October's top stories: New cancer drug delivery approach, J&J Ebola trial

UK researchers develop a new method to improve drug delivery in cancer treatment, J&J initiates clinical trial of Janssen's Ebola prime-boost vaccine regimen in Sierra Leone and Bayer begins Phase III trial of riociguat to treat children with PAH. Drugdevelopment-technology.com wraps up key headlines from October.


top october

Researchers in UK develop new method to improve drug delivery in cancer treatment

uk

Researchers at Cardiff University developed a method for improving the delivery of therapeutic molecules to kill cancer cells and cells affected by other diseases, such as tuberculosis.

The scientists said that due to their inability to reach the targeted parts of an affected cell, several drugs treatments fail to work in patients.

In order to overcome such problems, researchers at the University's Schools of Pharmacy and Pharmaceutical Sciences, and Biosciences have attempted to find ways to improve the delivery of a relatively new class of drugs called biotherapeutics.

Johnson & Johnson initiates Ebola vaccine clinical trial in Sierra Leone

J&J

Johnson & Johnson (J&J) initiated a clinical trial to evaluate the safety and immunogenicity of Janssen's Ebola prime-boost vaccine regimen in Sierra Leone.

The Ebola vaccine regimen is currently under development at J&J's Janssen Pharmaceutical Companies.

The EBOVAC-Salone trial is the first study conducted of Janssen's Ebola vaccine regimen in a West African country affected by the recent Ebola epidemic.

The company had already started patient enrolment in the trial, and the first volunteers had received their initial vaccine dose.

Bayer begins Phase III trial of riociguat to treat children with PAH

bayer

Bayer HealthCare started a Phase III trial of riociguat, a soluble guanylate cyclase (sGC) stimulator, to treat children suffering from pulmonary arterial hypertension (PAH).

Since 2013, riociguat has been approved to treat adults suffering from this life-threatening lung disorder.

Riociguat is being developed and commercialised as part of Bayer's worldwide strategic collaboration with Merck in the field of soluble guanylate cyclase (sGC) modulation.

Currently, there are only two approved treatment options available for children with PAH.

Anthera begins Sollpura Phase III trial to treat EPI in patients with cystic fibrosis

fibrosis

Anthera Pharmaceuticals started a Phase III trial (Solution) of Sollpura (liprotamase) to treat patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).

Solution is a study of oral liprotamase unit-matched therapy of non-porcine origin in people with CF.

Sollpura is a new, non-porcine pancreatic enzyme replacement therapy (PERT) that features a biotechnology derived formulation of cross-linked crystalline lipase, crystalline protease, and amorphous amylase with substrate specificity.

The trial was designed to evaluate the efficacy and safety of Sollpura, a microbial derived, biotech PERT, compared to an approved, porcine-derived, enteric-coated product.

Astellas begins Phase III trial of gilteritinib to treat AML

Japanese pharmaceutical firm Astellas began its Phase III trial of gilteritinib (ASP2215) in patients with relapsed or refractory (R/R) acute myeloid leukaemia (AML).

Overall survival (OS) was the main focus of the Phase III trial.

Discovered through a research collaboration between Astellas and Kotobuki Pharmaceutical, gilteritinib is a receptor tyrosine kinase inhibitor of FLT3 and AXL, which are involved in cancer cell growth.

Adocia and Lilly begin Phase Ib trial of BioChaperone Lispro to treat type 2 diabetes

Adocia and Eli Lilly started a Phase Ib clinical trial evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly for the treatment of patients with type 2 diabetes.

BioChaperone Lispro uses Adocia's technology, BioChaperone, to accelerate insulin absorption.

The trial is designed to measure the effect of BioChaperone Lispro injected at mealtime on post-meal glycemic control in these patients compared to that of Humalog (insulin lispro rDNA origin) over the same two-week period.

Genticel starts Phase I trial of GTL001 against HPV 16/18 infections

Genticel started the US Phase I clinical trial of GTL001, a first-in-class therapeutic vaccine candidate against human papillomavirus (HPV) 16/18 infections.

The French biotechnology firm develops new immunotherapies to prevent cancers caused by HPV.

Patients in the Phase I trial are infected with HPV 16 and/or 18, which cause 70% of cervical cancer cases.

Phase I is being conducted at three investigational sites in the US, and is designed to evaluate GTL001's safety and tolerance profile in 20 women aged from 25 to 65. The trial will therefore include older women than those previously studied in Europe.

Inotek begins dosing in Phase III MATRx-1 trial of trabodenoson to treat glaucoma

US-based Inotek Pharmaceuticals started dosing in MATRx-1, the first pivotal Phase III trial of its lead clinical candidate trabodenoson for the treatment of glaucoma.

Trabodenoson is a first-in-class selective adenosine mimetic under investigation for reduction of intraocular pressure.

Approximately 335 patients diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) are enrolled in this randomised, double-masked, placebo-controlled Phase III MATRx-1 trial.

The trial was designed to evaluate the efficacy, safety and tolerability of trabodenoson over three months of treatment.