Celecoxib

Panbela Provides Business Update and Reports Q4 and FY 2024 Financial Results

Retrieved on: 
Tuesday, March 26, 2024
Research, Topotecan, PBLA, Neuroblastoma, Patient, Data monitoring committee, Acquisition, Celecoxib, Doctor of Philosophy, AACR, MSN, CPP, Pancreatic cancer, Therapy, DSMB, Poster, DFMO, Cyclophosphamide, Pharmaceutical industry

MINNEAPOLIS, March 26, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter and full year ended December 31, 2023.

Key Points: 
  • MINNEAPOLIS, March 26, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter and full year ended December 31, 2023.
  • “Looking ahead, Panbela remains unwavering in its commitment to patients and in its pursuit of maximizing value for stockholders.
  • Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately $5.4 million.
  • Gross proceeds from the raise, which closed on January 31, 2024, were approximately $9 million.

Virios Therapeutics Announces Publication of International Patent for IMC-2 Covering Antiviral Treatment of Long-COVID

Retrieved on: 
Tuesday, March 26, 2024
Fibromyalgia, DSM-IV codes, Epstein–Barr virus, WIPO, COVID-19, Patient, Conditional sentence, Orthostatic intolerance, System, Celecoxib, Anxiety, Medical statistics, EBV, MD, Fatigue, Treatment, Therapy, Patent, Pain, Valaciclovir, FDA, Pharmaceutical industry

ATLANTA, March 26, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today announced that the World Intellectual Property Organization (WIPO) has published Virios’ global patent application titled “Valacyclovir and Celecoxib for the Treatment of Alzheimer’s and COVID-19”, which covers the use of IMC-2, a proprietary combination of valacyclovir and celecoxib. This milestone enables Virios to streamline the process for obtaining patent protection globally, representing a precursor to the national phase of patent examination by targeted countries across the globe.

Key Points: 
  • This milestone enables Virios to streamline the process for obtaining patent protection globally, representing a precursor to the national phase of patent examination by targeted countries across the globe.
  • An open-label, exploratory LC study sponsored by Virios demonstrated that treatment with the combination of valacyclovir and celecoxib resulted in clinical and statistically significant reductions in LC associated fatigue, orthostatic intolerance, pain and anxiety.
  • Previous estimates suggest that up to 10 million children in the US have also experienced LC.
  • There are no treatments approved by the FDA to treat the symptoms associated with LC, further highlighting the need for new treatments.

Virios Therapeutics Issues Shareholder Letter Highlighting Corporate Progress and Key Upcoming Milestones

Retrieved on: 
Wednesday, February 28, 2024
Celecoxib, Fibromyalgia, Letter, Famciclovir, FDA, Management, Food, Conditional sentence, Valaciclovir, Therapy, Research, Pharmaceutical industry

ATLANTA, Ga., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today issued a Shareholder Letter highlighting the Company’s progress and key milestones in 2024.

Key Points: 
  • ATLANTA, Ga., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today issued a Shareholder Letter highlighting the Company’s progress and key milestones in 2024.
  • On behalf of the Virios directors and the executive team, we would like to provide a corporate progress report on several key topics as we proceed through the first quarter of 2024.
  • Approval of this proposal does not commit the Company to the execution of a reverse stock split.
  • The Virios team remains committed to delivering on the promise of combination antiviral therapy to address a multitude of serious health issues and illnesses.

Virios Therapeutics Announces Plans to Advance Development of IMC-2 as Treatment for Symptoms Associated with Long-COVID

Retrieved on: 
Monday, January 22, 2024
Conditional sentence, Fibromyalgia, Patient, Therapy, Orthostatic intolerance, Partnership, Fatigue, Chronic fatigue syndrome, Celecoxib, Valaciclovir, FDA, Pharmaceutical industry

ATLANTA, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today announced plans for advancing IMC-2 (combination of valacyclovir and celecoxib) as a treatment for the fatigue, orthostatic intolerance and other symptoms associated with LC, also known as post-acute sequelae of SARS-CoV-2 infection (“PASC”). The Company is targeting the initiation of a Phase 2 program in the second half of 2024, with data expected in 2025.

Key Points: 
  • The Company is targeting the initiation of a Phase 2 program in the second half of 2024, with data expected in 2025.
  • “We believe the profound unmet medical need associated with LC symptoms provides a unique and timely opportunity for Virios to advance our combination therapy, IMC-2,” said Greg Duncan, Chairman and CEO of Virios Therapeutics.
  • “There are currently no FDA-approved LC treatments, thus IMC-2 has potential to be one of the first therapies for addressing LC symptoms.
  • In addition, we have received input from the FDA on development requirements and key endpoints associated with advancing IMC-2 into Phase 2 development as a treatment for LC symptoms.

