Clinical Datasets

Targetable ERBB2 mutation status is an independent marker of adverse prognosis in estrogen receptor positive, ERBB2 non-amplified primary lobular breast carcinoma: a retrospective in silico analysis of public datasets | 8/11/2020

… suggesting further acquisition of ERBB2 mutations in CDH1 -altered ILC due to the selective pressure of treatment [ 21 ]. To demonstrate the potential clinical benefit of targeting low frequency somatic mutations, prognostic analyses using large clinical datasets are required. In the MA12 trial comprising 328 premenopausal patients with ER+ primary breast cancer of all histological subtypes, non-silent ERBB2 mutations occurred in 5.2% of patients ( N  = 17) and were adversely prognostic …

Machine learning-based prediction of acute coronary syndrome using only the pre-hospital 12-lead electrocardiogram | 8/7/2020

… such models to real-world clinical settings remain questionable, and it is likely these algorithm were overfitting the data contained in the PTB dataset On the other hand, there were few studies that used clinical datasets to build ML classifiers. However, most of these studies combined classical ECG features (e.g., diagnostic ST–T amplitude changes) with a full range of other clinical data elements (e.g., patient history, physical exam abnormalities …

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Eloxx Pharmaceuticals Reports Second Quarter 2020 Financial and Operating Results and Provides Business Update Nasdaq:ELOX | Globe Newswire | 8/6/2020

… codons found at the end of healthy transcripts is maintained. This indicates that translation integrity is preserved with target-therapeutic exposure of ELX-02, consistent with the favorable tolerability profile across our preclinical and clinical datasets . On June 17, 2020, we announced that enrollment in our cystic fibrosis Phase 2 clinical trial in Europe and Israel had been resumed, while the trial in the U.S. remains paused due to the …

Targeting RET Kinase in Neuroendocrine Prostate Cancer | 8/4/2020

… RET kinase, and RET kinase itself, were enriched and activated in the AR-independent cell lines when compared with AR-dependent cell lines. In addition, RET kinase was overexpressed in NEPC tumors in multiple clinical datasets . We found that the NEPC cell line, NCI-H660, was dependent on RET expression for proliferation and that targeted RET pathway inhibitors, AD80, and two other inhibitors currently being evaluated in the clinic, LOXO …

Pathnova Laboratories (PATHNOVA) Enters into Partnership to Commercialize Todos Medicals COVID-19 and Breast Cancer Tests in Singapore | Globe Newswire | 8/3/2020

… of the Todos Tests in Singapore, and Todos will assist PATHNOVA in commercializing its nasopharyngeal cancer tests through its affiliates in the United States and Singapore. Todos will provide PATHNOVA with access to existing clinical datasets for its breast cancer diagnostics TM-B1 and TM-B2, and PATHNOVA will work closely with Todos to optimize its AI-driven algorithm to support regulatory approval in the United States and Singapore. Reciprocally …

Pathnova Laboratories (PATHNOVA) Enters into Partnership to Commercialize Todos Medicals … | 8/3/2020

… of the Todos Tests in Singapore, and Todos will assist PATHNOVA in commercializing its nasopharyngeal cancer tests through its affiliates in the United States and Singapore. Todos will provide PATHNOVA with access to existing clinical datasets for its breast cancer diagnostics TM-B1 and TM-B2, and PATHNOVA will work closely with Todos to optimize its AI-driven algorithm to support regulatory approval in the United States and Singapore. Reciprocally …

Breaking News: Pathnova Laboratories (PATHNOVA) Enters into Partnership to Commercialize Todos Medicals COVID-19 and Breast Cancer Tests in Singapore | 8/3/2020

… of the Todos Tests in Singapore, and Todos will assist PATHNOVA in commercializing its nasopharyngeal cancer tests through its affiliates in the United States and Singapore. Todos will provide PATHNOVA with access to existing clinical datasets for its breast cancer diagnostics TM-B1 and TM-B2, and PATHNOVA will work closely with Todos to optimize its AI-driven algorithm to support regulatory approval in the United States and Singapore. Reciprocally …

Todos Medical Announces Partnership with Pathnova Laboratories | 8/3/2020

… of the Todos Tests in Singapore, and Todos will assist PATHNOVA in commercializing its nasopharyngeal cancer tests through its affiliates in the United States and Singapore. Todos will provide PATHNOVA with access to existing clinical datasets for its breast cancer diagnostics TM-B1 and TM-B2, and PATHNOVA will work closely with Todos to optimize its AI-driven algorithm to support regulatory approval in the United States and Singapore. Reciprocally …

