October’s top stories: Eurocine Vaccines initiated influenza vaccine study, IVF usage led to conceiving male child
Eurocine Vaccines initiated a Phase I/II influenza vaccine study and a new study suggested in-vitro fertilisation increases the chances of conceiving a male child. Drugdevelopment-technology.com wraps up the key headlines from October 2016.
Eurocine Vaccines commenced a phase I/II clinical study of the quadrivalent influenza vaccine candidate Immunose FLU, a novel nose drop formulation based on the company's technology Endocine and inactivated split antigens.
The first subjects have been dosed in the trial.
The study is conducted during the present influenza season of 2016 / 2017.
Researchers at the Colorado Center for Reproductive Medicine (CCRM) discovered that use of assisted reproductive technology (ART) will increase the chances of conceiving a baby boy.
As part of the study, CCRM researchers examined infertility patients with a mean age of 37.1 years who underwent in-vitro fertilisation (IVF).
The research involved examining the embryos at the blastocyst stage, by using comprehensive chromosomal screening (CCS).
Drug discovery and development company Apitope enrolled the first patient in the Phase I clinical trial of its peptide therapy, ATX-GD-59, to treat Graves’ disease.
Apitope’s ATX-GD-59 has the potential to treat and prevent the generation of stimulating antibodies against TSHR (thyroid stimulating hormone receptor) that lead to Graves’ disease.
The Phase I study will enrol up to 30 patients and is intended to analyse the safety and initial efficacy of the product.
Stealth BioTherapeutics initiated IDDEA-HF, a Phase 2 study evaluating elamipretide in patients hospitalised due to congestive heart failure.
Heart failure causes more than two million hospitalisations in the US and Europe every year.
Stealth vice president of clinical development Jim Carr said: “In heart failure, mitochondrial dysfunction may not only be a causative factor, but may also contribute to the progression of the disease and the associated fluid build-up that causes congestion, due to muscle weakness from a lack of energy production.
US-based Celgene's Swiss subsidiary Celgene International reported positive data from its exploratory Phase Ib CD-001 study of GED-0301 (mongersen) to treat active Crohn’s disease.
GED-0301 is an orally administered anti-sense therapy and an oligonucleotide designed to target the messenger RNA (mRNA) for Smad7, resulting in the reduction of Smad7 protein levels.
Crohn’s disease is characterised by abnormally high levels of Smad7 that interfere with TGF-β1 anti-inflammatory pathways in the gut, causing an increased inflammation.
UK-based Infirst Healthcare reported positive top-line data from its Phase III IFH-2014-002 FLARE study of BC1054 to treat knee pain.
BC1054 is an orally administered soft capsule containing 200mg of lipid formulated ibuprofen used for rheumatic or muscular pain and pain of non-serious arthritic conditions to help relieve pain and swelling, as well as ease stiffness of the joints.
It is formulated in a lipid excipient matrix based on Infirst's portfolio of patented technologies.
Shire reported positive data results from a Phase 2 study analysing maribavir (SHP620), an investigational anti-viral agent studied in patients with cytomegalovirus (CMV) infection undergoing hematopoietic stem cell transplant or solid organ transplant who are resistant or refractory to (val) ganciclovir or foscarnet drugs used to treat these infections.
Memorial Sloan Kettering Cancer Centre infectious diseases specialist Genovefa Papanicolaou said: "Cytomegalovirus infection that is resistant or refractory to standard therapy in transplant patients is associated with significant complications and high mortality.
“The Phase 2 findings support further research to confirm these results among patients who have limited options to combat the infection.”
OncoGenex reported positive survival results from Apatorsen Phase 2 Borealis-2 trial in metastatic bladder cancer
OncoGenex Pharmaceuticals reported positive survival results from the final analysis of the Phase 2 Borealis-2 trial of apatorsen in combination with docetaxel treatment in 200 patients suffering from metastatic bladder cancer, whose disease had progressed following first-line platinum-based chemotherapy.
Patients who received apatorsen treatment saw a 20% reduction in risk of death, compared to patients receiving docetaxel alone.
The primary analysis was a superiority test of overall survival, performed at a one-sided 0.10 significance level using a stratified log-rank test.
US-based clinical-stage biopharmaceutical company Viking Therapeutics initiated its Phase II clinical trial of VK2809 to treat primary hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD).
VK2809 is an orally administered, tissue and receptor-subtype selective agonist of the thyroid beta receptor, as well as a type of pro-drug cleaved in vivo to generate potent thyromimetics.
It selectively activates the TRß receptor in liver tissue that is instrumental in favourably affecting cholesterol and lipoprotein levels via multiple mechanisms, including increasing the expression of low-density lipoprotein (LDL) receptors and increasing mitochondrial fatty acid oxidation.
Boston Biomedical dosed the first patient in CanStem303C, a new global Phase III study investigating napabucasin in combination with standard of care (FOLFIRI) in patients with previously treated metastatic colorectal carcinoma (mCRC).
Around 1.4 million patients are diagnosed with colorectal cancer every year, making the disease the fourth leading cause of cancer-related deaths annually, with almost 700,000 deaths reported worldwide.
An estimated 50% of all colorectal cancer patients will experience disease recurrence.