ANN ARBOR — Adeona Pharmaceuticals Inc. (NYSE Amex: AEN) said Thursday that it had started a Phase II clinical trial of Trimesta (oral estriol) for the treatment of cognitive dysfunction in multiple sclerosis in women.
This clinical trial is intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients at the University of California, Los Angeles and is being conducted at by Principal Investigator, Rhonda Voskuhl, M.D., director of the UCLA MS program.
There is currently no approved therapy for the treatment of cognitive dysfunction in MS.
“Statistics show that 50 to 65 percent of patients affected by MS will develop disabilities due to a reduction in their cognitive processing speed,” said Voskuhl, who is principal investigator in the trial. “Despite the fact that cognitive dysfunction is a primary source of work related disability in MS, there remains no treatment to target this disability. The goal of this trial is to address this unmet need for MS patients, potentially improving a person’s mental sharpness and ability to continue working.”
This randomized, double-blind, placebo-controlled Phase II clinical trial is based on findings from a previously completed 10-patient, single-agent, crossover Phase I/II clinical trial conducted by Dr. Voskuhl and colleagues at UCLA.
The results from the Phase I/II trial demonstrated a statistically significant 14 percent improvement from baseline in Paced Auditory Serial Addition Test cognitive testing scores in relapsing-remitting MS patients after six months of Trimesta therapy. The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability and is widely used in MS to measure cognitive function. Estriol has also been shown to have neuroprotective benefits in animal models of MS, a property not generally shared by currently approved MS therapies.
The new Phase II clinical trial is a randomized, double-blind, placebo-controlled trial intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients. Subjects will be equally randomized to receive either once-daily Trimesta or matching placebo. The primary outcome measure is the average change in PASAT scores at 12 months between each group. Secondary outcome measures include relapse rates (the primary endpoint of the ongoing Phase II clinical trial of Trimesta for relapsing-remitting MS), whole brain atrophy determined by MRI and safety. Charitable organizations have pledged to financially support a majority of the new MS clinical trial. Detailed information regarding this clinical trial, including contact information for the clinical site, is available at www.clinicaltrials.gov/ct2/show/NCT01466114.
In addition to the clinical trial of Trimesta for cognitive dysfunction in MS, Trimesta is also the subject of a separate ongoing 15-center Phase II, randomized, double-blind, placebo-controlled clinical trial seeking to demonstrate Trimesta’s ability to reduce relapse rates in women with the relapsing-remitting form of MS.
With more than $8 million in grant funding awarded to date, this separate ongoing Trimesta clinical trial should be funded to its completion. Additional information regarding the relapsing-remitting multiple sclerosis clinical trial is available at www.clinicaltrials.gov/ct2/show/NCT00451204.
“While our Board of Directors has strategically implemented several actions to prioritize our focus on the emerging field of synthetic biologics, our continued commitment to this important new MS clinical trial, having substantial external funding, is consistent with our mission of maintaining and building value for our shareholders,” said Jeffrey Riley, Adeona’s board chairman.
More at www.adeonapharma.com.