Adverse effect

Inventiva announces that screening in the NATiV3, Phase III, clinical trial evaluating lanifibranor in NASH has resumed

Retrieved on: 
Thursday, March 7, 2024

Inventiva has lifted the voluntary pause on screening and randomization in the NATiV3 clinical trial following the approval from the US central IRB of the amended protocol and ICF.

Key Points: 
  • Inventiva has lifted the voluntary pause on screening and randomization in the NATiV3 clinical trial following the approval from the US central IRB of the amended protocol and ICF.
  • Other sites and countries are expected to resume screening and randomization activities progressively over the next weeks.
  • Clinical sites located in the United States operating under central IRB have meanwhile resumed screening and randomization activities.
  • Inventiva anticipates the last patient first visit for the NATiV3 clinical trial in the first half of 2024.

Inventiva reports preliminary 2023 fiscal year financial Information¹ and provides an update on its clinical trial NATiV3

Retrieved on: 
Thursday, February 15, 2024

Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “2023 has been an eventful year for the company.

Key Points: 
  • Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “2023 has been an eventful year for the company.
  • This allowed us to draw down the second tranche of €25 million of the €50 million EIB loan in January 2024.
  • We have advanced our pivotal NATiV3 Phase III clinical trial with lanifibranor in NASH after the implementation of the revised study design in early 2023, with 913 patients randomized to date.
  • An adverse event of elevated aminotransferases has been reported in a patient enrolled in the trial following a scheduled visit.

Sinoveda Is Using AI With Health and Wellness

Retrieved on: 
Tuesday, October 31, 2023

FORT LAUDERDALE, Fla., Oct. 31, 2023 /PRNewswire/ -- One of the biggest concerns with natural health and wellness solutions is the lack of consistency from one product to the next. The global supplement industry alone was valued at $164 billion in 2022, and yet, despite its size and scope, it remains largely unregulated and unstandardized. The team at Sinoveda has spent nearly twenty years bringing decades of experience and scientific acumen to bear on the issue of the lack of consistency across the natural health landscape.

Key Points: 
  • The team at Sinoveda has spent nearly twenty years bringing decades of experience and scientific acumen to bear on the issue of the lack of consistency across the natural health landscape.
  • "We developed PPT® as a way to quantify and standardize natural compounds and elements," explains Sinoveda co-founder Dr. Nuzhat Tam-Zaman.
  • "We are engaged in drug discovery but not in the traditional interest of isolating individual synthetics used in pharmaceuticals.
  • With each product, the primary focus is bringing the precision of science to bear on natural health solutions.

Magenta Therapeutics Voluntarily Pauses the MGTA-117 Phase 1/2 Dose-Escalation Clinical Trial to Investigate Drug Safety

Retrieved on: 
Wednesday, January 25, 2023

CAMBRIDGE, Mass., Jan. 25, 2023 (GLOBE NEWSWIRE) -- Magenta Therapeutics (Nasdaq: MGTA) today announced that the latest participant dosed at the Cohort 3 level (0.08 mg/kg) in the ongoing MGTA-117 Phase 1/2 Dose-Escalation Clinical Trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) experienced a Grade 5 Serious Adverse Event (SAE) (respiratory failure and cardiac arrest resulting in death) deemed to be possibly related to MGTA-117.

Key Points: 
  • CAMBRIDGE, Mass., Jan. 25, 2023 (GLOBE NEWSWIRE) -- Magenta Therapeutics (Nasdaq: MGTA) today announced that the latest participant dosed at the Cohort 3 level (0.08 mg/kg) in the ongoing MGTA-117 Phase 1/2 Dose-Escalation Clinical Trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) experienced a Grade 5 Serious Adverse Event (SAE) (respiratory failure and cardiac arrest resulting in death) deemed to be possibly related to MGTA-117.
  • The known information has been reported to the U.S. Food and Drug Administration (FDA) as a Suspected Unexpected Serious Adverse Reaction (SUSAR).
  • After consultation with the trial’s safety Cohort Review Committee and with the highest regard for patient safety, Magenta has voluntarily paused dosing in the clinical trial and is working to evaluate the totality of available data and determine next steps for the development of MGTA-117.

Magenta Therapeutics Provides Update for MGTA-117 Phase 1/2 Dose Escalation Clinical Trial

Retrieved on: 
Tuesday, December 20, 2022

CAMBRIDGE, Mass., Dec. 20, 2022 (GLOBE NEWSWIRE) -- Magenta Therapeutics (Nasdaq: MGTA) today announces that, per the clinical trial protocol for the MGTA-117 Phase 1/2 Dose Escalation Clinical Trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), it has stopped dosing participants at the Cohort 4 dosing level (0.13 mg/kg) and plans to dose additional participants at the Cohort 3 dosing level (0.08 mg/kg).

