ANN ARBOR, Mich., June 23, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that it has expanded its pipeline of proprietary zinc-based therapies to include a planned Phase IIb clinical trial of patients suffering from amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease. Preparations are underway to evaluate the safety and efficacy of the Company's proprietary drug candidates, AEN-100, a gastroretentive, sustained-release zinc-based tablet, and AEN-200, a copper tablet, in a multi-center, double-blind, placebo-controlled clinical trial in ALS patients intended to be conducted under an Investigational New Drug (IND) application. Adeona will provide the study medications and fund the clinical trial, which will be conducted by the neurology team at the PNA Center for Neurological Research in collaboration with The Institute for EthnoMedicine.
Planned Phase IIb Clinical Trial in ALS Patients Evaluating Adeona's Zinc-Based Therapy
Preparation of the planned Phase IIb clinical protocol is currently ongoing for submission to the Food & Drug Administration (FDA) as an addition to a current IND application. Efforts are also underway for the manufacturing of clinical trial medications and protocol review by an Institutional Review Board. The multi-center trial is intended to take place at up to six major ALS centers in the United States. It is anticipated that the trial will enroll 60 ALS patients, who will continue on RILUTEK® (riluzole) as the standard of care treatment. The patients will be randomized into treatment and matching placebo groups and will receive clinical trial medications for 12 months with periodic monitoring. The treatment group will receive Adeona's proprietary drug candidates – AEN-100, a zinc-based tablet, and AEN-200, a copper tablet.
The planned co-primary endpoints are: 1) determining the safety of AEN-100 (elemental zinc) at 150 mg (two 75mg tablets) given to patients once daily with ALS by assessing adverse events and measuring zinc and copper levels every three months; and 2) determining the efficacy of AEN-100 by assessing the rate of disease progression as measured by the ALSFRS-R, a revised ALS functional rating scale that incorporates assessments of respiratory function.