November's top stories: GSK’s Ebola vaccine, heroin offered outside trial

GlaxoSmithKline (GSK) reported positive results from an Ebola vaccine Phase I trial, AstraZeneca and Amgen announced data from the multi-arm Phase III AMAGINE-2 trial of brodalumab in plaque psoriasis and prescription heroin is offered in Vancouver to a few severely addicted individuals. Drugdevelopment-technology.com wraps-up key headlines from November.


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GSK and NIH's Ebola vaccine shows promise in first Phase I human trial

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British drug-maker GlaxoSmithKline (GSK) reported positive results from an Ebola vaccine Phase I trial, which showed that the drug was well-tolerated and produced an immunological response in each of the 20 healthy adults in the US.

The new vaccine candidate was co-developed by the National Institutes of Health' (NIH) National Institute of Allergy and Infectious Diseases (NIAID) and Okairos, a biotechnology firm acquired by GSK in 2013.

The trial was conducted by the NIH and results were published in the New England Journal of Medicine (NEJM).

AstraZeneca and Amgen report positive results from Phase III trial of brodalumab

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AstraZeneca and Amgen reported positive results from the multi-arm Phase III AMAGINE-2 trial of brodalumab in patients with moderate-to-severe plaque psoriasis.

The trial evaluated the safety and efficacy of brodalumab given at two doses every two weeks through subcutaneous injection compared with Stelara and placebo in these patients.

More than 1,800 patients with moderate-to-severe plaque psoriasis were included in the trial that met its primary endpoints, the company said. All key secondary endpoints comparing brodalumab with placebo were also met.

Bristol-Myers Squibb's Phase III trial of Opdivo meets primary endpoint

Bristol-Myers Squibb reported positive results from a Phase III trial (CheckMate -066) comparing an investigational PD-1 immune checkpoint inhibitor, Opdivo, to the chemotherapy dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type advanced melanoma.

A total of 418 patients with treatment naïve BRAF wild-type unresectable Stage III and IV melanoma were enrolled in the trial and they were randomised to receive either Opdivo 3mg/kg every two weeks or DTIC 1000mg/m2 every three weeks.

The randomised double blind trial met the primary endpoint of overall survival (OS) with the median OS not reached for Opdivo versus 10.8 months for DTIC.

Merck's Phase II trial of melanoma drug pembrolizumab meets primary endpoint

Merck reported positive data from a pivotal Phase II trial (KEYNOTE-002) of its anti-PD-1 therapy pembrolizumab in patients with ipilimumab-refractory advanced melanoma.

Pembrolizumab is a humanised monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

The global, randomised Phase II KEYNOTE-002 trial evaluated pembrolizumab at doses of 2mg/kg every three weeks and 10mg/kg every three weeks compared to investigator's choice chemotherapy (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine or temozolomide) in these patients.

Sanofi and Regeneron report positive Phase IIb trial results of dupilumab in asthma patients

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Sanofi and Regeneron Pharmaceuticals reported positive results from the interim analysis of a dose-ranging Phase IIb trial of dupilumab, a fully-human monoclonal antibody, in adult patients with uncontrolled moderate-to-severe asthma.

Dupilumab is directed against the IL-4 receptor alpha subunit, which blocks signalling from both IL-4 and IL-13, which are major cytokines required for the initiation and maintenance of the Type 2 helper T-cell (Th2) immune response.

Created using Regeneron's VelocImmune technology, dupilumab is currently being co-developed with Sanofi in asthma, atopic dermatitis and chronic sinusitis with nasal polyposis.

Boehringer's Phase III LUX-Lung 3 trial of afatinib meets primary endpoint

Germany-based Boehringer Ingelheim reported positive data from a pre-specified subgroup-analysis of the Phase III LUX-Lung 3 trial of afatinib in Asian non-small cell lung cancer (NSCLC) patients.

The trial showed that these patients with the most common type of EGFR mutation, (exon 19 deletion; del19), lived significantly longer after receiving first-line treatment with afatinib compared to chemotherapy.

The LUX-Lung 3 trial also met its primary endpoint of progression-free survival in the overall study population.

University of Nebraska Medical Center evaluating new Alzheimer's drug

The University of Nebraska Medical Center is participating in a new Alzheimer's disease (AD) clinical research trial (NOBLE), to evaluate the potential benefits of an investigational drug in mild-to-moderate AD patients who are already being treated with donepezil (Aricept).

The NOBLE trial is evaluating an investigational drug, T-817MA, which may have the potential to modify the pace of the disease in those who are currently suffering with mild-to-moderate AD.

Initiation of this NOBLE trial comes at a time when the AD clinical research community is moving to prevention-oriented trials that do not include those already diagnosed with the disease.

Vancouver offers prescription heroin to addicts outside of clinical trial

Prescription heroin is reportedly being offered by doctors in Vancouver, British Columbia, to a few severely addicted individuals in the city.

It is claimed that this is the first time in North America that the narcotic has been dispensed outside a clinical trial.

Crosstown Clinic run by Providence Health Care will begin dispensing the first batch of prescription heroin produced in a lab in Switzerland.