Penn State Hershey College of Medicine

MONDAY, Sept. 30, 2024 -- The rates of sudden unexpected infant death (SUID) and sudden infant death syndrome (SIDS) increased during the intrapandemic period, according to a study published online Sept. 26 in JAMA Network Open . Emma G. Guare, from the Penn State College of Medicine in Hershey, and colleagues compared prepandemic and intrapandemic rates of SUID and SIDS in a cross-sectional study using U.S. mortality data from the U.S. Centers for Disease Control and Prevention for Jan. 1, 2018, through Dec. 31, 2021. The researchers identified 14,308 SUID cases from Jan. 1, 2018, to Dec. 31, 2021. The risk for SUID increased during the intrapandemic period compared with the prepandemic period (intensity ratio, 1.06). An increased risk for SUID was seen beyond the prepandemic baseline starting in July 2020, with a pronounced epidemiologic shift from June to December 2021 (ranging from 10 to 14 percent). Compared with the prepandemic baseline, the rates of SIDS were elevated throughout the intrapandemic period, with the greatest increases in July and August 2021 (intensity ratios, 1.18 and 1.17, respectively). "Our observational data show an epidemiologic shift of SUID and SIDS during the pandemic where a plausible unifying hypothesis may be an infectious stimulus contributing to a proportion of cases," the authors write. "While our assessment is merely hypothetical and meant to be hypothesis generating, if a clear infectious contributor to SIDS were identified, mitigation efforts might incorporate infection prevention strategies to protect vulnerable infants beyond the currently used safe sleep practices." Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

TAIPEI, July 11, 2024 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), announced IND Submission to US FDA for the Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors. This investigator-initiated trial (IIT) will be conducted by the Penn State Health Children's Hospital and the prestigious Beat Childhood Cancer Research Consortium, a group of over 50 universities and children's hospitals, based at Penn State College of Medicine in Hershey, Pa., that offers a worldwide network of pediatric cancer clinical trials. The funding is sponsored by the Four Diamonds Foundation, with Senhwa Biosciences providing the investigational drug, Silmitasertib (CX-4945). The clinical trial is conducted in two phases: the first phase focuses on establishing the safety and dosage of Silmitasertib (CX-4945) in pediatric patients with relapsed or refractory solid tumors, while the second phase evaluates its efficacy and potential as a novel treatment option. As high CK2 activity is noted across several pediatric cancers, including neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, medulloblastoma, and liposarcoma. Recent study has shown that CK2 is one of the key kinases that is essential for maintaining the stabilization of MYCN protein, the oncogenic driver in neuroblastoma. In view of the anti-tumor activity of CK2 inhibitor, the Beat Childhood Cancer Research Consortium at The Pennsylvania State University regards Silmitasertib (CX-4945) high therapeutic potential of treating pediatric cancers. Neuroblastoma is the most common type of solid malignant tumor in children, aside from brain tumors and lymphomas. Over 90% of cases are diagnosed before the age of 5. 70% of patients already have metastatic disease by the time symptoms appear, and the 20-year survival rate is only around 30%. In the US, there are 700-800 new cases each year, accounting for about 6% of childhood cancers, meeting the definition of a rare disease. Senhwa Biosciences is planning to apply for Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPD) for Silmitasertib (CX-4945) for the treatment of neuroblastoma. If these designations are granted and the drug is successfully commercialized, the company would obtain a Priority Review Voucher (PRV). The holder of a PRV can designate any future human drug application to receive priority review, potentially shortening the review time to 6 months, which could accelerate the timeline for the company (or its partners) to bring other products to market. The clinical trial design also includes Ewing's sarcoma and osteosarcoma, which are common pediatric bone cancers with poor prognoses, representing unmet medical needs. SOURCE Senhwa Biosciences, Inc.

