Clinical trials

Personalis to Announce First Quarter 2020 Financial Results on May 7, 2020

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Thursday, April 23, 2020
Research, Genetics, Clinical trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, Genetic mapping, Genomics, NASDAQ, Genome, Finance, Economy of the United States

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced it will release its first quarter 2020 financial results after the market closes on Thursday, May 7, 2020.

Key Points: 
  • Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced it will release its first quarter 2020 financial results after the market closes on Thursday, May 7, 2020.
  • In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.
  • The live webinar of the call may be accessed by visiting the Events section of the company's website at investors.personalis.com.
  • Personalis also provides genomic information to the VA Million Veterans Program as part of their goal to sequence over a million veteran genomes.

Study Shows Sense of Touch Can Be Returned to Those with Spinal Cord Injury

Retrieved on: 
Thursday, April 23, 2020
Biotechnology, Technology, Other Health, Health, Other Technology, Medical devices, Research, Surgery, Science, Hardware, Clinical trials, Organ systems, Nervous system, Neuroanatomy, Paralysis, Spinal cord, Nerve, Somatosensory system

The breakthrough came from analysis of years of data collected from NeuroLifeTM program study participant Ian Burkhart, who suffered a spinal cord injury in 2010 when diving into the ocean, and now lives with paralysis in his hands and legs.

Key Points: 
  • The breakthrough came from analysis of years of data collected from NeuroLifeTM program study participant Ian Burkhart, who suffered a spinal cord injury in 2010 when diving into the ocean, and now lives with paralysis in his hands and legs.
  • Furthermore, Ian has a very severe SCI that should essentially block hand touch signals from even reaching the brain.
  • However, analysis has shown that subperceptual touch following a spinal cord injury affects Burkharts motor cortex even though there is essentially a block from the nerves in his arms and their connection back to the brain.
  • Ian has demonstrated that by recovering even simple touch sensations, his ability to control his hand through BCI improves dramatically.

AMRI Leads the Industry in Highest Ranking from SafeBridge for Highly Potent Compound Safety

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Thursday, April 23, 2020
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Amri, Pharmaceutical industry, AMRI Global, Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Amri, Pharmaceutical industry, AMRI Global

Albany Molecular Research Inc. (AMRI) announced today that the companys manufacturing facility in Rensselaer, NY has been designated Industry Leader as part of its re-certification under the SafeBridge program for "Potent Compound Safety Certification."

Key Points: 
  • Albany Molecular Research Inc. (AMRI) announced today that the companys manufacturing facility in Rensselaer, NY has been designated Industry Leader as part of its re-certification under the SafeBridge program for "Potent Compound Safety Certification."
  • The facility is the first in the industry to achieve Leader Status based on quantitative results of the Potent Compound Safety Certification program administered by SafeBridge.
  • Certification confirms that AMRI not only meets the standards identified to be an Industry Leader for the safe handling of potent active pharmaceutical ingredients (APIs), but that currently AMRI holds the top position for potent compound safety in the industry category for this classification.
  • This accomplishment emphasizes our commitment to excellence and advancing the industry standard for highly potent manufacturing, said John Ratliff , CEO.

Biomarck Announces, Phase 2a Clinical Trial Results of BIO-11006 for Acute Respiratory Distress Syndrome (ARDS)

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Thursday, April 23, 2020
Research, Other Health, Pharmaceutical, Oncology, Medical devices, Hospitals, Clinical trials, Science, Biotechnology, Medical Supplies, FDA, Health, Other Science, Health, Medicine, Medical specialties, Acute respiratory distress syndrome, Intensive care medicine, Respiratory physiology, Respiratory distress syndrome, Clinical trial, Varespladib, Evofosfamide, the Phase 2a Study, ARDS, BIO-11006, Biomarck Pharmaceuticals, Ltd.

Biomarck Pharmaceuticals, Ltd. , a biopharmaceutical company developing targeted anti-MARCKS technology for the treatment of ARDS [Acute Respiratory Distress Syndrome], cancer and other difficult to treat diseases, today announced results of a Phase 2a clinical study for patients with ARDS.

Key Points: 
  • Biomarck Pharmaceuticals, Ltd. , a biopharmaceutical company developing targeted anti-MARCKS technology for the treatment of ARDS [Acute Respiratory Distress Syndrome], cancer and other difficult to treat diseases, today announced results of a Phase 2a clinical study for patients with ARDS.
  • Based on these data and BIO-11006s safety and efficacy profile, we intend to move the investigational therapy towards a Phase 3 clinical study.
  • The Phase 2a placebo-controlled trial ( NCT03202394 ) was conducted on 38 patients enrolled at four clinical sites.
  • For more information please visit: https://clinicaltrials.gov : Identifier ( NCT03202394 )
    Globally, acute respiratory distress syndrome affects over 3 million people a year.