Panbela Announces Publication of Clinical Data Titled: Phase 1 study of high-dose DFMO, celecoxib, cyclophosphamide and topotecan for patients with relapsed neuroblastoma: A New Approaches to Neuroblastoma Therapy Trial

Retrieved on: 
Thursday, January 18, 2024
DFMO, Pediatrics, Patient, Therapy, Biology, MD, PBLA, Prostate cancer, University, Celecoxib, Neuroblastoma, Risk, PD, PFS, FDA, Doctor of Philosophy, MYC, Pharmaceutical industry

According to Hogarty et al, children with relapsed refractory neuroblastoma have dismal outcomes and new therapeutic options are needed.

Key Points: 
  • According to Hogarty et al, children with relapsed refractory neuroblastoma have dismal outcomes and new therapeutic options are needed.
  • The work reflects the Company’s previous collaboration with New Advances in Neuroblastoma Therapy Consortium (NANT) (https://www.nant.org/).
  • From the Phase 1 dose range finding study of CPP-1X in heavily pretreated neuroblastoma patients, CPP-1X was well tolerated.
  • “We are excited about the publication of these Phase 1 trial results in light of the recent DFMO FDA approval for patients in maintenance therapy.

AIM ImmunoTech Announces Publication of Data from Roswell Park Comprehensive Cancer Center Phase 1 Study Evaluating Ampligen® as a Component of a Chemokine-Modulating (CKM) Regimen in Metastatic Triple-Negative Breast Cancer

Retrieved on: 
Tuesday, November 14, 2023
CTL, AIM, Safety, NYSE, Senior, Breast cancer, Celecoxib, Roswell Park, Rintatolimod, Paper, Patient, TLR3, Journal, Immunology, CKM, Pembrolizumab, AIM ImmunoTech, Science of team science, Immunotherapy, Doctor of Philosophy, Manuscript, Pharmaceutical industry, Management, Cancer, MD

OCALA, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the publication of results from the Phase 1 study at Roswell Park Comprehensive Cancer Center in patients with metastatic triple-negative breast cancer using chemokine modulation therapy, including AIM ImmunoTech Inc.’s drug candidate Ampligen® (also known as rintatolimod), interferon α-2b and celecoxib, followed by pembrolizumab.

Key Points: 
  • OCALA, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the publication of results from the Phase 1 study at Roswell Park Comprehensive Cancer Center in patients with metastatic triple-negative breast cancer using chemokine modulation therapy, including AIM ImmunoTech Inc.’s drug candidate Ampligen® (also known as rintatolimod), interferon α-2b and celecoxib, followed by pembrolizumab.
  • The data were published in a manuscript titled, “ Systemic Infusion of TLR3-Ligand and IFNα in Breast Cancer Patients Reprograms Local Tumor Microenvironment for Selective CTL Influx ,” in The Journal for ImmunoTherapy of Cancer.
  • The pilot study evaluated the safety of systemic CKM composed of intravenous rintatolimod (Ampligen; selective TLR3 ligand), interferon α-2b and celecoxib, and the combination’s ability to promote local CTL influx to mTNBC lesions.
  • For more information about the study, please visit ClinicalTrials.gov: NCT03599453 .

Scilex Holding Company announces the State of Indiana Medicaid will add Elyxyb as a preferred agent to its preferred drug list (PDL) effective October 1, 2023

Retrieved on: 
Monday, September 25, 2023
Single, State, Medicaid, PALO, MHS, Patient, UnitedHealth Group, Centene Corporation, Chronic pain, CareSource, Pharmaceutical industry, Health insurance, Celecoxib

PALO ALTO, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced the State of Indiana Medicaid will add Elyxyb as a preferred agent to its Preferred Drug List (“PDL”) effective October 1, 2023.

Key Points: 
  • PALO ALTO, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced the State of Indiana Medicaid will add Elyxyb as a preferred agent to its Preferred Drug List (“PDL”) effective October 1, 2023.
  • As Indiana is a Single PDL State, where the five Indiana Managed Medicaid plans (Anthem, CareSource, MDwise, Managed Health Services (MHS), and UnitedHealthcare) must follow the State PDL, this change improves access to Elyxyb for all eligible patients under the Indiana Medicaid umbrella, the combined traditional Medicaid and Managed Medicaid populations, totaling approximately 1.2M lives, between the ages of 18-64.
  • Under the new terms, Elyxyb will be Preferred with the following prior authorization (PA) criteria:
    Elyxyb will have a QL of 6 bottles.
  • “We are pleased to announce our first Elyxyb managed health care win with the Medicaid plan in Indiana, which we believe is an important step to expand utilization of Elyxyb throughout the U.S.

