"George Tachas, PhD, director of drug discovery and patents at Antisense Therapeutics Ltd. — the company that developed ATL1102 — in Victoria, Australia, told Neurology Today that the company has submitted a formal request to the FDA for a Pre-Investigational New Drug (Pre-IND) assessment of its plans for further clinical trials in MS.
“We are seeking FDA guidance and agreement on the content of the planned IND submission, including the proposed Phase IIb clinical study design and supporting non-clinical toxicology studies,” he said.
The principal investigator, Volker Limmroth, MD, PhD, a professor of neurology and chairman of the department of neurology and palliative care medicine at the University of Cologne in Köln, Germany, told Neurology Today that the study provided the first Class I evidence that the antisense treatment works in neurological disorders.
“VLA-4 antisense appears to be highly effective in the treatment of RRMS, comparable with monoclonal antibodies such as [natalizumab] or even better,” he said.
“Neurologists should tell patients with RRMS that the results are very encouraging, and within the next five years patients can expect new innovative drugs with completely new mechanisms of action, resulting in higher efficacy and better safety.""
I anticipate earlier under compassionate usage Gasman, but like others I eagerly await an update from the company regarding progress in this area of development.
Give Anp an income stream and its a whole new ball game.
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