Latest news with #OA
Miami Herald
7 days ago
- Business
- Miami Herald
Adolore BioTherapeutics Announces Publication Demonstrating Biosafety and Efficacy of Kv7 Activating rdHSV-CA8* Analgesic Gene Therapy for Chronic Pain via the Intra-Articular Route in Mice
Findings highlight the advantages of Adolore's approach for the delivery of proprietary gene therapy directly to specialized pain-sensing peripheral nerves (nociceptors) that mediates profound analgesia with the potential to address the great unmet need for non-opioid chronic pain therapies Data further supports the clinical-translational value of Adolore's proprietary non-opioid analgesics for treating chronic non-cancer pain These data support the Company's continuing efforts to progress with IND-enabling studies of ADB-102 gene therapy for the treatment of osteoarthritis (OA) chronic knee pain. DELRAY BEACH, FL / ACCESS Newswire / June 15, 2025 / Adolore BioTherapeutics ("Adolore" or the "Company"), a biotechnology company focused on developing breakthrough opioid-free gene therapy treatments for chronic pain and neurological disorders, today announced the publication of its manuscript titled, "Biosafety and Efficacy of Kv7 Activating rdHSV-CA8* Analgesic Gene Therapy for Chronic Pain Via the Intra-Articular Route in Mice1," in the peer-reviewed journal, Molecular Therapy. Roy Clifford Levitt, MD, Clinical Professor at the University of Miami, Principal Investigator and Program Director of the NIH, NINDS, HEAL Award supporting ADB-102 development for the treatment of chronic knee pain due to OA, and Founder & Executive Chairman of Adolore BioTherapeutics, published biosafety and efficacy data from preclinical studies of Adolore's gene therapy expressing a human carbonic anhydrase-8 variant peptide (CA8*). In model systems, replication-defective, disease-free, herpes simplex virus (rdHSV) gene therapy expressing an analgesic carbonic anhydrase-8 (CA8*) peptide variant corrects somatosensory hyperexcitability by activating Kv7 voltage-gated potassium channels, produces profound, long-lasting analgesia and treats chronic pain from knee OA. In these studies, we provide the first non-Good Laboratory Practices (GLP) biosafety, efficacy, biodistribution, shedding, and histopathology examination of this rdHSV-CA8* via the intra-articular knee route of administration. Naive mice were examined for clinical safety, distribution of virus across all major tissues, knee histopathology, and analgesic efficacy. We observed no signs of persistent toxicity or histopathology, viral genomes remained where they were injected, and there was no evidence of shedding. Profound analgesia persisted for >6 months without functional impairments. These initial biosafety and efficacy data support further development of rdHSV-CA8* for treating chronic knee pain due to moderate-to-severe OA. Dr. Levitt, commented, "Kv7 voltage-gated potassium channel activators, like rdHSV-CA8* open these channels and hyperpolarize nociceptors making them less excitable to produce profound analgesia. Kv7 activators are well-known to produce potent non-opioid-based analgesia in many human chronic pain conditions. While Kv7 openers are no longer available due to off-target adverse events related to systemic administration, they have been successfully translated from animal models to human chronic pain conditions. Bolstered by our substantial body of published data, we continue to develop our innovative approach to address the significant serious unmet need for safe and effective locally acting pain therapies to replace opioids. Our preclinical data strongly support continued preclinical development toward an IND and clinical studies of ADB-102." The Company's lead development program for the treatment of chronic pain in knee osteoarthritis is fully funded by a UG3/UH3 grant awarded to the University of Miami by NIH/NINDS HEAL program to support all formal pre-clinical GLP/GMP/GCP development work through a first-in-human study of ADLR-1l01 in patients expected to commence in 2026. 