Virios Therapeutics Announces Termination of At-The-Market Sales Agreement

Retrieved on: 
Monday, September 18, 2023
Drug discovery, Celecoxib, Polaris Sales Agreement, Disorder, Long COVID, Patent, Capital, Fibromyalgia, Conditional sentence, Therapy, Valaciclovir, Food, Fatigue, Pharmaceutical industry

ATLANTA, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases such as fibromyalgia and Long-COVID, today announced that it provided notice of termination of the Capital on Demand™ Sales Agreement entered into between the Company and JonesTrading Institutional Services LLC on July 14, 2023 (the “Sales Agreement”).

Key Points: 
  • ATLANTA, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases such as fibromyalgia and Long-COVID, today announced that it provided notice of termination of the Capital on Demand™ Sales Agreement entered into between the Company and JonesTrading Institutional Services LLC on July 14, 2023 (the “Sales Agreement”).
  • The Company has initiated the 10-day termination process under the Sales Agreement, with the official termination taking effect on September 28, 2023.
  • The Company will make no sales under the Sales Agreement during this period.
  • Prosecuting a patent application covering the treatment of Long-COVID and Alzheimer’s disease with combination antiviral formulations.

NeuroSense Granted Patents in Europe, Japan, and Israel for its ALS Drug PrimeC

Retrieved on: 
Tuesday, September 19, 2023
Maintenance, Israel Patent Office, Food and Drug Administration, Celecoxib, IP, Motor neuron diseases, Patent, Mood stabilizer, Ciprofloxacin, FDA, Food, Pharmaceutical industry, ALS

The patents relate to NeuroSense's unique fixed-dose combination of ciprofloxacin and celecoxib, two U.S. Food and Drug Administration (FDA) approved drugs that are the active ingredients in PrimeC, the Company's lead drug candidate for treating Amyotrophic Lateral Sclerosis (ALS).

Key Points: 
  • The patents relate to NeuroSense's unique fixed-dose combination of ciprofloxacin and celecoxib, two U.S. Food and Drug Administration (FDA) approved drugs that are the active ingredients in PrimeC, the Company's lead drug candidate for treating Amyotrophic Lateral Sclerosis (ALS).
  • Corresponding patents have been issued in the U.S., Canada, and Australia and are valid through 2038, subject to appropriate maintenance.
  • Additional patent applications relating to the novel formulation of PrimeC and methods for the treatment of other neurodegenerative diseases using NeuroSense's platform of combination therapies including StabiliC and CogniC are pending as well.
  • ALS remains a pressing unmet need, and our unwavering commitment to advancing our program, supported by robust intellectual property, underscores our dedication to delivering an effective therapy for individuals battling ALS."

AIM ImmunoTech Announces Report of Complete Topline Data from Roswell Park Comprehensive Cancer Center Study Evaluating Ampligen® as a Component of a Chemokine-Modulating (CKM) Regimen, with Paclitaxel, for the Treatment of Early-Stage Triple Negative Bre

Retrieved on: 
Monday, September 11, 2023
CKM, TNBC, Roswell Park Comprehensive Cancer Center, Science of team science, AIM, IV, Senior, DL, Safety, DLT, SITC, Paclitaxel, Immunotherapy, Celecoxib, Cyclophosphamide, Trae tha Truth, Roswell Park, Research, AC, Neoplasm, Biomarker, Doctor of Philosophy, PCR, Assistant, NAC, Patient, Blood, Rintatolimod, Society for Immunotherapy of Cancer, Financial toxicity, Immunology, Infrared spectroscopy correlation table, Physician, NYSE, Medical imaging, Pharmaceutical industry, MD

OCALA, Fla., Sept. 11, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that Roswell Park Comprehensive Cancer Center has reported the complete topline data from its Phase 1 study evaluating Ampligen® (rintatolimod) as a component of a CKM regimen for the treatment of early-stage triple negative breast cancer (TNBC). The complete topline results are now available on ClinicalTrials.gov: NCT04081389.

Key Points: 
  • The complete topline results are now available on ClinicalTrials.gov: NCT04081389 .
  • “We are pleased to bolster our growing body of data from Ampligen and the results demonstrated in the Phase 1 study with the completed topline data report now in hand.
  • Secondary endpoints included pCR rate where 5/9 (56%) of patients attained pCR and 1 more patient attained ypTmic.
  • For more information about the Phase 1 study, visit ClinicalTrials.gov: NCT04081389 .