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Dogwood Therapeutics Announces Enrollment of First Fifty Patients in Ongoing ±á²¹±ô²Ô±ð³Ü°ù´Ç²Ô® Phase 2b Trial

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Dogwood Therapeutics (NASDAQ:DWTX) has reached a significant milestone in its Phase 2b clinical trial for ±á²¹±ô²Ô±ð³Ü°ù´Ç²Ô®, enrolling the first 50 patients to evaluate the drug's effectiveness in treating Chemotherapy-Induced Neuropathic Pain (CINP). The trial, known as HALT-CINP, demonstrates promising early safety data with only a 6% discontinuation rate among the first 35 patients.

The study focuses on cancer patients with neuropathy from platinum or taxane-based chemotherapy, administering 8 daily subcutaneous doses over 14 days with a 28-day follow-up. The company remains on track for its Q4 2025 interim analysis of approximately 100 patients, with full results expected in mid-2026. The trial will be conducted across 25 U.S. sites, evaluating primary endpoints of safety and pain intensity reduction.

Dogwood Therapeutics (NASDAQ:DWTX) ha raggiunto un traguardo importante nella sua sperimentazione clinica di Fase 2b per ±á²¹±ô²Ô±ð³Ü°ù´Ç²Ô®, arruolando i primi 50 pazienti per valutare l'efficacia del farmaco nel trattamento del dolore neuropatico indotto dalla chemioterapia (CINP). Lo studio, denominato HALT-CINP, mostra dati preliminari promettenti in termini di sicurezza, con un tasso di interruzione del solo 6% tra i primi 35 pazienti.

La ricerca si concentra su pazienti oncologici con neuropatia causata da chemioterapia a base di platino o taxani, somministrando 8 dosi sottocutanee giornaliere per 14 giorni, seguite da un monitoraggio di 28 giorni. L’azienda conferma di essere in linea con l’analisi intermedia prevista per il quarto trimestre 2025 su circa 100 pazienti, con i risultati completi attesi per la metà del 2026. La sperimentazione si svolgerà in 25 centri negli Stati Uniti, valutando come endpoint primari la sicurezza e la riduzione dell’intensità del dolore.

Dogwood Therapeutics (NASDAQ:DWTX) ha alcanzado un hito importante en su ensayo clínico de Fase 2b para ±á²¹±ô²Ô±ð³Ü°ù´Ç²Ô®, inscribiendo a los primeros 50 pacientes para evaluar la eficacia del medicamento en el tratamiento del dolor neuropático inducido por quimioterapia (CINP). El ensayo, conocido como HALT-CINP, presenta datos iniciales prometedores de seguridad con una tasa de abandono del 6% entre los primeros 35 pacientes.

El estudio se centra en pacientes con cáncer que presentan neuropatía por quimioterapia basada en platino o taxanos, administrando 8 dosis subcutáneas diarias durante 14 días con un seguimiento de 28 días. La compañía mantiene su calendario para el análisis intermedio en el cuarto trimestre de 2025 con aproximadamente 100 pacientes, y se esperan resultados completos para mediados de 2026. El ensayo se llevará a cabo en 25 sitios en EE.UU., evaluando como objetivos principales la seguridad y la reducción de la intensidad del dolor.

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Dogwood Therapeutics (NASDAQ:DWTX) a atteint une étape importante dans son essai clinique de phase 2b pour ±á²¹±ô²Ô±ð³Ü°ù´Ç²Ô®, en recrutant les 50 premiers patients afin d’évaluer l’efficacité du médicament dans le traitement de la douleur neuropathique induite par la chimiothérapie (CINP). L’essai, appelé HALT-CINP, présente des données de sécurité préliminaires prometteuses avec un taux d’abandon de seulement 6% parmi les 35 premiers patients.

Cette étude cible des patients atteints de cancer souffrant de neuropathie due à une chimiothérapie à base de platine ou de taxanes, administrant 8 doses sous-cutanées quotidiennes pendant 14 jours, suivies d’un suivi de 28 jours. La société reste en bonne voie pour une analyse intermédiaire au quatrième trimestre 2025 portant sur environ 100 patients, les résultats complets étant attendus pour mi-2026. L’essai sera mené dans 25 centres aux États-Unis, évaluant comme critères principaux la sécurité et la réduction de l’intensité de la douleur.

