Last update 15 Nov 2024

Celecoxib

Last update 15 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryCELEBREX (celecoxib) is a nonsteroidal anti-inflammatory drug. Celecoxib has analgesic, anti-inflammatory, and antipyretic properties.The mechanism of action of CELEBREX is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro. Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.CELEBREX

Drug Type

Small molecule drug

Synonyms

Celecoxib (JAN/USP/INN), p-(5-p-Tolyl-3-(trifluoromethyl)pyrazol-1-yl)benzenesulfonamide, AD-2111

+ [20]

Target

COX-2

Mechanism

COX-2 inhibitors(Cyclooxygenase-2 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesInfectious Diseases+ [7]

Active Indication

Migraine DisordersPainToothache+ [18]

Inactive Indication

Actinic KeratosisAdenocarcinoma of EsophagusAdenocarcinoma of prostate+ [37]

Originator Organization

Pfizer Inc.

Active Organization

Scilex Pharmaceuticals, Inc.Viatris Pharmaceuticals LLC

Astellas Pharma, Inc.

+ [6]

Inactive Organization

Pfizer Inc.

Viatris, Inc.Dr. Reddy's Laboratories Ltd. (Russia)

+ [10]

Drug Highest PhaseApproved

First Approval Date

US (31 Dec 1998),

OsteoarthritisRheumatoid Arthritis

RegulationOrphan Drug (US), Accelerated Approval (US), Priority Review (CN)

Structure

Molecular FormulaC17H14F3N3O2S

InChIKeyRZEKVGVHFLEQIL-UHFFFAOYSA-N

CAS Registry169590-42-5

691

Clinical Trials associated with Celecoxib

IRCT20200306046708N1 / SuspendedPhase 2/3IIT

Celecoxib added to mood stabilizer for treating acute mania: A randomized, double-blind, placebo-controlled trial

Start Date15 Dec 2633

Sponsor / Collaborator

Mashhad University of Medical Sciences

NCT03590821 / Not yet recruitingEarly Phase 1IIT

Modulating Celecoxib Induced Blood Pressure Changes by Timed Administration of Aspirin and the Human Chronobiome

To determine whether timed administration of aspirin ameliorates the effects of celecoxib on blood pressure.

Start Date01 Dec 2026

Sponsor / Collaborator

University of Pennsylvania

NCT04860635 / SuspendedPhase 2/3

An Open Label Safety Study of a Single Administration of F14 in Patients Undergoing Unilateral Total Knee Replacement

Open-label single-arm study in which all subjects receive F14 as part of a scheduled TKR and multimodal analgesia

Start Date01 Jan 2025

Sponsor / Collaborator

Arthritis Innovation Corp.

100 Clinical Results associated with Celecoxib

100 Translational Medicine associated with Celecoxib

100 Patents (Medical) associated with Celecoxib

7,334

Literatures (Medical) associated with Celecoxib

01 Jan 2025·JOURNAL OF ETHNOPHARMACOLOGY

Efficacy and safety of SKCPT in patients with knee osteoarthritis: A multicenter, randomized, double-blinded, active-controlled phase III clinical trial

Article

Author: In, Yong ; Bin, Sung Il ; Bin, Sung Ii ; Lee, Myung Chul ; Sim, Jae-Ang ; Kim, Young-Mo ; Seon, Jong-Keun ; Lee, Sang Jin ; Han, Seung-Beom ; Bae, Ki-Cheor ; Moon, Young-Wan ; Yoon, Kyoung Ho ; Kang, Seung-Baik ; Park, Kwan Kyu ; Chang, Chong Bum

ETHNOPHARMACOLOGICAL RELEVANCE:

Osteoarthritis (OA) is the most prevalent type of arthritis worldwide and a leading cause of years lost to pain and disability. Among the current pharmacological treatments for OA, symptomatic slow-acting drugs for OA (SYSADOA) induce pain relief and aim to improve joint function by relieving inflammation while causing fewer gastrointestinal and cardiovascular adverse events than non-steroidal anti-inflammatory drugs (NSAIDs). SKCPT is a herbal SYSADOA formulated from Clematis mandshurica, Trichosanthes kirilowii, and Prunella vulgaris powdered extracts. This preparation has been shown to induce cartilage protection and anti-inflammatory effects in preclinical studies and inhibit glycosaminoglycan degradation and catabolic gene expression in human OA chondrocytes and cartilage.

