Wyoming Department of Health warns. If the space is very dirty or full of mice, take extra care by wearing gloves, shoe covers, coveralls and N95 masks before cleaning. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

In 2019, more than 12,000 new cases of cervical cancer were diagnosed and upwards of 4,000 patients died in the U.S. The causal link between human papillomavirus (HPV) infection and the development of cervical cancer is well documented. Cervical cancer screening guidelines are currently in the review process for updates. In 2019, more than 12,000 new cases of cervical cancer were diagnosed and upwards of 4,000 patients died in the U.S. The causal link between human papillomavirus (HPV) infection and the development of cervical cancer is well documented. Cervical cancer screening guidelines are currently in the review process for updates. On May 15, 2024, the U.S. Food and Drug Administration (FDA) approved patient-collected testing (vaginal self-collection) for HPV. Several countries, including the Netherlands and Australia, have introduced HPV self-collection as a part of their national screening programs. In a new study from Boston University Chobanian & Avedisian School of Medicine and the University of Hawaii at Manoa School of Nursing, researchers found more than half of healthcare providers would definitely or possibly offer HPV self-collection to their patients if the FDA approved the procedure, indicating substantial acceptance of this technology among the healthcare provider community. "Healthcare providers felt that self-collection would be particularly beneficial for those who did not have access to clinician-collected screening, as well as for patients who may have difficulty with pelvic exams for any reason, such as those with history of trauma, sexual or gender minority patients and those with mobility issues," explained senior author Rebecca B. Perkins, MD, MSc, professor of obstetrics & gynecology at BU and an obstetrician & gynecologist at Boston Medical Center. This study incorporated a mixed methods design including conducting a national survey and interviews of healthcare providers who perform cervical cancer screening. Quantitative measures consisted of provider/practice characteristics, willingness to recommend and preferences related to self-collection. Interviews further elucidated the provider perspectives. The study found that male providers, advanced practice providers, internal and family physicians, and those practicing in an academic medical center, hospital, or community health setting were more likely to support self-collection than female participants, OB-GYN physicians, and those in private practice. "While we found providers considered HPV self-collection to be a way to expand access for patients, they also expressed concerns related to the quality of the sample in generating accurate results," added Holly Fontenot, PhD, RN/NP, FAAN,professor of nursing at University of Hawaii and lead author of the study. According to the researchers, the recent approval of HPV self-collection in the U.S. provides another option for cervical cancer screening, which can help reduce barriers related to access or to personal medical conditions. These findings appear online in the journal Women's Health Issues. Funding for this study was supported in part by a research grant from American Cancer Society Award RSG19-011-01CPHPC.

Advanced subunit vaccine technology, including SuVax™ and MarVax™, to be discussed alongside mRNA and viral vectored vaccine approaches PRINCETON, N.J., June 14, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that Professor Axel Lehrer, University of Hawaiʽi at Mānoa (UHM), will be presenting key data from the Company's thermostable vaccine technology platform developed in collaboration with UHM, including results from the filovirus vaccine candidates for both Sudan ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™). The presentation will be given at the upcoming American Society of Microbiology (ASM) Microbe Conference, Atlanta, Georgia, USA, June 13-17, 2024. The presentation will be followed by a panel discussion comparing advanced vaccine technologies and their advantages and disadvantages. Oral Presentation / Panel Discussion: Session Title: Immune Responses to Viral Vaccine Platforms: Comparison of Live, mRNA, and Protein Subunit Vaccines on June 17, 2024 from 8:15-10:15 am. The official conference program can be found here. Oral Presentation Title: Thermostable, adjuvanted protein subunit vaccines reduce logistical concerns and induce durable immunity presented by Axel Lehrer; University of Hawaiʽi at Mānoa, Honolulu, HI on June 17, 2024 at 8:45 AM - 9:15 AM. Under the Company's Public Health Solutions business segment, Soligenix is developing thermostabilized subunit vaccines. Thermostabilization is achieved by using a combination of Generally Recognized as Safe (GRAS) excipients and lyophilization (freeze-drying) to yield a