Evaluation of quantitative sensory testing (QST) using subcutaneous administration of single escalating doses of halneuron® (tetrodotoxin (TTX)) for injection in healthy volunteers

开始日期2023-10-06

申办/合作机构

Academisch Ziekenhuis Leiden

NCT05359133

/ Terminated临床2期

A Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Trial of Single Cycle Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain

To be eligible for the trial, subjects must have ongoing moderate to severe neuropathic pain related to a prior course of platinum and/or taxane chemotherapy and have no clinical evidence of actively progressive disease.
The trial period will comprise a Screening period (up to 35 Days), randomization and a 4-day treatment period, followed by a 12-week follow up period (12 weeks total after initial treatment), and an End-of-Trial/Follow-up visit which will occur at Week 13. This is a study to research the effects of the study drug on neuropathic pain compared placebo.

开始日期2022-04-19

申办/合作机构

WEX Pharmaceuticals, Inc.

NCT04083833

/ Completed临床1期

A Phase 1, Single Ascending Dose, Randomized, Double-Blind, Placebo and Positive Controlled Study to Evaluate the Cardiovascular Effect of Tetrodotoxin in Healthy Adult Subjects

To determine if a single subcutaneous (SC) administration of TTX at various dose levels has an effect on the QT/QTc intervals when assessing concentration QT (C-QT) relationship (i.e., QT/QTc intervals prolongation in relation to plasma levels of TTX) in healthy adult subjects.
Secondary:
To determine if a single SC administration of TTX at various dose levels has an effect on other important electrocardiogram (ECG) parameters in healthy adult subjects.
To demonstrate sensitivity of this QTc assay using moxifloxacin as a positive control.
To confirm plasma pharmacokinetic (PK) of a single SC administration of TTX at various dose levels when administered to healthy adult subjects.
To determine the overall safety and tolerability of a single SC administration of TTX at various dose levels when administered to healthy adult subjects.
Test Product, Dose, Duration, Mode of Administration, and Batch Number:
The test product was 30 µg/mL tetrodotoxin (TTX) for injection, Lot No. F141124-001.
Subjects were also administered:
Tetrodotoxin matching placebo a sterile 0.9% sodium chloride injection or normal saline for injection, Lot No. 84-093-DK
400 mg Avelox® (moxifloxacin hydrochloride) tablets, Lot No. BXHJ1S1
Moxifloxacin matching placebo film-coated tablets, Id.-No.: K15372, Batch No.: C1606007
Treatments were as follows:
Treatment Arm (n = 9)
Treatment A:
(Period 1) A single TTX dose of 15 μg (0.5 mL of TTX 30 μg/mL injection solution) administered as 1 SC injection with a single oral moxifloxacin matching placebo (1 x placebo tablet)
Treatment B:
(Period 2) A single TTX dose of 30 μg (1 mL of TTX 30 μg/mL injection solution) administered as 1 SC injection with a single oral moxifloxacin matching placebo (1 x placebo tablet)
Treatment C:
(Period 3) A single TTX dose of 45 μg (1.5 mL of TTX 30 μg/mL injection solution) administered as 2 SC injections with a single oral moxifloxacin matching placebo (1 x placebo tablet)
Subjects randomized to the Control Arm were further randomized to receive 1 of 2 treatment sequences (Treatment Sequence DEF [n = 8] and Treatment Sequence GHI [n = 8]):
Control Arm (n = 16)
Treatment D:
(Period 1) A single matching-TTX placebo (0.5 mL of placebo injection solution) administered as 1 SC injection with a single oral moxifloxacin matching placebo (1 x placebo tablet)
Treatment E:
(Period 2) A single matching-TTX placebo (1 mL of placebo injection solution) administered as 1 SC injection with a single oral 400 mg moxifloxacin (1 x 400 mg tablet)
Treatment F:
(Period 3) A single matching-TTX placebo (1.5 mL of placebo injection solution) administered as 2 SC injections with a single oral moxifloxacin matching placebo (1 x placebo tablet)
Treatment G:
(Period 1) A single matching-TTX placebo (0.5 mL of placebo injection solution) administered as 1 SC injection with a single oral 400 mg moxifloxacin (1 x 400 mg tablet)
Treatment H:
(Period 2) A single matching-TTX placebo (1 mL of placebo injection solution) administered as 1 SC injection with a single oral moxifloxacin matching placebo (1 x placebo tablet)
Treatment I:
(Period 3) A single matching-TTX placebo (1.5 mL of placebo injection solution) administered as 2 SC injections with a single oral 400 mg moxifloxacin (1 x 400 mg tablet) All oral study drugs were administered with approximately 240 mL of water.

