Phase

Agendia Announces First Patient Enrolled in DEBRA Trial Using MammaPrint®

Retrieved on: 
Thursday, February 1, 2024

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

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

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

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).

REGENXBIO Announces Presentations at the 20th Annual WORLDSymposium 2024

Retrieved on: 
Wednesday, January 31, 2024

ROCKVILLE, Md., Jan. 31, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations on its program for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, will be shared at the 20th Annual WORLDSymposium™ 2024, taking place in San Diego, CA February 3-9, 2024.

Key Points: 
  • ROCKVILLE, Md., Jan. 31, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations on its program for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, will be shared at the 20th Annual WORLDSymposium™ 2024, taking place in San Diego, CA February 3-9, 2024.
  • The presentations include the topline results from the pivotal phase of the Phase I/II/III CAMPSIITE® trial of RGX-121 for the treatment of MPS II.
  • The poster presentations will be presented as follows:
    REGENXBIO will host a conference call Wednesday, February 7 at 4:30 p.m.
  • A replay of the webcast will also be available via the Company's investor website approximately two hours after the call's conclusion.

SIGMA LITHIUM SIGNIFICANTLY INCREASED AUDITED MINERAL RESOURCE BY 27% TO 109Mt: GROTA DO CIRILO IN BRAZIL BECOMES WORLD'S 4TH LARGEST OPERATING INDUSTRIAL PRE-CHEMICAL LITHIUM BENEFICIATION & MINING COMPLEX; GROTA DO CIRILO EXPECTED TO FURTHER INCREASE TO

Retrieved on: 
Wednesday, January 31, 2024

Newly revised NI 43-101 Mineral Resource estimate represents an increase of 27% from the previous technical report dated January 2023.

Key Points: 
  • Newly revised NI 43-101 Mineral Resource estimate represents an increase of 27% from the previous technical report dated January 2023.
  • Contained lithium carbonate equivalent tonnage also increased by 27% as Sigma Lithium maintained the high quality of its mineral resource while substantially increasing its scale.
  • Grota do Cirilo now becomes world's 4th largest operating industrial pre-chemical lithium beneficiation complex, fully integrated with 100% wholly-owned spodumene mining operations.
  • The revised audited mineral resource estimate represents a 27% increase when compared to the last technical report, dated January 2023.

EQS-News: G.ST Antivirals reports positive Phase I trial results for 2-Deoxy-D-glucose against upper respiratory infections

Retrieved on: 
Tuesday, January 30, 2024

Results of the Phase I trial demonstrated that an intranasal administration of 2-DG is safe, well tolerated and does not lead to any serious adverse events (SAEs).

Key Points: 
  • Results of the Phase I trial demonstrated that an intranasal administration of 2-DG is safe, well tolerated and does not lead to any serious adverse events (SAEs).
  • Alongside these clinical results, the company has raised funds totalling over EUR 6 million to complete the Phase II clinical trial.
  • “The results of the Phase I trial confirm the safety of our innovative approach of using 2-DG to treat respiratory infections.
  • “While viral infections of the upper respiratory tract are ubiquitous, they are currently insufficiently treated, and RVs are responsible for most of these infections.

Annovis Bio Refines Timeline for Parkinson’s Phase III Study Data Announcement

Retrieved on: 
Wednesday, January 24, 2024

MALVERN, Pa., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, has announced a postponement in the Phase III study data release for buntanetap in Parkinson’s Disease.

Key Points: 
  • MALVERN, Pa., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, has announced a postponement in the Phase III study data release for buntanetap in Parkinson’s Disease.
  • This adjustment is due to ongoing data cleaning efforts to ensure the accuracy and reliability of the study results.
  • “We acknowledge the ongoing anticipation for the Phase III data announcement initially set for the end of January 2024.
  • The Company is dedicated to maintaining open communication and will continue to provide updates for Parkinson’s Phase III study results in a timely and informative manner.

Phase 1 Clinical Data for SYS6002 (CRB-701) to be presented at 2024 ASCO GU

Retrieved on: 
Tuesday, January 23, 2024

The data referred to in the abstract dates to September of 2023; the upcoming presentation will include data as of December 2023.

Key Points: 
  • The data referred to in the abstract dates to September of 2023; the upcoming presentation will include data as of December 2023.
  • ASCO GU will be held January 25-27, 2024 in San Francisco, CA and online.
  • Additionally, by administering SYS6002 (CRB-701) on a Q3W schedule there is an opportunity to increase clinical convenience and patient compliance.
  • Continued development of SYS6002 (CRB-701) as both a monotherapy and in combination is planned both in China (CSPC), U.S. and Europe (Corbus Pharmaceuticals Holdings, Inc.).

Bionomics Provides a Review of 2023 and of 2024 Plans

Retrieved on: 
Monday, January 22, 2024

ADELAIDE, Australia and CAMBRIDGE, Mass., Jan. 22, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today provided a 2023 review and its outlook for 2024.

Key Points: 
  • ADELAIDE, Australia and CAMBRIDGE, Mass., Jan. 22, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today provided a 2023 review and its outlook for 2024.
  • “Bionomics continued its evolution into a U.S.-focused, late-stage clinical company last year.
  • Voluntarily delisted from the Australian Stock Exchange in August 2023 and is currently solely listed on the NASDAQ Global Market.
  • Bionomics continues to plan the initiation of its first Phase 3 study of BNC210 in patients with SAD.