1 Levitt et al., Biosafety and efficacy of Kv7 activating rdHSV-CA8* analgesic gene therapy for chronic pain via the intraarticular route in mice, Molecular Therapy (2025), About Carbonic Anhydrase-8 (CA8*) Gene Therapy CA8* (variants of naturally occurring human carbonic anhydrase-8 analgesic peptides) gene therapies are a novel class of neuronal calcium channel inhibitors that activate Kv7 voltage-gated potassium channels and are administered locally and long-acting. Oral small molecule pain therapeutics that activate Kv7 voltage-gated potassium channels demonstrated proven analgesic efficacy before they were removed from the market due to severe adverse events related to systemic exposure and their metabolism. CA8* gene therapy provides versatile dosing regimens and routes of administration, including intra-articular, intra-neuronal (nerve block), and intradermal injection. This non-opioid CA8* mechanism-of-action addresses neuropathic, inflammatory, and nociceptive pain, which applies to a broad range of chronic pain indications and neurological disorders. These conditions include osteoarthritis, lower back, and cancer pain; diabetes and other forms of peripheral neuropathy; as well as rare pain conditions such as erythromelalgia, a heritable chronic pain condition and epilepsy and hearing loss. About Adolore BioTherapeutics, Inc. Adolore BioTherapeutics, Inc., is a biotechnology company focused on developing novel therapies for treating chronic pain using a revolutionary intra-cellular replication-defective HSV (rdHSV) drug delivery platform that is disease-free, non-toxic, and permits localized peripheral nervous system delivery of proprietary biotherapeutics. This rdHSV gene therapy technology incorporates an established re-dosing strategy and an excellent safety profile. HSV vectors are known for their stability and prolonged gene expression, providing an excellent basis for the long- term treatment of chronic pain conditions and neurological disorders. Our best-in-class CA8* programs are long-acting, locally administered gene therapies that are opioid-free Disease-Modifying Anti-Pain therapies (DMAPs) designed to treat many forms of chronic pain, epilepsy and hearing loss. Leveraging its innovative gene therapy vectors expressing CA8* analgesic peptides (ADLR-1001), Adolore is currently advancing two preclinical development programs: ADB-101 for the treatment of patients' chronic pain caused by erythromelalgia, an orphan disease, and ADB-102, their lead program for the treatment of patients with chronic pain caused by knee OA. Based on substantial compelling preclinical data generated to date, the Company is progressing these programs toward IND filings and first-in-human clinical studies. Adolore has two additional programs: ADB-104 for Drug-Resistant Refractory Focal Epilepsy and ADB-105 for Acute Severe Hearing Loss. For more information, visit Forward-Looking Statements To the extent, this announcement contains information and statements that are not historical, they are considered forward-looking statements within the meaning of the federal securities laws. You can identify forward-looking statements by the use of the words "believe," "expect," "anticipate," "intend," "estimate," "project," "will," "should," "may," "plan," "intend," "assume" and other expressions which predict or indicate future events and trends and which do not relate to historical matters. You should not rely on forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, some of which are beyond the control of the Company. These risks and uncertainties include but are not limited to those associated with drug development. These risks, uncertainties, and other factors may cause the actual results, performance, or achievements of the Company to be materially different from the anticipated future results, performance, or achievements expressed or implied by the forward- looking statements. Investor Relations Contact Paul Barone (215)622-4542pbarone@ SOURCE: Adolore Biotherapeutics, Inc.
