An Omaha biomedical startup and two partners have secured a $1.7 million grant from the U.S. Department of Defense that will allow them to take the next step in testing a nanoparticle that has shown promise in preclinical testing in treating acute spinal cord injuries.
The three-year grant will allow ProTransit Nanotherapy to make a final formulation of the nanoparticle, invented by company co-founder Vinod Labhasetwar, and to conduct further testing, said Gary Madsen, ProTransits other co-founder and chief executive officer. Labhasetwar, now a professor of biomedical engineering at the Cleveland Clinic in Ohio, is a former researcher at the University of Nebraska Medical Center. ProTransit occupies leased space on the UNMC campus.
If successful, the results of those tests will be combined with initial studies to file an investigational new drug application with the U.S. Food and Drug Administration, a critical first step toward a clinical trial in humans.
Were very pleased to be able to move it into the next phase of development, said Madsen, former entrepreneur in residence at UNeMed Corp., UNMCs technology licensing arm.
Madsen said grants such as the one from the Defense Department are important because its difficult for startups like ProTransit to obtain venture capital funding for experimental therapies. If the company can demonstrate success in additional testing, he said, it should be able to attract investor attention that would allow it to take the therapy the next step into human trials.
The treatment involves nanoparticles, tiny spheres loaded with antioxidant enzymes. The nanoparticles, Madsen said, accumulate at the site of the injury and release the antioxidant enzymes. The enzymes neutralize free radicals, chemical byproducts of natural processes in the body, that develop at the site of the injury and cause further damage.
What were trying to do is eliminate them before they cause their damage, he said.
In a preclinical study conducted by Labhasetwar and his team, the nanoparticle demonstrated the ability to prevent further damage to the spinal cord and to help along the bodys natural repair mechanisms when injected soon after injury.
We dont know what this will do in humans, of course, Madsen said, but in preclinical testing, animals were able to get up and move around much more effectively than nontreated animals.
Madsen and his team next will make a final formulation of the nanoparticle in their lab. Then theyll make bigger batches in conjunction with the Nebraska Nanomedicine Production Plant at UNMC.
Further testing will be led by Dr. Brian Kwon, a spine surgeon and Canada Research Chair in Spinal Injury at the University of British Columbia in Vancouver. Madsen said Kwon is well known in the spinal cord research field.
The grant was awarded to ProTransit, Cleveland Clinic and the University of British Columbia. In a statement released by the clinic, a Defense Department official said the technology caught the departments attention because of its potential for use in the field.
Madsen said the researchers are looking at administering the treatment within hours of injury. Once a diagnosis is made, it would be injected almost immediately. They dont believe it could be used for older injuries.
In addition to the spinal treatment, ProTransit also is developing a topical skin application to deliver antioxidant enzymes to the skins deepest layers to prevent damage that leads to wrinkles, blemishes and cancer. Madsen said the company, after seeing some good results in various tests, is applying for another federal grant to broaden its trials and demonstrate that the product is safe and effective. It also would seek Food and Drug Administration approval so it could make a labeling claim that the product reduces the incidence of skin cancer.
julie.anderson@owh.com, 402-444-1066
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$1.7 million grant will help Omaha startup test spine injury treatment - Omaha World-Herald
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