Cerenis Reports Positive Results for Phase 1 Study of CER-001 for the Treatment of Cardiovascular Disease
News May 18, 2010
Cerenis Therapeutics has announced the completion of a Phase 1 study of the Company's CER-001 investigational product candidate to treat patients with acute coronary syndromes.
Results of the completed study provide evidence that the investigational therapy was safe and well-tolerated at all dose levels evaluated, including those intended for future clinical development.
The Phase 1 randomized, double-blind, placebo-controlled, cross-over, single rising dose study of 32 healthy dyslipidemic human volunteers, was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single intravenous infusions of CER-001.
In this study, each subject received dosages up to 45 mg/kg and placebo in a two period crossover design. No drug related adverse events were reported for CER-001, and cholesterol mobilization was observed at dose levels of 2mg/kg and higher.
The results from this study were consistent with pre-clinical findings in demonstrating evidence of dose-related cholesterol mobilization, as well as evidence of substantial increases in HDL-cholesterol levels. Because of these properties, we believe that administration of CER-001 may promote reverse cholesterol transport and stimulate cholesterol removal in patients.
“These positive results represent an important milestone for the CER-001 program and Cerenis’ approach to developing potent HDL mimetics.” said Jean-Louis Dasseux, CEO of Cerenis. “The data are strongly supportive of continued clinical development of CER-001 as a treatment for patients with high-risk atherosclerosis, including acute coronary syndromes.”
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
'Body-on-a-Chip' Could Advance Drug EvaluationNews
MIT engineers have developed new technology that could be used to evaluate new drugs and detect possible side effects before the drugs are tested in humans. Using a microfluidic platform that connects engineered tissues from up to 10 organs, the researchers can accurately replicate human organ interactions for weeks at a time.READ MORE
Hope for Hot Flushes: New Class of Menopause Drugs Reduces SeverityNews
A new class of experimental drugs reduces hot flushes in menopausal women by almost three-quarters in just three days. The new analysis, published in the journal Menopause, also revealed sleep and concentration significantly improved in the three-day window.