Phase

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
Oxygen, Liver, OTCQB, CABG, User experience, Injury, Science Advances, Inflammation, Randomness, Hospital, Kidney disease, Acute kidney injury, National Research Council, TMX Group, Kidney, Yolo Bypass, IRI, Risk, Placebo-controlled study, Reperfusion, Prevalence, Arch, Ischemia, Disease, Patient, AKI, Phase, Mortality, Erciyes University, Faculty, Pharmaceutical industry

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.

BioCardia Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure

Retrieved on: 
Monday, March 4, 2024
Stroke, Incidence, Randomized controlled trial, FDA, University, Hospital, Splenic infarction, Heart failure, Safety, Arrhythmia, Death, Patient, MSC, HF, Phase, THT, Mortality, Pharmaceutical industry

Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress.

Key Points: 
  • Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress.
  • Patients treated with CardiAMP cell therapy saw an almost 5% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (8.3% vs. 13.2%, respectively).
  • CardiAMP cell therapy was also associated with trends toward reduced ventricular tachyarrhythmias, enhanced heart function as measured by left ventricular ejection fraction, and improved NTproBNP.
  • “These positive results for CardiAMP cell therapy are very encouraging, especially for patients with elevated NTproBNP, who encompass the majority of heart failure patients that we see in our daily practice,” said trial co-principal investigator Dr. Raval.

NMD Pharma announces poster and oral presentations on skeletal muscle targeted ClC-1 therapy at two leading neuromuscular disease conferences

Retrieved on: 
Friday, March 1, 2024
EVP, Exercise, Hubli railway division, Conference, Phase II, SMA, Safety, Muscular Dystrophy Association, Science, Fatigue, Muscle weakness, Patient, NMD, Poster, Myasthenia gravis, Phase, MDA, Trial of the century, Congress, Pharmaceutical industry

ClC-1 is a chloride ion channel specifically expressed in skeletal muscle cells that normally dampens muscle fiber excitability and is involved in regulating muscle fiber excitability during exercise.

Key Points: 
  • ClC-1 is a chloride ion channel specifically expressed in skeletal muscle cells that normally dampens muscle fiber excitability and is involved in regulating muscle fiber excitability during exercise.
  • ClC-1 inhibition could be a possible mechanism to improve muscle fiber activation to address muscle weakness and fatigue in neuromuscular diseases.
  • Details of NMD Pharma’s poster presentations are below:
    The 4th Scientific International Congress on SMA is taking place in Ghent, Belgium, from 14-16 March.
  • : NMD Pharma be presenting one poster and one oral presentation at the congress.

Cardiff Oncology Provides Clinical Update on Phase 2 Randomized Second-line ONSEMBLE Trial in Patients with RAS-mutated mCRC

Retrieved on: 
Thursday, February 29, 2024
NRAS, CRDF, SAN, MD, FDA, Cancer, Bev, PLK1, Standard of care, FACP, Patient, Suggestion, SOC, Phase, Mutation, Pharmaceutical industry

SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today provided a clinical update on the first release of data from its second-line RAS-mutated metastatic colorectal cancer (mCRC) ONSEMBLE trial. Although the Phase 2 ONSEMBLE trial was discontinued as part of the company’s shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms prior to closing the trial to new enrollment. The 23 enrolled patients continued treatment per protocol. The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company’s earlier Phase 1b/2 KRAS-mutated mCRC trial.

Key Points: 
  • Although the Phase 2 ONSEMBLE trial was discontinued as part of the company’s shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms prior to closing the trial to new enrollment.
  • The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company’s earlier Phase 1b/2 KRAS-mutated mCRC trial.
  • “The randomized data from the ONSEMBLE trial further validates the opportunity for onvansertib in the first-line RAS-mutated mCRC setting.
  • We look forward to sharing the topline results of our first-line CRDF-004 trial in mid-2024.”
    In August 2023, Cardiff Oncology discontinued enrollment in the second-line ONSEMBLE trial to focus on its new lead program in first-line RAS-mutated mCRC.

Itronics Updates Investors - Announces Plan to Activate Auric Gold & Minerals, Inc.

Retrieved on: 
Thursday, February 29, 2024
Engineering, Fertilizer, Growth, Sale, Activate, IMI, Health, ITRO, San Francisco Bay Area, Probability, Mineral, Copper, Zinc, Marketing, OTC, Geology, Tree, Phase, Silver, Water, United States Geological Survey, Metal, Gold, IP, Knowledge, Nursery, Acquisition, Clean technology, Rock, Intellectual property, Mining

Itronics believes its subsidiaries, each based on their own unique Intellectual Property (IP) can generate interest from crowdfunding investors.

Key Points: 
  • Itronics believes its subsidiaries, each based on their own unique Intellectual Property (IP) can generate interest from crowdfunding investors.
  • This timing is very opportunistic for Itronics due to forecasted increases in silver and gold prices for 2024 and future years.
  • Plan to Activate and Fund Auric Gold & Minerals, Inc.
    Itronics owns a majority interest in Auric Gold & Minerals, Inc. (“Auric”) through its wholly owned Technical Services subsidiary Whitney & Whitney, Inc.  Auric controls a large mineral land package consisting of 148 lode mining claims (almost 3,000 acres) called the Auric Fulstone Project in the Yerington Mining District near Yerington, Nevada.
  • Itronics believes that the steps being taken will produce a significant increase in value to its shareholders through its Auric ownership.

uniQure Announces 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Wednesday, February 28, 2024
Acquisition, Fabry disease, TMS, Natural history, CSL Behring, ALS, Research, FDA, Partnership, Cerebrospinal fluid, Food, CSL, Etranacogene dezaparvovec, Sale, TFC, Conference, SOD1, Unified, Information technology, AFL, Immunosuppression, Patient, Disease, Phase, Hand, IND, CGMP, State, Temporal lobe epilepsy, Pharmaceutical industry

LEXINGTON, Mass. and AMSTERDAM, Feb. 28, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the fourth quarter and full year 2023 and highlighted recent progress across its business.