开始日期2018-02-07

申办/合作机构

WEX Pharmaceuticals, Inc.

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100 项与替曲朵辛相关的临床结果

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100 项与替曲朵辛相关的转化医学

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100 项与替曲朵辛相关的专利（医药）

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15,189

项与替曲朵辛相关的文献（医药）

2025-02-01·EUROPEAN JOURNAL OF PEDIATRIC SURGERY

Interferential Current Stimulation Enhances Rectal Motor Activity: Insights from an Isolated Perfused Porcine Model

Article

作者: Martel, Richard ; Hoyos, Nicolas Andres ; Herrmann, Martin ; Magerl, Walter ; Boettcher, Michael ; Herrmann, Irmgard ; Klinke Petrowsky, Michaela

Introduction Interferential current (IFC) has been studied in several clinical trials for the treatment of bowel motility disorders, most often in children. However, only moderate effects are reported, and in contrast to IFC, the so-called placebo application is indiscernible. The mechanisms and neuroanatomic points of action remain elusive. Therefore, this therapy remains being questioned. Methods To gain objective experimental data about IFC stimulation, we examined this method ex vivo in an isolated perfused porcine rectum including the mesorectum. To elucidate the role of plexus nerve fibers and enteric ganglia, we performed IFC stimulation also in the presence of tetrodotoxin (TTX) or hexamethonium (HXN). We applied the commonly used stimulation modes with a beat frequency sweeping between 5 and 25 Hz (IFCd5–25) and 80 and 150 Hz (IFCd80–150). We monitored intraluminal pressure and motility by online barometry and video recording, respectively. Motor activity, reflected by changes in the intraluminal pressure (cm H2O·s−1) and longitudinal movements (pixels·s−1), was quantified over time as root mean squares (RMSs). Results After IFCd5–25, we observed a 30% increase in the rectal motility in the pressure changes which was sustained over 30 minutes post-stimulation (p < 0.02); only a minor effect was detected for IFCd80–150. Both TTX and HTX abolished the stimulation. This suggests neuronal modulation. Conclusion IFCd5–25 stimulates rectal motor activity in the isolated perfused porcine rectum. Ganglia in the enteric nervous system are modulated to allow increased activity for at least 30 minutes. Therefore, the isolated porcine rectum is a suitable tool to study the effectiveness of various IFC settings in the rectum.

2025-01-01·FOOD CONTROL

Species authentication and conservation challenges in Chinese fish maw market using Mini-DNA barcoding

作者: Wang, Yanguo ; Xing, Bingpeng ; Sun, Rouxin ; Wang, Chunguang ; Chen, Xiaoyin ; Xiang, Peng ; Wu, Qiong

Fish maws, derived from the swim bladders of fish, are valued for their high collagen content and nutritional benefits, leading to significant market demand, especially in Asia.This study investigates the species authenticity of fish maw products using mini-DNA barcoding technol. to address issues of mislabeling and substitution.Out of 350 samples, 347 were successfully sequenced, revealing a high mislabeling rate of 51.01% among identified species.Species such as Diodon liturosus and Diodon hystrix were found, posing significant health risks due to the presence of tetrodotoxin, a potent neurotoxin.The study also highlights the conservation implications of this market, with endangered species like Totoaba macdonaldi being illicitly traded.These findings underscore the urgent need for accurate species identification, stringent labeling regulations, and enhanced fishery management to protect endangered species and ensure consumer safety.This research advocates for robust international cooperation and reporting to combat illegal fishing and trade, promoting the sustainable development of fish populations and marine ecosystem health.