single-vial presentation of vaccine that is stable at ambient and higher temperatures and that can be reconstituted with water for injection immediately prior to use. Mono-, bi- and tri-valent vaccine candidates for filoviruses (including Sudan ebolavirus and Marburg marburgvirus) have demonstrated complete protection in non-human primate challenge studies using thermostabilized formulations. Soligenix has recently been granted Orphan Drug Designation for the prevention and post-exposure prophylaxis against both Sudan ebolavirus and Marburg marburgvirus. About the ASM Microbe Conference ASM Microbe is presented annually by the American Society for Microbiology (ASM) and is the largest microbial sciences gathering in the world. With 8 thematic scientific tracks, including clinical infections and vaccines (CIV), and over 200 sessions, this conference is a key event every year. More information about the conference, and registration to attend can be found here. About SuVax™ SuVax™ is a subunit protein vaccine of recombinantly expressed Sudan Ebola virus glycoprotein, developed in partnership with Dr. Axel Lehrer at the University of Hawaiʽi at Mānoa. The vaccine includes a protein found on the surface of Sudan ebolavirus (SUDV), to engender an appropriate immune response without posing a risk of infection, as well as a novel adjuvant which stimulates both humoral and cell mediated immune responses, in combination with GRAS excipients that enable lyophilization (i.e., freeze-drying) of the vaccine. The resulting product is manufactured as a heat stable powder in a vial which is reconstituted with generically available water for injection immediately prior to use. SuVax™, as a heat stable protein subunit vaccine, has protected 100% of non-human primates exposed to a lethal injection of SUDV. Stability studies have demonstrated that SuVax™ is heat stable for at least 2 years at temperatures of at least 40 degrees Celsius (104 degrees Fahrenheit). Manufacture of the recombinant protein utilized in SuVax™ utilizes a robust protein manufacturing process, developed and tested in other subunit vaccines advanced through clinical testing. Similarly, the selected adjuvant, while novel, has also been independently tested in Phase 1 and Phase 2 clinical studies. SuVax™ can also be used as part of a multivalent vaccine, in combination with antigens against Marburg marburgvirus (MARV) for example. Soligenix has been granted Orphan Drug Designation by the United States Food and Drug Administration for the prevention and post-exposure prophylaxis against Sudan ebolavirus infection. In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a Biologics License Application (BLA), and certain tax credits. About MarVax™ MarVax™ is a subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, developed in partnership with Dr. Axel Lehrer at the University of Hawaiʽi at Mānoa. The vaccine includes a protein found on the surface of MARV, to engender an appropriate immune response without posing a risk of infection, as well as a novel adjuvant which stimulates both humoral and cell mediated immune responses, in combination with GRAS excipients that enable lyophilization (i.e., freeze-drying) of the vaccine. The resulting product is manufactured as a heat stable powder in a vial which is reconstituted with generically available water for injection immediately prior to use. Stability studies have demonstrated that MarVax™ is heat stable for at least 2 years at temperatures of at least 40 degrees Celsius (104 degrees Fahrenheit). MarVax™ has demonstrated 100% protection of non-human primates exposed to a lethal injection of MARV. Manufacture of the recombinant protein utilized in MarVax™ utilizes a robust protein manufacturing process, developed and tested in other subunit vaccines advanced through clinical testing. Similarly, the selected adjuvant, while novel, has also been independently tested in Phase 1 and Phase 2 clinical studies. MarVax™ can also be used as part of a multivalent vaccine, in combination with antigens against Sudan ebolavirus for example. Soligenix has been granted Orphan Drug Designation by the United States Food and Drug Administration for the prevention and post-exposure prophylaxis against Marburg marburgvirus infection. In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a BLA, and certain tax credits. About Filovirus Infection Ebola Virus Disease is caused by one of six species of Ebolavirus, four of which are known to cause disease in humans, including its best-known member, Zaire ebolavirus (Ebola virus), with Sudan ebolavirus being the second-most common cause of human infection in this family. All species of ebolavirus belong to the Filoviridae family, a family that further contains the equally human pathogenic Marburg virus. Filoviruses are believed to be harbored in various animal species in Africa, particularly bats, although the specific reservoir host for many of these viruses is still unknown. There have