By Mary Welch
Palatin Technologies Inc. reported Phase III results showing LeuTech, its antibody-based infection imaging agent, detected appendicitis in 91 percent of positive subjects and correctly predicted the absence of appendicitis in 96 percent of negative scans.
¿We¿re right on schedule. This product¿s been three years in development and we¿re very pleased with the Phase III data,¿ said Edward Quilty, chairman and CEO of the Princeton, N.J-based company. ¿One of the investigators summed it up when he said that you don¿t often get an exciting product like this with broad-reaching applications in so many areas. We¿re optimistic.¿
The company will meet with the FDA next month with a projected filing of a biologics license application (BLA) scheduled for July. If approved, the diagnostic product could be on the market in the summer of 2000.
Palatin¿s stock was up significantly Monday despite release of the news after the market closed. The stock (NASDAQ:PLTN) gained more than 12 percent, closing at $6.75.
LeuTech, a monoclonal antibody labeled with technetium, is injected intravenously and accumulates quickly at the site of an infection, giving a bright, clear image on a gamma camera. The company is in final negotiations to partner LeuTech in the United States, Quilty said.
The Phase III trial included 10 sites and 203 patients with equivocal (suspected) appendicitis. Patient ages ranged from 5 to 86 years. The company said the typical time from injection to the first positive image was eight minutes in all patients, with as few as four minutes occurring in 38 percent of the patients. Another advantage is that there is no blood handling with LeuTech, unlike with other current infection imaging methods, the company said.
No adverse effects were reported.
Diagnostic Could Save Patients Money
¿LeuTech is a diagnostic tool that helps to either confirm or rule out appendicitis both quickly and accurately,¿ Quilty said. ¿It has tremendous utility. There are a quarter of a million suspected appendicitis cases in the U.S. each year, with half being equivocal. The changes in patient management improved both the quality and cost effectiveness of patient care. Doctors could tell patients to go home rather than be admitted under observation. It cuts costs for all patients, maybe as much as $1,000 per patient.¿
LeuTech also is in Phase II studies for the detection of osteomyelitis (bone infection), which Quilty says is a ¿base market of $40 million to $50 million.¿ Other possible indications include fever of unknown origin, postsurgical infections and inflammatory bowel disease.
Earlier this month, Phase III results on LeukoScan (sulesomab) for patients with acute atypical appendicitis were released by Immunomedics Inc., of Morris Plains, N.J., showing the diagnostic imaging agent correctly predicted that surgery would be unnecessary in 97 percent of all cases. The company submitted its BLA for three indications: acute atypical appendicitis, osteomyelitis and osteomyelitis in the setting of diabetic foot ulcers. (See BioWorld Today, April 7, 1999, p. 1.) n