RetroSense Therapeutics hit a significant milestone when the U.S. Food & Drug Administration granted the Ann Arbor-based startup an orphan designation for its lead technology.
Orphan status for a biopharmaceutical company is actually much better than it sounds. It gives the company bureaucratic cover to continue keep pushing forward its commercialization efforts by helping protect its rights to its research.
"It's a form of intellectual property identification," says Sean Ainsworth, CEO of RetroSense Therapeutics. "That's a key part of it."
The 4-year-old startup is developing a novel gene therapy to restore vision in retinal degenerative diseases, using technology licensed from Wayne State University. RetroSense Therapeutics' platform extracts a new gene from blue-green algae that helps make cells more photo sensitive. The company plans to apply this gene to human cells to regenerate photo receptors in the retina.
The FDA Orphan designation is intended to support the development of medicines and technologies that diagnose, treat or prevent rare diseases and conditions that impact 200,000 people or fewer in the U.S. It serves as an incentive for their development by designating a seven-year period of market exclusivity following FDA approval, along with certain tax credits for clinical testing expenses.
"It gives us the chance to demonstrate efficacy," Ainsworth says. "We expect to see that in our stage one clinical study."
RetroSense Therapeutics employs four people. It is in the process of wrapping up some of its pre-clinical testing and plans to launch clinical tests in 2015.
Source: Sean Ainsworth, CEO of RetroSense Therapeutics
Writer: Jon Zemke
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