2025-01-01·NEUROSCIENCE

Deciphering the peculiarities of cell types in the septum

Article

作者: Beroun, Anna ; Bijoch, Łukasz ; Kanigowski, Dominik ; Pękała, Martyna ; Kodirov, Sodikdjon A ; Trojan, Michael ; Bekisz, Marek ; Colom, Luis V ; Legutko, Diana

Similar to other brain regions, the neurons in the lateral septum (LS) are of heterogeneous populations. However, their resting membrane potential (RMP) on average is not too far apart. Cells were characterized based on biological markers by using brain slices, as under these in vitro conditions, neurons retain their morphologies. Since the LS neurons are not spontaneously excitable at RMP, the action potentials (APs) were evoked via injections of currents of moderate magnitude during the patch-clamp recordings. In coronal brain slices of rats, a smaller portion of neurons generated a train of APs of complex nature. In order to define the types of neurons with similar phenotypes, we subsequently used the four lines of td-Tomato transgenic mice. The brains of these mice express the promoter fluorophore td-Tomato and enhanced green fluorescent protein (eGFP). Therefore, recordings were conducted in a targeted manner in neurons expressing glutamic acid decarboxylase (GAD), parvalbumin (PV), somatostatin (SOM), or vasoactive intestinal polypeptide (VIP). Similar spike phenotypes that we refer to as type III, in order to distinguish from AP in principal cells - type I and those in interneurons - type II, also exist in mice, substantiating a similitude among rodents. The type III AP is selectively triggered by Ca²⁺ in GAD and SOM-positive neurons. Conclusions are supported by established pharmacologic tools, nimodipine, TTX, and ZD7288, a selective HCN channel antagonist.Collectively, these observations revitalize our knowledge from pioneering studies with regard to the brain of mammals in general and septal structures in particular.

项与替曲朵辛相关的新闻（医药）

2024-11-18

·GlobeNewswire-Health Care

Dogwood Therapeutics, Inc. Announces Low Dose IMC-2 Treatment Reduces Long-COVID Related Fatigue and Sleep Disturbance in an Investigator-Initiated Study

- IMC-2 treatment, dosed as valacyclovir 750 mg + celecoxib 200 mg twice daily, demonstrated clinically meaningful reduction in Long-COVID related fatigue and sleep disturbance as compared to placebo – - Top-line results from the Bateman Horne Center’s Long-COVID study provide key insights into final design of Dogwood’s planned Phase 2 study, projected to enroll approximately 200 participants - ATLANTA, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company advancing new medicines to treat pain and fatigue-related disorders, today announced top line data from the recently completed BHC IMC-2 Long-COVID study. The study was conducted via an investigator-initiated, investigational research grant provided to the Bateman Horne Center (“BHC”). The study demonstrated that the low dose combination antiviral therapy IMC-2 treated patient cohort (valacyclovir 750 mg + celecoxib dosed 200 mg twice daily) exhibited clinically meaningful reductions in Long-COVID associated fatigue and sleep disturbance, as compared with the placebo treated cohort. The high dose IMC-2 treated cohort (valacyclovir 1500 mg + celecoxib 200 mg dosed twice daily) did not exhibit clinically meaningful differences versus placebo, believed to be related to higher levels of gastrointestinal (GI) adverse events associated with the higher dose regimen. “To date, there are no FDA approved medicines to treat Long-COVID symptoms,” said Lucinda Bateman, MD, Founder and Chief Medical Officer of the Bateman Horne Center and the study’s principal investigator. “This trial provides evidence that IMC-2 has the potential to improve fatigue and sleep symptoms associated with Long-COVID illness on a scale not previously observed in Long-COVID research. I believe this finding warrants further investigation of IMC-2 in larger scale, multi-center Long-COVID studies.” “The primary goals of this trial were to determine the IMC-2 treatment effect size versus placebo and the associated patient sample size to design our planned IMC-2 Phase 2 Long-COVID study in a manner that maximizes probability of success,” said R. Michael Gendreau, MD, Chief Medical Officer of Dogwood Therapeutics, Inc. “IMC-2 demonstrated a robust reduction in fatigue, the primary endpoint agreed with the Food & Drug Administration to advance IMC-2 into Phase 2 development. We look forward to finalizing these plans and providing further information on next steps in the coming months.” IMC-2 Long-COVID Development Program Summary: BHC Study 201: Investigator-initiated, open-label, matched control study assessing IMC-2 treatment versus patients matched by age, duration of effect, vaccination status and gender. In this study, completed in 2023, the combination of valacyclovir and celecoxib exhibited statistically significant reductions in Long-COVID related fatigue, orthostatic intolerance, pain and anxiety, while improving overall patient health. The dosage used in this study was valacyclovir 1500 mg + celecoxib 200 mg dosed twice daily. BHC Study 202: This recently completed study was designed as an investigator-initiated, double-blinded, placebo controlled follow-on study to BHC 201. While not statistically significant given the small sample size recruited for this trial (14-15 per group), the study demonstrated that the low dose combination antiviral therapy IMC-2 exhibited clinically meaningful improvements in fatigue and sleep disruption as compared to placebo treated patients. Overall, the IMC-2 adverse event profile was favorable in this study. The high dose IMC-2 treatment (valacyclovir 1500 mg + celecoxib 200 mg dosed twice daily) resulted in more GI related adverse events compared to the low dose and placebo cohorts. Additional Assets in Dogwood Therapeutics Proprietary Pipeline: Halneuron® is in Phase 2b development as a non-opioid, Nav 1.7 inhibitor to treat the neuropathic pain resultant from chemotherapy treatment. Halneuron® has been granted Fast Track Designation from the FDA for the treatment of Chemotherapy-Induced Neuropathic Pain (CINP).Next milestone: Interim data from the ongoing Phase 2 CINP study are expected in the second half of 2025. IMC-1 (famciclovir + celecoxib) is Phase 3 development ready as a combination antiviral treatment for fibromyalgia (FM). IMC-1 has been granted fast track designation by the FDA as a treatment for FM. Next milestone: Dogwood is exploring partnerships for IMC-1 to execute the Phase 3 FM program as agreed with the FDA. 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 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 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 FM and LC. 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 and the Company’s quarterly report on Form 10-Q for the quarterly period ended September 30, 2024, which are 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

