January's top stories: Profectus Ebola trial, AstraZeneca-Incyte lung cancer drug
Profectus BioSciences began VesiculoVax-vectored vaccine trial, AstraZeneca and Incyte announced combination drug evaluation, SillaJen started Phase III trial for Pexa-Vec. Drugdevelopment-technology.com wraps-up the key headlines from January.
Profectus BioSciences started a Phase I trial of its VesiculoVax-vectored vaccine to treat Ebola.
Ebola is a filovirus that causes periodic outbreaks of a highly contagious and infectious human disease associated with severe hemorrhagic fever, with a mortality rate that ranges between 50% and 90%.
Transmitted from wild animals, the virus spreads in the human population through human-to-human transmission.
AstraZeneca and Incyte collaborated on a trial evaluating a new combination drug to treat lung cancer.
The firms will collaborate on a Phase I / II trial, which will be conducted by Incyte.
The trial is designed to evaluate the efficacy and safety of Incyte's Janus-associated kinase (JAK) 1 inhibitor, INCB39110, in combination with AstraZeneca's next-generation epidermal growth factor receptor (EGFR) inhibitor, Tagrisso (osimertinib).
German biotech company Mologen entered a clinical trial collaboration with the University of Texas MD Anderson Cancer Center (MD Anderson) to assess the safety and efficacy of immunomodulator lefitolimod (MGN1703) in combination with immunotherapy Yervoy (ipilimumab) in advanced solid malignancies.
The Phase I trial has been designed to evaluate MGN1703 in combination with Bristol-Myers Squibb's checkpoint inhibitor ipilimumab in an expansion phase.
The study is called 'A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients with Advanced Solid Malignancies'.
US-based biotherapeutics firm SillaJen started a Phase III study of its lead product candidate, Pexa-Vec (formerly JX-594), in patients with advanced liver cancer, also called hepatocellular carcinoma (HCC).
The Phase III trial (PHOCUS trial) is designed to evaluate the use of Pexa-Vec in treating HCC patients who have failed locoregional therapies, and are eligible for treatment with sorafenib (Nexavar), the only approved drug for advanced HCC.
A total of 600 patients who have not received prior systemic treatment for their cancer will be enrolled in this trial and they will be randomised to one of two treatment groups: one which will receive Pexa-Vec followed by sorafenib and one which will receive sorafenib alone.
A patient died after being left braindead following a Phase I clinical trial at the University Hospital of Rennes in France.
As part of the trial begun in June last year, the drug developed by Portuguese pharmaceutical company Bial was administered to 108 patients.
The Guardian reported that 90 patients were given the drug at varying doses, while the rest of them were given placebos.
Galapagos's experimental bowel disease treatment, named GLPG1205, has failed to meet the end point of its clinical trial.
The Belgium-based biotechnology company will discontinue clinical development of the drug.
Galapagos carried out an ORIGIN study that showed GLPG1205 did not differentiate from the placebo on (partial) Mayo scores.
Australian biotechnology firm Prima BioMed started a Phase I clinical trial (TACTI-mel) of IMP32, a potential treatment for melanoma.
IMP321 represents one of the first proposed active immunotherapy drugs in which the patient's own immune system is harnessed to respond to tumour antigenic debris created by chemotherapy.
In the Phase I trial, patients with unresectable or metastatic melanoma will be dosed with IMP321 in combination with an approved checkpoint inhibitor.
US-based AbbVie and Neurocrine Biosciences started the first of two Phase III trials to evaluate Elagolix in patients with uterine fibroids.
Elagolix is an orally administered, gonadotropin-releasing hormone (GnRH) antagonist. It is currently being evaluated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis.
The two clinical trials are part of the company's Elagolix Phase III uterine fibroid clinical development programme.