Dogwood Announces Enrollment of First 100 Patients in Ongoing Halneuron(R) Phase 2b Trial, Interim Sample Size Analysis on Track for December 2025
Dogwood (Nasdaq:DWTX) announced it has enrolled the first 100 patients in the HALT-CINP Phase 2b trial of Halneuron® for chemotherapy-induced neuropathic pain as of November 11, 2025. The company says early termination rates remain low among the first 80 completers, suggesting tolerability. A prespecified interim sample-size analysis is on track for Q4 2025 to evaluate whether the planned 200-patient sample remains adequate. The study randomizes patients to Halneuron® or placebo, delivers 8 subcutaneous doses over 14 days, follows patients for 28 days, and is running at ~25 US sites, with final data targeted for mid-2026.
Dogwood (Nasdaq:DWTX) ha annunciato di aver arruolato i primi 100 pazienti nello studio HALT-CINP di fase 2b di Halneuron® per la neuropatia da chemioterapia al 11 novembre 2025. L'azienda afferma che i tassi di terminazione precoce rimangono bassi tra i primi 80 pazienti che hanno completato, suggerendo una buona tollerabilità. Un'analisi prespecificata della dimensione del campione intermedio è in corso ed è in linea per essere disponibile nel Q4 2025 per valutare se il campione pianificato di 200 pazienti rimanga adeguato. lo studio randomizza i pazienti tra Halneuron® e placebo, eroga 8 dosi sottocutanee in 14 giorni, segue i pazienti per 28 giorni, ed è condotto in circa 25 siti negli Stati Uniti, con i dati finali previsti per metà del 2026.
Dogwood (Nasdaq:DWTX) anunció que ha inscrito a los primeros 100 pacientes en el ensayo HALT-CINP de fase 2b de Halneuron® para el dolor neuropático inducido por quimioterapia al 11 de noviembre de 2025. La empresa dice que las tasas de terminación anticipada se mantienen bajas entre los primeros 80 completantes, lo que sugiere tolerabilidad. Un análisis interino de tamaño de muestra prespecificado está en camino para Q4 2025 para evaluar si la muestra prevista de 200 pacientes sigue siendo adecuada. El estudio asigna al azar a los pacientes a Halneuron® o placebo, administra 8 dosis subcutáneas durante 14 días, sigue a los pacientes durante 28 días, y se realiza en ~25 sitios de EE. UU., con los datos finales destinados para mitad de 2026.
Dogwood (Nasdaq:DWTX)는 Halneuron®의 화학요법으로 유발된 신경통 통증에 대한 HALT-CINP 위상 2b 시험에서 처음 100명의 환자를 등록했다고 2025년 11월 11일자로 발표했습니다. 회사는 처음 80명의 완료자 사이에서 조기 중단 비율이 낮은 상태를 유지하고 있어 내약성을 시사한다고 말합니다. 사전 설정된 중간 표본 크기 분석은 2025년 4분기에 맞춰 진행 중이며 계획된 200명 환자 표본이 여전히 충분한지 평가합니다. 연구는 환자들을 Halneuron® 또는 위약으로 무작위 배정하고, 14일 동안 8회 피하 투여를 실시하며, 환자들을 28일간 추적하고, 미국 내 약 25곳 정도의 site에서 진행되며, 최종 데이터는 2026년 중반에 목표로 하고 있습니다.
Dogwood (Nasdaq:DWTX) a annoncé avoir enrôlé les premiers 100 patients dans l'essai HALT-CINP de phase 2b de Halneuron® pour la douleur neuroalgia induite par la chimiothérapie au 11 novembre 2025. L'entreprise indique que les taux d'abandon anticipé restent faibles parmi les premiers 80 patients ayant terminé, suggérant une bonne tolérance. Une analyse intermédiaire pré-spécifiée de la taille de l'échantillon est en cours et est en bonne voie pour être prête au Q4 2025 afin d'évaluer si l'échantillon prévu de 200 patients demeure adéquat. L'étude randomise les patients entre Halneuron® et placebo, délivre 8 dosages sous-cutanés sur 14 jours, suit les patients pendant 28 jours, et se déroule dans environ 26 sites américains, les données finales étant prévues pour mi-2026.
Dogwood (Nasdaq:DWTX) hat bekannt gegeben, dass die ersten 100 Patienten in die HALT-CINP-Phase-2b-Studie von Halneuron® zur chemotherapieinduzierte Neuropathie aufgenommen wurden, Stand 11. November 2025. Das Unternehmen erklärt, dass die Frühterminationsraten unter den ersten 80 Vollständigen niedrig bleiben, was auf eine Verträglichkeit hindeutet. Eine prespezifizierte Zwischenstichprobenanalyse ist im Gange und soll bis Q4 2025 verfügbar sein, um zu prüfen, ob die geplante 200-Patienten-Stichprobe weiterhin ausreichend ist. Die Studie randomisiert Patienten zu Halneuron® oder Placebo, verabreicht 8 subkutane Dosen über 14 Tage, verfolgt die Patienten 28 Tage lang und läuft an ca. 25 US-Standorten, wobei die Enddaten für Mitte 2026 angestrebt werden.