Dogwood Therapeutics (NASDAQ:DWTX) hat einen wichtigen Meilenstein in seiner Phase-2b-Studie zu ±á²¹±ô²Ô±ð³Ü°ù´Ç²Ô® erreicht, indem die ersten 50 Patienten eingeschlossen wurden, um die Wirksamkeit des Medikaments bei der Behandlung von durch Chemotherapie verursachten neuropathischen Schmerzen (CINP) zu bewerten. Die Studie, bekannt als HALT-CINP, zeigt vielversprechende erste Sicherheitsdaten mit einer Abbruchrate von nur 6% bei den ersten 35 Patienten.

Die Studie konzentriert sich auf Krebspatienten mit Neuropathie durch platinhaltige oder taxanbasierte Chemotherapie, wobei 8 tägliche subkutane Dosen über 14 Tage verabreicht werden, gefolgt von einer 28-tägigen Nachbeobachtung. Das Unternehmen befindet sich auf Kurs für die Zwischenanalyse im vierten Quartal 2025 mit etwa 100 Patienten, die vollständigen Ergebnisse werden für Mitte 2026 erwartet. Die Studie wird an 25 Standorten in den USA durchgeführt und bewertet primäre Endpunkte hinsichtlich Sicherheit und Schmerzlinderung.

Positive
  • Low discontinuation rate of 6% suggests good tolerability
  • Trial enrollment progressing as planned with interim analysis on track for Q4 2025
  • Unique drug mechanism targeting Nav 1.7 sodium channel inhibition differentiates from competitors
  • Strong interest from patients and research community based on prior positive trial results
Negative
  • Final results not expected until mid-2026
  • Study still requires determination of final sample size based on interim data

Insights

Dogwood's Phase 2b CINP trial progress shows promising safety profile with low discontinuation rate while advancing toward Q4 interim analysis.

Dogwood Therapeutics has reached a significant milestone with 50 patients enrolled in its Phase 2b trial evaluating ±á²¹±ô²Ô±ð³Ü°ù´Ç²Ô® for chemotherapy-induced neuropathic pain (CINP). The most notable aspect of this update is the remarkably low discontinuation rate of only 6% among the first 35 patients completing the trial, suggesting the treatment is being well-tolerated—a critical factor for pain medications where tolerability often determines clinical utility.

The company remains on track for its interim data readout in Q4 2025, which will analyze approximately 100 patients and determine the final sample size needed for the study. The interim analysis represents a critical inflection point that could validate Halneuron's® mechanism of action as a specific Nav 1.7 sodium channel inhibitor.

The trial design is robust, featuring a randomized, placebo-controlled structure with participants receiving 8 subcutaneous doses over 14 days with a 28-day follow-up. Primary endpoints appropriately focus on safety and pain intensity reduction, while secondary measures examine effects on sleep, fatigue, and overall health—all crucial quality-of-life factors for cancer patients suffering from chemotherapy-induced neuropathy.

Particularly promising is management's indication of strong interest from both patients and the research community, allowing them to expand to additional qualified research sites. This suggests the clinical community recognizes the potential value of Halneuron's® approach, which specifically targets Nav 1.7 sodium channels as an alternative to current pain management options in an area with significant unmet need.

- Halneuron® Chemotherapy-Induced Neuropathic Pain (“CINP�) Phase 2b study interim data readout remains on track as projected for Q4 2025 -

- Low discontinuation rate (6%) due to adverse events amongst the first 35 patients completing the trial suggests Halneuron® and placebo treatment have been generally well tolerated -

ATLANTA, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company�), a development-stage biotechnology company developing new medicines to treat pain and fatigue-related disorders, today announced it has enrolled the first 50 patients in its ongoing Phase 2b CINP trial and remains on track to execute its planned interim analysis on approximately 100 patients who will have completed the four week trial during the fourth quarter of this year.

