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 tab
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