Gene therapy for Parkinson's disease set for clinical trials

A study, recently published in The Lancet, found that a gene-bearing virus injected into the midbrains of 12 patients suffering from Parkinson's disease showed motor function improvements. “The safety and effectiveness clearly indicate that this is something worth pursuing,” said Michael Kaplitt, neurological surgeon at New York-Presbyterian Hospital. The researchers used a harmless virus to transport a gene that codes for an enzyme, called glutamic acid decarboxylase, into neurons in the area of the brain called the subthalamic nucleus. The gene prompted the subthalamic cells to produce gamma-aminobutyric acid, which made the neurons settle down and restore motor function. The 12 subjects were monitored for a period of one year and their motor function showed up to 65% improvement. The researchers are hoping to have a full scale clinical trial for the gene therapy set by the year's end.

Peregrine Pharmaceuticals, a clinical stage biopharmaceutical company, recently announced the initiation of a new Phase II clinical trial designed to evaluate the safety and efficacy of its tumor necrosis therapy (TNT) agent – Cotara – in patients with glioblastoma multiforme (GBM), a deadly form of brain cancer. In a pilot study, Cotara has demonstrated a 58% increase in the expected median survival time in a group of 28 patients suffering from recurrent late stage glioblastoma multiforme. “We anticipate that positive data from this study, together with dosimetry and dosing data being collected in ongoing U.S. Cotara trials, will help us determine the optimal design of Phase III product registration trials,” said Steven W. King, president and CEO of Peregrine.

Generex Biotechnology Corporation recently announced at the 67th Scientific Sessions of the American Diabetes Association, that the company is initiating a Phase III clinical trial of Generex Oral-lyn, an oral insulin spray product. The six month trial would include 750 type 1 diabetes mellitus patients. “We enter this trial with a great deal of confidence that the results will validate the successful outcomes that patients have experienced in previous clinical trials,” said Anna Gluskin, president and CEO of Generex.

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