Dogwood (Nasdaq:DWTX) أعلنت أنها قامت بتسجيل أول 100 مريضاً في تجربة HALT-CINP من المرحلة 2b لHalneuron® لعلاج الألم العصبي الناتج عن العلاج الكيميائي 11 نوفمبر 2025. تقول الشركة إن معدلات الإنهاء المبكر ما تزال منخفضة بين أول 80 مكملاً، ما يشير إلى احتمال تحمل العلاج. التحليل المؤقت المسبق لتحديد حجم العينة جارٍ وسيكون جاهزاً في الربع الرابع من 2025 لتقييم ما إذا كانت عينة 200 مريض كافية أم لا. الدراسة تعيّن للمرضى عشوائياً Halneuron® أو دواء وهمياً، وتقدم 8 جرعات تحت الجلد على مدى 14 يوماً، وتتابع المرضى لمدة 28 يوماً، وتُنفّذ في نحو 25 موقعاً في الولايات المتحدة، مع هدف الوصول إلى البيانات النهائية في منتصف 2026.
- 100 patients enrolled in HALT-CINP as of November 11, 2025
- Prespecified interim sample-size analysis on track for Q4 2025
- Low early termination rate among first 80 completers suggests tolerability
- Trial running at ~25 US sites supporting recruitment pace
- Study currently plans a 200-patient sample but may require adjustment
- Primary endpoint based on 4-week change in daily pain scores (short follow-up)
- Final data not expected until mid-2026, extending timeline for readout
Insights
Enrollment hit 100; interim sample size analysis remains scheduled for Q4 2025, with final data expected mid-2026.
Enrollment of the first 100 patients in the HALT-CINP Phase 2b study shows continued operational momentum for Halneuron® in chemotherapy-induced neuropathic pain. The trial remains on track to perform the prespecified interim sample size analysis in
The near-term business mechanism is clear: the interim analysis will determine whether the prespecified sample size remains appropriate to detect a statistically significant treatment effect on the primary endpoint (change from baseline to week four in weekly average daily 24-hour pain scores). Key dependencies and risks are operational (continued low early termination and site enrollment across ~25 US sites) and statistical (the interim analysis outcome could require enlarging the sample or changing assumptions).
Concrete items to watch include the interim sample size analysis outcome in
- Continued low early termination rate among the first 80 study completers suggests Halneuron® and placebotreatmenthave been well tolerated
ATLANTA, GEORGIA / ACCESS Newswire / November 11, 2025 / Dogwood Therapeutics, Inc. (Nasdaq:DWTX) (the "Company"), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced it has successfully enrolled the first 100 patients in its ongoing HALT-CINP Phase 2b CINP trial. HALT-CINP remains on track to conduct a prespecified interim analysis during the fourth quarter of 2025 on patients who have completed or been terminated from the four-week study.
"High interest among cancer patients, significant unmet medical need and positive word of mouth among patients who have participated in the study have contributed to the brisk pace of recruitment in this landmark chemotherapy-induced neuropathic pain study," said R. Michael Gendreau, M.D., Ph.D., Dogwood Therapeutics Chief Medical Officer. "The primary goal of our fourth quarter interim analysis is to evaluate and adjust, if needed, the Phase 2b study sample size required to demonstrate statistically significant results. We are currently continuing with the original plan for a 200-patient sample size for this study, with final data available by the middle of 2026."
Halneuron® CINP Phase 2b Trial ("HALT-CINP") Overview (NCT06848348)
HALT-CINPis a randomized, phase 2b clinical trial evaluating the safety and effectiveness of Halneuron® versus placebo in cancer patients with established neuropathy due to a previous platinum or taxane based chemotherapy regimen. Participants receive 8 sub-cutaneous doses of Halneuron® or placebo over a 14-day period and will be followed for a total of 28 days for safety and effectiveness. The primary endpoint for this study is the change from baseline to week four in the weekly average of daily 24-hour recall pain intensity scores. The study is being conducted at approximately 25 sites in the US. Secondary measures will assess Halneuron's® treatment effects on sleep, fatigue, neuropathy symptoms and overall patient health.
About Dogwood Therapeutics
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® and SP16 IV.
Our lead product candidate, Halneuron®, is in Phase 2b development 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. Halneuron® is a non-opioid, NaV 1.7 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® treatment has demonstrated pain reduction in pain related to general cancer and in pain related to chronic chemotherapy-induced neuropathic pain ("CINP").
SP16 IV is a low-density lipoprotein receptor related protein-1 (LRP1) agonist 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 CINP trial is fully funded by the National Cancer Institute.
For more information, please visit www.dwtx.com.
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.
Investor Relations:
CORE IR
(516) 222-2560
IR@dwtx.com
SOURCE: Dogwood Therapeutics, Inc.
View the original press release on ACCESS Newswire
FAQ
How many patients has Dogwood (DWTX) enrolled in the HALT-CINP Phase 2b trial as of November 11, 2025?
When is the interim sample-size analysis for Dogwood's DWTX HALT-CINP trial scheduled?
What sample size is Dogwood (DWTX) planning for the HALT-CINP Phase 2b study?
What is the primary endpoint and follow-up duration in the HALT-CINP trial (DWTX)?
Does the HALT-CINP trial report any tolerability signals for Halneuron® in DWTX's announcement?
When does Dogwood expect final HALT-CINP Phase 2b data for DWTX?
