Neuralgia

-- Zero shingles cases after 18.8 months follow-up in 619 patients receiving any dose of amezosvatein, a development-stage adjuvanted subunit vaccine -- Ten shingles cases would have been expected absent vaccination -- Updated data will be featured in an oral presentation at the World Vaccine Congress Barcelona, 31 October 2024, in Theatre 5 at 13:30 CEST SEATTLE, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Curevo Vaccine (Curevo), a privately-held clinical-stage biotechnology company dedicated to developing varicella zoster virus (VZV) vaccines with improved tolerability and accessibility, today announced an upcoming oral presentation at the World Vaccine Congress currently underway in Barcelona of shingles case outcomes data from an 876-patient Phase 2 trial of amezosvatein (a non-mRNA, adjuvanted subunit vaccine also known as CRV-101) head-to-head versus Shingrix® in participants aged 50 years and older. There were zero confirmed cases of herpes zoster (shingles) in the amezosvatein arm of participants, regardless of dose, after mean follow-up of 18.8 months in this post-hoc analysis of the Phase 2 trial. Based on the shingles incidence rate from the placebo arm North American cohort of ZOSTER-006, a Phase 3 trial of Shingrix, 10 of the 876 participants in the Phase 2 trial should have been diagnosed with a confirmed shingles case absent effective vaccination.1 There were also no shingles cases in the Shingrix arm of this Phase 2 trial. “With the duration of follow-up in our Phase 2 trial now sufficient for comparison, we are excited to report zero shingles cases for amezosvatein,” said Dr. Guy De La Rosa, Curevo’s Chief Medical Officer. “These data provide outcomes-based confirmation of the non-inferiority immunogenicity data we reported earlier.” “These data support our efforts to bring a new shingles vaccine to global markets,” stated George Simeon, Curevo’s Chief Executive Officer. “Though somewhat unsurprising, given amezosvatein also showed non-inferior immunogenicity to Shingrix at day 84 in this trial, these longer-term data represent additional de-risking for the program.” About the Phase 2 trialThe Phase 2 trial (NCT05304351) enrolled 876 participants to receive either amezosvatein or Shingrix on an identical two-dose, two months apart schedule. 876 participants were randomized to receive one of four different amezosvatein doses or Shingrix. The mean follow-up of the 619 participants receiving amezosvatein was 18.8 months. Mean follow-up of the 257 participants who received Shingrix was 21.5 months. The co-primary endpoint of the Phase 2 trial was anti-gE antibody humoral immune responses one month after the second vaccine dose (Day 84). The randomized, observer-blind, and active-controlled trial was conducted at multiple centers in the USA. All suspected cases of shingles were confirmed by either PCR test or, if PCR testing was inconclusive or unavailable, by a blinded panel of shingles experts – a system similar to one used in multiple prior shingles vaccine pivotal studies. As presented earlier in the month at the IDWeek scientific conference, this co-primary immunogenicity endpoint was met in the highest amezosvatein dose studied (100 μg gE plus 15 μg SLA-SE) as participants’ immune responses to amezosvatein were non-inferior to participants’ immune responses to Shingrix. High-dose amezosvatein and Shingrix generated similar serum neutralizing antibodies to the varicella zoster virus (VZV) and T-cell responses specific for the gE antigen. Vaccines are studied for both safety and reactogenicity/tolerability. Data on the reactogenicity/tolerability of amezosvatein and Shingrix were collected via a participant diary filled out for the seven days after each injection. Participants were asked to grade the tolerability of each vaccine on a scale of Grade 1 to Grade 3. Grade 1 represents what are considered normal reactions to an active vaccine that do not interfere or prevent daily activity. Grade 2 represents reactogenicity events interfering with daily activities. Grade 3 represents reactogenicity events preventing daily activities. Amezosvatein and Shingrix demonstrated comparable safety in this Phase 2 trial. However, the highest dose of amezosvatein demonstrated a clinically-meaningful and statistically-significant improvement for Grade 2 and Grade 3 reactogenicity versus Shingrix. Just 7.3% of participants in the trial receiving the highest dose of amezosvatein reported a Grade 2 (interferes with daily activity) or Grade 3 (prevents daily activity) reactogenicity event compared to 33.3% of participants receiving Shingrix. This result was statistically significant (p<0.001 in a post hoc analysis unadjusted for multiple comparisons). Reactogenicity events were broken down between local reactions (injection site pain, redness, or swelling) and systemic reactions (fever, headache, fatigue, myalgia/muscle pain, chills). Just 3.6% of high-dose amezosvatein participants had a Grade 2 or Grade 3 local reactogenicity event compared to 25.3% of Shingrix participants. For systemic reactogenicity events, 5.5% of high-dose amezosvatein participants had a Grade 2 or Grade 3 event versus 19.1% for Shingrix. Both results were statistically significant (p=0.0002 and p=0.0139, respectively, in a post hoc analysis unadjusted for