TUESDAY, June 18, 2024 -- Two new studies offer reassurance that using the diabetes drug metformin before and during pregnancy is not linked to birth defects. The latest findings, which apply to men planning to conceive with their partners or women in early pregnancy, contradict a 2022 study that found metformin use by men in the three months before they conceived a baby was associated with a 40% increased risk of birth defects in their children. “Conventionally and traditionally, the mother has been the focus when it comes to pregnancy and when it comes to fetal health and the health of the newborn. What we are increasingly finding is that the father is also important,” Dr. Ran Rotem , who authored the new study on the paternal use of metformin and birth defects, told CNN . “We know that diabetes itself is not good when it is in the mother, and we are finding evidence that it’s also tricky for the fathers,” Rotem noted. “If you can manage diabetes with just changing your lifestyle -- doing more exercise, watching your diet -- that’s probably good, and that’s helpful anyways. But if you have to be medicated, it seems like metformin is a safe choice for both.” The raised risk of birth defects seen in earlier research could have been associated with diabetes itself or with related illnesses, instead of the medication, noted Rotem, a researcher at the Harvard T.H. Chan School of Public Health in Boston. “When we think about a medication, we also have to think about the underlying conditions in which the medication is usually prescribed,” Rotem said. “We know that diabetes itself is tricky when it comes to both fertility and potential complications in pregnancy and in newborns.” In Rotem's study, his team analyzed data from medical records on nearly 400,000 babies born in Israel between 1999 and 2020. They compared that with information on the babies’ fathers, such as their ages, lab test results and medication records. His team found the rate of major birth defects was 4.7% in children of fathers not exposed to diabetes medications in the months leading up to conception, compared with 6.2% in children of fathers exposed to metformin before conceiving. But when the researchers also weighed fathers’ other underlying health conditions and whether the mother also had diabetes or related co-morbidities, they found no increased risk of major birth defects in children exposed to paternal metformin. The data did show that the risk of a birth defect was higher when the father used other medications along with metformin. “When we examined specific treatment regimens, modestly elevated excess risks were still observed, specifically among children of fathers who used metformin in tandem with some other diabetes medication,” Rotem said. “But we also observed that fathers who took multiple medications had more poorly controlled diabetes,” he added. “This again indicates that the modestly elevated risk seen for diabetes polytherapies was likely not caused by the medications themselves, but rather by the worse cardio-metabolic health profile of the fathers.” The second study, published Tuesday in the Annals of Internal Medicine alongside Rotem's research, reported similar findings for women. Those who continued using metformin while adding insulin as a treatment in their first trimester of pregnancy showed little to no increased risk of giving birth to a baby with birth defects. Those researchers, also from Harvard T.H. Chan School of Public Health, studied Medicaid data on more than 12,000 women with type 2 diabetes and their pregnancies. The estimated risk for giving birth to a baby with birth defects was about 6% when the mother received insulin plus metformin, versus 8% when the mother received insulin alone. “We were not surprised by our findings. Although metformin may cross the placenta, potentially affecting the fetus, metformin can help with blood sugar control which may lower the risk of birth defects,” study author Dr. Yu-Han Chiu , a researcher at the Harvard T.H. Chan School of Public Health and Penn State College of Medicine, told CNN . “Poor blood sugar control is a risk factor for birth defects. Insulin in combination with metformin may result in better blood sugar control than using insulin alone. This may explain why we observed a slightly lower risk of live birth with congenital malformations when comparing with using insulin alone,” Chiu said. The new studies begin to clarify the risks of metformin use around pregnancy by both parents, Dr. Sarah Martins da Silva , of the University of Dundee in Scotland, wrote in an editorial published with the studies. “Nonetheless, these recent analyses suggest that metformin is a safe and effective treatment option for [type 2 diabetes] for men and women trying to conceive as well as managing hyperglycemia [high blood sugar] in pregnant women in the first trimester, and it may be time to reconsider current prenatal care guidelines that advocate switching to insulin therapy,” she added. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.