{"id":964044,"date":"2026-05-18T09:25:16","date_gmt":"2026-05-18T13:25:16","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/"},"modified":"2026-05-18T09:25:16","modified_gmt":"2026-05-18T13:25:16","slug":"dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/","title":{"rendered":"Dogwood Therapeutics Announces Commencement of Halneuron\u00ae Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"center\">\n        <em>New study to assess Halneuron<\/em><br \/>\n        <sup>\u00ae<\/sup><br \/>\n        <em> pain reduction effect over three months of treatment, additional safety data to bolster planned end of Phase 2 FDA submission package<\/em>\n      <\/p>\n<p align=\"center\">\n        <em>Patients completing the ongoing Halneuron<\/em><br \/>\n        <sup>\u00ae<\/sup><br \/>\n        <em> 4-week CINP Phase 2b study are now eligible to enroll in the new 12-week open-label follow-on trial <\/em>\n      <\/p>\n<p align=\"justify\">ALPHARETTA, Ga., May  18, 2026  (GLOBE NEWSWIRE) &#8212; Dogwood Therapeutics, Inc. (NASDAQ: DWTX) (\u201cDogwood\u201d or the \u201cCompany\u201d), a biopharmaceutical company developing first-in-class, non-opioid medicines to treat pain and neuropathy, today announced commencement of a new Halneuron<sup>\u00ae<\/sup> chemotherapy induced neuropathic pain (\u201cCINP\u201d) phase 2b extension study. Based on a positive interim assessment demonstrating a Halneuron<sup>\u00ae<\/sup> 4-week treatment effect versus placebo, Dogwood previously submitted plans to FDA to support commencement of a Halneuron<sup>\u00ae<\/sup> 12-week follow-on open-label extension study for patients completing the 4-week double-blinded treatment period. Several patients have already been enrolled in the new study that will assess the safety and efficacy of continued Halneuron<sup>\u00ae<\/sup> treatment for an additional 3 months, using various dosing regimens. Data from the forthcoming extension trial will add to the data package the Company plans to submit to the FDA to support its planned Phase 3 development program, presently projected to start in the first half of 2027.<\/p>\n<p align=\"justify\">Dogwood Therapeutics previously announced that a pre-planned interim analysis of the double-blinded Halneuron<sup>\u00ae<\/sup> CINP Phase 2b study supported continuation of the study, with a sample size in the 210-240 range to achieve 80% power. This recommendation by an independent group of statisticians was based on the observed treatment difference between Halneuron<sup>\u00ae<\/sup>-treated and placebo-treated patients amongst the 97 patients completing the trial. The double-blinded portion of the ongoing CINP study is expected to meet enrollment objectives to support release of top-line results in the fall of 2026. The current overall study dropout rate of under 5% is far below rates typically observed during other FDA-approved chronic pain clinical studies. Patients completing the ongoing CINP Phase 2b trial will be eligible to receive Halneuron<sup>\u00ae<\/sup> for an additional 12 weeks to control their moderate-to-severe pain following chemotherapy treatment. A review of the demographics of the patients included in the interim analysis revealed that the mean duration of CINP for study enrollees exceeded five years, demonstrating the extraordinary medical need for novel new medicines to improve care for patients suffering from CINP. Currently, there are no FDA-approved treatments for CINP patients.<\/p>\n<p align=\"justify\">\u201cNeuropathic pain is a difficult to treat chronic condition, as evidenced by the five-year mean duration of symptoms for the patients enrolling in our current Halneuron<sup>\u00ae<\/sup> CINP Phase 2b trial,\u201d commented R. Michael Gendreau, MD, Chief Medical Officer\u00a0of Dogwood. \u201cThis new 12-week long term extension will generate important additional data on how best to optimize Halneuron<sup>\u00ae<\/sup> maintenance treatment for our planned Phase 3 program and potential commercialization.\u201d<\/p>\n<p align=\"justify\">\n        <strong>About Dogwood Therapeutics:<\/strong>\n      <\/p>\n<p align=\"justify\">Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron<sup>\u00ae<\/sup>\u00a0and SP16.