ANN ARBOR, Mich., Nov. 30, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative disease-modifying medicines for serious illnesses, announced today that the Company's clinical collaborator for amyotrophic lateral sclerosis (ALS), PNA Center for Neurological Research (PNA), reported top-line results from its pilot Phase I/II open label, three month safety study of oral high dose zinc therapy in ALS, also known as Lou Gehrig's disease. The clinical study met its primary outcome as no safety issues related to zinc therapy were observed. In addition, an average decrease in the monthly rate of disease progression was observed in the ALS patients on zinc therapy, compared to published historical controls, as well as compared to the average monthly rate of disease progression of the subjects prior to enrollment in the study.
PNA's clinical study data was presented at the 22nd International Symposium on ALS/Motor Neurone Disease in Sydney, Australia on Wednesday, November 30, 2011 at 6:00 p.m. ( Wednesday, November 30, 2011 at 2:00 a.m. Eastern Standard Time), by David S. Saperstein, M.D., and Nicole C. Hank, M.H.S.M., from PNA.
Ten patients diagnosed with sporadic ALS and on stable doses of RILUTEK® (riluzole) were enrolled in the open label, three month study of oral high dose zinc therapy. The study was conducted under an Investigational New Drug application (IND) and was registered at http://clinicaltrials.gov/ct2/show/NCT01259050. The rate of disease progression was measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a widely used, validated rating scale that assesses the progression of disability in patients with ALS, revised to also incorporate assessments of respiratory function. At baseline, the average ALSFRS-R score of these patients was 33 and the average time from symptom onset was one year.Patients were administered pills containing 90mg of elemental zinc per day, as well as 2 mg of copper every other day to prevent potential copper depletion. Eight out of the ten patients enrolled completed three months of zinc therapy. Two patients dropped out within the first month for reasons unrelated to the zinc therapy. All patients reported taste disturbance (metallic taste) and two of eight patients reported nausea (both of whom were able to complete the study after reducing their dose to 60mg of zinc per day).