Scientific Manager (Biomarker Discovery OMNI) : South San Francisco | 7/21/2020

Scientific Manager (Biomarker Discovery OMNI) South San Francisco Return to Search Results The Position The Biomarker Discovery OMNI department is seeking a talented, collaborative and experienced Scientific Manager to develop assay systems for evaluating and translating hits from clinical datasets to biomarkers and targets for inflammatory bowel disease (IBD). The successful candidate will have expertise in in vitro systems suitable for the evaluation of interactions between the gut microbiota, intestinal …

The Law Offices of Frank R. Cruz Announces Investigation on Behalf of CytoDyn Inc. Investors (CYDY) | Business Wire | 7/2/2020

… Drug Administration for Leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients.” Then, on May 7, 2020, CytoDyn announced that its BLA for Leronlimab “will be considered completed after the clinical datasets are submitted on May 11, 2020.” On this news, the Company’s share price fell as much as $0.225, or more than 7%, during intraday trading on May 8, 2020. On June 30, 2020, Citron …

INVESTOR ALERT: Law Offices of Howard G. Smith Continues Investigation of CytoDyn Inc. (CYDY) on Behalf of Investors | Business Wire | 7/1/2020

… Drug Administration for Leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients.” Then, on May 7, 2020, CytoDyn announced that its BLA for Leronlimab “will be considered completed after the clinical datasets are submitted on May 11, 2020.” On this news, the Company’s share price fell as much as $0.225, or more than 7%, during intraday trading on May 8, 2020. On June 30, 2020, Citron …

CytoDyn and NIH of Mexico Complete Memorandum of Understanding to Conduct Small Covid-19 Phase 3 Trial for Severe and Critically Ill Patients | Globe Newswire | 6/29/2020

… drug therapies currently in use. The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously …

Targeting CD70 with cusatuzumab eliminates acute myeloid leukemia stem cells in patients treated with hypomethylating agents | 6/29/2020

… enhanced αCD70 mAb cusatuzumab has superior efficacy in reducing LSCs than αCD70 blockade alone. Fig. 3: Treatment schedule and response. Fig. 4: Cusatuzumab reduces LSCs in patients with AML. Data availability The patient-related clinical datasets in the paper were generated during and analyzed as part of a multicenter clinical trial ( NCT03030612 ). The datasets are not publicly available because the trial is ongoing, but data can be requested by any …

FACIT Backs Made-In-Ontario Data Science and Medtech Innovations | 6/24/2020

… created by Dr. Khaled El Emam , a serial entrepreneur whose previous venture, FACIT-backed Privacy Analytics , was acquired by IMS Health. Replica Analytics is developing modeling software to create synthetic data based on real clinical datasets . High quality synthetic data is increasingly sought after by researchers, the pharmaceutical industry, and other entrepreneurs who require the datasets to build new models and enable AI innovation in healthcare. Recommended AI News: AMD …

FACIT backs made-in-Ontario data science and medtech innovations through Prospects Oncology Fund | PR Newswire | 6/23/2020

… created by Dr. Khaled El Emam , a serial entrepreneur whose previous venture, FACIT-backed Privacy Analytics, was acquired by IMS Health. Replica Analytics is developing modeling software to create synthetic data based on real clinical datasets . High quality synthetic data is increasingly sought after by researchers, the pharmaceutical industry, and other entrepreneurs who require the datasets to build new models and enable AI innovation in healthcare. Dr. Czarnota, Senior Scientist …

CytoDyn Reached Its Enrollment Target for Phase 2 COVID-19 Trial for Mild to Moderate Indication – Primary End Point Announcement Is Next | Globe Newswire | 6/11/2020

… drug therapies currently in use. The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously …

CytoDyn Initiates Phase 2 Clinical Trial With Leronlimab for Treatment of NASH Other OTC:CYDY | Globe Newswire | 6/11/2020

… drug therapies currently in use. The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously …

Fireside Chat with Ryan Zarychanski, Paul Komenda, and Marshall Pitz of MindSet | 6/10/2020

… administrative data, which is different than clinical data that’s unique and individual to a patient, while administrative data could be at the population level. But, there is a clear gap in connecting these rich clinical datasets . So when you go to the hospital or doctor’s office, they’ll take lab work and you’ll have lab data generated, they may take an X-ray or a CT scan and you’ll have diagnostic …

DNAnexus raises $100M for a cloud-based analytics platform aimed at genomics and other clinical big data | 6/9/2020

DNAnexus , which provides a cloud platform for governments, universities, doctors, and pharmaceutical companies to tap into DNA and other clinical datasets and collaborate on scientific research projects, is today announcing a big step ahead in its efforts to grow its reach and purpose. The 10 year-old startup, originally spun out of Stanford’s school of medicine, has raised $100 million in funding. The round, technically a Series G, is being …