AIM OF THE STUDY:

We aimed to evaluate the non-inferiority of SKCPT to celecoxib and safety for treating knee OA.

MATERIALS AND METHODS:

This multicenter, randomized, double-blind, phase III clinical trial enrolled adults with primary knee OA who were randomized (1:1) to SKCPT 300 mg twice daily or celecoxib 200 mg once daily for 12 weeks.

RESULTS:

In total, 278 patients were assigned to treatment (SKCPT, 136; celecoxib, 142) for approximately 12 weeks. The primary endpoint was the mean change of Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC) pain subscale scores from baseline to Day 84. The mean change (least squares [LS] mean ± standard error) from baseline to Day 84 was -23.74 ± 1.48 for SKCPT and -25.88 ± 1.44 for celecoxib. The two-sided 95% confidence interval of the difference (LS mean) between groups was [-1.94, 6.20], confirming that the upper limit was less than the non-inferiority margin of 10. Additionally, there were no significant differences in the secondary endpoints (mean changes of K-WOMAC pain, physical, stiffness subscale, and total score, and the frequency and number of doses of rescue medications) between groups at all time points. Differences between groups in adverse events and adverse drug reactions were not significant, and no serious adverse events occurred.

CONCLUSIONS:

SKCPT efficacy was non-inferior, and its safety profile was similar, to celecoxib. Building on previous results showing that SYSADOA reduce NSAID intake, the present results suggest that the SYSADOA SKCPT could effectively replace NSAIDs in knee OA treatment while avoiding long-term side effects.

01 Jan 2025·JOURNAL OF ETHNOPHARMACOLOGY

Yiqi Yangxue formula inhibits cartilage degeneration in knee osteoarthritis by regulating LncRNA-UFC1/miR-34a/MMP-13 axis

Article

Author: Wang, Xinchang ; Qin, Dongdong ; Li, Zhaofu ; Zhao, Ting

ETHNOPHARMACOLOGICAL RELEVANCE:

Knee osteoarthritis (KOA) is a prevalent and disabling clinical condition affecting joint structures worldwide. The Yiqi Yangxue formula (YQYXF) is frequently prescribed in clinical settings for the treatment of KOA. Existing research has primarily focused on alterations in drug metabolism, with limited investigation into the epigenetic effects of YQYXF, particularly in relation to non-coding RNA.

AIM OF THE STUDY:

Exploring the effects of YQYXF on critical factors of long chain non-coding RNA UFC1/miR-34a/matrix metalloproteinase-13 (MMP-13) axis and their interrelationships.

METHODS:

UHPLC-QE-MS technology was used to identify the YQYXF ingredients in rat serum. KEGG and GO analysis were performed on the targets of blood components acting on KOA using a database. Simultaneously, a protein interaction network was constructed using target proteins and metabolites to identify the core components and key pathways of YQYXF. The KOA rat model was established using an improved Hulth method. SPF SD rats were randomly divided into normal group, sham surgery group, model group, celecoxib capsules group (18 mg/kg), YQYXF low, medium and high dose groups (4.6 g/kg, 9.2 g/kg, 18.4 g/kg). Observe the synovial and cartilage tissues of rats using pathological methods. RT-PCR was used to detect the levels of UFC1, miR-34a, and MMP-13 in cartilage. Immunohistochemistry was used to detect the levels of MMP-13 and ADAMTS-5 in cartilage. ELISA method was used to detect the levels of MMP-13 and ADAMTS-5 in serum. In addition, we further validated the regulation of crucial factor expression levels of UFC1/miR-34a/MMP-13 axis in rat chondrocytes and degenerative chondrocytes of KOA patients by YQYXF, providing a basis for its treatment of KOA.

