BALTIMORE -- Keynote speaker James Carville had troublewarming up his audience as he asked for support for healthcare reform at Alex. Brown & Sons 18th Annual Health CareSeminar here .
Speaking before the biotechnology audience was "a little likebeing a fire plug in a dog pound," President Clinton's formercampaign manager said.
Nonetheless, his plea for the president's plan ultimately wonrespectable applause, and the mood was upbeat as moneymavens met, mixed and packed large meeting rooms to learnabout new products and companies' progress.
Nor was Carville's message forgotten. William Rastetter, chiefexecutive officer of Idec Pharmaceuticals Corp. (NASDAQ:IDPH)of La Jolla, Calif., was quick to point out that the antibodies hiscompany is developing to fight cancer and autoimmunediseases would reduce toxicity, side effects, complications andhealth care costs as they enable hospital inpatients to becomeoutpatients.
He said Idec filed on Monday a final protocol with the FDA,including responses to comments from the agency, for a PhaseIII trial of its 15-antibody panel called Specifid, designed toprolong remissions of B cell lymphoma. The company hopes tobegin the trials this summer.
The cancer, which afflicts 200,000 people in the U.S., alwaysreturns, and chemotherapy becomes increasingly ineffective ascancer cells develop pumps that bail the drugs faster thandoctors can pump them in.
Specifid is like scattershot, directed at the wide variety ofantigens presented by different cancer cells. It works in 25percent to 30 percent of patients. Prior to treatment, the panelis cross-reacted to find the right antibodies for each patient'scancer. Then the effective antibodies will be used as an adjunctto chemotherapy for low-grade lymphoma. "Every time you dochemotherapy, it does a worse job," Rastetter said. "The PhaseIII trial will seek to extend the quality and duration ofchemotherapy-induced remissions by debulking tumors andremoving the chemotherapy-resistant cells."
An aggressive form of the disease often kills patients in two to11 months. Idec has submitted to FDA a protocol for a Phase IIopen-label, no-control protocol to treat this form, which thecompany hopes to get on the agency's fast track for approval.
In a still more aggressive, but less specific strategy against Bcell lymphoma, Idec has developed a genetically engineeredantibody that in monkey studies killed all mature b-cells butspared stem cells that lack the CD20 marker.
"We anticipate spontaneous regrowth of the bone marrow,"Richard Krawiec, the company's director of investor relations,told BioWorld. The compound is in Phase I/II trials at StanfordUniversity.
In addition to killing cancer cells, monoclonal antibodies cantame an overactive immune system to ameliorate autoimmunedisorders. But immune systems frequently react to chronicadministration of mouse-derived antibodies by developingantibodies to the monoclonals.
Idec's "primatized" monoclonals are an effort to solve thisproblem. Primatized antibodies from macaque monkeys are sosimilar to human antibodies that the human immune systemdoesn't see them. Yet they are different enough to home in onoveractive CD4 cells.
Idec' first therapy will be directed at rheumatoid arthritis. "Wehope to be in clinic by midyear," Krawiec said.
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.