临床2期临床结果快速通道临床3期

2024-11-07

·GlobeNewswire-Health Care

Dogwood Therapeutics Announces Third Quarter 2024 Financial Results

- Dogwood Therapeutics, Inc. (Nasdaq: “DWTX”) formed in October by combination of Virios Therapeutics, Inc. and Pharmagesic (Holdings) Inc., 100% parent company of Wex Pharmaceuticals, Inc. (the “Combination”) - - Expanded pipeline with multiple programs in large markets with high unmet need - - Strategic financing results in combined working capital of approximately $23 million to fund operations and advance Phase 2b Halneuron® development through 2025 - - Top-line results from Long-COVID Phase 2a study expected in mid-November 2024 - - NaV 1.7 inhibition pain treatment, Halneuron®, Phase 2b study for chemotherapy-induced neuropathic pain expected interim readout 2H 2025 - ATLANTA, Nov. 07, 2024 (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 financial results for the third quarter ended September 30, 2024 and provided a business update. “The formation of Dogwood Therapeutics last month represents a transformational expansion of our pipeline with the addition of Halneuron®, a non-opioid, novel NaV 1.7 modulator to treat neuropathic pain associated with chemotherapy, purposefully complementing our promising development assets IMC-1 and IMC-2,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “The concurrent strategic financing to be provided by an affiliate of CK Life Sciences Int’l., (Holdings) Inc. (“CKLS”), former owner of Pharmagesic (Holdings) Inc., provides us with operating capital through 2025. We see this as a win-win for legacy Virios shareholders and CKLS, with both short-term and medium-term value creation opportunities associated with forthcoming data from the Bateman-Horne Center (“BHC”) managed IMC-2 Phase 2 Long-COVID trial, and the Halneuron® Phase 2b interim data projected for the second half of next year.” Key Highlights Dogwood’s expanded pipeline includes three late-stage assets: Halneuron®, currently in Phase 2b development for chemotherapy-induced neuropathic pain (“CINP”); IMC-1, poised for Phase 3 development as a treatment for fibromyalgia (“FM”); and IMC-2, currently in Phase 2 development to treat Long-COVID (“LC”) sequelae.In connection with the Combination, the Company announced that it raised $19.5 million in committed debt financing by an affiliate of CKLS in two tranches with $16.5 million funded as of October 7, 2024 and an additional $3.0 million to be funded in 1Q 2025, subject to certain conditions. This financing is expected to fund research and operations through several key milestones, including the release of results from the Halneuron® Phase 2b interim analysis assessment expected in 2H 2025.Top-line results from the ongoing BHC IMC-2 LC Phase 2a study, assessing two doses of the combination of valacyclovir + celecoxib versus placebo, are expected by mid-November 2024. Dogwood Therapeutics Proprietary Pipeline Includes: Halneuron® is in Phase 2b development as a non-opioid, NaV 1.7 inhibitor to treat 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. Next milestone: Interim data from the ongoing Phase 2b CINP study are expected in 2H 2025. IMC-2 (valacyclovir + celecoxib) is in Phase 2a development as a combination antiviral treatment for LC. Next milestone: Topline data from an investigator led, double blind controlled proof of concept study, assessing two doses of IMC-2 vs placebo, are expected in mid-November 2024. IMC-1 (famciclovir + celecoxib) is ready for Phase 3 development as a combination antiviral treatment for FM. IMC-1 has been granted fast track designation by the FDA for the treatment of FM. Dogwood is exploring partnerships for IMC-1 to execute the Phase 3 FM program agreed upon by the FDA. Third Quarter 2024 Financial Results Research and development expenses increased by $0.2 million for the third quarter