DUBLIN, Ohio — Neoprobe Inc. has filed a request with the U.S. Food and Drug Administration to begin Phase 3 clinical trials of an injectable drug that identifies colorectal cancer that other tests cannot find.
The company has already received European regulatory approval for the proposed trial’s design and is hoping to receive approval from the FDA sometime in the second quarter, according to Chief Financial Officer Brent Larson. The trial would last between 18 and 24 months and could begin as soon as the end of this year if the company gets the OK from the FDA, Larson said.
Neoprobe’s RIGScan drug 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.
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The drug is likely four to five years away from commercialization, Larson said.
In 1997, the FDA denied the company’s application for approval of the drug, but Neoprobe has looked to revive the drug in recent years. In September, Neoprobe signed a deal with Laureate Pharma to develop and produce RIGScan.
The clinical study would involve about 250 patients, some of whom would receive RIGScan treatment while others would undergo traditional surgical care, according to a statement from Neoprobe. The trial would evaluate RIGScan’s ability to detect cancerous tissue and compare survival rates of the two patient groups.
Neoprobe in December announced that it had completed a Phase 3 trial of another cancer-detection drug, Lymphoseek, which identifies cancerous lymph nodes in patients with breast cancer or melanoma. The company plans later this year to seek FDA approval to sell the drug.
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