“There has been increasing interest in the role of Nav 1.7 and Nav 1.8 sodium channel inhibition as alternatives for pain treatment over the past few years,� said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “We believe the novelty of Halneuron’s® specificity and potency for Nav 1.7 sodium channel inhibition, as well as the uniqueness of the cancer and chemotherapy related neuropathic pain disease targets differentiates our program from other sodium channel research programs.�

“Positive data from prior Halneuron® cancer pain and CINP clinical trials underpins both patient and research community interest in participating in this landmark study,� said Michael Gendreau, MD, PhD, Chief Medical Officer of Dogwood Therapeutics. “Based on this interest, we continue to add qualified research sites to our study with the goal to deliver full results from the Phase 2b trial in mid-2026.�

Halneuron® CINP Phase 2b Trial (“HALT-CINP�) Overview (NCT06848348)

HALT-CINP is a randomized, phase 2b clinical trial evaluating the safety and effectiveness of Halneuron® vs placebo in cancer patients with established neuropathy due to a platinum or taxane based chemotherapy regimen. Participants receive 8 once daily sub-cutaneous doses of Halneuron® or placebo over 14 days and will be followed for 28 days for safety and effectiveness. The primary endpoints for this study will assess overall safety and the change from baseline in the weekly average of daily 24-hour recall pain intensity over the course of four weeks of treatment with either Halneuron® or placebo. We expect that the study will be conducted across 25 sites in the U.S. Secondary measures will assess Halneuron’s® treatment effect on sleep, fatigue and overall patient health. Interim data from approximately 100 patients completing the trial will be used to determine the final Phase 2b trial sample size in Q4 2025.

About Halneuron®

Our lead product candidate, Halneuron®, is in Phase 2b development as a non-opioid, NaV 1.7 inhibitor to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the Food and Drug Administration (“FDA�) for the treatment of CINP.

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 with a non-opioid analgesic program and an antiviral program. The proprietary, non-opioid, NaV 1.7 analgesic program is centered on our lead development candidate, Halneuron®, which is a highly specific voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain transmission. In clinical studies, Halneuron® treatment has demonstrated pain reduction in pain related to general cancer and in pain related to chronic chemotherapy-induced neuropathic pain (“CINP�). Interim data from the ongoing Halneuron® Phase 2 CINP study are expected in Q4 of 2025.

Dogwood’s antiviral program includes IMC-1 and IMC-2, which are novel, proprietary, fixed-dose combinations of anti-herpes antivirals and the anti-inflammatory agent celecoxib. These combination antiviral approaches are being applied to the treatment of illnesses believed to be related to reactivation of previously dormant herpesviruses, including fibromyalgia (“FM�) and Long-COVID (“LC�). IMC-1 is poised to progress into Phase 3 development as a treatment for FM and is the focus of external partnership activities. IMC-2 has been assessed in both active control and double-blind, placebo-controlled clinical trials and, in both cases, demonstrated successful reduction of the fatigue associated with LC. The company has reached an agreement with FDA on using reduction in fatigue as the primary endpoint for future IMC-2 LC research.

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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 Annual Report on Form 10-K for the year ended December 31, 2024, 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.

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FAQ

What is the current status of Dogwood Therapeutics' Halneuron Phase 2b trial for CINP?

The trial has enrolled its first 50 patients, with interim analysis of 100 patients expected in Q4 2025. Early safety data shows a low 6% discontinuation rate among the first 35 patients.

How does DWTX's Halneuron differ from other pain treatments?

±á²¹±ô²Ô±ð³Ü°ù´Ç²Ô® features unique specificity and potency for Nav 1.7 sodium channel inhibition, specifically targeting cancer and chemotherapy-related neuropathic pain, distinguishing it from other sodium channel research programs.

What are the primary endpoints of the HALT-CINP trial?

The trial's primary endpoints are overall safety and the change from baseline in weekly average daily 24-hour recall pain intensity over four weeks of treatment.

When will Dogwood Therapeutics release the full results of the Halneuron Phase 2b trial?

The company expects to deliver full results from the Phase 2b trial in mid-2026.

How is the Halneuron CINP Phase 2b trial being conducted?

The trial administers 8 once-daily subcutaneous doses of ±á²¹±ô²Ô±ð³Ü°ù´Ç²Ô® or placebo over 14 days, with 28-day follow-up, across 25 U.S. sites.
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