June’s top stories: NIH’s Phase I/II trial for chikungunya, Boehringer & Eli Lilly’s empagliflozin trial

A new Phase I/II clinical trial of MV-CHIKV for the prevention of the chikungunya virus began enrolment, while Boehringer Ingelheim, along with Eli Lilly and Company, made plans to evaluate empagliflozin in a new clinical outcomes trial for chronic kidney disease. Drugdevelopment-technology.com wraps up the key headlines from June.


New Phase I/II trial of MV-CHIKV for chikungunya began enrolment

A new Phase I/II clinical trial of MV-CHIKV sponsored by the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) for the prevention of the chikungunya virus began enrolling healthy adult subjects at three US clinical centres.

The trial is being conducted at various NIAID-funded vaccine and treatment evaluation units.

Developed by Austrian-based biotechnology company Themis Bioscience, MV-CHIKV is an experimental candidate of the measles vaccine virus that is altered to generate chikungunya virus proteins.


Boehringer and Lilly planned to assess empagliflozin for chronic kidney disease

Boehringer Ingelheim, in collaboration with Eli Lilly and Company, planned to evaluate empagliflozin in a new clinical outcomes trial to treat patients suffering from chronic kidney disease.

Marketed under the name Jardiance, empagliflozin is an oral, once-daily, highly selective inhibitor of sodium glucose cotransporter 2 (SGLT2).

The new trial is designed to enrol up to 5,000 chronic kidney disease patients with and without type 2 diabetes.


Prostate cancer trial showed improved survivability with additional hormone therapy

The Phase II/III clinical trial (STAMPEDE) currently being conducted by the University of Birmingham, UK, demonstrated improved survivability of 37% with the use of an additional hormone therapy to treat prostate cancer patients.

The trail evaluated Abiraterone (Zytiga) as an additional treatment in patients scheduled to receive long-term hormone therapy.

Abiraterone is a hormone therapy designed to block the production of testosterone, on which prostate cancer cells depend for growth, while traditional hormone therapies only prevent the hormone’s action.


AstraZeneca and Chi-Med began Phase III trial of savolitinib for PRCC

AstraZeneca and Hutchison China MediTech (Chi-Med) began a Phase III SAVOIR clinical trial of savolitinib to treat patients with papillary renal cell carcinoma (PRCC). 

Savolitinib is an oral, highly selective inhibitor of the c-MET receptor tyrosine kinase enzyme found in various solid tumours.

The global, open-label, randomised, multi-centre, controlled, registration Phase III trial is designed to assess the safety and efficacy in around 18 patients with c-MET-driven, unresectable, locally advanced or metastatic PRCC when compared with sunitinib. 


New ovarian cancer drug found to shrink tumours in women

An early clinical trial of a new targeted treatment called ONX-0801 demonstrated a positive outcome in ovarian cancer patients.

The trial is part of a bigger Phase I trial conducted by the Institute of Cancer Research (ICR), London and The Royal Marsden NHS Foundation Trust, UK.

Discovered at the ICR, ONX-0801 acts by mimicking the action of folic acid to enter cancer cells.


Bial and Eisai reported positive results from Phase II trial of Zebinix for epilepsy

Bial and Eisai reported a positive outcome from a Phase II clinical trial (Study 208) of Zebinix (eslicarbazepine acetate) in children with focal-onset epilepsy.

Eslicarbazepine acetate is a voltage-gated, sodium channel blocker currently being designed to selectively target the channel’s slow inactivated state.

The results showed no negative impact of Zebinix on neurocognitive functions such as attention, information processing and working memory of the subjects.


New Oxford study indicated bleeding risk by aspirin in elderly patients

A new study by scientists at Oxford University, UK, showed that long-term use of aspirin may lead to a high risk of disabling or fatal bleeding in patients aged 75 or older.

According to the researchers, the short-term use of the drug after a stroke or heart attack has benefits, but patients older than 75 who need to take aspirin daily must be given a proton-pump inhibitor / heartburn medication to minimise the bleeding risk.

The observational Oxford Vascular study examined a total of 3,166 patients, 50% of which were aged 75 and above at the time of enrolment.


New Phase I/II trial indicated positive outcome for Astellas' cancer drug

US researchers at the University of Pennsylvania’s Perelman School of Medicine and Abramson Cancer Centre reported positive data from a Phase I/II clinical trial of Astellas Pharmaceuticals’ new drug gilteritinib in patients with acute myeloid leukaemia (AML). 

Gilteritinib is an inhibitor of FMS-like tyrosine kinase 3 (FLT3) gene, the mutation of which is considered to be a predictor of AML relapse and short survival. 

Results from the Phase I/II trial indicated that the response to the drug was more sustained in relapsed patients with an FLT3 mutation. 


RedHill Biopharma commenced Phase III trial of RHB-105 to treat H. pylori infection

Israeli-based specialist biopharmaceutical firm RedHill Biopharma commenced a confirmatory Phase III ERADICATE Hp 2 clinical trial of RHB-105 (Talicia) for the treatment of patients with Helicobacter pylori (H. pylori) infection.

Talicia is an oral, fixed-dose combination of two antibiotics and a proton pump inhibitor (PPI) in a single capsule.

The two-arm, randomised, double-blind, active comparator, confirmatory Phase III trial is designed to recruit 444 subjects at approximately 65 clinical centres in the US.


Threshold Pharma began dosing of cancer drugs evofosfamide and ipilimumab in Phase I trial

US-based biopharmaceutical firm Threshold Pharmaceuticals began dosing patients in a Phase I clinical trial of evofosfamide in combination with ipilimumab to treat various cancers.

The trial included patients with metastatic or locally advanced prostate cancer, metastatic pancreatic cancer, melanoma or human papillomavirus (HPV) negative squamous cell carcinoma of head and neck in case conventional treatment does not provide the potential for increased survival.

Threshold’s evofosfamide is an investigational, hypoxia-activated prodrug of a bis-alkylating agent that is selectively triggered under severe hypoxic tumour conditions found in multiple solid tumours.