Inflammation

Positive Results from Phase 3 OPTIMIZE-1 Trial of Once Daily OCS-01 for the Treatment of Inflammation and Pain Following Cataract Surgery Presented at the 2024 American Society of Cataract and Refractive Surgery Annual Meeting

Retrieved on: 
Monday, April 8, 2024
Inflammation, Pain, Patient, OCS

Dr. Donnenfeld presented the “Once Daily OCS-01, an OPTIREACH® Formulation of High Concentration Dexamethasone Eye Drop, for Inflammation and Pain Following Cataract Surgery – a Phase 3, Double-Masked, Vehicle-Controlled Study” on Sunday, April 7th.

Key Points: 
  • Dr. Donnenfeld presented the “Once Daily OCS-01, an OPTIREACH® Formulation of High Concentration Dexamethasone Eye Drop, for Inflammation and Pain Following Cataract Surgery – a Phase 3, Double-Masked, Vehicle-Controlled Study” on Sunday, April 7th.
  • The results showed that 57.2% of patients treated with OCS-01 were inflammation free (i.e.
  • absence of anterior chamber cells) at Day 15 (vs. 24.0% with vehicle, p
  • The two Phase 3 OPTIMIZE trials are expected to support an NDA submission.

Ocugen Announces Positive Data and Safety Monitoring Board Review and Initiation of Enrollment in Medium Dose for OCU410—a Modifier Gene Therapy—in Phase 1/2 ArMaDa Study for Geographic Atrophy

Retrieved on: 
Friday, April 5, 2024
Retina, Disease, Inflammation, Patient, Data, Cohort, Șaeș, Life, Clinical trial, Armada, MPH, Injection, Safety, DSMB, FACS, Vaccine, Lipid metabolism, Geographic atrophy, Oxidative stress, Pharmaceutical industry

Three subjects with geographic atrophy (GA) were dosed in the Phase 1/2 clinical trial to date.

Key Points: 
  • Three subjects with geographic atrophy (GA) were dosed in the Phase 1/2 clinical trial to date.
  • An additional three subjects will be dosed with the medium dose (Cohort 2) and three patients with the high dose (Cohort 3) of OCU410 in the dose-escalation phase.
  • “The DSMB has recommended moving forward to medium dose for dosing subjects with GA,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410 clinical trial.
  • Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)].

Contineum Therapeutics Announces Pricing of Initial Public Offering

Retrieved on: 
Friday, April 5, 2024
Montgomery Street, Goldman Sachs, Vesey Street, Telephone, Inflammation, SAN, Sale, Attention, Security (finance), Prospectus, Morgan Stanley, Suite, Therapy, Varick Street, Equity capital markets, RBC Capital Markets

All of the shares are being offered by Contineum.

Key Points: 
  • All of the shares are being offered by Contineum.
  • The gross proceeds to Contineum from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Contineum, are expected to be $110.0 million.
  • In addition, Contineum has granted the underwriters a 30-day option to purchase up to an additional 1,031,250 shares of its Class A common stock at the initial public offering price, less underwriting discounts and commissions.
  • Goldman Sachs & Co. LLC, Morgan Stanley, Stifel, and RBC Capital Markets are acting as joint book-running managers for the offering.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Hut 8, Ventyx, and Anavex and Encourages Investors to Contact the Firm

Retrieved on: 
Friday, April 5, 2024
Bitcoin, Research, Bankruptcy, Psoriasis, Register, Form, Patient, Defendant, News, IPO, Crohn's disease, Security (finance), Data mining, Inflammation, Rett syndrome, Prospectus, Complaint, Hut 8, P.C, Clinical trial, MCI, Radar, File, Mergers and acquisitions, Cryptocurrency

In November 2023, Hut 8 formed following the merger of Hut 8 Mining Corp. (“Legacy Hut”) and U.S. Data Mining Group, Inc. d/b/a US Bitcoin Corp. (“USBTC”) (the “Merger”).