RESULTS:

The compounds that YQYXF enters the bloodstream mainly contain flavonoids and phenylpropanoid compounds. The core components that act on OA include quercetin, fisetin, and demethylweldelolactone. The main target pathways are the IL-17 signaling pathway, lipid and atherosclerosis, cellular sensitivity, inflammatory mediator regulation of TRP channels, TNF signaling pathway, relaxin signaling pathway and C-type lectin receptor signaling pathway. YQYXF inhibited the expression of miR-34a and MMP-13 mRNA, and reduced the protein levels of MMP-13 and ADAMTS-5. In vitro studies have confirmed that 20% YQYXF serum promoted UFC1 and reduce miR-34a levels. In addition, miR-34a in sh-UFC1+10% YQYXF serum and sh-UFC1+20% YQYXF serum groups significantly decreased compared to the sh-UFC1 group.

CONCLUSION:

The anti-KOA cartilage degeneration effect of YQYXF might be related to inhibiting cell apoptosis and promoting cell proliferation, which regulated the lncRNA-UFC1/miR-34a/MMP-13 axis.

01 Jan 2025·BRAIN BEHAVIOR AND IMMUNITY

Long-term characterisation of the relationship between change in depression severity and change in inflammatory markers following inflammation-stratified treatment with vortioxetine augmented with celecoxib or placebo

Article

Author: Hohoff, Christa ; Schwarte, Kathrin ; Oliver Schubert, K. ; Mills, Natalie T. ; Fourrier, Célia ; Cearns, Micah ; Oliver Schubert, K ; Sampson, Emma ; Baune, Bernhard T ; Hori, Hikaru ; Mills, Natalie T ; Baune, Bernhard T.

BACKGROUND:

Major depressive disorder (MDD) is a highly prevalent condition with a substantial incidence of relapse or treatment resistance. A subset of patients show evidence of low-grade inflammation, with these patients having a higher likelihood of more severe or difficult to treat courses of illness. Anti-inflammatory treatment of MDD has been investigated with mixed results, and no known studies have included assessments beyond cessation of the anti-inflammatory agent, meaning it remains unknown if any benefit from treatment persists. The objective of the present study was to investigate treatment outcomes up to 29 weeks post-cessation of celecoxib or placebo augmentation of an antidepressant, and how concentrations of selected inflammatory markers change over the same period.

METHODS:

The PREDDICT parallel-group, randomised, double-blind, placebo-controlled trial (University of Adelaide, Australia) ran from December 2017 to April 2020. Participants with MDD were stratified into normal range or elevated inflammation strata according to screening concentrations of high sensitivity C-reactive protein (hsCRP). Participants were randomised to treatment with vortioxetine and celecoxib or vortioxetine and placebo for six weeks, and vortioxetine alone for an additional 29 weeks (35 total weeks). Following a previous publication of results from the six-week RCT phase, exploratory analyses were performed on Montgomery-Åsberg Depression Rating Scale (MADRS) scores, response and remission outcomes, and selected peripheral inflammatory markers across the entire study duration up to week 35.

RESULTS:

Participants retained at each observation were baseline N=119, week 2 N=115, week 4 N=103, week 6 N=104, week 8 N=98, week 22 N=81, and week 35 N=60. Those in the elevated hsCRP celecoxib-augmented group had a statistically significantly greater reduction in MADRS score from baseline to week 35 compared to all other groups, demonstrating the greatest clinical improvement long-term, despite no group or strata differences at preceding time points. Response and remission outcomes did not differ by treatment group or hsCRP strata at any time point. Changes in hsCRP between baseline and week 35 and Tumour Necrosis Factor-α (TNF-α) concentrations between baseline and week 6 and baseline and week 35 were statistically significantly associated with MADRS scores observed at week 6 and week 35 respectively, with reducing TNF-α concentrations associated with reducing MADRS scores and vice versa in each case. A post-hoc stratification of the participant cohort by baseline TNF-α concentrations led to significant prediction by the derived strata on clinical response at weeks 6, 8 and 35, with participants with elevated baseline TNF-α less likely to achieve clinical response.