<\/p>\n<p align=\"justify\">Our lead product candidate, Halneuron<sup>\u00ae<\/sup>,\u00a0is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron<sup>\u00ae<\/sup>\u00a0has been granted fast track designation from the FDA for the treatment of CINP. Halneuron<sup>\u00ae<\/sup>\u00a0is a non-opioid, Na<sub>V<\/sub>\u00a01.7 analgesic which is a highly specific voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain transmission. In clinical studies, Halneuron<sup>\u00ae<\/sup>\u00a0treatment has demonstrated pain reduction in pain related to general cancer and in pain related to chronic chemotherapy-induced neuropathic pain. SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (LRP1) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b chemotherapy-induced pain and peripheral neuropathy trial is fully funded by the National Cancer Institute.<\/p>\n<p align=\"justify\">Dogwood Therapeutics\u2019 largest shareholder is a member of CK Life Sciences Int\u2019l., (Holdings) Inc., which is listed on the Hong Kong Stock Exchange (Stock code: 0775). For more information, please visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=A_lo4FpeQF-3wJJsXboggPKcKX99UQWdQ0_aSL3tuMpT1f1BdwKqRHmkz_MLQIrVxk-iif4FQxHiSCXu6kk_QAziEQriCBM7OxyKDWQ9kSNBG8NkNDKo8Hvt5deqjLayVrVkJRJrfnJCFEfqShniWI8wNz7YqbIM6PbGqBIALpTRkHeInSh4Eb9o-n-T3XBwwCck6hsNjnCUl-EzyDF3uO-MjCgaGIfuPO_8Q3O4DbS53sTxOZGheFFT5i-DMz9WcpdM-SD2SAzg1KF38aCITlAc3vCRftmXJ6M_CI8yykoJIdUxwd18DZtjb4rfEflc-ycfBmJdhTxgW_I_myvqEDXRDnNPFlLY5boNlPjtchg2FDpM9qkGh8Pn_3Ecr8EY2y3HKQbDDzoRfeRuLjtJeyyZs4xeYrQRNi36lWhfgto=\" rel=\"nofollow\" target=\"_blank\">www.dwtx.com<\/a>.<\/p>\n<p align=\"justify\">\n        <strong>Forward-Looking Statements:<\/strong>\n      <\/p>\n<p align=\"justify\">Statements in this press release contain \u201cforward-looking statements,\u201d 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 \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontemplate,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cseek,\u201d \u201cmay,\u201d \u201cmight,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201csuggest,\u201d \u201ctarget,\u201d \u201caim,\u201d \u201cshould,\u201d &#8220;will,\u201d \u201cwould,\u201d 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\u2019s 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\u2019s 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 \u201cRisk Factors\u201d in the most recently filed Annual Report on Form 10-K, which has been 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.<\/p>\n<p>\n        <strong>Investor Relations:<\/strong>\n      <\/p>\n<p>Dan Ferry<br \/>Managing Director<br \/>LifeSci Advisors, LLC<br \/>daniel@lifesciadvisors.com<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcyMTg2NiM3NjA3ODA3IzIyMDM5OTQ=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/OTdjYjZmMTgtYzIwNi00Y2M1LWIwYjAtYzI5NDIxNmRlOTY3LTEyMTU1NDctMjAyNi0wNS0xOC1lbg==\/tiny\/Dogwood-Therapeutics-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>New study to assess Halneuron \u00ae pain reduction effect over three months of treatment, additional safety data to bolster planned end of Phase 2 FDA submission package Patients completing the ongoing Halneuron \u00ae 4-week CINP Phase 2b study are now eligible to enroll in the new 12-week open-label follow-on trial ALPHARETTA, Ga., May 18, 2026 (GLOBE NEWSWIRE) &#8212; Dogwood Therapeutics, Inc. (NASDAQ: DWTX) (\u201cDogwood\u201d or the \u201cCompany\u201d), a biopharmaceutical company developing first-in-class, non-opioid medicines to treat pain and neuropathy, today announced commencement of a new Halneuron\u00ae chemotherapy induced neuropathic pain (\u201cCINP\u201d) phase 2b extension study. Based on a positive interim assessment demonstrating a Halneuron\u00ae 4-week treatment effect versus placebo, Dogwood previously submitted plans to FDA to support commencement of a &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Dogwood Therapeutics Announces Commencement of