March’s top news stories

2nd April 2018 (Last Updated April 2nd, 2018 00:00)

Arrowhead Pharmaceuticals dosed the first subject in a Phase I/II clinical trial of ARO-HBV for the treatment of patients with chronic hepatitis B virus (HBV) infection, and CSL Behring started AEGIS-II Phase III clinical trial of CSL112 to reduce early recurrent cardiovascular events after an acute myocardial infarction (MI). Drugdevelopment-technology.com wraps up the key headlines from March 2018.

Arrowhead dosed first patient in Phase I/II trial of ARO-HBV

Arrowhead Pharmaceuticals dosed the first subject in a Phase I/II clinical trial of ARO-HBV for the treatment of patients with chronic hepatitis B virus (HBV) infection.

As part of the AROHBV1001 (NCT03365947) trial, Arrowhead will assess the safety, tolerability, and pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in healthy adult subjects.

The trial also evaluated the safety, tolerability, and pharmacodynamic of multiple-ascending doses (MAD) of ARO-HBV in patients with chronic HBV.


CSL Behring initiated AEGIS-II Phase III trial of CSL112

CSL Behring started the ApoA-I Event reducinG in Ischemic Syndromes II (AEGIS-II) Phase III clinical trial of CSL112 to reduce early recurrent cardiovascular events after an acute myocardial infarction (MI).

The study will evaluate the efficacy and safety of CSL112 in reducing the risk of major adverse cardiovascular events (MACE) in patients with acute coronary syndrome (ACS).

MACE is defined as heart attack, stroke or cardiovascular death.


Australia’s USC launched trial of new vaccine for coeliac disease

Clinical Trials Centre at the University of the Sunshine Coast (USC) in Australia launched a clinical trial of a new vaccine for coeliac disease by switching off the immune response of those suffering with the disease to gluten.

Adults aged between 18 and 70 can participate in the trial if they have medically diagnosed the disease and have been following a strict gluten-free diet for one year or more.

Coeliac disease is a chronic medical condition in which the ingestion of even a small amount of gluten will lead to an immune response that damages the small intestine.


AOBiome reported positive safety results in Phase Ib/IIa trial

AOBiome Therapeutics reported positive safety results from a Phase Ib/IIa clinical trial of its Ammonia Oxidizing Bacteria (AOB) product candidate for intranasal delivery to treat seasonal allergic rhinitis (SAR).

The trial aims to evaluate the safety and tolerability of the AOB candidate in up to 24 healthy subjects, and preliminary efficacy as a prophylaxis therapy in up to 42 individuals with a history of SAR due to ragweed pollen.

The results are included in the first part of the multi-dose, vehicle-controlled trial.


Deinove acquired Redx Pharma antibiotics programme

Biotech Deinove acquired anti-infective programme Novel Bacterial Topoisomerase Inhibitor (NBTI), created by British company Redx pharma. The programme is designed to help develop a novel antibiotic group for treating infections caused by Gram-negative bacteria.

Under the deal, Deinove received the option for a licence on a series of molecules about to enter preclinical development, as well as becoming responsible for the continuation of Redx’s anti-infective program.

“Deinove has powerful tools and a strong team to quickly develop the NBTI program, said Redx chairman Iain Ross."


Two genes identified for possible virus-related cancer treatment

Researchers at Virginia Commonwealth University’s Massey Cancer Center identified two genes that could be used in the development of novel treatments for virus-associated diseases such as stomach cancer and lymphomas.

The genes under examination, PIAS1 and IRF8, play a crucial role in halting the replication of the Epstein-Barr virus (EBV). EBV assists the growth of several types of cancer and is one of the most common viral infections seen in humans. Around 95% of adults carry it and according to the US Department of Health and Human Services, it contributes to almost 200,000 cases of cancer and over 140,000 deaths every year.

Cancers that derive from EBV include Burkitt’s lymphoma, Hodgkin’s lymphoma, nasopharyngeal cancer and subtypes of stomach cancer.


Humanigen ended enrolment in Phase I trial of lenzilumab for CMML

Humanigen finished enrolling patients in its ongoing Phase I trial of lenzilumab in patients with previously treated chronic myelomonocytic leukaemia (CMML).

The trial seeks to examine the maximum tolerated dose, safety and efficacy of single-agent lenzilumab in 12 patients with CMML who are relapsed, refractory to, or intolerant to standard-of-care treatments.

It also intends to provide additional data on pharmacokinetics and pharmacodynamics.


GSK initiated Phase III trial of Benlysta and rituximab combination

GlaxoSmithKline (GSK) started its Phase III trial evaluating Benlysta (belimumab) in combination with rituximab to treat adult patients with systemic lupus erythematosus (SLE).

The 104-week superiority study, BLISS-BELIEVE, will enrol around 200 patients with SLE.

The trial aims to determine the efficacy and safety of belimumab administered in combination with a single cycle of rituximab. Additionally, the study will evaluate whether co-administration improves the treatment effect of belimumab and provides sustained disease control that could lead to clinical remission.


New study reported potential of DMAU as male birth control pill

Findings from a new study demonstrated that the experimental male oral contraceptive, dimethandrolone undecanoate (DMAU), could be effectively used as a birth control pill for men.

The study was conducted at the University of Washington Medical Center and Harbor-UCLA Medical Center in Torrance, California. It showed that DMAU is safe when used every day for a month, with hormone responses consistent with effective contraception.

The trial included 100 healthy men, aged 18 to 50 years, of whom 83 completed the study.


Benitec started Phase II trial of BB-401 for HNSCC

Australian biotechnology company Benitec Biopharma commenced a Phase II trial to evaluate BB-401 for the treatment of patients with head and neck squamous cell carcinoma (HNSCC).

The open-label trial has been designed to examine the safety, tolerability and efficacy of BB-401 following intratumoral injections into the lesions of patients with recurrent or metastatic HNSCC.