of 2024 compared to the third quarter of 2023. The quarter-over-quarter change was primarily due to increases in expenses associated with the grant to BHC for the second proof-of-concept study in LC of $0.3 million offset by a decrease in regulatory expenses of $0.1 million. General and administrative expenses increased by $0.9 million for the third quarter of 2024 compared to the third quarter of 2023. The quarter-over-quarter change was primarily due to higher legal and professional fees related to the business combination in October 2024 of $1.0 million offset by lower insurance expenses associated with being a public company of $0.1 million. Net loss for the third quarter of 2024 was $2.3 million, or $2.05 basic and diluted net loss per share, compared to a net loss of $1.2 million, or $1.62 basic and diluted net loss per share for the third quarter of 2023 (as adjusted to reflect the reverse stock split implemented on October 9, 2024). The Company estimates that its current cash of $2.0 million at September 30, 2024 along with the $16.5 million in loan proceeds received on October 7, 2024 is not sufficient to fund operating expenses and capital requirements for at least the next 12 months. The Company will need to secure the additional $3.0 million of loan proceeds available to us under the terms of the loan agreement in February 2025 to continue to fund our operations through 2025. 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 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 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 FM and 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 and the Company’s quarterly report on Form 10-Q for the quarterly period ended September 30, 2024, which are 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 DOGWOOD THERAPEUTICSSelected Financial Data (unaudited) Condensed Statements of Operations Data Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Revenue $— $— $— $— Operating expenses: Research and development 535,162 374,200 1,214,964 1,429,757 General and administrative 1,766,010 900,089 3,470,133 2,879,036 Total operating expenses 2,301,172 1,274,289 4,685,097 4,308,793 Loss from operations (2,301,172) (1,274,289) (4,685,097) (4,308,793)Other Income: Interest income 20,488 39,215 63,245 115,951 Total Other income 20,488 39,215 63,245 115,951 Net loss $(2,280,684) $(1,235,074) $(4,621,852) $(4,192,842)Net loss per share of common stock — basic and diluted, as adjusted $(2.05) $(1.62) $(4.95) $(5.63)Weighted average shares outstanding — basic and diluted, as adjusted 1,110,317 763,750 932,872 774,586 Condensed Balance Sheet DataSeptember 30, December 31, 2024 2023 Cash$2,039,819 $3,316,946 Total assets 2,283,249 4,165,442 Total liabilities 1,333,818 358,548 Total stockholders’ equity 949,431 3,806,894 Source: Dogwood Therapeutics, Inc.

临床2期财报快速通道

2024-10-31

·GlobeNewswire-Health Care

Dogwood Therapeutics to Report Third Quarter 2024 Financial Results and Provide Corporate Update on Thursday, November 7, 2024

ATLANTA, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), formerly Virios Therapeutics, Inc., a clinical‐stage biopharmaceutical company, announced today that it will report third quarter 2024 financial results on Thursday, November 7, 2024 before the open of the financial markets. Management will also host a webcast and conference call on November 7, 2024 at 8:30 a.m. ET to discuss the results and provide a corporate update. The live and archived webcast of the call may be accessed on the Dogwood Therapeutics website under the Investors section: Events and Presentations. The live call can be accessed by dialing 888-506-0062 (domestic) or 973-528-0011 (international) and asking to be connected to the "Dogwood Therapeutics Conference Call" using the access code: 838895. 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

