Techniclone Says FDA Has OKd Testing of Lymph Cancer Drug
Techniclone International Corp., a Santa Ana drug research and development firm, said Monday that the U.S. Food and Drug Administration has approved expedited testing of a drug it developed for treatment of lymph cancer.
The drug, a monoclonal antibody called LYM-I, is produced by Techniclone and marketed under license by a pharmaceutical subsidiary of American Cyanamid Corp., which will conduct the clinical testing under the FDA’s so-called orphan drug status.
Techniclone expects the expedited testing--which can pare as much as 3 1/2 years from the normal drug testing timetable--to enable it to begin making a profit late next year. It would be the first profit in the company’s six-year history, according to Techniclone’s chief executive officer, Lon H. Stone.
“It means a lot to us in that 12 months . . . the company should be in a profitable position,” said Stone.
Stone said the FDA has granted LYM-I orphan drug status under a relatively new law intended to give pharmaceutical firms financial incentive to develop drugs to treat life-threatening conditions that affect a relatively small portion of the national population. Because such drugs have a limited sales potential, few companies are willing to spend the millions of dollars necessary for the development and testing that is needed to win FDA marketing approval.
About 40,000 people a year are diagnosed with lymph cancer, which represents about 10% of all cancers in the United States, he said.
Because of LYM-I’s new “orphan drug”status, Stone said, the FDA will help develop and administer the drug’s testing program to speed up the process of FDA approval for national sale.
Without the FDA’s special assistance, he said, the clinical testing of a biological drug takes from three to five years. By contrast, he said, testing of LYM-I is expected to take between nine and 18 months.
A monoclonal antibody is a disease-fighting substance created in the laboratory by fusing an antibody--a protein that can help build immunity to a specific toxin, such as those associated with certain cancers--with a cell that can reproduce in a culture. The resulting process enables technicians to mass-produce the antibodies in the lab.
‘Grown’ and ‘Harvested’
Normally, antibodies are produced through a much slower process in which they are “grown” in a live animal host and “harvested” by a complex process of drawing blood and filtering out and isolating the desired antibodies. If Techniclone’s drug receives FDA approval, Stone said, it will be marketed by Lederle Laboratories, an American Cyanamid Corp. division which is financing the clinical trials. He said Techniclone has retained the manufacturing rights to the drug and would receive royalties on sales of LYM-I.
Techniclone, a publicly traded company which sells other monoclonal antibodies and general chemicals, lost $38,000 in its latest fiscal year ended April 30 on $500,000 in annual sales.
