Penn State Health

SUNDAY, Dec. 8, 2024 -- Shingles can strike anyone who had chickenpox when they were young, and the intense pain that can accompany this body rash has sidelined many a senior. Here, one expert explains how and why shingles can surface, and what you can do to treat it, or better yet, avoid it. Shingles can happen at any age, but it most typically affects people over 50 who have stress and compromised immunity. “Shingles is caused by the varicella-zoster virus. It’s the same virus that causes chickenpox,” said Dr. Eugene Fellin , a family medicine physician at Penn State Health Medical Group – Fleetwood. “For most of us who grew up before the 1990s, when children began being immunized against chickenpox, we’ve been exposed to the virus and are at risk for shingles.” How can shingles surface? After lying dormant in the nervous system for years, the virus can reemerge as shingles, which causes painful rashes that typically surface on the face or around the side of the torso, Fellin explained. “It’s like a poison ivy rash that won’t go away,” he added in a Penn State news release. “It can occur in patches, but along that same nerve root. A lot of times, people feel some tingling or a burning sensation prior to the rash actually breaking out,” Fellin noted. “When we’re looking for the rash, it will be in a string on the torso because the nerves wrap around the torso. You get a line around you, from the back to the front.” “The other issue we worry about is if it breaks out on the face and involves the eye because this can lead to blindness,” Fellin said. “Shingles around the eye is considered dangerous, and an instant referral to an ophthalmologist is always recommended.” What can you take to treat shingles? Antivirals such as Valacyclovir can be prescribed, but they’re time-sensitive and need to be taken within 36 hours of the start of the rash because they work by slowing the spread of the virus, Fellin said. While symptoms subside after three to five weeks, pain can sometimes return in the form of postherpetic neuralgia , he said. This long-term nerve pain occurs where the shingles rash appeared and can last for months or even years. Older adults are more likely to develop postherpetic neuralgia and have longer lasting and more severe pain, Fellin said. Luckily, there is something you can do to avoid shingles altogether: get vaccinated. The U.S. Centers for Disease Control and Prevention recommends the Shingrix vaccine, given in two doses, with the second dose given two to six months after the first. People who get shingles can still receive the vaccine, which can lower the chances of another outbreak, Fellin noted. Most family doctors and pharmacies stock the vaccine, which is covered by Medicare, he added. “Most insurance programs are covering it because it has been out long enough and shows a real benefit,” Fellin said in a Penn State news release. “There’s a lot of misinformation about vaccines circulating out there. My message is this: Don’t be afraid of this or any vaccine.” SOURCE: Penn State Health, news release, Dec. 5, 2024 Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

PHILADELPHIA--( BUSINESS WIRE )-- Imvax, Inc. , a clinical-stage biotechnology company developing personalized, whole-tumor derived immunotherapies, today announced an oral presentation and two poster presentations at the 2024 Society for NeuroOncology (SNO) 29 th Annual Meeting in Houston, Texas, from November 21-24, 2024. Separately, the Company will also host a symposium focused on the development of IGV-001 for the treatment of newly diagnosed glioblastoma. Imvax will present blinded safety data from the Company’s ongoing randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM). The Phase 2b study to assess the safety and efficacy of IGV-001 in patients with ndGBM (NCT04485949) has completed enrollment and top-line results are expected to be presented in mid-2025. Imvax will also present follow-on data from its Phase 1b study of IGV-001 in patients with ndGBM, as well as preclinical data of IGV-001 in combination with checkpoint inhibitors. The details of the oral presentation and two poster presentations are below: Title: Early safety data from a randomized, multicenter, double-blind, phase 2b study of IGV-001, an autologous cell immunotherapy, versus placebo, in newly diagnosed glioblastoma (ndGBM) Number: CTIM-14 Timing: November 22, 7:25 p.m. – 7:35 p.m. CST Presenter: Brad Elder, M.D. Title: Long-term survivors from a Phase 1b study of IGV-001 in patients with newly diagnosed glioblastoma Number: CTIM-11 Timing: November 21-22, 7:30 p.m. – 9:30 p.m. CST Presenter: Raul-Perez Olle, M.D., Ph.D. Title: IGV-001: A biologic-device combination product elicits potent anti-GBM responses as a monotherapy and in combination with check point inhibition Number: IMMU-30 Timing: November 21-22, 7:30 p.m. – 9:30 p.m. CST Presenters: Jenny