Randomness

Arch Biopartners Announces Dosing of First Patient in Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Thursday, March 7, 2024

TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The Arch Biopartners team is currently working with hospital sites in Canada to prepare for their participation in this Phase II trial.
  • The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.

Cartesian Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 7, 2024

GAITHERSBURG, Md., March 07, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today reported financial results for the full year ended December 31, 2023, and recent corporate updates.

Key Points: 
  • Enrollment remains ongoing in the Company’s Phase 2b randomized, double-blind, placebo-controlled trial of Descartes-08 in patients with MG (NCT04146051), with topline results expected in mid-2024.
  • Announced Positive Long-Term Follow-Up Data from Phase 2a Study of Descartes-08 in Patients with MG.
  • In January 2024, Cartesian announced that the FDA cleared its IND application for Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T product candidate.
  • General and administrative expenses were $40.6 million for the year ended December 31, 2023, compared to $23.9 million for the year ended December 31, 2022.

Invitation to Participate in STOP-PC Clinical Trial

Retrieved on: 
Monday, March 4, 2024

AGOURA HILLS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) invites participation in our STOP-PC clinical trial which is now open for recruitment.

Key Points: 
  • AGOURA HILLS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) invites participation in our STOP-PC clinical trial which is now open for recruitment.
  • The Phase 2/3 trial that you are being asked to participate in will compare OT-101 plus mFOLFORINOX with mFOLFORINOX alone as second line therapy in patients whose cancer progressed.
  • The mFOLFIRINOX was chosen as the most well tolerated combination of choice through discussion with regulatory authorities and key opinion leaders.
  • We believe this trial will deliver the decisive win against pancreatic cancer," expressed Dr. Vuong Trieu, CEO of Oncotelic.

BioAegis Therapeutics Unveils Upcoming Clinical Study of Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS)

Retrieved on: 
Tuesday, February 27, 2024

Approximately 80 sites in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others will conduct the study.

Key Points: 
  • Approximately 80 sites in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others will conduct the study.
  • The planned primary outcomes are all-cause mortality at Day 28 between treatment groups and incidence, causality, and severity of SAEs in rhu-pGSN vs placebo treatment.
  • Breathing becomes difficult and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system.
  • In the U.S. alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions.

New Data from Incyte’s Growing Dermatology Portfolio to be Presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting

Retrieved on: 
Monday, March 4, 2024

Incyte (Nasdaq:INCY) today announced multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2024 American Academy of Dermatology (AAD) Annual Meeting, held March 8-12, 2024, in San Diego.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2024 American Academy of Dermatology (AAD) Annual Meeting, held March 8-12, 2024, in San Diego.
  • “We are pleased to convene at this year’s AAD Annual Meeting and share data, including two late-breaking presentations, from our growing dermatology portfolio,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte.
  • “Our presence at this year’s meeting showcases Incyte’s commitment to find solutions for patients where there continues to be critical unmet needs.
  • They will also be published online via the Journal of the American Academy of Dermatology (JAAD) supplement in Fall 2024.

Optinose Announces the Publication of ReOpen Phase 3 Clinical Trial Program Evaluating XHANCE in the Journal of Allergy and Clinical Immunology: In Practice

Retrieved on: 
Thursday, January 18, 2024

YARDLEY, Pa., Jan. 18, 2024 (GLOBE NEWSWIRE) --  Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced peer-reviewed publication of results from both ReOpen1 and ReOpen2 in the Journal of Allergy and Clinical Immunology: In Practice1.

Key Points: 
  • The ReOpen program evaluated XHANCE for treatment of adults with chronic sinusitis (chronic rhinosinusitis).
  • “Patients with chronic sinusitis often suffer for years and may use multiple over-the-counter treatments in a search for ways to alleviate their symptoms.
  • Chronic sinusitis is also common: data suggests it is one of the top diagnoses in adult outpatient physician visits.
  • The safety profile and tolerability of XHANCE for patients in the ReOpen trials was generally consistent with its currently labeled safety profile.

