Clinical trial to test a neuroprotective compound
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The company Acorda Therapeutics recently announced that the U.S. Army Medical Research and Material Command (USAMRMC) is supporting a new clinical trial with a budged of 2.67 million dollars that will test a compound called AC105 in a Phase II clinical trial on acute spinal cord injury. This trial, intended mostly to evaluate the safety and tolerability of AC105 in people with acute SCI will start enrolling patients in the first half of 2013.
The compound AC105 is a modified form of the mineral magnesium. Loss of magnesium after spinal cord injuries creates a cascade of problems followed by a loss of functions. Restoring magnesium to proper levels leads to a protection of the neural tissue, also termed “Neuroprotection”. Giving high doses of magnesium to patients would unfortunately result in numerous side effects, including in the brain and the heart. The compound called AC105 has a formulation of magnesium that includes polyethylene glycol (PEG), improving thereby the accessibility of magnesium to the injured nervous system. Polyethylene glycol is a flexible, water-soluble polymer that once diluted in water has a viscous consistence. Polyethylene glycol alone also showed in the past some degree of neuroprotection in experimental spinal cord injuries models (see figure 1). AC105 will be therefore simply injected in the blood circulatory system, not causing any further damage to the initial injury, and will access through the blood flow the central nervous system (see figure 2).
Preclinical studies, performed by the company, demonstrated that AC105 has neuroprotective properties and leads to an improvement of locomotor function in SCI when therapy was initiated within several hours of injury. The U.S. Food and Drug Administration (FDA) granted Fast Track designation for AC105 and gave green light to conduct the phase 2 clinical trial acute SCI patients.
Acorda Therapeutics also announced that two additional compounds are being investigated in preclinical studies as a treatment for spinal cord injury: The molecule GGF2 and an altered version of the enzyme Chondroitinase.