Key Points: 
  • In November 2023, Hut 8 formed following the merger of Hut 8 Mining Corp. (“Legacy Hut”) and U.S. Data Mining Group, Inc. d/b/a US Bitcoin Corp. (“USBTC”) (the “Merger”).
  • USBTC held a 50% interest in a joint venture bitcoin mining facility, located in King Mountain, Texas (the “King Mountain JV”), which was acquired in the Merger.
  • In addition, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects.
  • For more information on the Anavex class action go to: https://bespc.com/cases/AVXL

Caribou Biosciences Expands Clinical Development of CB-010 with FDA Clearance of IND in Lupus

Retrieved on: 
Thursday, April 4, 2024
Logic, LN, Transplant, Medical College of Wisconsin, Rachel Haurwitz, Infection, Lupus, Risk, Medical college, Patient, Inflammation, Tissue, Autoimmune disease, Standard of care, Doctor of Philosophy, MD, Autoantibody, IND, Congress, HLA, Reindeer, Antibody, CRISPR, Safety, Immune system, Fatigue, FDA, Lupus nephritis, Autoimmunity, Bone marrow, ERL, Medicine, CD19, Food, PD-1, Pharmaceutical industry

BERKELEY, Calif., April 04, 2024 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.

Key Points: 
  • The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.
  • CB-010 targets CD19, a protein on the surface of B cells, and has a PD-1 knockout (KO) that reduces CAR-T cell exhaustion.
  • CB-010 holds the potential for deep depletion of disease-causing B cells which could reset the immune system, leading to sustained drug-free remission.
  • Instead, the chRDNA technology allows for precise insertion of the CAR at an intended location within the T cell genome.

ANI Pharmaceuticals Recognizes Sarcoidosis Awareness Month and Patients Living with Sarcoidosis

Retrieved on: 
Thursday, April 4, 2024
Sarcoidosis, ANI, Disease, Incidence, Education, Patient, African Americans, Research, FSR, CAC, Inflammation, Human, Granuloma, Pharmaceutical industry

BAUDETTE, Minn., April 04, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) https://www.anipharmaceuticals.com/ (Nasdaq : ANIP) is proud to support the Foundation for Sarcoidosis Research’s (FSR) commitment to sarcoidosis patients and efforts to increase disease awareness during April’s Sarcoidosis Awareness Month.

Key Points: 
  • BAUDETTE, Minn., April 04, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) https://www.anipharmaceuticals.com/ (Nasdaq : ANIP) is proud to support the Foundation for Sarcoidosis Research’s (FSR) commitment to sarcoidosis patients and efforts to increase disease awareness during April’s Sarcoidosis Awareness Month.
  • During the month of April, members of the ANI organization are raising awareness of sarcoidosis by wearing “Say Sarcoidosis” pins offered through FSRs National Awareness Campaign, “Say Sarcoidosis.” In addition, ANI members will also be wearing purple on April 13th in honor of “World Sarcoidosis Awareness Day.”
    According to the FSR, sarcoidosis is a rare inflammatory disease characterized by the formation of granulomas predominately in the lungs and, to a lesser extent, in other organs of the body.
  • “We applaud the Foundation for Sarcoidosis Research’s Awareness Campaign – “Say Sarcoidosis” and their ongoing education and support of people who live with sarcoidosis.
  • “We are grateful for ANI Pharmaceuticals’ commitment to increasing awareness and education about those living with sarcoidosis,” said Mary McGowan, Chief Executive Officer of the FSR.

ZyVersa Therapeutics Highlights Published Data Demonstrating NLRP3 Inflammasome Inhibition Has Potential to Decrease Atherosclerotic Lesions in Patients with Diabetes

Retrieved on: 
Thursday, April 4, 2024
Diabetes, Disease, Super Meat Boy, Serum, Coronary artery disease, IL-6, Inflammation, Patient, Mortality, Death, NLRP3, ASC, Therapy, Inflammasome, CAD, Pharmaceutical industry

The published data show that inhibiting the NLRP3 inflammasome pathway significantly reduces atherosclerotic lesions and improves hyperglycemic-induced plaque instability.

