The FDA granted the status to the company's BC-819 treatment. Biocancell uses targeted therapy, focusing on the H19 gene, to treat cancer while preserving healthy surrounding tissue. The H19 gene is expressed at high levels in over 30 types of human cancer tissues, yet is at a nearly undetectable level in surrounding normal tissues.
The FDA designation means that if the drug reaches the market and is the first drug to be registered for this usage, it will receive 7 years of protection from competition. Orphan drug status is given by the FDA to treatments for diseases that affect 200,000 or fewer people in the US.
BC-819 is in a Phase I/IIa clinical trial against pancreatic cancer, and results are expected in several weeks. The drug is also in clinical trials against ovarian cancer and a Phase I/IIa trial against bladder cancer.
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