Adeona Announces Additional $860,000 Grant For Oral Estriol Multiple Sclerosis Clinical Trial

Main Category: Multiple Sclerosis
Also Included In: Clinical Trials / Drug Trials
Article Date: 10 Jan 2010 - 0:00 PDT

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Adeona Pharmaceuticals, Inc., (AMEX: AEN), a specialty pharmaceutical company dedicated to the awareness, diagnosis, prevention and treatment of zinc deficiency and chronic copper toxicity in the mature population, announced that the ongoing clinical trial of its Trimesta™ (oral estriol) drug candidate being conducted by Dr. Rhonda Voskuhl, Director, UCLA Multiple Sclerosis Program, UCLA Dept. of Neurology has received an additional $860,440 in grant funding through the American Recovery and Reinvestment Act. The current phase II/III clinical study is a double-blind, placebo-controlled trial taking place at sixteen sites in the US and will enroll up to 150 female Multiple Sclerosis (MS) patients. Investigators will administer Trimesta along with glatimer acetate (Copaxone®), an FDA approved therapy for MS, to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS. This ongoing clinical trial previously received a $5 million grant from the National Multiple Sclerosis Society (NMSS) in partnership with the National MS Society's Southern California chapter, with support from the National Institutes of Health (NIH).

According to Dr. Voskuhl, "This additional funding has already had a very positive impact on our trial. It has greatly increased the rate of enrollment by supporting the addition of 9 more clinical sites, bringing the total up to 16 sites across the US. We were extremely pleased that our trial was deemed important enough to be supplemented with these additional funds."

Previous Phase II Clinical Trial Results in Relapsing Remitting Multiple Sclerosis

Trimesta (oral estriol) has previously completed an initial 22-month, single-agent, crossover Phase I/II clinical trial in the US for the treatment of MS in relapsing remitting patients, with highly encouraging results. The results showed the total volume and number of enhancing pathogenic myelin lesions (established neuroimaging measurements of disease activity in MS) decreased during the treatment period as compared to a six-month pretreatment baseline period. The median total enhancing lesion volumes decreased by 79 percent (p=0.02) and the number of lesions decreased by 82 percent (p=0.09) within the first three months of treatment with Trimesta. Following a six-month drug holiday during which the patients weren't on any drug therapies, Trimesta therapy was reinitiated during a four-month retreatment phase of this clinical trial. The relapsing-remitting MS patients again demonstrated a decrease in enhancing lesion volumes of 88 percent (p=0.008) and a decrease in the number of lesions by 48 percent (p=0.04) compared with original baseline scores (1),(2).

Improvement in Cognitive Testing Scores

During the prior Phase I/II clinical trial, a 14-percent improvement in Paced Auditory Serial Addition Test ("PASAT") cognitive testing scores (p=0.04) was also observed in the MS patients at six months of therapy. PASAT is a routine cognitive test performed in patients with a wide variety of neuropsychological disorders such as MS. The PASAT scores were expressed as a mean percent change from baseline and were significantly improved in the relapsing-remitting group.

About the Trimesta Phase II/III Study

In the current phase II/III study, Trimesta is being given orally once-a-day versus placebo to 150 female relapsing-remitting MS patients in combination with a standard of care background therapy, subcutaneously injected glatimer acetate. The primary endpoint for the study will evaluate effects of the treatment combination on relapse rates at two years with a one year interim analysis using standard clinical measures of MS disability as well as secondary endpoints of magnetic resonance imaging measurements of brain lesion and effects on cognition. The study is approaching 50% enrollment with the rate of enrollment benefiting significantly from the expansion of clinical sites.

About Trimesta

Trimesta is an orally active, immunomodulatory and anti-inflammatory molecule which has been approved and marketed throughout Europe and Asia for approximately 40 years for the treatment of post-menopausal hot flashes, but which has never been introduced in North America. Estriol, the active ingredient in Trimesta, is a weak estrogenic-based molecule that is produced in the placenta by women during pregnancy. Estriol is considered to play an important role in the immunologic privilege offered to the fetus during pregnancy, and is also thought to be responsible for the spontaneous remission of Th1-mediated autoimmune diseases of women (such as multiple sclerosis and rheumatoid arthritis) during pregnancy, especially during the third trimester. Adeona has an exclusive worldwide license from UCLA to issued and pending patents invented by Dr. Voskuhl including U.S. Patent 6,936,599 covering estriol's use for MS. While currently marketed therapies for MS sell billions of dollars annually, all require frequent injections and currently is no FDA-approved oral therapy for the treatment of MS.

Source
Adeona Pharmaceuticals, Inc.

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