Key Points: 
  • Three participants have been dosed in Cohort 4, and dose-limiting toxicities (DLTs) were observed in the second and third dosed participants.
  • Magenta reported the clinical data and other information applicable to the first observed DLT to the U.S. Food and Drug Administration (FDA) today.
  • In accordance with the clinical trial protocol and following the recommendation of the trial’s safety Cohort Review Committee on December 19, 2022, Magenta plans to continue enrollment at the Cohort 3 dose level.
  • The Company continues to believe that the benefit/risk profile at the Cohort 3 dose level is acceptable to continue enrolling participants in this trial.

FDA Advisory Committee Unanimously Endorses eli-cel Gene Therapy for Cerebral Adrenoleukodystrophy

Retrieved on: 
Thursday, June 9, 2022

On the question Do the benefits of eli-cel outweigh the risks, for the treatment of any sub-population of children with early active cerebral adrenoleukodystrophy (CALD)?

Key Points: 
  • On the question Do the benefits of eli-cel outweigh the risks, for the treatment of any sub-population of children with early active cerebral adrenoleukodystrophy (CALD)?
  • We are grateful to the families, clinicians and committee members who participated in todays advisory committee discussion and remain committed to working with the FDA as it completes its review of the eli-cel Biologics License Application.
  • In addition to granting eli-cel BLA priority review, the FDA previously granted eli-cel Orphan Drug status, Rare Pediatric Disease designation, and Breakthrough Therapy designation.
  • Founded in 2010, bluebird has the largest and deepest ex-vivo gene therapy data set in the worldsetting the standard for industry.

bluebird bio Announces FDA Priority Review of Biologics License Application for eli-cel Gene Therapy for Cerebral Adrenoleukodystrophy (CALD) in Patients Without a Matched Sibling Donor

Retrieved on: 
Friday, December 17, 2021

It is estimated that more than 70% of patients diagnosed with CALD do not have a matched sibling donor.

Key Points: 
  • It is estimated that more than 70% of patients diagnosed with CALD do not have a matched sibling donor.
  • The BLA for eli-cel is supported by efficacy and safety data from the completed Phase 2/3 Starbeam study (ALD-102) (N=32).
  • All patients who completed ALD-102, as well as those who will complete ALD-104, are invited to participate in a long-term follow-up study (LTF-304).
  • bluebird bio is pursuing curative gene therapies to give patients and their families more bluebird days.

Adverum Presents Clinical Data on ADVM-022 at the American Society of Retina Specialists 39th Annual Scientific Meeting

Retrieved on: 
Saturday, October 9, 2021

Adverum is planning clinical development of ADVM-022 at low doses (2 x 10^11 vg/eye and lower) in patients with wet age-related macular degeneration (wet AMD).

Key Points: 
  • Adverum is planning clinical development of ADVM-022 at low doses (2 x 10^11 vg/eye and lower) in patients with wet age-related macular degeneration (wet AMD).
  • Last weekend, new long-term data from the OPTIC trial of ADVM-022 for wet AMD were presented at the Retina Societys 54th Annual Scientific Meeting on October 1, 2021.
  • Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

Adverum Presents 2-Year OPTIC Data Demonstrating Sustained Durability and Promising Safety Profile from Single Intravitreal Injection of ADVM-022 in Wet AMD Patients Who Previously Required Frequent Anti-VEGF Injections

Retrieved on: 
Friday, October 1, 2021

REDWOOD CITY, Calif., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced new long-term data from the OPTIC clinical trial of ADVM-022 single, in-office intravitreal (IVT) injection gene therapy in patients requiring frequent anti-VEGF injections for their neovascular or wet age-related macular degeneration (wet AMD). Safety and efficacy data from patients followed through 2 years post injection are being presented at the Retina Society’s 54th Annual Scientific Meeting in Chicago, Illinois. The presentation is available on the Publications page in the Pipeline section of Adverum’s website.

Key Points: 
  • Safety and efficacy data from patients followed through 2 years post injection are being presented at the Retina Societys 54th Annual Scientific Meeting in Chicago, Illinois.
  • Dr. Fischer stated, We continue to analyze all data from patients receiving ADVM-022 in OPTIC and our INFINITY study in diabetic macular edema.
  • "I look forward to continuing to provide input into the future development plans forADVM-022 in patients with neovascular AMD.
  • In patients with wet AMD, an aggressive form of AMD, abnormal blood vessels grow underneath and into the retina.

Medolife Rx Clinical Observations Demonstrates Effectiveness of Escozine in Complementary Use with COVID-19 Vaccines

Retrieved on: 
Thursday, July 8, 2021

Physicians observed that patients who originally had strong adverse reactions to COVID-19 vaccines and who were given Escozine, experienced significantly lessened side effects.

Key Points: 
  • Physicians observed that patients who originally had strong adverse reactions to COVID-19 vaccines and who were given Escozine, experienced significantly lessened side effects.
  • Escozine, which is comprised of scorpion peptides that have been polarized by the Companys proprietary process, is Medolifes lead drug candidate.
  • Medolife Rx, Inc. is a global biotechnology company with operations in clinical research, manufacturing, and consumer products.
  • Beyond its own clinical and consumer applications, the polarization technology used by Medolife and its subsidiaries has many potential applications.