multiple comparisons). No Grade 3 reactogenicity events were reported for amezosvatein. About amezosvatein‘Amezosvatein’ is the assigned non-proprietary name for CRV-101, a non-mRNA adjuvanted subunit vaccine under investigation by Curevo. Like Shingrix, amezosvatein uses a subunit protein antigen called glycoprotein ‘E’ (gE). Targeting the gE antigen is proven to elicit a long-term, protective immune response to prevent shingles. Also like Shingrix, amezosvatein uses an adjuvant targeting the TLR4 pathway to boost the immune response to the gE antigen. Amezosvatein was engineered to have a best-in-class safety profile in addition to manufacturing advantages to improve vaccine accessibility. The SLA-SE adjuvant formulation was developed at Seattle-based Access to Advanced Health Institute (AAHI) and amezosvatein was licensed from the Mogam Institute for Biomedical Research, a research institute funded by South Korea’s GC Biopharma. About shinglesAlso called ‘herpes zoster’, shingles occurs when the varicella zoster virus causing childhood chickenpox re-emerges from sensory ganglion nervous system cells where the virus lies dormant after initial exposure. Virtually all adults have been exposed to the varicella zoster virus and around 30% will develop shingles at least once in their lifetime. The blistering skin rash accompanying shingles also causes severe pain, with both pain and rash lasting up to four weeks. Between 10-18% of those who get shingles develop post-herpetic neuralgia (PHN), a condition marked by debilitating nerve pain lasting over six months and often beyond one year. There is no approved treatment for PHN. Shingles may also affect the eyes, potentially causing loss of vision. Contracting shingles has also been linked with increased risk of heart attack, stroke, and dementia/Alzheimer’s disease. About CurevoCurevo is a privately held, clinical-stage biotechnology company based near Seattle dedicated to reducing the burden of infectious disease by developing vaccines with improved tolerability and accessibility. Curevo’s lead product is amezosvatein, a non-mRNA sub-unit vaccine to prevent shingles, a serious medical condition involving a painful, blistering skin rash where 10-18% of people also develop serious, long-lasting nerve pain. The current $4+ billion shingles vaccine market is characterized by accessibility issues and vaccine hesitancy/dose avoidance related to vaccine tolerability. Curevo is also developing a non-live, non-mRNA subunit chickenpox vaccine intended to reduce or eliminate barriers to immunizing immunocompromised children. For more information visit https://curevovaccine.com/. 1. Lal, et al. New England Journal of Medicine, May 2015. Shingrix® is a registered trademark of GlaxoSmithKline, PLC.

LOS ANGELES, Oct. 30, 2024 /PRNewswire/ -- Dr. Scott McMahon of Whole World Health Care is happy to announce the launch of the MEDICINE AND MIRACLES podcast during the month of October, recognized as Health Literacy Month, an international observance where many health organizations work together to promote health literacy awareness. The podcast, hosted by Dr. McMahon, will integrate medical expertise with spiritual healing, offering a unique look at health and recovery through a faith-based perspective. Each episode will delve into inspiring stories, healing practices, and transformative journeys. Dr. McMahon hopes to create a supportive community that embraces positivity, fosters personal growth and give listeners a sense of hope. Continue Reading MEDICINE AND MIRACLES, hosted by Dr. Scott McMahon, will integrate medical expertise with spiritual healing, offering a unique look at health and recovery through a faith-based perspective. Many of the episodes will address the mystery of Chronic Inflammatory Response Syndrome (CIRS), triggered by mold illness and exposure, which debilitates the health of millions each year. Dr. McMahon is a pediatrician and medical expert, specializing in the field of CIRS in kids and adults. He's considered one of the top CIRS pediatric expert across the country, and one of the top CIRS specialists in the world. "Chronic Inflammatory Response Syndrome (CIRS) is still a mystery to the medical community. Each year, millions of people are misdiagnosed and suffer from a multitude of symptoms, caused by mold illness and exposure," said Dr. McMahon. "I hope the MEDICINE AND MIRACLES podcast will offer listeners some accessible, bite-sized information about the condition; spark some 'aha moments' about their own health; and lead them down a road of healing and recovery." Dr. McMahon added he wants to give listeners, who may be dealing with a chronic health issue, a sense of hope because "miracles still happen every single day!" he said. CIRS is a multisystem illness affecting many areas of the body. Every year, mold exposure affects the health of millions of Americans – kids, teens and adults -- with symptoms that include chronic fatigue and pain, watery eyes, headaches, respiratory issues, brain fog, irritability and sleep problems – just to name a few. Oftentimes, these symptoms can lead to patients being misdiagnosed for other disorders like lupus, rheumatoid arthritis, Sjogren's syndrome, chronic fatigue syndrome, IBS, fibromyalgia, multiple sclerosis (MS), chronic regional pain syndrome