Neoprobe Corp. (OTCBB:NEOP) has taken a step forward in the often-lengthy regulation process to commercialize its cancer-detection drug, RIGScan.
The company said it intends to file a Biologic License Application (BLA) for the drug, the first of several steps with the Food and Drug Administration that the company must complete before it begins more clinical testing, according to a statement from the Dublin, Ohio-based company.
A BLA is a request for permission to introduce a biologic product into interstate commerce, according to the FDA. Later, the company plans to file another document with the FDA, an Investigational New Drug Application, which also is a precursor for clinical testing.
RIGScan works by attaching itself to cancerous cells in the body, which can then be identified by a handheld radiation-detection device. A cancer patient is injected with the drug before surgery, and the radiation scanner directs the surgeon to cancerous tissue in the patient’s body.
The drug, or more precisely, the “targeting agent,” may enable more effective colorectal cancer surgeries, according to Neoprobe.
RIGScan is likely four or five years away from hitting the market, CFO Brent Larson said earlier this year.
The company is expected to further detail its plans for RIGScan next month during a conference call to discuss its third-quarter results.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In the meantime, Neoprobe also is pushing forward with attempts to commercialize its Lymphoseek drug, which is is a tracing agent that identifies cancerous lymph nodes in patients with breast cancer and melanoma. Lymphoseek could enter the market as soon as next year.