been several known Ebola (both Sudan and Zaire) and Marburg Virus Disease outbreaks since 1967. The most recent SUDV outbreak occurred in August – October, 2022 in Uganda according to the Centers for Disease Control and Prevention (CDC). The most recent MARV outbreaks occurred in February – June 2023 in Equatorial Guinea and in March – May 2023 in Tanzania, with no relationship between the two outbreaks, according to the CDC. Cases of Marburg Virus Disease were also recorded in Ghana in 2022 and 2021. Transmission of filoviruses requires direct contact with bodily fluids from an infected person or contact with infected animals. The mortality rates following filovirus infections are extremely high, and, in the absence of wide availability of effective therapeutics, are affected by the quality of supportive care available with a focus on early initiation of treatment. Resolution of the disease largely depends on the patient's own immune system. There are limited treatment options for Ebola Virus Disease and no available treatments for Sudan Virus or Marburg Virus Disease, although steady progress has also been made in development of immunotherapeutics for filoviruses beyond Zaire ebolavirus. There are approved vaccines for Ebola virus (Zaire ebolavirus), requiring stringent ultra-low cold-chain storage, but no efficacious vaccines are yet available for Marburg virus (Marburg marburgvirus) or Sudan virus (Sudan ebolavirus). Filoviruses are one of the virus families identified as having the ability to cause pandemics. On the heels of the COVID-19 pandemic, the US government is accelerating its investment in pandemic preparedness, including having "the ability to rapidly make vaccines effective against any virus family." Specific initiatives have been spear-headed by the White House and Biden-Harris administration, as evidenced by the "American Pandemic Preparedness: Transforming Our Capabilities" white paper released in September 2021. About John A. Burns School of Medicine, University of Hawaiʽi at Mānoa The John A. Burns School Medicine (JABSOM) at the University of Hawaiʻi at Mānoa is one of the leading medical institutions and one of the most ethnically diverse institutions in the United States. For more than a decade, JABSOM has ranked in the top 10% of allopathic medical schools for graduate retention with one of our UH-sponsored residency programs. Hawaiʻi's cultural diversity and geographical setting affords JABSOM an unique research environment to excel in research directed at eliminating diseases that disproportionately affect people in Hawaii and the Pacific region. JABSOM faculty bring in extramural funds of $46 million into the state, annually. In addition, JABSOM was the first U.S. medical school to create a clinical department dedicated to the health and well-being of an indigenous population, Native Hawaiians. About Soligenix, Inc. 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 Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behçet's Disease. Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). 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), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA). For further information regarding Soligenix, Inc., please visit the Company's website at and follow us on LinkedIn and Twitter at @Soligenix_Inc. 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, and include the expected amount and use of proceeds from the offering and the expected closing date of the offering. 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 any of its clinical/preclinical trials. Despite the statistically significant result achieved in the first HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that the second HyBryte™ (SGX301) Phase 3 clinical trial will be successful or that a marketing authorization from the FDA or EMA will be granted. Additionally, although the EMA has agreed to the key design components of the second HyBryte™ (SGX301) Phase 3 clinical trial, no assurance can be given that the Company will be able to modify the development path to adequately address the FDA's concerns or that the FDA will not require a longer duration comparative study. Notwithstanding the result in the first HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma and the Phase 2a clinical trial of SGX302 for the treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Despite the positive efficacy results demonstrated in the Phase 2 and 3 clinical studies of SGX942 for the treatment of oral mucositis due to chemoradiation therapy for head and neck cancer, there can be no assurance as to the timing or success of the clinical trials of SGX945 for the treatment of Behçet's Disease. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission (the "SEC"), including, but not limited to, the Company's preliminary prospectus (Registration No. 333-271049) filed with the SEC on May 4, 2023, and 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. SOURCE Soligenix, Inc.