Though it continues to focus on oncology and cardiovascular surgical and diagnostic products, Neoprobe Corp. formed a new subsidiary called CIRA Biosciences Inc., providing a home for its shelved Activated Cellular Therapy (ACT) technology.
CIRA Bio will explore the development of patient specific cellular therapies, combining Neoprobe's ACT technology for oncology treatment with similar technology for viral and autoimmune disease treatments.
"Neoprobe had rights to the oncology technology," Neoprobe's president and CEO David Bupp told BioWorld Today. "Because we, in the past, had helped fund the cost in doing the clinical studies for the viral and autoimmune applications, we wanted a vehicle to bring all of the technologies under one umbrella."
Neoprobe, of Dublin, Ohio, and a holding company, CIRA LLC, licensed various cellular therapy technologies beginning in the late 1990s from the Ohio State University Research Foundation (OSURF). With the formation of CIRA Bio, Neoprobe amended the agreement with OSURF providing CIRA Bio with development and commercialization rights to three issued U.S. patents covering the oncology and autoimmune applications of the technology, as well as several pending patent applications. CIRA Bio also will assume Neoprobe's established investigational new drug application to begin a Phase II study in cancer patients.
Neoprobe will own about 90 percent of the outstanding shares of CIRA Bio with the remaining shares owned by principals of CIRA LLC. CIRA Bio intends to raise capital in the second half of 2005 in order to re-activate development of the technologies.
Despite promising results seen in early clinical trials, Neoprobe shelved the technology in 2000.
"We went through a series of restructurings in the late 1990s and didn't have the resources to move it forward," said Brent Larson, Neoprobe's vice president of finance and chief financial officer. With CIRA Bio, the company now can "reinvigorate this technology and get it back on an active development front," Larson said.
Bupp estimated that Neoprobe has invested about $4 million in the technology, and the company will invest between $250,000 and $300,000 to do preclinical work and complete a commercialization assessment until an initial financing is conducted.
CIRA Bio has contracted with researchers at Battelle Memorial Institute, of Columbus, Ohio, to complete the assessment. The company also intends to form a scientific advisory group to help develop clinical and regulatory strategies for the company. Bupp said it is hard to say when the company might begin clinical trials again.
"It may be as long as a year," he said. "Part of that is going to be an outgrowth of what Battelle comes up with."
ACT has shown positive results in five clinical trials in 83 patients. It has been studied in a Phase I/II trial of 43 end-stage colorectal cancer patients, demonstrating a median life extension of 14 months. In a Phase I trial of 10 colorectal and breast cancer patients whose tumors did not respond to chemotherapy regimens, it showed an improvement in tumor response. In a Phase I HIV study involving 10 patients, the therapy sustained viral load reduction in all of the patients. In a Phase I trial of 10 patients co-infected with HIV and hepatitis C, the therapy demonstrated a sustained reduction of hepatitis C virus levels. And in a Phase I trial involving 10 chronic fatigue patients, the therapy demonstrated a long-term and sustained response in eight of the patients, bringing them back to normal activity levels.
"ACT uses a patient's own lymph node lymphocytes, and the lymphocytes are expanded and activated using a validated process ex vivo," Bupp said.
The cell expansion and activation process takes about 10 days. Then, the cells are re-administered back into the patient by an intravenous route.
During a conference call Wednesday, an investor made note of the fact that a Washington University doctor who recently moved to Johns Hopkins University had been working with actor Christopher Reeve on spinal cord injury using the same technique.
John Ridihalgh, CIRA Bio's new chief scientific officer and its interim president and CEO, responded that spinal cord injury is an interesting additional application, but the initial focus for CIRA Bio will be in the areas of oncology, and autoimmune and viral diseases.
"We're certainly going to keep track of those things," Ridihalgh said, "but in the immediate future, we'll be looking at the things where we've already seen results from clinical trials."
Neoprobe's stock (OTC BB:NEOP) rose 8 cents, or 14.4 percent Wednesday, to close at 64 cents.