Key Points: 
  • The published data show that inhibiting the NLRP3 inflammasome pathway significantly reduces atherosclerotic lesions and improves hyperglycemic-induced plaque instability.
  • WESTON, Fla., April 04, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc .
  • (Nasdaq: ZVSA or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, highlights data from a peer-reviewed article published in Biochemical and Biophysical Research Communications.
  • This article demonstrates that NLRP3 inhibition results in improved glucose tolerance and markedly smaller and more stable atherosclerotic lesions in a diabetic mouse model.

Biognosys and Alamar Biosciences Forge Strategic Partnership in Proteomics to Advance Biopharma and Precision Medicine Research

Retrieved on: 
Thursday, April 4, 2024
Plasma, NSCLC, Disease, Partnership, Inflammation, Patient, Biomarker, Research, Acquisition, Protein, Proteomics, Biology, Medicine, AACR, Chemokine, Society, Cytokine, Mass spectrometry, Fluid mechanics, Proteome, Annual general meeting, Pharmaceutical industry

This collaboration brings together Biognosys’ expertise in unbiased discovery through data independent acquisition mass spectrometry (DIA-MS) and Alamar’s cutting-edge immunoassays.

Key Points: 
  • This collaboration brings together Biognosys’ expertise in unbiased discovery through data independent acquisition mass spectrometry (DIA-MS) and Alamar’s cutting-edge immunoassays.
  • Building upon this successful proof-of-concept study, Biognosys and Alamar are planning to further collaborate both commercially and scientifically as part of their strategic partnership.
  • Research Collaboration: Biognosys and Alamar will embark on a joint research initiative to explore plasma biology.
  • Oliver Rinner, Ph.D., Founder and CEO of Biognosys, expressed enthusiasm about the collaboration: “We are excited to join forces with Alamar to advance proteomics research.

Surrozen Publishes Study in 'Respiratory Research' Demonstrating the Promise of a Wnt Mimetic Antibody in Treating Pulmonary Fibrosis

Retrieved on: 
Wednesday, April 3, 2024
Research, Extracellular matrix, B cell, ECM, Regeneration, Idiopathic pulmonary fibrosis, AT2, Inflammation, Lung, SWAP, Respiratory Research, Macrophage, IPF, Pulmonary fibrosis, Fibrosis, Therapy, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., April 03, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively modulate the Wnt pathway for tissue repair and regeneration, announced today publication of data in Respiratory Research highlighting the potential for Surrozen’s Wnt mimetic technologies to treat serious lung diseases like idiopathic pulmonary fibrosis (IPF) https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-0.... The results observed with systemic administration of Surrozen’s Wnt mimetic antibody in an acute bleomycin model of pulmonary fibrosis demonstrate a Wnt pathway mediated decrease in inflammation and fibrosis and improvement in lung function.

Key Points: 
  • The results observed with systemic administration of Surrozen’s Wnt mimetic antibody in an acute bleomycin model of pulmonary fibrosis demonstrate a Wnt pathway mediated decrease in inflammation and fibrosis and improvement in lung function.
  • Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by areas of myofibroblast accumulation and extracellular matrix (ECM) deposition, disruption of alveolar architecture, and restricted lung physiology.
  • In pulmonary fibrosis, multiple cell types may need to be targeted to provide a regenerative environment facilitating repair.
  • “This work published in Respiratory Research represents a breakthrough in understanding the role of the Wnt pathway in lung fibrosis and the potential for Wnt mimetics to reduce fibrosis and improve lung function.”

UHN Joins the Phase II Trial of LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Wednesday, April 3, 2024
Kidney, UHN, User experience, AKI, Patient, Kidney disease, Inflammation, ACTU, Ethics, TMX Group, Pain management, Acute kidney injury, Ischemia, Injury, IRI, Science Advances, Arch, Oxygen, Reperfusion, Placebo-controlled study, Phase, University Health Network, OTCQB, Liver, Yolo Bypass, Randomness

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

Key Points: 
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.
  • Details of the Phase II trial, entitled “ Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery” can be viewed at clinicaltrials.gov .
  • There is no treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.