Microbiotica, Cancer Research UK and Cambridge University Hospitals Collaborate in Landmark Cancer Microbiome Study - Business Wire | 6/8/2020

… About Microbiotica Microbiotica is a leading player in the field of microbiome-based therapeutics, biomarkers and targets. The Company is building a growing pipeline of best-in-class differentiated products based on high quality clinical datasets and unique bacterial signatures that drive biology, identified by its proprietary platform. Consisting of the world’s leading microbiome Reference Genome Database, Culture Collection, mass culturing technology (Personalised Bacterial Bank) and proprietary AI tools, Microbiotica’s …

CytoDyn Receives BLA Acknowledgment Letter From the FDA | Markets Insider | Business Insider | 6/8/2020

… drug therapies currently in use. The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously …

CytoDyn Receives BLA Acknowledgment Letter From the FDA Other OTC:CYDY | Globe Newswire | 6/8/2020

… drug therapies currently in use. The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously …

Microbiotica, Cancer Research UK and Cambridge University Hospitals Collaborate in Landmark Cancer Microbiome Study | Business & Finance | manchestertimes.com | Business Wire | 6/8/2020

… About Microbiotica Microbiotica is a leading player in the field of microbiome-based therapeutics, biomarkers and targets. The Company is building a growing pipeline of best-in-class differentiated products based on high quality clinical datasets and unique bacterial signatures that drive biology, identified by its proprietary platform. Consisting of the world’s leading microbiome Reference Genome Database, Culture Collection, mass culturing technology (Personalised Bacterial Bank) and proprietary AI tools, Microbiotica’s …

Health Questions • Re: COVID-19 | 6/4/2020

RE all the scientists here laughing at my naivete: I would expect in most fields there are well-known data vendors using some sort of consortium standards that would do acquisition / normalization for these cross-institutional clinical datasets . AFAIK, that’s how data and standards sharing usually works, at least in industry. That some mysterious new data provider nobody has ever heard of before was used was, I don’t know, a …

How a Crowdsourcing Challenge Turbocharged Brain Research During Lockdown | 6/2/2020

… and machine learning, large-scale collaborations for mapping the brain have already been made possible through data-sharing, such as the Human Brain Project or the BRAIN Initiative. However, applying these collaborative ideas to clinical datasets has been difficult, in part due to the complexity and messiness of the data, as well as privacy concerns. The Neureka TM challenge is much smaller in scale, but it embodies the same principles …

Food and Drug Administration

The Law Offices of Frank R. Cruz Announces Investigation on Behalf of CytoDyn Inc. Investors (CYDY) | Business Wire | 7/2/2020

Food and Drug Administration for Leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients.” Then, on May 7, 2020, CytoDyn announced that its BLA for Leronlimab “will be considered completed after the clinical datasets are submitted on May 11, 2020.” On this news, the Company’s share price fell as much as $0.225, or more than 7%, during intraday trading on May 8, 2020. On June 30 …

INVESTOR ALERT: Law Offices of Howard G. Smith Continues Investigation of CytoDyn Inc. (CYDY) on Behalf of Investors | Business Wire | 7/1/2020

Food and Drug Administration for Leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients.” Then, on May 7, 2020, CytoDyn announced that its BLA for Leronlimab “will be considered completed after the clinical datasets are submitted on May 11, 2020.” On this news, the Company’s share price fell as much as $0.225, or more than 7%, during intraday trading on May 8, 2020. On June 30 …

NIH

CytoDyn Signs MOU With NIH of Mexico for Coronavirus Study - June 30, 2020 - Zacks.com | 6/30/2020

… Memorandum of Understanding (MOU) with the Coordinating Commission of the National Institutes of Health and High Specialty Hospitals of Mexico (NIH) to conduct a COVID-19 study on its investigational candidate, leronlimab. The study will … patients on Apr 27, 2020, and submitted additional FDA requested clinical datasets on May 11. CytoDyn Inc. Price CytoDyn Inc. price CytoDyn Inc. Quote Zacks Rank & Stocks to Consider CytoDyn currently carries a Zacks Rank …

CytoDyn and NIH of Mexico Complete Memorandum of Understanding to Conduct Small Covid-19 Phase 3 Trial for Severe and Critically Ill Patients | Globe Newswire | 6/29/2020

… announced today the Company and the Coordinating Commission of the National Institutes of Health and High Specialty Hospitals of Mexico (NIH) have entered into a Memorandum of Understanding (MOU) to conduct a COVID-19 clinical … FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation …

Coronavirus

CytoDyn and NIH of Mexico Complete Memorandum of Understanding to Conduct Small Covid-19 Phase 3 Trial for Severe and Critically Ill Patients | Globe Newswire | 6/29/2020

