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news.The FDA has granted orphan drug status to BioAxone Therapeutic's drug candidate Cethrin which is currently in a phase I/IIa clinical trial for patients with acute thoracic and cervical spinal cord injuries.
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Cethrin has demonstrated neuro-protective and neuro-regenerative properties in vitro as well as in vivo studies suggesting its potential as an effective treatment for acute spinal cord injury.
Acute spinal cord injury can lead to complete and permanent loss of sensory and motor functions and require life-long specialized care for the vast majority of patients. There is currently no effective treatment for the condition.
In addition to creating significant health care costs, spinal cord injury has a dramatic impact on the quality of life of patients and those who care for them.
“The orphan drug status, granted for rare diseases afflicting less than 200,000 patients per year in the US, provides BioAxone with considerable strategic advantages for accelerating the development of its lead drug candidate Cethrin by extending its patent protection, reducing clinical development costs and facilitating regulatory filings in other countries” said Dr Frank Bobe, president and CEO of BioAxone.