Phase

Oragenics, Inc. Preparing for Phase II Clinical Trials to Treat Concussion

Retrieved on: 
Monday, February 5, 2024
Mental Health, Health, Neurology, Clinical Trials, General Health, Pharmaceutical, NCE, Memory, Concussion, CTE, Chronic traumatic encephalopathy, Traumatic brain injury, Nasal administration, Patient, Safety, Diagnosis, Brain, Animal, DSM-IV codes, Nasal cavity, Phase, Traffic, Common, Pharmaceutical industry

Oragenics has begun the final process of synthesizing and formulating the drug needed for its Phase II clinical trial.

Key Points: 
  • Oragenics has begun the final process of synthesizing and formulating the drug needed for its Phase II clinical trial.
  • We are excited to get the Phase II clinical trials underway,” commented Dr. James “Jim” Kelly, Neurologist and Executive Director of the Marcus Institute of Brain Health and an advisor on the planned phase II trial.
  • The drug has a large safety margin between dosages used in the animal toxicology program and those used in the Phase I study and planned for the upcoming Phase II clinical trial.
  • Post concussion syndrome is linked to long term disability and occurs in as high as 20% of concussed patients.

Sirnaomics to Present Latest Developments of STP705 for Focal Fat Reduction at IMCAS World Congress 2024

Retrieved on: 
Monday, February 5, 2024
Poster, FFR, Plastic surgery, Division, Clinical trial, Therapy, Safety, PNP, RNA interference, University of Miami, Phase, University, Conference

and SUZHOU, China, Feb. 5, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", Stock Code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, presented the latest developments on Polypeptide Nanoparticle (PNP) platform, and its pipeline program STP705 for Focal Fat Reduction's positive clinical data, at IMCAS World Congress 2024, which is taking place in Paris from February 1st - 3rd, 2024.

Key Points: 
  • and SUZHOU, China, Feb. 5, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", Stock Code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, presented the latest developments on Polypeptide Nanoparticle (PNP) platform, and its pipeline program STP705 for Focal Fat Reduction's positive clinical data, at IMCAS World Congress 2024, which is taking place in Paris from February 1st - 3rd, 2024.
  • Previously, Sirnaomics had reported that a poster with positive clinical data of STP705 for focal fat reduction (FFR) was presented at the 2023 Fall Clinical Dermatology Conference.
  • The safety and efficacy results of this Phase I study support further investigation of STP705 as a potential alternative to other injectables for FFR.
  • The positive data from the Phase I clinical study has led to the Group advancing the program to the Phase II clinical study stage.

ANeuroTech publishes Phase IIIa data for ANT-01, an adjunctive anti-depression drug, in Personalized Medicine in Psychiatry

Retrieved on: 
Wednesday, January 31, 2024
Com, Psychosis, Dopamine, Patient, Serotonin, Depression, MDD, Mental health, Phase, Anhedonia, Citalopram, Patent, Prodrug, Pleasure, Pipamperone, Pharmaceutical industry

ANeuroTech publishes Phase IIIa data for ANT-01, an adjunctive anti-depression drug, in Personalized Medicine in Psychiatry

Key Points: 
  • ANeuroTech publishes Phase IIIa data for ANT-01, an adjunctive anti-depression drug, in Personalized Medicine in Psychiatry
    Alken, Belgium – 31 January 2024: ANeuroTech, a leader in the development of innovative mental health treatments with minimal or no side effects, today announced the publication of Phase IIIa data for ANT-01, its adjunctive anti-depression drug, in the journal of Personalized Medicine in Psychiatry.
  • The Company also filed a Composition of Matter (CoM) patent for the long-acting effects of ANT-01.
  • The paper was co-authored by Erik Buntinx, Lars Bastiaanse, Alan S Schatzberg, Charles B Nemeroff and Philip D Harvey.
  • At ANeuroTech, we are working to bring effective treatments, with minimal or no side-effects, to patients who suffer with depression.

Terra Balcanica Intercepts 551 g/t AgEq Over 4.8 m At Cumavici Ridge in Bosnia and Herzegovina

Retrieved on: 
Tuesday, January 30, 2024
FRA, News, TERA, Phase, NW

VANCOUVER, British Columbia, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Terra Balcanica Resources Corp. (“Terra” or the “Company”) (CSE:TERA; FRA:UB1) is pleased to announce the final geochemical assay results from the Phase II drill campaign at Cumavici Ridge confirming continuation of the high-grade epithermal vein mineralization at the Viogor-Zanik project in Bosnia and Herzegovina.