Yahoo
05-06-2025
- Health
- Yahoo
Artelo's Fatty Acid Binding Protein 5 Inhibitor, ART26.12, Compares Favorably to Naproxen in an Osteoarthritis Pain Study
SOLANA BEACH, Calif., June 05, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological or neurological conditions, today announced its presentation of new data at the British Pain Conference held in Newport, Wales, UK on June 3-5, 2025 ( that further validates the therapeutic potential of Fatty Acid Binding Protein (FABP) inhibitors in treating osteoarthritis (OA) pain. Professor Saoirse O'Sullivan, Vice President of Translation Sciences at Artelo Biosciences, presented results from an animal study titled: 'The Fatty Acid Binding Protein 5 Inhibitor ART26.12 is a Novel Analgesic for Osteoarthritis Pain.' The data builds upon an extensive set of pre-clinical data for ART26.12 that demonstrates analgesic and anti-nocicpetive effects in multiple models of pain. Positive effects of ART26.12 were observed in a surgical rat model of osteoarthritis, in which either single or repeated oral doses of Artelo's FABP5 inbitor increased the ability of rats to bear weight on the limb with OA out to four weeks. Professor O'Sullivan stated, 'ART26.12 was effective in a dose-responsive manner, with sustained and consistent effects over 28 days. The analgesic effect of ART26.12 was similar to naproxen, a proven first-line therapy which is often hampered by a number of serious side effects when taken chronically.' Now undergoing human trials, ART26.12 is a novel, non-opioid, non-steroidal drug candidate initially in development for the prevention and treatment of peripheral neuropathy caused by common chemotherapy treatments with potential for development as an alternative for chronic OA pain. OA is a progressive joint disease in which cartilage wears away over time, causing chronic pain, stiffness, swelling, and significant loss of mobility, especially in the knees, hips, hands, and spine. It affects approximately 606.9 million people globally, including over 32 million in the U.S., and can lead to disabling pain, reduced quality of life, and loss of independence, especially in advanced cases. About ART26.12 ART26.12, Artelo's lead FABP5 inhibitor, is being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic. Data from the first Phase 1 trial with ART26.12 is anticipated in Q2 2025. The initial clinical development planned is for chemotherapy-induced peripheral neuropathy (CIPN). FABPs are a family of intracellular proteins that chaperone lipids important to normal cellular function. FABP is overexpressed and associated with abnormal lipid signaling in several pathologies. In addition to ART26.12 in CIPN, Artelo's extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. About Artelo Biosciences Artelo Biosciences, Inc. is a clinical-stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways. Artelo is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the Company applies leading-edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at and X: @ArteloBio. Forward Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, efficacy of the Company's product candidates, results and conclusions from preclinical studies and clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, 'expect,' 'anticipate,' 'intend,' 'plan,' 'believe,' 'estimate,' 'potential,' 'predict,' 'project,' 'should,' 'would' and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission, including our ability to raise additional capital in the future. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by applicable securities laws. Investor Relations Contact:Crescendo Communications, LLCTel: 212-671-1020Email: ARTL@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
27-05-2025
- Business
- Yahoo
PA making state government workforce stronger and more competitive
May 26—WILKES-BARRE — To mark the one year anniversary of Gov, Josh Shapiro's executive order to strengthen the Commonwealth state employee workforce, the Shapiro Administration this week announced the completion of key milestones to improve recruitment, hiring, retention, and development so that Commonwealth agencies can continue to attract highly qualified and dedicated public servants to address the needs of Pennsylvanians. Initiatives to hire more bilingual workers, expand access to childcare, and engage with job seekers are delivering real results that build on Gov. Shapiro's goal of making the Commonwealth a top employer. "Pennsylvania state government should be a place where the best and brightest want to work; a place where every Pennsylvanian, no matter their background, can see themselves thriving in meaningful careers," said Secretary of Administration Neil Weaver. "Through the work of the HIRE Committee and the actions taken through the Governor's executive order, we are making tangible progress in creating a workforce that is as diverse, dynamic, and innovative as the people we serve." "At DGS, we're