By Randall Osborne
Facing approval delays in the U.S. and Europe for RIGScan CR49, its radiolabeled monoclonal antibody to detect metastatic colon cancer, Neoprobe Inc. has cut staff by 20 percent as part of a restructuring plan.
David Bupp, president and CEO of Dublin, Ohio-based Neoprobe, called the layoff of 15 workers and the shuffling of two top executives part of a "modified strategic direction" that will let to the company "do a few things very well."
One of those things is to push RIGScan CR49 to market.
In December, the FDA asked for more information in support of a biologics licensing application (BLA) for the product. A month earlier, the European Agency for the Evaluation of Medical Products had recommended Neoprobe submit a new marketing application for it. (See BioWorld Today, Jan. 5, 1998, p. 1.)
Neoprobe has put together its response to the FDA's request for more information on manufacturing the product, and is working on a package of clinical information, Bupp said.
"We feel we need to have clarification and guidance [on the request for clinical information]," he said. "We're making a request to have a meeting with them."
The company expects to meet with European regulators "in a short time" as well, Bupp said.
The terms of service for all voting members of the European agency expired last December, he added, and the company intends to meet with each of the new members.
"We're not going to fence ourselves in to exact time frames," Bupp said.
In the restructuring, Bupp, formerly president and chief operating officer, became president and CEO; and John Ridihalgh, formerly board chairman and CEO, became board chairman and chief scientific officer.
RIGS, or radioimmunoguided surgery, uses a radiolabeled agent that targets cancer cells and a hand-held radiation detection probe to locate areas where the targeting agent has accumulated.
Neoprobe also markets instruments for gamma guided surgery. The latter uses a radiolabeled drug in a non-specific, freely circulating application, while RIGS employs a tumor-specific, engineered drug, Bupp said.
The company also has begun enrolling patients with both HIV and chronic active hepatitis B or C in a Phase I trial of activated cellular therapy. Enlarged lymph nodes are removed in an outpatient surgery. Effector cells from the nodes are then activated and multiplied in a laboratory. Ten to 14 days after surgery, the cells are reinfused into the patient with the goal of bolstering the immune system.
As of Sept. 30, 1997, Neoprobe had $30.4 million in cash, with a net loss of $5.41 million for the third quarter of 1997. The company's stock (NASDAQ:NEOP) closed Wednesday at $4.938, down $0.218. *