Neuraptive Therapeutics, Inc. Announces Achievement of Proof of Concept in The NEUROFUSE Study of NTX-001 for the Adjunct Treatment of Transected Peripheral Nerves

Retrieved on: 
Monday, January 8, 2024

Neuraptive Therapeutics, Inc. is dedicated to revolutionizing patient care through innovative therapies, and NTX-001 has the potential to redefine the standard of care.

Key Points: 
  • Neuraptive Therapeutics, Inc. is dedicated to revolutionizing patient care through innovative therapies, and NTX-001 has the potential to redefine the standard of care.
  • Key highlights from the NEUROFUSE Study:
    The NEUROFUSE Study is a 48-week, Multicenter, Randomized, Controlled, Evaluator-Blinded Study comparing NTX-001 as an adjunct treatment to standard of care vs. standard of care alone.
  • The study was to enroll 60 patients, and patients were randomized in a 1:1 ratio between treatments.
  • For more information about Neuraptive Therapeutics, Inc., and our pioneering work in peripheral nerve injury treatments, please visit Neuraptive.com.

SPR Therapeutics Announces Completion of Enrollment in the RESET Clinical Trial of the SPRINT® PNS System for Low Back Pain

Retrieved on: 
Tuesday, December 12, 2023

CLEVELAND, Dec. 12, 2023 (GLOBE NEWSWIRE) -- SPR Therapeutics, Inc. today announced the final patient was enrolled in the RESET Clinical Trial of SPRINT® PNS for the treatment of chronic low back pain (LBP).

Key Points: 
  • CLEVELAND, Dec. 12, 2023 (GLOBE NEWSWIRE) -- SPR Therapeutics, Inc. today announced the final patient was enrolled in the RESET Clinical Trial of SPRINT® PNS for the treatment of chronic low back pain (LBP).
  • This large multicenter randomized controlled trial (RCT) compares percutaneous peripheral nerve stimulation (PNS) with standard interventional treatments of chronic LBP.
  • The “RESET Clinical Trial: A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain” is a large RCT being conducted at more than 20 clinical centers across the United States.
  • “We are thrilled to announce the completion of enrollment in this important study, which is the largest randomized controlled trial to date studying the SPRINT PNS System.

Justice Benefits Inc Unveils Innovative RMTS System to Revolutionize Federal Program Compliance and Efficiency

Retrieved on: 
Monday, November 20, 2023

This advanced web-based system is set to redefine how government agencies and public entities manage and document federally funded programs.

Key Points: 
  • This advanced web-based system is set to redefine how government agencies and public entities manage and document federally funded programs.
  • The RMTS system represents a significant leap forward in helping government agencies demonstrate compliance and accountability in their operations.
  • By employing a valid random sampling technique, RMTS accurately captures time and activities, fulfilling documentation requirements for multiple federal revenue programs.
  • A key feature of the RMTS system is its user-friendly interface, designed to cater to users with diverse technical backgrounds.

NGM Bio Presents Positive Phase 2b Results from the ALPINE 4 Trial of Aldafermin in Patients with Compensated Cirrhosis (F4) Due to NASH at AASLD The Liver Meeting®

Retrieved on: 
Monday, November 13, 2023

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today shared positive, comprehensive results from its Phase 2b ALPINE 4 trial of aldafermin, an engineered FGF19 analog product candidate, in patients with compensated cirrhosis (liver fibrosis stage 4 or F4) due to NASH in an oral plenary presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®.

Key Points: 
  • The ALPINE 4 data shared at AASLD The Liver Meeting follow positive topline results on the primary endpoint reported by NGM Bio in May 2023.
  • It’s gratifying to see the potential impact aldafermin is having on NASH progression and liver health in patients with F4 NASH.
  • This Phase 2b data set furthers our belief in aldafermin’s therapeutic potential,” said Hsiao D. Lieu, M.D., Chief Medical Officer at NGM Bio.
  • ELF measures direct markers of liver fibrosis and can be used to predict liver-related events in patients with NASH and compensated cirrhosis.