and many other illnesses. For more information about CIRS, visit CIRSx.com. Throughout the year, Dr. McMahon speaks on mold-related health concerns and CIRS at many statewide, national and international medical conventions and meetings. Throughout his career, he's evaluated approximately 2,000 patients for CIRS from 48 states and 21 countries. And when he's not working with patients, he's also a medical expert in court cases nationwide for mold-related lawsuits. MEDICINE AND MIRACLES can be found on digital platforms, including Spotify, iHeart Radio and Amazon Podcast. JUST DROPPED!! THE MEDICINE AND MIRACLE PODCAST Now on Spotify: Now on iHeartRadio: Now on Amazon Podcasts: ABOUT SCOTT MCMAHON | pediatrician, medical expert and author Dr. Scott McMahon is a pediatrician, author and medical expert, specializing in the field of Chronic Inflammatory Response Syndrome (CIRS), in kids and adults. He is the author of several books, including "The Art and Science of CIRS Medicine," co-written with Dr. Ritchie Shoemaker and Dr. Andrew Heyman, which addresses mold illness. He's also authored or co-authored more than a dozen scientific papers on mold illness and contributed to a couple of medical textbooks. He's one of the leading voices on advancing the science to treat, educate and serve those suffering with CIRS. And when he's not working with patients, he serves as a medical expert in courts across the country, participating in "mold litigation" for plaintiff and the defense cases. He's recognized as a qualified CIRS medical expert for the judicial system in ten states in the United States as well as Quebec, Canada. He's been involved in more than 100 disability, workers compensation and personal injury cases, testifying in ten states as well as Canada, England and soon in the Bahamas. He received his bachelor's degree in chemistry from Creighton University, located in Omaha, Nebraska, in 1985 and completed his medical degree at Creighton University School of Medicine in 1989. Dr. McMahon went on to finish a prestigious pediatric residency at Duke University Medical Center in Durham, North Carolina in 1992. He has maintained board certification since 1992 and practiced pediatrics in Roswell, New Mexico, for more than 30 years. Four years ago, he retired from active pediatric practice; but continues to serve as a pediatric hospitalist. Dr. McMahon currently resides in Roswell, New Mexico with his wife, Mary, and their eight children. He's also an ordained minister through Joan Hunter Ministries. For more about Dr. McMahon and the podcast, visit MedicineAndMiracles.co. SOURCE Dr. Scott McMahon of Whole World Health Care WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ATLANTA, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), formerly Virios Therapeutics, Inc., a clinical‐stage biopharmaceutical company, announced today that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. The listing compliance matter is now closed. Below are some recent key developments in the business. Key Highlights Top-line results from the Bateman Horne Center’s phase 2a study of IMC-2 for the treatment of Long-COVID are expected to be released in mid-November 2024.Integration efforts continue following the Company’s acquisition of Pharmagesic (Holdings) Inc. in early October 2024. About Dogwood Therapeutics Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders. The Dogwood research pipeline includes two separate mechanistic platforms that include a non-opioid analgesic program and an antiviral program. The proprietary non-opioid, Nav 1.7 analgesic program is centered on lead development candidate, Halneuron® which is a voltage-gated sodium channel blocker, a mechanism known to be effective for reducing pain. Halneuron® treatment has demonstrated pain reduction of both general cancer related pain and chemotherapy-induced neuropathic pain (“CINP”). Interim data from the forthcoming Phase 2 CINP study are expected in 2H 2025. The antiviral program includes IMC-1 and IMC-2, which are novel, proprietary, fixed dose combinations of nucleoside analog, anti-herpes antivirals and the anti-inflammatory agent, celecoxib, for the treatment of illnesses believed to be related to reactivation of previously dormant herpes viruses, including fibromyalgia (“FM”) and Long-COVID (“LC”). Top-line data from an ongoing IMC-2 Phase 2 LC study are expected in mid-November 2024. IMC-1 is poised to progress into Phase 3 development as a treatment for FM and is the focus of external partnership activities. For more information, please visit www.dwtx.com. Follow Dogwood Therapeutics Email Alerts: https://ir.dwtx.com/resources/email-alerts LinkedIn: https://www.linkedin.com/company/dogwoodther/ Twitter: https://twitter.com/dogwoodther Facebook: https://www.facebook.com/dogwoodther Forward-Looking Statements Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Dogwood’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing and results of current and future clinical studies relating to Dogwood’s product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Amended Annual Report on Form 10-K/A for the year ended December 31, 2023, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Dogwood undertakes no duty to update such information except as required under applicable law. Contact: IR@dwtx.com