Zilberberg, Ph.D. & Mark A. Exley, Ph.D. On Friday, November 22, 2024, from 12:45 p.m. – 1:45 p.m. CST, Raul Perez-Olle, M.D., Ph.D., SVP, Head of Clinical Development and Medical Affairs at Imvax, Brad Zacharia, M.D., M.S., FAANS, Associate Professor of Neurosurgery and Otolaryngology at Penn State Health, and Brad Elder, M.D., Director, Neurosurgical Oncology, and Associate Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center, will host a symposium, entitled “ Development of IGV-001 for the treatment of newly diagnosed glioblastoma,” focused on Imvax’s proprietary Goldspire ® platform and the development of IGV-001 for the treatment of ndGBM. Register for the session here . About IGV-001 IGV-001 is an autologous biologic-device combination product derived from Imvax’s proprietary Goldspire ® immuno-oncology platform for solid tumors, which involves a unique approach to inducing a broad and durable immune response against tumors. Phase 1 studies showed that IGV-001 was safe and well tolerated, and a Phase 1b ndGBM study also yielded several efficacy signals, including significant improvements in PFS, OS, radiographic evidence of tumor response, and multiple biomarker changes that supported the presence of an immune response (Andrews DW, et al., Clin Cancer Res. 2021;27(7):1912-1922). In ten Stupp-eligible ndGBM patients in the highest dose cohort treated with IGV-001, median PFS was 17.1 months, compared with 6.5 months in historical standard-of-care (SOC) treatment, and median OS was 38.2 months, compared with 16.2 months in historical SOC. About Imvax, Inc. Imvax is a clinical-stage biotechnology company with a unique platform technology, Goldspire ® , focused on delivering personalized, whole tumor-derived immunotherapies across a range of solid tumors. Imvax’s most advanced program, IGV-001, is currently being evaluated in a Phase 2b clinical trial in newly diagnosed glioblastoma patients. Imvax’s portfolio also includes several other programs designed to stimulate a patient’s immune system against the entire antigen signature of their tumor. Imvax is headquartered in Philadelphia, PA. For additional information, please visit www.imvax.com .

–Phase 3 trial data show that early treatment is correlated with shorter attack duration– – Rigorous comparison of Phase 3 results for oral sebetralstat and pivotal trial results of IV recombinant C1-inhibitor for on-demand treatment of HAE attacks shows no differences in time to beginning of symptom relief – CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Oct. 28, 2024-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced the presentation of new sebetralstat data at the American College of Allergy Asthma and Immunology (ACAAI) taking place in Boston, MA from October 24 - 28, 2024. Tim Craig, DO, Professor, Departments of Medicine and Pediatrics, Division of Pulmonary, Allergy and Critical Care Medicine, Penn State Health, and KONFIDENT investigator, presented data on the Correlation of Time to Treatment with Attack Duration in the Sebetralstat KONFIDENT Phase 3 Trial that showed complete attack resolution was achieved faster in attacks that were treated earlier (1st quartile) compared with those treated later (4th quartile). “This is the first time in a Phase 3 on-demand trial where we can see that treating attacks within minutes versus hours has a meaningful impact on clinical outcomes. While injectable on-demand therapies are effective, there are numerous barriers patients face that lead to delay or denial of HAE on-demand treatment,” said Dr. Craig. “These data help to clarify the potential value of sebetralstat if approved: reduced burden enabling patients to treat attacks early and achieve earlier symptom relief and shorter attack duration.” William Lumry, MD, Medical Director AARA Research Center, Dallas and KONFIDENT investigator, presented data on the Substantial Reduction of HAE Symptom Burden in the Sebetralstat Phase 3 KONFIDENT Trial which showed that among attacks that had progressed to at least moderate severity on the Patient Global Impression of Severity (PGI-S) prior to treatment, those treated with sebetralstat 300mg (n=49, P=0.002) and sebetralstat 600mg (n=52, P=0.034) achieved a faster reduction in substantial symptom burden (reduction in PGI-S to “mild”) than with placebo (n=46), with median times of 5.0 hours, 5.2 hours, and >12 hours, respectively. “All other clinical trial designs for on-demand therapy have required attacks to be at least moderate in severity to be eligible to treat. This changed with the sebetralstat Phase 2 and 3 trials which, consistent with modern HAE guidelines, instructed patients to treat attacks early. Despite this, approximately half of attacks progressed in severity prior to treatment,” said Dr. Lumry. “Among these more severe attacks, which were treated somewhat later, sebetralstat reduced symptom burden to “mild” significantly