临床2期财报

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肿瘤	临床3期	加拿大	WEX Pharmaceuticals, Inc.	2008-04-01
癌症疼痛	临床3期	加拿大	WEX Pharmaceuticals, Inc.	2008-04-01
海洛因依赖	临床2期	中国	江苏宏锦天药业有限公司	2015-02-05
海洛因戒断	临床2期	中国	江苏宏锦天药业有限公司	2015-02-05
镇痛	临床2期	中国	南宁枫叶药业有限公司	2014-05-07
神经痛	临床2期	美国	WEX Pharmaceuticals, Inc.	2012-07-01
阿片相关性障碍	临床2期	加拿大	WEX Pharmaceuticals, Inc.	-
中毒	临床2期	中国	南宁枫叶药业有限公司	-
麻醉	临床前	加拿大	WEX Pharmaceuticals, Inc.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ARVO2023	N/A	低眼压	-	Tetrodotoxin (TTX)	繭顧網鹽願壓範餘廠艱(積蓋觸醖廠築夢餘範膚) = 範選選鬱築憲醖蓋壓鹹餘壓鬱鬱艱選窪壓襯窪 (鑰鹹鹹築醖襯鏇鏇築範 ) 更多	-	2023-04-23
NCT01655823 (TTX-CINP-201, CTgov)	临床2期	神经痛	125	Placebo (Placebo (Twice Daily))	蓋糧獵醖鏇簾繭襯願顧(鑰鏇餘壓夢壓廠網壓醖) = 衊鹽積廠餘繭遞觸餘鬱鹹淵齋鹹製壓淵遞繭鬱 (憲齋觸蓋醖獵襯淵窪簾, 簾衊築憲鏇憲構鹹範憲 ~ 鹽鹹齋獵壓膚窪淵憲夢) 更多	-	2018-10-30
				Tetrodotoxin (Low Dose Tetrodotoxin (Twice Daily))	蓋糧獵醖鏇簾繭襯願顧(鑰鏇餘壓夢壓廠網壓醖) = 窪鹹餘醖獵鹹鏇鹽網鹹鹹淵齋鹹製壓淵遞繭鬱 (憲齋觸蓋醖獵襯淵窪簾, 餘願願顧衊獵艱壓鏇衊 ~ 襯鬱鏇艱觸餘蓋餘餘衊) 更多
NCT00725114 (TEC-006, Pubmed \| Pain Res Manag) 人工标引	临床3期	癌症疼痛	165	Tetrodotoxin	顧簾鬱繭築膚簾艱顧構(顧夢繭蓋鏇襯願膚鑰範) = 壓築顧膚夢鬱網繭製築繭鬱鬱齋衊壓選醖糧糧 (積選網糧襯積憲築餘糧 ) 更多	积极	2017-01-01
				Placebo	繭衊膚積積範觸艱選膚(製鏇鏇壓鏇獵鑰願構鹹) = 築艱衊網選選顧膚顧憲鹽膚鹹願網衊糧窪壓觸 (構遞願獵窪衊壓醖齋網 )
ARVO2004	N/A	-	-	Tetrodotoxin	憲觸選簾築鏇夢鏇淵鹽(壓窪夢窪醖壓糧醖選網) = 鑰築選蓋製簾蓋衊憲範繭願選鏇膚壓製廠鏇鏇 (蓋鬱獵製淵襯網蓋顧簾 )	-	2004-05-01
SFN2002	N/A	-	-	tetrodotoxin (Intact-Original)	窪艱遞鑰選淵築廠鬱淵(襯夢窪鹹糧夢選選襯顧) = 鹽鏇網觸積鬱築艱蓋衊壓構鑰網蓋壓淵願繭糧 (膚選簾襯蓋製窪襯壓願 )	-	2002-11-05
				tetrodotoxin (Unilateral-Different)	窪艱遞鑰選淵築廠鬱淵(襯夢窪鹹糧夢選選襯顧) = 獵齋衊鹹獵廠獵糧繭艱壓構鑰網蓋壓淵願繭糧 (膚選簾襯蓋製窪襯壓願 )