May’s top news stories

1st June 2018 (Last Updated June 1st, 2018 00:00)

Abivax unveiled new data that may suggest its clinical candidate ABX464 could be a safe, functional cure for human immunodeficiency virus (HIV), as well as a method to treat inflammatory diseases; and Cancer Research UK and Experimental Cancer Medicine Centres (ECMC) Network joint venture (JV) Combinations Alliance started the SeluDex trial, a Phase I clinical study to evaluate selumetinib in combination with dexamethasone for treating leukaemia.

May’s top news stories

Abivax believed it has made progress towards HIV cure

Abivax unveiled new data that may suggest its clinical candidate ABX464 could be a safe, functional cure for human immunodeficiency virus (HIV), as well as a method to treat inflammatory diseases.

ABX464, which is an oral, novel, small molecule, binds to the cap binding complex (CBC) and enhances the splicing of two types of ribonucleic acid (RNA). The first is a segment of viral RNA that HIV requires for replication and therefore the molecule inhibits HIV replication.

When this is joined with a long non-coding human RNA it causes the expression of miR124, a small microRNA with anti-inflammatory properties. The expression of miR124 occurs in both ex-vivo and HIV patients.


Combinations Alliance started SeluDex trial for leukaemia treatment

Cancer Research UK and Experimental Cancer Medicine Centres (ECMC) Network joint venture (JV) Combinations Alliance started the SeluDex trial, a Phase I clinical study to evaluate selumetinib in combination with dexamethasone for treating leukaemia.

Conducted by the Cancer Research UK Clinical Trials Unit at the University of Birmingham, the trial will initially enrol 42 patients.

The trial aims to evaluate both adults and children who have had a relapse of their acute lymphoblastic leukaemia (ALL) or refractory ALL, and who have a mutation in a gene involved in the RAS pathway.


NIH started Phase l trial of mAb114 to treat Ebola

The US National Institutes of Health’s (NIH) Clinical Center in Bethesda, Maryland, US, started the VRC 608 Phase l clinical trial to evaluate the safety and tolerability of mAb114 for the treatment of Ebola virus disease.

The first-in-human, open-label, dose-escalation trial aims to enrol 18 to 30 healthy subjects aged 18 to 60.

As part of the trial, the first three participants will receive a 5mg/kg intravenous infusion of mAb114 for 30 minutes.


Pfizer started Phase l/ll trial of RSV vaccine

Pfizer commenced a Phase l/ll study of its unnamed respiratory syncytial virus (RSV) vaccine candidate in healthy adult subjects.

RSV is a common respiratory virus that affects the lungs and airways, as well as significantly impacts young children and older adults.

The randomised, placebo-controlled, observer-blind, dose-ranging trial will enrol subjects in two age groups in parallel to support both the maternal and older adult indications.


Emulate and AstraZeneca announced Organs-on-Chips partnership

AstraZeneca announced a collaboration with Emulate to develop and embed the start-up’s Organs-on-Chips technology within its Innovative Medicines and Early Development (IMED)  Drug Safety organisation laboratories.

The collaboration first began in 2013, with recent work published during the Society of Toxicology annual meeting in March.

Under the terms of the agreement, Emulate will co-locate scientists within AstraZeneca’s labs, while its technology will be adopted across the pharma firm’s therapeutic areas.


NIAID-sponsored trial started enrolment to treat MERS-CoV

An early stage clinical trial sponsored by the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) with an aim to treat people with Middle East respiratory syndrome coronavirus (MERS-CoV) started enrolling patients.

The trial is designed to test the safety of two human monoclonal antibodies (mAbs), including REGN3048 and REGN3051, for the treatment of MERS-CoV.

Discovered and developed by scientists at US-based biotechnology company Regeneron, the mAbs have already proved their ability to neutralise MERS-CoV in a mouse model of MERS in a study conducted by researchers at Regeneron and the University of Maryland School of Medicine.


Trovagene ended first dosing cohort in Phase lb/ll trial of PCM-075

Trovagene completed dosing the first cohort of patients in its Phase lb/ll clinical trial of PCM-075 in combination with low-dose cytarabine (LDAC) for the treatment of Acute Myeloid Leukemia (AML).

The first cohort includes three patients who received a once-daily oral dose of PCM-075 at 12mg/m² on one to five days of the treatment cycle, in combination with LDAC.

Patients included in Phase lb portion of the trial have relapsed or refractory disease and may have received as many as three prior regimens for treatment of their AML.


CBD found to reduce number of seizures in epilepsy patients

A recent study by the NYU School of Medicine found cannabidiol (CBD)-based drug Epidiolex significantly reduces the frequency of seizures in patients with Lennox-Gastaut syndrome (LGS), a severe form of epilepsy.

The Phase III trial is the third published in a major journal to evaluate an oral solution of CBD in children with a rare type of treatment-resistant epilepsy.

It compared two doses of CBD to placebo, with a total of 225 patients put on one of three courses: a 20 mg/kg/d CBD regime, 10 mg/kg/d CBD regime, or placebo. The first group reported a 41.9% decrease in ‘drop seizures’ (which cause a severe loss of muscle control and balance), while the second reported a 37.2% reduction, and the placebo group reported a 17.2% reduction.


FDA approved first non-opioid treatment for opioid withdrawal

The US Food and Drug Administration (FDA) announced its approval of Lucemyra (lofexidine hydrochloride), the first non-opioid medication intended for the reduction of withdrawal symptoms associated with opioid use disorder (OUD) in adults, enabling patients’ discontinuation of opioid treatments.

Lucemyra, manufactured by pharmaceutical company US WorldMeds, is an alpha 2-adrenergic receptor agonist that decreases the release of norepinephrine, a hormone thought to cause many opioid withdrawal symptoms. The drug’s safety and efficacy was demonstrated by two placebo-controlled trials that enrolled 866 adults who were physically dependent on opioids.

In the trials, patient progression was measured using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), which assesses opioid withdrawal symptoms based on patient-reported data. The studies found SOWS-Gossop scores to be lower for patients treated with Lucemyra compared to placebo, while more patients completed the treatment period of the studies in the Lucemyra group compared to the placebo group.


Cell recycling process could treat neurodegenerative conditions

Researchers from Brown University in Providence, US, discovered a new means of stimulating autophagy, the process by which cells recycle their damaged or worn-out parts and which could provide a basis for future neurodegenerative treatments.

The research team made the discovery while examining the biological process of aging.

They found autophagy to increase the lifespans of worms and flies, while experiments conducted in human cells demonstrated its potential in future treatments for neurodegenerative conditions such as Alzheimer’s disease and amyotrophic lateral sclerosis (ALS).

“Autophagy dysfunction is present across a range of age-related diseases, including neurodegeneration,” study leader Louis Lapierre said.

“We and others think that by learning how to influence this process pharmacologically, we might be able to affect the progression of these diseases. What we’ve shown here is a new and conserved entry point for stimulating autophagy,” he said.