faster than placebo, with a median time of approximately 5 hours for sebetralstat vs >12 hours for placebo.” The following are details for the additional ePoster - Meet the Author data presentations at ACAAI 2024: Indirect Treatment Comparison of Oral Sebetralstat and Intravenous rhC1-INH as On demand Treatments for Hereditary Angioedema: H. Henry Li, Institute for Asthma and Allergy, Chevy Chase, MD, USA The network meta-analysis (NMA) fixed effects model found no significant differences in time to beginning of symptom relief between sebetralstat 300mg and IV-rhC1-INH 50 IU/kg (HR [95% CI] 0.96 [0.42-2.15] to 1.19 [0.58-2.45]). After adjusting for baseline attack severity, matching-adjusted indirect comparison showed numerically favorable results with sebetralstat versus IV-rhC1-INH. On-demand Treatment of Laryngeal Hereditary Angioedema Attacks with Sebetralstat: Pooled Analysis from KONFIDENT and KONFIDENT-S: Emel Aygören-Pürsün, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt, Germany Pooled Analysis from KONFIDENT and KONFIDENT-S included 16 laryngeal attacks treated with sebetralstat 600mg. Median time to treatment was 8 minutes. Median time to beginning of symptom relief was 1.5 hours; median time to reduction in severity was 1.7 hours; median time to complete attack resolution was 9.7 hours. Patient-Reported Anxiety Impacts Utilization of Injectable On-demand Treatment of Hereditary Angioedema Attacks: Cristine Radojicic, Duke University School of Medicine, Durham, NC, USA The survey highlighted patients with Type I/II HAE who reported waiting 2.4 hours to treat their HAE attack after recognizing the initial onset of the attack. Those who were experiencing anxiety related to their injectable on-demand treatment were most likely to delay or not treat attacks. The network meta-analysis (NMA) fixed effects model found no significant differences in time to beginning of symptom relief between sebetralstat 300mg and IV-rhC1-INH 50 IU/kg (HR [95% CI] 0.96 [0.42-2.15] to 1.19 [0.58-2.45]). After adjusting for baseline attack severity, matching-adjusted indirect comparison showed numerically favorable results with sebetralstat versus IV-rhC1-INH. Pooled Analysis from KONFIDENT and KONFIDENT-S included 16 laryngeal attacks treated with sebetralstat 600mg. Median time to treatment was 8 minutes. Median time to beginning of symptom relief was 1.5 hours; median time to reduction in severity was 1.7 hours; median time to complete attack resolution was 9.7 hours. The survey highlighted patients with Type I/II HAE who reported waiting 2.4 hours to treat their HAE attack after recognizing the initial onset of the attack. Those who were experiencing anxiety related to their injectable on-demand treatment were most likely to delay or not treat attacks. “The HAE community has long sought a less invasive treatment option that combines needed efficacy with lower treatment burden. These presentations continue to demonstrate that sebetralstat has the potential to provide injectable-like efficacy in a pill,” said Ben Palleiko, CEO of KalVista Pharmaceuticals. “If approved, sebetralstat will be the only on-demand treatment option that will have demonstrated the ability to enable compliance with treatment guidelines that call for early treatment of attacks, regardless of severity or location.” Links to all posters and presentations can be found on the KalVista website under Publications. About Sebetralstat Discovered and developed entirely by the scientific team at KalVista, sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE). Sebetralstat received Fast Track and Orphan Drug Designations from the U.S. FDA, as well as Orphan Drug Designation and an approved Pediatric Investigational Plan from the European Medicines Agency (EMA). About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the location affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc. is a global pharmaceutical company whose mission is to develop and deliver life-changing oral medicines for people affected by rare diseases with significant unmet need. Sebetralstat, our novel, investigational candidate for the oral, on-demand treatment of hereditary angioedema, is under regulatory review by the U.S. FDA with a PDUFA goal date of June 17, 2025. In addition, we have completed marketing authorization application (MAA) submissions for sebetralstat to the European Medicines Agency as well as the United Kingdom, Switzerland, Australia, and Singapore, and we anticipate filing a MAA in Japan in late 2024. For more information, please visit www.kalvista.com or follow on social media at @KalVista and LinkedIn. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20241028943529/en/ Jenn Snyder Vice President, Corporate Affairs (617) 448-0281 jsnyder@kalvista.com Ryan Baker Head, Investor Relations (617) 771-5001 ryan.baker@kalvista.com Source: KalVista Pharmaceuticals, Inc.