Key Points: 
  • and AMSTERDAM, Feb. 28, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the fourth quarter and full year 2023 and highlighted recent progress across its business.
  • “We are pleased with the progress made across the company in 2023 and are now laser-focused on execution across multiple clinical programs,” stated Matt Kapusta, chief executive officer of uniQure .
  • By the end of 2024, the Company expects to have greater clarity regarding a potential approval pathway for AMT-130.
  • AMT-191 for the treatment of Fabry disease – In November 2023, the Company announced the clearance of an IND for the Phase I/IIa clinical study of AMT-191.

Supernus Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024
Central nervous system, Topiramate, Investigational New Drug, PD, Total, New Drug Application, FDA, Food, Growth, PDUFA, Safety, GAAP, CNS, Depreciation, IQVIA, Patient, AISRS, Attention deficit hyperactivity disorder, DSM-IV codes, ADHD, Phase, MDD, Prescription, MADRS, Pharmaceutical industry

ROCKVILLE, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2023 and associated Company developments.

Key Points: 
  • Fourth quarter 2023 net sales of Qelbree® increased 97% to $46.4 million compared to fourth quarter 2022; Full year 2023 net sales of Qelbree increased 129% to $140.2 million compared to full year 2022.
  • Fourth quarter 2023 net sales of GOCOVRI® increased 10% to $32.0 million compared to fourth quarter 2022; Full year 2023 net sales of GOCOVRI increased 15% to $119.6 million compared to full year 2022.
  • Full year 2023 operating loss (GAAP) was $(5.3) million; Full year 2023 operating earnings (non-GAAP)(2), were $125.1 million.
  • ROCKVILLE, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2023 and associated Company developments.

Recce Pharmaceuticals Announces Expansion of Phase I/II Trial of RECCE® 327 for the Treatment of Diabetic Foot Infections

Retrieved on: 
Tuesday, February 27, 2024
Diabetes, Infection, Ankle, Principal, Ulcer, Quality of life, Clinical trial, Foot, Ambulatory care, RCE, Amputation, Safety, ASX, Liverpool Hospital, DFI, Patient, Data analysis, DFU, Phase, Pharmaceutical industry

The objective of this trial is to evaluate R327’s potential as a topical broad-spectrum anti-infective treatment.

Key Points: 
  • The objective of this trial is to evaluate R327’s potential as a topical broad-spectrum anti-infective treatment.
  • In the coming months, additional study sites both locally and overseas will become active and include the broader patient population in the study.
  • Of the estimated 537 million people worldwide who have diabetes, 19–34% will develop a DFU in their lifetime.
  • “A non-invasive method to treat the burdensome challenges of diabetic foot ulcer infections gives hope to better patient outcomes and avoid limb amputation, as is so commonly the case with these complicated patients.

Philogen provides update on pre-planned interim analysis of the Phase III FIBROSARC trial investigating Onfekafusp alfa (L19TNF) in patients with first-line advanced or metastatic Soft Tissue Sarcoma

Retrieved on: 
Tuesday, February 20, 2024
PFS, Soft-tissue sarcoma, MD, Doxorubicin, Progression-free survival, Risk, Science Translational Medicine, Safety, STS, Death, Patient, BIT, CSO, Phase, DSMB, Control arm, Pharmaceutical industry

SIENA, Italy, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Philogen S.p.A. (BIT:PHIL) is pleased to announce that the Phase III FIBROSARC trial (NCT04650984) will continue as planned by the protocol. The decision was made by an Independent Data and Safety Monitoring Board (DSMB) following the review of efficacy and safety data in the pre-planned interim analysis.

Key Points: 
  • The decision was made by an Independent Data and Safety Monitoring Board (DSMB) following the review of efficacy and safety data in the pre-planned interim analysis.
  • FIBROSARC is a Phase III 1:1 randomized trial (NCT04650984) which studies L19TNF in combination with doxorubicin (Experimental Arm) versus doxorubicin alone (Control Arm) in 118 patients as first-line therapy for advanced or metastatic Soft Tissue Sarcoma (STS).
  • The Phase III FIBROSARC trial was designed to demonstrate a significant clinical benefit of L19TNF plus doxorubicin compared to doxorubicin alone.
  • For more information about Onfekafusp alfa (also known as Fibromun), FIBROSARC Phase III study (NCT04650984), Soft Tissue Sarcoma, and Philogen, please visit https://www.philogen.com/investors/press-releases/ .

RenovoRx Highlights Key Leadership Promotions

Retrieved on: 
Friday, March 8, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, CPA, Strategic planning, Growth, Standard of care, Safety, LAPC, Phase, Controller, Financial management, Research

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today highlighted the recent key leadership promotions of Leesa Gentry to Chief Clinical Officer and Ronald B. Kocak, CPA to Principal Accounting Officer.

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today highlighted the recent key leadership promotions of Leesa Gentry to Chief Clinical Officer and Ronald B. Kocak, CPA to Principal Accounting Officer.
  • Since joining RenovoRx, Ms. Gentry has demonstrated exemplary leadership and commitment to advancing the Company’s clinical pipeline.
  • Mr. Kocak has been promoted to the position of Principal Accounting Officer and will retain his roles as Vice President and Controller of RenovoRx.
  • In this new leadership role, Mr. Kocak will oversee all financial management, reporting and strategic planning initiatives crucial to furthering the Company’s research and development efforts.