proud to play a key role in supporting Governor Shapiro's vision of making the Commonwealth a top-tier employer by investing in the people who serve Pennsylvania every day," said Secretary of General Services Reggie McNeil. "From expanding access to quality childcare to improving physical accessibility and ensuring dignity through free menstrual products and single-use restrooms, our work is focused on creating a workplace that values every employee and meets the needs of a modern workforce." Over the past year, the HIRE Committee has built on this foundation through targeted initiatives and pilot programs that include: —Eliminating Waiting Periods for Benefits — Effective Aug. 1, 2025, the waiting period for new hires to enroll dependents into PEBTF medical, prescription drug, dental, and vision coverage without paying additional out of pocket costs will be eliminated. —Offering Financial Incentives for Bilingual Employees — Launched in April, this pilot program at L&I provides a $1.00 per hour bonus — almost $1,000 more over the course of the 6-month pilot — for bilingual employees in certain Unemployment Compensation and PA CareerLink positions to ensure Pennsylvanians who speak a language other than English receive efficient, effective service. —Fostering Re-entrant Success through Employment Opportunities — OA is piloting a hiring program with the Department of Corrections to promote pathways to employment in state government for people who have previously interacted with the criminal justice system. —Hosting the Second Annual Commonwealth Job Fair — OA hosted the second multi-agency job fair for job seekers in the Harrisburg area in March, attracting over 1,000 registrants to learn about open positions and opportunities to join public service. —Enhancing Services for Pennsylvanians with Limited English Proficiency — After hiring the first enterprise language access program manager, OA has prioritized expanding technical assistance and training for agency staff on procuring high-quality translations and language services, supporting agencies as they develop language access plans, and building open and continuous communication with agencies to distribute translated materials and information to Pennsylvanians who need it most. —Promoting Employee Work/Life Balance — The Commonwealth has expanded assistance for mental health and substance misuse issues, family care-giving, and more to support the well-being of all employees. —Expanding Access to Employee Child Care — DGS is managing the expansion of the Keystone Early Learning Center, a year-round childcare facility available to Commonwealth employees. —Improving Accessibility of Commonwealth Buildings — DGS continues to lead an accessibility study that is the first step in helping to improve access and inclusivity for individuals with disabilities throughout the Pennsylvania Capitol Complex. —Offering Free Menstrual Products — DGS has placed menstrual products in woman's restrooms and single-use restrooms throughout Commonwealth buildings directly managed by the agency to ensure that essential hygiene products are readily available to employees and visitors who need them. —Continuing to Add Single-Use Restrooms — DGS has added 12 single-use restrooms in state government facilities following the issuance of the HIRE executive order. State graduates inaugural class of 15 small business owners from Mentor Protégé Program The Pennsylvania Department of General Services (DGS) this week graduated the inaugural cohort of the Mentor Protégé Program (MPP) — a key initiative started under the Shapiro-Davis Administration to expand opportunities and access for small, small diverse, and veteran-owned businesses seeking to compete in the Commonwealth's procurement process. The MPP, established under Governor Shapiro's Executive Order 2023-18, provides small business owners with one-on-one mentoring relationships with seasoned prime contractors. Mentors provide guidance, support, and valuable insights to help protégés improve their business management and contract bidding skills which could be useful in acquiring additional Commonwealth business. "This program is a reflection of the Shapiro-Davis Administration's commitment to economic equity and opportunity," said DGS Secretary Reggie McNeil. "By investing in mentorship and creating space for small, small diverse and veteran-owned businesses to grow, we're strengthening Pennsylvania's economy and seeking to ensure that our procurement processes reflect the diversity and talent of our business community." This first cohort, focused on IT services, included 15 business participants who engaged in targeted programming on business development, procurement readiness, leadership, and strategic planning. Lieutenant Governor Austin Davis participated in the ceremony with a special pre-recorded message, applauding the graduates and reaffirming the Shapiro-Davis Administration's commitment