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news.US-based biotech firm Bexion Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for Saposin C, an active ingredient in its proprietary drug BXQ-350, to treat glioblastoma multiforme.
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BXQ-350 is a nanovesicle formulation of Saposin C (sphingolipid activator protein C) and the phospholipid dioleoylphosphatidylserine (DOPS).
Earlier, the company secured a Phase II Bridge Award (Small Business Innovation Research Grant; SBIR) from the National Cancer Institute (NCI) to support the manufacture and clinical testing of BXQ-350.
The orphan drug status allows the company to a seven-year period of marketing exclusivity in the US for BXQ-350, if it is approved by the FDA to treat glioblastoma multiforme.
Bexion founder and CEO Dr Ray Takigiku said: "Orphan Drug status for BXQ-350 is an important milestone in the development of this new treatment modality.
"Few treatment options are available for patients suffering from glioblastoma multiforme and this designation recognizes the unmet need that exists with this disease, as well as the unique attributes of BXQ-350.
"In addition, orphan designation allows Bexion to benefit from important financial, regulatory and commercial considerations and we have seen recently that products with orphan designation have become sought after assets."
In pre-clinical trials, the company’s first-in-class biologic, BXQ-350 has shown promising results in selectively inducing cell death in the laboratory.