INTERPRETATION:

The present analysis suggests for the first time a possible longer-term clinical benefit of celecoxib augmentation of vortioxetine in inflammation-associated MDD treatment. However, further research is needed to confirm the finding and to ascertain the reason for such a delayed effect. Furthermore, the trial suggests that TNF-α may have a stronger relationship with anti-inflammatory MDD treatment outcomes than hsCRP, and should be investigated further for potential predictive utility.

CLINICAL TRIALS REGISTRATION:

Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000527369p. Registered on 11 April 2017, http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000527369p.

242

News (Medical) associated with Celecoxib

12 Nov 2024

·www.businesswire.com

Natera Announces Completion of Signatera™ Analysis from the CALGB (Alliance)/SWOG 80702 Randomized, Phase III Clinical Trial in Colorectal Cancer

AUSTIN, Texas--( BUSINESS WIRE )-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced the completion of a study using Signatera from the CALGB (Alliance)/SWOG 80702 randomized, phase III clinical trial. CALGB (Alliance)/SWOG 80702 evaluated the benefit of adding celecoxib to FOLFOX in postoperative treatment of stage III colorectal cancer (CRC) in a biomarker unselected population. This pre-specified analysis includes 1,011 CRC patients with available post-surgical plasma samples and investigates Signatera’s ability to identify a subgroup of patients who may benefit from adding celecoxib to FOLFOX. Disease free survival (DFS) and overall survival (OS) are the study’s primary and secondary endpoints, respectively. Additional details on CALGB (Alliance)/SWOG 80702 In the CALGB (Alliance)/SWOG 80702 trial, patients were randomized to receive standard-of-care adjuvant chemotherapy FOLFOX (+/-) celecoxib, a non-steroidal anti-inflammatory drug (NSAID). Although the results showed that the addition of celecoxib did not significantly improve disease-free survival 1 , NSAIDs have shown promise in benefiting certain subpopulations in CRC, including reducing the risk of developing precancerous colon polyps. In addition, NSAIDs are typically well-tolerated, widely available, and generally low-cost. “ We see this trial as one of the most important in the space given its size, randomized design, and indication,” said Alexey Aleshin, MD, MBA, general manager of oncology and chief medical officer of Natera. “ There is a clear need for additional adjuvant treatment options for patients with colorectal cancer as there has not been a new drug approval in the space in over 20 years. We are hopeful that Signatera-guided therapy selection can help open the door to effective treatment options in CRC, personalized to the patients who are most likely to benefit.” Results have been accepted as a late-breaking abstract to be shared at the American Society of Clinical Oncology Gastrointestinal Symposium (ASCO GI), which takes place from Jan. 23-25, 2024 in San Francisco, CA. About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 90 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 200 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov . References Meyerhardt JA, Shi Q, Fuchs CS, et al. Effect of Celecoxib vs Placebo Added to Standard Adjuvant Therapy on Disease-Free Survival Among Patients With Stage III Colon Cancer: The CALGB/SWOG 80702 (Alliance) Randomized Clinical Trial. JAMA . 2021;325(13):1277-1286. doi:10.1001/jama.2021.2454

Phase 3ASCOClinical ResultImmunotherapy

07 Nov 2024

·www.globenewswire.com

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.