Halneuron\u00ae Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-964044","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dogwood Therapeutics Announces Commencement of Halneuron\u00ae Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dogwood Therapeutics Announces Commencement of Halneuron\u00ae Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"New study to assess Halneuron \u00ae pain reduction effect over three months of treatment, additional safety data to bolster planned end of Phase 2 FDA submission package Patients completing the ongoing Halneuron \u00ae 4-week CINP Phase 2b study are now eligible to enroll in the new 12-week open-label follow-on trial ALPHARETTA, Ga., May 18, 2026 (GLOBE NEWSWIRE) &#8212; Dogwood Therapeutics, Inc. (NASDAQ: DWTX) (\u201cDogwood\u201d or the \u201cCompany\u201d), a biopharmaceutical company developing first-in-class, non-opioid medicines to treat pain and neuropathy, today announced commencement of a new Halneuron\u00ae chemotherapy induced neuropathic pain (\u201cCINP\u201d) phase 2b extension study. Based on a positive interim assessment demonstrating a Halneuron\u00ae 4-week treatment effect versus placebo, Dogwood previously submitted plans to FDA to support commencement of a &hellip; Continue reading &quot;Dogwood Therapeutics Announces Commencement of Halneuron\u00ae Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-05-18T13:25:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcyMTg2NiM3NjA3ODA3IzIyMDM5OTQ=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Dogwood Therapeutics Announces Commencement of Halneuron\u00ae Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study\",\"datePublished\":\"2026-05-18T13:25:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\\\/\"},\"wordCount\":957,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTcyMTg2NiM3NjA3ODA3IzIyMDM5OTQ=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\\\/\",\"name\":\"Dogwood Therapeutics Announces Commencement of Halneuron\u00ae Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/","og_locale":"en_US","og_type":"article","og_title":"Dogwood Therapeutics Announces Commencement of Halneuron\u00ae Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study - Market Newsdesk","og_description":"New study to assess Halneuron \u00ae pain reduction effect over three months of treatment, additional safety data to bolster planned end of Phase 2 FDA submission package Patients completing the ongoing Halneuron \u00ae 4-week CINP Phase 2b study are now eligible to enroll in the new 12-week open-label follow-on trial ALPHARETTA, Ga., May 18, 2026 (GLOBE NEWSWIRE) &#8212; Dogwood Therapeutics, Inc. (NASDAQ: DWTX) (\u201cDogwood\u201d or the \u201cCompany\u201d), a biopharmaceutical company developing first-in-class, non-opioid medicines to treat pain and neuropathy, today announced commencement of a new Halneuron\u00ae chemotherapy induced neuropathic pain (\u201cCINP\u201d) phase 2b extension study. Based on a positive interim assessment demonstrating a Halneuron\u00ae 4-week treatment effect versus placebo, Dogwood previously submitted plans to FDA to support commencement of a &hellip; Continue reading \"Dogwood Therapeutics Announces Commencement of Halneuron\u00ae Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/","og_site_name":"Market Newsdesk","article_published_time":"2026-05-18T13:25:16+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcyMTg2NiM3NjA3ODA3IzIyMDM5OTQ=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Dogwood Therapeutics Announces Commencement of Halneuron\u00ae Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study","datePublished":"2026-05-18T13:25:16+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/"},"wordCount":957,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcyMTg2NiM3NjA3ODA3IzIyMDM5OTQ=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/dogwood-therapeutics-announces-commencement-of-halneuron-chemotherapy-induced-neuropathic-pain-phase-2b-long-term-extension-study\/","name":"Dogwood Therapeutics Announces Commencement of Halneuron\u00ae Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study - 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