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December 6, 2019

November’s top news stories

Eli Lilly and Boehringer Ingelheim started a Phase III clinical trial, EMPULSE, to evaluate whether Jardiance (empagliflozin) improves acute heart failure, and The Janssen Pharmaceutical Companies of Johnson & Johnson is reimagining digital clinical trial design with the launch of a new study. Clinicaltrialsarena.com wraps up key headlines from November 2019.

Lilly and Boehringer begin study of Jardiance in heart failure

Eli Lilly and Boehringer Ingelheim started a Phase III clinical trial, EMPULSE, to evaluate whether Jardiance (empagliflozin) improves acute heart failure.

Jardiance is an inhibitor of sodium glucose cotransporter 2 (SGLT2) and is indicated to lower blood sugar in adults with Type 2 diabetes when used with diet and exercise.

The drug is also intended to mitigate the risk of cardiovascular death in Type 2 diabetes patients with known cardiovascular disease.


Janssen reimagines digital clinical trial design with CHIEF-HF

The Janssen Pharmaceutical Companies of Johnson & Johnson is reimagining digital clinical trial design with the launch of a new study.

Known as Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF), the trial is a completely decentralised, mobile, indication-seeking clinical study. It will involve a population of patients with heart failure, with or without Type 2 diabetes.

It is expected to use personal smartphones and wearable devices to track participants, with no in-person clinical visits required. It will also include an individualised patient-centric outlook.

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Pembrolizumab shows ability to extend life in prostate cancer patients

A major clinical study demonstrated that immunotherapy pembrolizumab can extend life expectancy in men with advanced prostate cancer.

The Phase II clinical study conducted by a team at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust showed that one in 20 men with end-stage prostate cancer responded to pembrolizumab.

Researchers found that a small proportion of men were ‘super responders’ and were still alive after the trial had concluded.


Deep 6 AI raises funds to accelerate recruitment in clinical trials

Clinical trials acceleration software provider Deep 6 AI raised $17m through a Series A financing programme led by Point72 Ventures.

The financing round also included participation from GSR Ventures and other strategic partners.

The investment will enable Deep 6 AI to meet the demand from healthcare providers, pharma companies, and contract research organisations for the company’s suite of AI-driven tools.


Congo trial shows investigational drugs reduce Ebola death risk

Results from a clinical study carried out in the Democratic Republic of the Congo (DRC) have demonstrated that investigational drugs reduce death risk from Ebola virus disease (EVD).

Investigational therapeutics mAb114 and REGN-EB3 performed better compared to investigational treatment ZMapp. However, drug remdesivir performed similar to ZMapp.

ZMapp monoclonal antibody cocktail has been developed by Mapp Biopharmaceutical.


Roche says Tecentriq plus Avastin improves OS in liver cancer patients

Roche reported that the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) improved overall survival (OS) in unresectable hepatocellular carcinoma (HCC) patients in the Phase III IMbrave150 clinical trial.

When compared to sorafenib, the combination also led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS).

Tecentriq is a monoclonal antibody that acts on programmed death-ligand 1 (PD-L1) to activate T-cells, while Avastin is a biologic antibody targeting the vascular endothelial growth factor (VEGF) to hinder the tumour’s blood supply.


Sanofi and Aetion to integrate real-world data platforms

Sanofi formed an enterprise-wide collaboration with healthcare technology company Aetion to integrate real-world data platform Darwin with the Aetion Evidence Platform.

Sanofi has formed an enterprise-wide collaboration with healthcare technology company Aetion to integrate real-world data platform Darwin with the Aetion Evidence Platform.

The collaboration aims to develop studies capable of standing up to regulatory requirements by advancing the efficiency of real-world evidence (RWE).


Takeda reports positive long-term data for Alunbrig in ALK+ NSCLC

Takeda Pharmaceutical reported positive results from the Phase III ALTA-1L clinical trial of Alunbrig (brigatinib) in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC).

Alunbrig is a selective tyrosine kinase inhibitor (TKI) of the ALK fusion protein in NSCLC. The ALTA-1L trial assessed the drug in 275 adult patients who did not receive previous treatment with an ALK inhibitor.

In newly diagnosed participants whose cancer had spread to the brain at baseline, risk of disease progression or death decreased by 76% with Takeda’s drug compared to crizotinib.


Vertex-CRISPR’s CTX001 shows positive outcomes in trial patients

Vertex Pharmaceuticals and CRISPR Therapeutics reported positive interim results from two Phase I/II clinical trials of investigational, ex-vivo, CRISPR/Cas9 gene-edited therapy, CTX001.

CTX001 involves the engineering of a patient’s hematopoietic stem cells to generate high foetal haemoglobin levels in red blood cells.

The Phase I/II trials, CLIMB-Thal-111 and CLIMB-SCD-121, are being conducted to evaluate the safety and efficacy of a single CTX001 dose in patients with transfusion-dependent beta thalassemia (TDT) and sickle cell disease (SCD), respectively.


Hope Biosciences to trial stem cell therapy for Alzheimer’s

Hope Biosciences secured US Food and Drug Administration (FDA) approval to study its autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) in a Phase I/II trial for Alzheimer’s.

The company develops HB-adMSCs by extracting mesenchymal stem cells from a patient’s own fat tissue. The extracted cells are purified and cultured using the company’s HB-101 culture media.

Previously, the stem cell therapy was found to be safe and effective in studies for rheumatoid arthritis, Parkinson’s disease, spinal cord injury, thrombotic thrombocytopenic purpura, pancreatic cancer and cerebral palsy.

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