Posted on 09/22/2003 5:48:08 PM PDT by yonif
A drug developed at the Weizmann Institute of Science that is successful in slowing and minimizing neurological attacks on multiple sclerosis (MS) patients will soon undergo phase II clinical trials on patients with the fatal genetic disorder Huntington's disease (HD).
Named for Dr. George Huntington, who first identified it in 1872, HD is a degenerative brain disorder whose symptoms usually appear suddenly between the ages of 30 and 45, though it can show up even in toddlers. It slowly diminishes the ability of victims to walk, think, talk, and reason, causing severe disability before the victim dies. More than 250,000 Americans and hundreds or even thousands of Israeli either have HD or are symptomless carriers of the gene.
The study will be conducted in Israel and will initially include 20 to 40 patients between 18 and 70.
Proneuron Biotechnologies Inc. develops treatments for spinal cord injuries and other acute and chronic disorders of the central nervous system.
It purchased exclusive rights from Teva Pharmaceuticals for the use and commercialization of Copaxone for HD, amyotrophic lateral sclerosis (Lou Gehrig's disease or ALS), and other neurodegenerative disorders.
It has now received approval to begin the HD trial, which will assess the safety, immunological response, and efficacy of Copaxone.
The drug, developed over two decades by Dr. Dvora Teitelbaum, Prof. Ruth Arnon, and Prof. Michael Sela, received US Food and Drug Administration approval for MS patients a number of years ago.
Decades of research, led by Prof. Michal Schwartz of the Rehovot institute, have shown that neurological disorders may be effectively treated by controlling the immune activity in the central nervous system.
The neuroprotective effect of Copaxone was demonstrated in a variety of preclinical models of acute and chronic neurological disorders such as optic nerve injury, glaucoma, ALS, and HD. "The potential neuroprotective activity of Cop-1 was found in Proneuron's preclinical studies to be dependent on the regimen [frequency of administration of the drug]," said Dr. David Snyder, Proneuron vice president for clinical development. "The protocol of daily treatment, currently used for treatment of MS, did not provide neuroprotection, whereas a single periodic injection of Cop-1 appeared to maintain a long-term neuroprotective effect. A phase II clinical trial is therefore needed to find out the optimal regimen for human neurodegenerative disorders."
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