… is similar to our Phase 3 trial protocol in the U.S., with the exception of the number of patients.” About Coronavirus Disease 2019 CytoDyn has met its 75-patient enrollment target in its Phase 2 … FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation …

CytoDyn Reached Its Enrollment Target for Phase 2 COVID-19 Trial for Mild to Moderate Indication – Primary End Point Announcement Is Next | Globe Newswire | 6/11/2020

… and critically ill COVID-19 patients and we hope to have these important results in 2 to 3 weeks.” About Coronavirus Disease 2019 CytoDyn has met its 75-patient enrollment target in its Phase 2 … FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation …

Center for Devices and Radiological Health

Cytotron® Granted ‘Breakthrough Device Designation’ by U.S. FDA for Treatment of Breast, Liver, and Pancreatic Cancers | PR Newswire | 10/31/2019

Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD , ‘Breakthrough Device Designation’ for the CYTOTRON® - a CE marked, whole-body therapeutic medical device. “We are confident that the FDA will continue to interact with Shreis under the premises of the recent guidance ( Breakthrough Devices Program ), to enable the marketing submission, with the clinical datasets needed to …

Cytotron(R) Granted ‘Breakthrough Device Designation’ by U.S. FDA for Treatment of Breast, Liver, and Pancreatic Cancers | 10/31/2019

Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD, ‘Breakthrough Device Designation’ for the CYTOTRON® - a CE marked, whole-body therapeutic medical device. “We are confident that the FDA will continue to interact with Shreis under the premises of the recent guidance (Breakthrough Devices Program), to enable the marketing submission, with the clinical datasets needed to …

Novartis

Orchard Therapeutics plc (ORTX) Q1 2019 Earnings Call Transcript - Nasdaq.com | 5/28/2019

… of response going out to eight years or more, we believe we have one of the most robust and comprehensive clinical datasets in the field of gene therapy. In addition, the Orchard team has a … that you added around market access. Clearly, we had the Novartis Zolgensma product just approved last week, and they’ve announced their pricing strategy. I was just wondering if you could comment on how what you’re …

Orchard Therapeutics plc (ORTX) Q1 2019 Earnings Call Transcript - Nasdaq.com | 5/28/2019

… of response going out to eight years or more, we believe we have one of the most robust and comprehensive clinical datasets in the field of gene therapy. In addition, the Orchard team has a … that you added around market access. Clearly, we had the Novartis Zolgensma product just approved last week, and they’ve announced their pricing strategy. I was just wondering if you could comment on how what you’re …

Goldman Sachs

Orchard Therapeutics’ (ORTX) CEO on Q3 2019 Results - Earnings Call Transcript | Seeking Alpha | 11/9/2019

… Anvita Gupta – Guggenheim Gena Wang – Barclays Tessa Romero – JPMorgan Esther Rajavelu – Oppenheimer David Nierengarten – Wedbush Yaron Werber – Cowen Graig Suvannavejh – Goldman Sachs Operator Ladies and gentlemen, thank you for standing by, and welcome to the … believe we have one of the most robust and comprehensive clinical datasets in the field of gene therapy …

Orchard Therapeutics plc (ORTX) Q1 2019 Earnings Call Transcript - Nasdaq.com | 5/28/2019

… of response going out to eight years or more, we believe we have one of the most robust and comprehensive clinical datasets in the field of gene therapy. In addition, the Orchard team has a … you. And, our next question comes from Graig Suvannavejh from Goldman Sachs. Your line is now open. Graig Suvannavejh – Goldman Sachs – Executive Director Great, thank you. Good morning and congrats on all the progress. I …

Mark Roth

Orchard Therapeutics’ (ORTX) CEO on Q3 2019 Results - Earnings Call Transcript | Seeking Alpha | 11/9/2019

… Therapeutics PLC (NASDAQ: ORTX ) Q3 2019 Earnings 7, 2019 4:30 PM ET Company Participants Renee Leck – Director of Investor Relations Mark Rothera – President and Chief Executive Officer Frank Thomas – Chief Financial Officer Bobby Gaspar – Chief … believe we have one of the most robust and comprehensive clinical datasets in the field of gene therapy …

Orchard Therapeutics plc (ORTX) Q1 2019 Earnings Call Transcript - Nasdaq.com | 5/28/2019

… obligation to update or revise any forward-looking statements. With that, I’ll turn the call over to President and CEO Mark Rothera. 10 stocks we like better than Orchard Rx Ltd When investing geniuses David … believe we have one of the most robust and comprehensive clinical datasets in the field of gene therapy. In addition, the Orchard team has a deep understanding of developing and commercializing medicines to treat rare …