Key Points: 
  • VANCOUVER, British Columbia, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Terra Balcanica Resources Corp. (“Terra” or the “Company”) (CSE:TERA; FRA:UB1) is pleased to announce the final geochemical assay results from the Phase II drill campaign at Cumavici Ridge confirming continuation of the high-grade epithermal vein mineralization at the Viogor-Zanik project in Bosnia and Herzegovina.
  • Terra Balcanica CEO, Dr. Aleksandar Mišković, commented: “Terra keeps on confirming average grades of over 500 g/t Ag Eq and average mineralization thicknesses of approximately 5-10 m of massive sulfides and associated Ag-Sb-Pb-Zn-Au mineralogy at Cumavici Ridge which is only one of six target zones along the 7.2 km corridor of vein-hosted epithermal mineralization.
  • This zone is de-risked by drilling shallow, high grade silver mineralization at both the Cumavici Ridge and Joseva targets over 2.3 km apart.
  • We are very excited to carry on adding to the existing mineralized horizon at Cumavici Ridge by testing it down dip to SW as well as along strike to NW while expanding drill campaign to Cumurnica and two other targets along the corridor in 2024.”

INmune Bio Announces FDA Removal of Clinical Hold for Alzheimer’s Disease Program

Retrieved on: 
Tuesday, January 30, 2024
TNF, Neuroinflammation, Patient, FDA, Phase

BOCA RATON, Florida, Jan. 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB)  (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) with XProTM (XPro1595; pegipanermin), a dominant-negative inhibitor of soluble TNF, received correspondence from the FDA confirming that the full clinical hold on the Company’s AD clinical trial program has been lifted. The Phase II trial is on track to enroll the last patient mid-2024. Top line data is expected approximately six months after the last patient is enrolled.

Key Points: 
  • The Phase II clinical trial in patients with Alzheimer’s disease with neuroinflammation is on track to complete enrollment mid-2024 with top line data expected approximately six months after the final patient is enrolled.
  • BOCA RATON, Florida, Jan. 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB)  (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) with XProTM (XPro1595; pegipanermin), a dominant-negative inhibitor of soluble TNF, received correspondence from the FDA confirming that the full clinical hold on the Company’s AD clinical trial program has been lifted.
  • The Phase II trial is on track to enroll the last patient mid-2024.
  • “We are pleased with the FDA’s response and will continue to work closely with the agency in anticipation of our Phase III AD program,” said RJ Tesi, CEO of INmune Bio.

Terra Balcanica Intercepts 551 g/t AgEq Over 4.8 m At Cumavici Ridge in Bosnia and Herzegovina

Retrieved on: 
Tuesday, January 30, 2024
FRA, News, TERA, Phase, NW

Vancouver, British Columbia, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Terra Balcanica Resources Corp. (“Terra” or the “Company”) (CSE:TERA; FRA:UB1) is pleased to announce the final geochemical assay results from the Phase II drill campaign at Cumavici Ridge confirming continuation of the high-grade epithermal vein mineralization at the Viogor-Zanik project in Bosnia and Herzegovina.

Key Points: 
  • Vancouver, British Columbia, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Terra Balcanica Resources Corp. (“Terra” or the “Company”) (CSE:TERA; FRA:UB1) is pleased to announce the final geochemical assay results from the Phase II drill campaign at Cumavici Ridge confirming continuation of the high-grade epithermal vein mineralization at the Viogor-Zanik project in Bosnia and Herzegovina.
  • Terra Balcanica CEO, Dr. Aleksandar Mišković, commented: “Terra keeps on confirming average grades of over 500 g/t Ag Eq and average mineralization thicknesses of approximately 5-10 m of massive sulfides and associated Ag-Sb-Pb-Zn-Au mineralogy at Cumavici Ridge which is only one of six target zones along the 7.2 km corridor of vein-hosted epithermal mineralization.
  • This zone is de-risked by drilling shallow, high grade silver mineralization at both the Cumavici Ridge and Joseva targets over 2.3 km apart.
  • We are very excited to carry on adding to the existing mineralized horizon at Cumavici Ridge by testing it down dip to SW as well as along strike to NW while expanding drill campaign to Cumurnica and two other targets along the corridor in 2024.”

Agendia Announces First Patient Enrolled in DEBRA Trial Using MammaPrint®

Retrieved on: 
Thursday, February 1, 2024
Surgery, FDA, Genetics, Clinical Trials, Health Technology, Biotechnology, Radiology, Health, Oncology, DEBRA, Breast cancer, Trial of the century, Radiation, Patient, Recurrence, Gene expression profiling, Manager, Phase, Risk, Biology, Woman, Medical imaging

Agendia®, Inc. , announced today that the first patient to use MammaPrint® as an enrollment biomarker for the DEBRA Trial is to be enrolled.