Phase 2Financial StatementFast Track

31 Oct 2024

·www.globenewswire.com

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

Phase 2Financial Statement

100 Deals associated with Celecoxib

External Link

KEGG	Wiki	ATC	Drug Bank
D00567	Celecoxib	L01XX33 M01AH01	DB00482

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Migraine Disorders	US	Scilex Pharmaceuticals, Inc.	05 May 2020
Pain	JP	Astellas Pharma, Inc.	22 Dec 2011
Toothache	JP	Viatris Pharmaceutical GK	22 Dec 2011
Bursitis	JP	Viatris Pharmaceutical GK	17 Jun 2009
Cervicobrachial syndrome	JP	Viatris Pharmaceutical GK	17 Jun 2009
Cervicobrachial syndrome	JP	Astellas Pharma, Inc.	17 Jun 2009
Low Back Pain	JP	Viatris Pharmaceutical GK	17 Jun 2009
Low Back Pain	JP	Astellas Pharma, Inc.	17 Jun 2009
Periarthritis	JP	Astellas Pharma, Inc.	17 Jun 2009
Tendinopathy	JP	Astellas Pharma, Inc.	17 Jun 2009
Tendinopathy	JP	Viatris Pharmaceutical GK	17 Jun 2009
Tenosynovitis	JP	Viatris Pharmaceutical GK	17 Jun 2009
Analgesia	JP	Viatris Pharmaceutical GK	26 Jan 2007
Inflammation	JP	Viatris Pharmaceutical GK	26 Jan 2007
Juvenile Idiopathic Arthritis	US	Upjohn US 2 LLC	15 Dec 2006
Primary dysmenorrhea	US	Upjohn US 2 LLC	18 Oct 2001
Acute Pain	CN	Viatris Pharmaceuticals LLC	01 Aug 2000
Ankylosing Spondylitis	CN	Viatris Pharmaceuticals LLC	01 Aug 2000
Adenomatous Polyposis Coli	US	Viatris Holdings LLC	23 Dec 1999
Osteoarthritis	US	Upjohn US 2 LLC	31 Dec 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Migraine With Aura	NDA/BLA	CA	Scilex Holding Co.	26 Dec 2023
Migraine Without Aura	NDA/BLA	CA	Scilex Holding Co.	26 Dec 2023
Actinic Keratosis	Phase 3	US	Dr. Reddy's Laboratories Ltd. (Russia)	14 Feb 2017
Arthritis, Gouty	Phase 3	US	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	CA	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	CO	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	CR	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	MX	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	PE	Viatris, Inc.	01 Feb 2008
Arthritis, Gouty	Phase 3	PH	Viatris, Inc.	01 Feb 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04765644 (ASCENT, CTgov)	Phase 4	-	44	Celecoxib+L-arginine (Celecoxib)	tfxnwthhav(tzoecpmsay) = dhdnuatdso cufojmjnek (aagccfjhjn, krgifqtveq - jansxwtscn) View more	-	28 Oct 2024
				Placebo+L-arginine + placebo (Placebo)	tfxnwthhav(tzoecpmsay) = vjpoyowvmy cufojmjnek (aagccfjhjn, hytldpmrrt - ahlkmuaylv) View more
NCT03859024 (CTgov)	Phase 4	Urethral Stricture \| Pain, Postoperative	48	Acetaminophen+Ibuprofen 800 mg+Oxycodone (Standard Protocol)	xyavisdkti(duukhzcsgw) = xucrynbnnh gihtxmqgdn (oyddmngchd, uxvjvoopcs - iovbgkikcn) View more	-	19 Sep 2024
