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Home » Topics » Clinical

Clinical
Clinical RSS Feed RSS

Trial site location not always a guarantee of diversity

April 20, 2021
By Mari Serebrov
Location, location, location. Not only is that the mantra for real estate, it often is seen as an answer to diversifying clinical trials. But having a trial site in or near an underserved community is no guarantee of a diverse study population, as health care disparities can be a more pervasive issue than location. That was one of the lessons learned from the development of Celltrans Inc.’s donislecel at the University of Illinois-Chicago.
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Leukemia illustration

Menin high places: Syndax leukemia status rises as QT gets third-degree with response measure

April 20, 2021
By Randy Osborne
Adverse events and criteria for determining remission in an otherwise positive early study by Syndax Pharmaceuticals Inc. with oral menin inhibitor SNDX-5613 apparently gave Wall Street pause, and shares (NASDAQ:SNDX) closed at $13.42, down $5.96, or 31%.
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Coronavirus, lungs

Implicit’s anti-CD14 MAb heads to the U.S. in NIH COVID-19 phase II trial

April 20, 2021
By Tamra Sami
PERTH, Australia – Implicit Bioscience Ltd.’s lead candidate, IC-14, is the first anti-CD14 monoclonal antibody (MAb) to progress to the clinic as it enters a phase II trial in the U.S. in COVID-19 patients. 
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In the clinic for April 20, 2021

April 20, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 180 Life Sciences, Alnylam, Bioarctic, Eisai, Eli Lilly, Incyte, Ionis, Janssen, Jazz, Leading, Medincell, Morphosys, Ripple, Siteone, Sorrento, Steba, Syndax, T3D.
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AGN1 LEOP SV kit image

FDA OKs IDE trial of Agnovos Healthcare’s breakthrough spine device

April 19, 2021
By Meg Bryant
Agnovos Healthcare LLC, a company using regenerative medicine to treat localized effects of bone disease, has received the FDA’s nod for an IDE clinical trial to assess its AGN1 local osteo-enhancement procedure (LOEP) small-volume (SV) kit in patients with vertebral compression fractures (VCFs). The investigational device is intended to treat stable but painful VCFs via a minimally invasive procedure. The kit, which comes in the form of two single-use trays, contains a calcium-based, resorbable, triphasic implant material that is designed to align the pace of resorption with bone formation, providing treated vertebrae with immediate and durable protection.
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Ayvakit product image

Standout in KIT’s caboodle for SM, Blueprint maps Cogent pathway

April 19, 2021
By Randy Osborne
At the recent American Association for Cancer Research (AACR) meeting, Blueprint Medicines Corp. unveiled results from the registrational phase II Pathfinder study with Ayvakit (avapritinib) in systemic mastocytosis (SM), adding more promise to the KIT inhibitor class.
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In the clinic for April 19, 2021

April 19, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aegis, Alzecure, Bergenbio, Checkmate, Erytech, Humanigen, Lyndra, Medivir, Pharmabcine, Sirnaomics, Todos Medical, Transcenta, Ziopharm, Zyus.
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CEO with Koelis software workstation

Koelis reports first procedures in 3D fusion imaging-guided focal ablation of prostate cancer

April 16, 2021
By Bernard Banga
Koelis SAS reported the first successful procedures for its platform in 3D fusion imaging-guided focal ablation of prostate cancer at the Clinique Nantes Atlantis in Saint-Herblain, France. These first procedures take place against the background of a multicenter prospective clinical trial starting on the Koelis platform. This includes eight European urology centers, of which six are in France, with data being stored in a dedicated registry.
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Human natural killer cell

Affimed aims to Rock NK space, put tumors on ICE

April 16, 2021
By Randy Osborne
Heidelberg, Germany-based Affimed NV described its progress at the American Association for Cancer Research meeting and discussed the research in a conference call on 2020 financial results, adding fuel to investor enthusiasm for the firm’s natural killer (NK) cell approach, although the update did not come without some confusion.
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Phathom goes deeper into GERD; sea change ahead for PPIs?

April 16, 2021
By Randy Osborne
With phase III data due from Phathom Pharmaceuticals Inc. in the near term, investor eyes are turning to the ways that lead compound vonoprazan, a potassium-competitive acid blocker, might distinguish itself from proton pump inhibitors (PPIs) in gastroesophageal reflux disease (GERD).
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