Cagent Vascular Announces FDA 510(k) Clearance for its Serranator Device for the Infrapopliteal Indication and Completion of its PRELUDE-BTK Clinical Trial Enrollment

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Thursday, April 23, 2020
Surgery, Medical devices, FDA, Hospitals, Diabetes, Clinical trials, Cardiology, Biotechnology, Health, Bruton's tyrosine kinase, Lluís Companys, Food and Drug Administration, Health, Government of Spain, Government, the PRELUDE-BTK Study, Cagent Vascular

The company also recently completed enrollment of its PRELUDE-BTK Study, a prospective, single-arm, multi-center feasibility study to show the safety and efficacy of the device.

Key Points: 
  • The company also recently completed enrollment of its PRELUDE-BTK Study, a prospective, single-arm, multi-center feasibility study to show the safety and efficacy of the device.
  • Six centers from Europe and New Zealand are participating in the trial which will include 30-day and 6-month follow up.
  • Carol A. Burns, President and CEO of Cagent Vascular added, Obtaining FDA clearance and completion of the PRELUDE-BTK trial enrollment were critical milestones for the companys growth.
  • The Serranator product offering for the infrapopliteal indication includes 2.5, 3.0, 3.5mm balloon diameters and 40, 80 and 120mm balloon lengths.

Sermo Reports Jury Is Still Out on Remdesivir; 31% of Physicians Who Have Used Remdesivir Rate It as Highly Effective; 31% Rate It with Low Effectiveness; 38% Rate It as Somewhere in the Middle

Retrieved on: 
Thursday, April 23, 2020
Data management, Technology, Health, General Health, Pharmaceutical, Communications, Social media, Research, Infectious diseases, Science, Clinical trials, Medical specialties, Branches of biology, Medicine, Immunology, Biotechnology, RTT, Glycoproteins, Immune system, Antibody, Monoclonal antibody, Melatonin

In the past, we have scaled up antibodies by producing them in sheep and horses, so it would be interesting to look into monoclonal antibodies.

Key Points: 
  • In the past, we have scaled up antibodies by producing them in sheep and horses, so it would be interesting to look into monoclonal antibodies.
  • Personally, I use antimalarials with azithromycin, high-dose steroids and vitamin C, sometimes an IL-6, and I also use melatonin and zinc.
  • A sample size of 250 point estimates have a precision of a +/- 6% at a 94% confidence level.
  • Sermo is the largest healthcare data collection company and social platform for physicians, reaching 1,3MM HCPs across 150 countries.

AIVITA Biomedical Publishes Study Comparing Immune Responses and Associated Survivals Induced by Dendritic and Tumor Cell Vaccines

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Thursday, April 23, 2020
Research, Genetics, Clinical trials, Biotechnology, Health, General Health, Other Science, Science, Oncology, Medicine, Medical specialties, Clinical medicine, Immune system, Immunotherapy, Virotherapy, Adaptive immune system, Immunology, Cancer vaccines

Robert O. Dillman, M.D., chief medical officer at AIVITA, and Gabriel I Nistor, M.D., chief scientific officer at AIVITA, authored the article.

Key Points: 
  • Robert O. Dillman, M.D., chief medical officer at AIVITA, and Gabriel I Nistor, M.D., chief scientific officer at AIVITA, authored the article.
  • The publication provides insight into the innate and adaptive immune responses induced by patient-specific autologous dendritic cell vaccines (DCV) and autologous tumor cell vaccines (TCV), and their impact on survival.
  • DCV was associated with a multipronged innate and adaptive immune response and correlated with improved survival compared to TCV.
  • Cytokine network analysis techniques used to analyze the serologic immune responses generated by each immunotherapy confirmed they triggered differing responses.

CEL-SCI Reports Recent Data Review by the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study

Retrieved on: 
Thursday, April 23, 2020
Oncology, Health, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Head and neck cancer, Otorhinolaryngology, RTT

CEL-SCI Corporation (NYSE American: CVM) announced today that the Independent Data Monitoring Committee (IDMC) for the Company's pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data.

Key Points: 
  • CEL-SCI Corporation (NYSE American: CVM) announced today that the Independent Data Monitoring Committee (IDMC) for the Company's pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data.
  • The IDMC meets periodically to review the safety and efficacy of the ongoing Phase 3 study.
  • The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study.
  • CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer.

Synteract Leverages the TriNetX Platform and COVID-19 Rapid Response Network to Find and Enroll Patients for Coronavirus Clinical Trials

Retrieved on: 
Thursday, April 23, 2020
Health, Pharmaceutical sciences, Clinical trials, Clinical research, Design of experiments, Pharmaceutical industry, Academic clinical trial

Since launching, seven clinical trials involving treatments and vaccines have been presented to HCOs within the network.

Key Points: 
  • Since launching, seven clinical trials involving treatments and vaccines have been presented to HCOs within the network.
  • Trial Connect, a key feature of the TriNetX platform, enables the pharmaceutical community to efficiently and directly engage clinical trial offices at HCOs with potential trial opportunities for COVID-19 patients.
  • "As the pandemic spreads, time is of the essence as we try to contain it," said Jennifer Stacey, Vice President, Clinical Sciences at TriNetX.
  • "Being able to provide access to up-to-date COVID-19 clinical data to researchers quickly is crucial since the world is depending on clinical trials to find ways to treat this disease.