to breaking down barriers for small, small diverse, and veteran-owned businesses. "Small businesses are the backbone of our communities—and when we empower them, we uplift all of Pennsylvania," Davis said. "This administration is committed to cutting red tape, reducing wait times, and creating real ladders of opportunity." League of Women Voters of Wilkes-Barre to hold Annual Meeting June 5 The League of Women Voters of Wilkes-Barre will hold its annual dinner meeting on Thursday, June 5, at 6 p.m., at Theo's Metro Restaurant, 596 Mercer Ave., Kingston. The guest speaker will be Ned Miller, the Northeast Regional Representative for Fair Districts PA. Fair Districts PA is a nonpartisan, statewide coalition that advocates redistricting reform to ensure that the process of determining Pennsylvania's congressional and state legislative districts is fair and transparent. The cost of the buffet dinner is $42 for members and $45 for non-members. RSVP by Friday, May 30. Founded in 1944, The League of Women Voters of the Wilkes-Barre Area (LWVWBA) is a nonpartisan organization that presents citizens of the Wilkes-Barre area with educational tools about issues and candidates so they can make informed decisions on election day. Activities include publishing a government directory and voters guides, voter registration drives, and hosting events where constituents can meet their elected officials. Entirely run by local volunteers, League membership is open to all, regardless of political affiliation or gender. To reserve your seat at the Annual Meeting, contact the League at — 570-675-3429 — or email at lwvwba@ Or visit the League Website at — League updates can be found on Facebook @LWVWB. Reach Bill O'Boyle at 570-991-6118 or on Twitter @TLBillOBoyle.
Sydney Morning Herald
16-05-2025
- Entertainment
- Sydney Morning Herald
‘Picture of misery': Opera Australia posts $10 million loss as audiences hit a cliff
Opera Australia has plunged deeper into financial crisis, posting a $10 million operating deficit as chair Rod Sims defended its worst results since the pandemic. Australia's largest performing arts company was forced to draw down on its emergency capital fund to offset its losses after its Sydney winter season and its much-hyped run of Sunset Boulevard failed to meet box office forecasts. Melbourne performances of the Andrew Lloyd Webber musical last year were blighted by poor reviews, unsold seats and long absences by its lead, Sarah Brightman, due to injury. In addition, OA blamed the closure of the company's State Theatre home in Melbourne and the need to perform in other venues for the hit to its bottom line. The results, branded a disaster privately by some long-term supporters who have been agitating for board changes, ratchet pressure on the board headed by Sims to reverse its fortunes as it approaches its 70th anniversary year in 2026. Loading They land as OA has yet to fill the key roles of artistic director Jo Davies and chief executive Fiona Allen, who resigned in quick succession of each other. The board is also digesting the findings of an independent review critical of OA's culture, morale and workplace structure which has been undertaken by veteran corporate adviser, Gabrielle Trainor. OA's box office revenue sank to $50.7 million in 2024, down from $65.7 million the previous year, according to its annual report.
The Age
16-05-2025
- Entertainment
- The Age
‘Picture of misery': Opera Australia posts $10 million loss as audiences hit a cliff
Opera Australia has plunged deeper into financial crisis, posting a $10 million operating deficit as chair Rod Sims defended its worst results since the pandemic. Australia's largest performing arts company was forced to draw down on its emergency capital fund to offset its losses after its Sydney winter season and its much-hyped run of Sunset Boulevard failed to meet box office forecasts. Melbourne performances of the Andrew Lloyd Webber musical last year were blighted by poor reviews, unsold seats and long absences by its lead, Sarah Brightman, due to injury. In addition, OA blamed the closure of the company's State Theatre home in Melbourne and the need to perform in other venues for the hit to its bottom line. The results, branded a disaster privately by some long-term supporters who have been agitating for board changes, ratchet pressure on the board headed by Sims to reverse its fortunes as it approaches its 70th anniversary year in 2026. Loading They land as OA has yet to fill the key roles of artistic director Jo Davies and chief executive Fiona Allen, who resigned in quick succession of each other. The board is also digesting the findings of an independent review critical of OA's culture, morale and workplace structure which has been undertaken by veteran corporate adviser, Gabrielle Trainor. OA's box office revenue sank to $50.7 million in 2024, down from $65.7 million the previous year, according to its annual report.
