Hollis-Eden Commences Phase II Clinical Trial with TRIOLEX™ in Type-2 Diabetes Patients
News Jul 17, 2008
Hollis-Eden Pharmaceuticals, Inc. has announced that it has commenced a Phase II clinical trial with its oral drug candidate TRIOLEX™ (HE3286) in type 2 diabetes patients, and that it is expanding the number of clinical sites to accelerate enrollment.
The Phase II, double-blinded placebo controlled 12-week dosing trial will enroll approximately 90 patients who are stable on metformin treatment only, the current first-line therapy for type 2 diabetes, with a hemoglobin A1c (HbA1c) level in excess of 7.5 percent.
The primary endpoints for the trial will be safety and a reduction in HbA1c. Hollis-Eden plans to release preliminary interim data from this trial in the fourth quarter of 2008, and to completely enroll by the end of the year.
TRIOLEX may represent a first-in-class insulin sensitizer that Hollis-Eden believes acts by modulating inflammatory pathways. Recently announced interim data from the Company’s on-going Phase I/II clinical trial with TRIOLEX demonstrate that the compound is safe and well tolerated to date, and that it significantly improved insulin sensitivity and lowered fasting blood glucose, insulin and triglyceride levels in obese insulin resistant subjects treated orally with the compound for 28 days when compared to placebo-treated subjects.
As would be expected in a population of insulin resistant subjects, blood levels of the chemokine monocyte chemoattractant protein (MCP-1) were elevated at baseline, before initiating treatment. MCP-1 plays a central role in the evolution of insulin resistance because it causes increased migration of macrophages into adipose tissue (and other tissues), leading to low-grade chronic inflammation and gradual loss of insulin sensitivity.
Subjects treated with TRIOLEX at the highest dose showed a significant drop in MCP-1 in blood and IL-6 production by peripheral blood mononuclear cells, compared to placebo-treated subjects. This finding is consistent with what the Company believes is the anti-inflammatory mechanism of action of TRIOLEX.
Leading academic researchers have linked inflammation and type-2 diabetes, reporting that the chronic stimulation of the inflammatory kinases JNK and IKK can impair insulin signaling by inhibiting the biological function of insulin receptor substrate-1 (IRS-1), a protein that acts as a major mediator of insulin action in target cells.
The involvement of inflammation through this pathway in causing insulin resistance and type 2 diabetes is well described in the scientific literature. In addition, activation of NF-kappaB due to inflammatory mediators or oxidative stress leads to a feed forward cycle of increased production of inflammatory cytokines such as MCP-1, TNF-alpha, IL-6 and IL-1beta.
Huntsman Cancer Institute Joins National Clinical Trial Targeting AMLNews
Huntsman Cancer Institute (HCI) at the University of Utah (U of U) has been selected to participate in the Beat AML Master Trial, an innovative clinical trial sponsored by The Leukemia & Lymphoma Society (LLS). The clinical trial is testing several new targeted therapies for the treatment of patients with acute myeloid leukemia (AML). HCI is the only facility in the Mountain West offering this trial to AML patients.READ MORE
3-D Tissue Model of Developing Heart Could Aid Drug Safety Testing for Pregnant WomenNews
The heart is the first organ to develop in the womb and the first cause of concern for many parents. Parents and doctors often have to consider the mother's health as well as the potential risk regarding how medication could affect their baby."We can try to rebuild the shape of the early development heart in the lab," said Professor Zhen Ma. "It mimics the very early stage, during the embryo genesis - how the heart was formed."READ MORE
Study Extends Potential of Personalized Cell-based ImmunotherapiesNews
New methods developed for the study could be applied to devise personalized, cell-based immunotherapies for epithelial ovarian cancer or other types of tumorsREAD MORE
Comments | 0 ADD COMMENT
World Congress on Pathology and Laboratory Medicine
Sep 10 - Sep 11, 2018
International Conference on Molecular Biology and Stem Cells
Aug 13 - Aug 15, 2018
10th International Conference on Mass Spectrometry and Chromatography
Oct 08 - Oct 09, 2018