				Acetaminophen+Ibuprofen 800 mg+celebrex+Dexamethasone+Oxycodone+Bupivacaine+Gabapentin (Enhanced Recovery Protocol)	xyavisdkti(duukhzcsgw) = xumojftwuh gihtxmqgdn (oyddmngchd, ljxgukqoli - kanzvhzlkr) View more
NCT05077969 (CTgov)	Phase 2	SARS-CoV-2 acute respiratory disease	4	Famotidine+Celecoxib (Group 1 (Study Product))	vhiabvupkx(eidpaukuor) = lyqzqotmuw ukmgzryzuc (jnsrjnbzov, lnqujzhtgr - eulvzgttry) View more	-	09 Jul 2024
				Placebo (Group 2 (Reference Therapy))	vhiabvupkx(eidpaukuor) = dnjvkorlie ukmgzryzuc (jnsrjnbzov, jpepeqwgbk - ctgcngqrnh) View more
NCT04015908 (CTgov)	Phase 4	-	100	Pregabalin+Acetaminophen+Celecoxib+Oxycodone (Multi-modal)	seatsjgckn(jwmcgcvvfy) = syoprpokex imxdcjieit (ebfulngmch, qfpnanxuev - vjqwnmxsfu) View more	-	08 Jul 2024
				Percocet (Control)	seatsjgckn(jwmcgcvvfy) = bdjdscavgr imxdcjieit (ebfulngmch, kcognxlehh - ilwemonqqk) View more
NCT05062083 (CTgov)	Phase 2	Multiple Sclerosis	7	11C-PS13+11C-MC1+Celecoxib+ketoprofen	bufjjkldta(yhtoekpcjl) = yorpphynez neurposiro (tyfyoiazdo, utorcaurtj - xbzksdekde) View more	-	27 Jun 2024
NCT03006276 \| NCT03009019 (GlobeNewswire) Manual	Phase 3	Migraine Disorders	-	ELYXYB (Triptan Insufficient Responders)	fncbwthawj(dcwolcfgyw) = kenpbxizfy cjbyqehltj (ggpvmmxsyb )	Positive	13 Jun 2024
				placebo (Triptan Insufficient Responders)	fncbwthawj(dcwolcfgyw) = lsxrmwrbin cjbyqehltj (ggpvmmxsyb )
NCT01479829 (CTgov)	Phase 4	Depressive Disorder \| Inflammation	100	Escitalopram+Celecoxib (Intervention Cohort)	vdandpfsvi(zxwyezbjys): Chi-square value = 5.3466, P-Value = 0.02 View more	-	09 Apr 2024
				Placebo+Escitalopram (Control Cohort)
NCT03818919 (CTgov)	Phase 2	Analgesia \| Rotator Cuff Tear Arthropathy	70	Acetaminophen+Diazepam+Ketorolac+Celecoxib+Gabapentin (Post-Operative Non Opioid Pain Protocol)	fcxchekfwy(riodtogsyz) = jxufzquhrv qapkkayitq (kjklbxvxqn, dypphgxwfy - ravwxluxxm) View more	-	02 Apr 2024
				Hydrocodone-Acetaminophen (Post-Operative Traditional Pain Protocol)	fcxchekfwy(riodtogsyz) = xfvcpzfwdf qapkkayitq (kjklbxvxqn, bugouelpjw - azkvywgcbw) View more
NCT04790812 (CTgov)	Phase 4	Toothache \| Pain, Postoperative	65	Placebo+Celecoxib (Celecoxib Plus Placebo)	zttvdukbtt(sofofjmwka) = lrrysuemsz qepnypvaxt (pxazelecdv, kekxftyatm - iyjxrbzwkb) View more	-	27 Mar 2024
				Acetaminophen+Celecoxib (Celecoxib Plus Acetaminophen)	zttvdukbtt(sofofjmwka) = cgkxacypwf qepnypvaxt (pxazelecdv, miqtyfzngg - heudtugkdz) View more
NCT02502006 (CTgov)	Phase 1	-	16	Celecoxib (Celecoxib)	hqfyyjxqgo(ipcratnnum) = voarimfifp vqemtnenbc (ypajxdskio, zgqvltqvqb - vkrscwpmwl) View more	-	13 Dec 2023
				Naproxen (Naproxen)	hqfyyjxqgo(ipcratnnum) = emyipwpovg vqemtnenbc (ypajxdskio, nlhatgytzk - udtbeqefdd) View more

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