Key Points: 
  • Agendia®, Inc. , announced today that the first patient to use MammaPrint® as an enrollment biomarker for the DEBRA Trial is to be enrolled.
  • The Phase III NRG Oncology De-Escalation of Breast Radiation (DEBRA) Trial ( NCT04852887 ) is a clinical study looking at safely reducing the use of breast radiation after lumpectomy for people with low-risk, early-stage breast cancer.
  • “With the first patient of this study being enrolled using MammaPrint, we look forward to participating in the development of a new path towards more precise, proactive treatment planning for early-stage breast cancer.”
    To learn more about the DEBRA Trial and enrollment criteria, visit www.nrgoncology.org/DEBRA-Trial .
  • For more information about Agendia, visit www.agendia.com and follow Agendia on Facebook , Twitter , YouTube , and LinkedIn .

Delta-Fly Pharma Inc.: Notice of Initiation of Phase III Pivotal comparative clinical trial of DFP-14323

Retrieved on: 
Friday, February 2, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, PMDA, Comparison, PFS, Lung cancer, Patient, Progression-free survival, Afatinib, Mutation, EGFR, Phase, Medication, Cancer, Pharmaceutical industry

And finally, we are pleased to announce that the submission of the protocol for the Phase III study to the PMDA has been approved and are ready to initiate the study.

Key Points: 
  • And finally, we are pleased to announce that the submission of the protocol for the Phase III study to the PMDA has been approved and are ready to initiate the study.
  • Furthermore, if non-inferiority to osimertinib (80 mg/day) can be confirmed in a comparative study, a huger market can be expected.
  • We intend to continue negotiations for out-licensing opportunities with pharmaceutical companies for the territory outside Japan.
  • Please find out the innovation for the miserable cancer patients by Delta-Fly Pharma Inc. (TOKYO:4598) and contact with us.

NEVADA KING PASSES 76,000M IN ITS PHASE II DRILL PROGRAM, RESULTS FOR 137 HOLES PENDING AT ATLANTA

Retrieved on: 
Thursday, February 1, 2024
National Instrument 43-101, OTCQX, OES, NI 43-101, Geology, News, CRF, ICP-OES, RC, Gold, Phase, National instrument

Since inception of the Phase II Atlanta drill program in June 2022 Nevada King has completed 391 holes totaling 76,249m, which includes 371 reverse-circulation ("RC") holes totaling 72,743m and 20 core holes totaling 3,506m.

Key Points: 
  • Since inception of the Phase II Atlanta drill program in June 2022 Nevada King has completed 391 holes totaling 76,249m, which includes 371 reverse-circulation ("RC") holes totaling 72,743m and 20 core holes totaling 3,506m.
  • Prior to initiating the Phase II program the Company completed 68 holes totaling 5,544m in it's maiden Phase I program.
  • To date, as part of its Phase II program, Nevada King has reported assays from 254 holes covering 46,201m with results from 137 drill holes totaling 30,048m currently pending.
  • The core rig that began operating in October 2023 successfully completed six holes (1,258m) needed for ongoing metallurgical testwork plus confirmation of RC drill results.

Ryvu Announces Dosing of the First Patient in the RIVER-81 Phase II Study of RVU120 in Combination with Venetoclax for the Treatment of Patients with Relapsed/Refractory AML

Retrieved on: 
Wednesday, January 31, 2024
Pharmacokinetics, Venetoclax, Ruxolitinib, MF, Ethics, Phases of clinical research, Clinical trial, Syndrome, Patient, Safety, ABM, AML, Therapy, Phase, Committee, Optimism, PD, Pharmaceutical industry

The primary goal of the RIVER-81 study will be to evaluate safety and efficacy of RVU120 in combination with venetoclax in r/r AML patients who have failed prior venetoclax treatment.

Key Points: 
  • The primary goal of the RIVER-81 study will be to evaluate safety and efficacy of RVU120 in combination with venetoclax in r/r AML patients who have failed prior venetoclax treatment.
  • The study is part of the RVU120 Development Plan presented in October 2023 and aligns with the company's cash runway to Q1 2026.
  • In H1 2024, Ryvu plans to launch four Phase II RVU120 clinical studies and enroll over 100 patients across the studies by the end of the year.
  • Following RIVER-81, Ryvu intends to initiate the RIVER-52 study (evaluating RVU120 as a monotherapy in patients with genetically defined subtypes of AML and in patients with HR-MDS).