8859
0
Posted on Nov 09, 2006, 5 a.m.
By Bill Freeman
The unbridled optimism that surrounded monoclonal antibodies in the 1980s was infectious. You had to be the world's toughest cynic not to be dazzled. Got cancer? No problem. Like heat-seeking missiles, monoclonal antibodies tipped with poisons or radioactive isotopes would home in on malignant cells and deliver their deadly payloads, wiping out cancer while leaving normal cells intact. How about an infectious disease? All would be well.
The unbridled optimism that surrounded monoclonal antibodies in the 1980s was infectious. You had to be the world's toughest cynic not to be dazzled. Got cancer? No problem. Like heat-seeking missiles, monoclonal antibodies tipped with poisons or radioactive isotopes would home in on malignant cells and deliver their deadly payloads, wiping out cancer while leaving normal cells intact. How about an infectious disease? All would be well. Monoclonals would surround marauding viruses and bacteria like goombahs from Tony Soprano's crew, muscling them into secluded byways where killer cells of the immune system would make them an offer they couldn't refuse.
If only things had been so simple. Monoclonal antibodies are highly pure populations of immune system proteins that attack specific molecular targets. Unfortunately, people who received infusions of the early therapeutic monoclonal antibodies tended to develop their own antibodies against the foreign ones, which caused them to become even sicker for reasons that are not entirely clear. And the liver showed a predilection for these early monoclonals, sopping them up before they could target their quarries. Clinical trials failed. Stocks plunged. Millions of dollars were lost. And a generation of scientists and biotechnology businesspeople developed the skepticism shared only by the once burned, twice shy.
Luckily, some of those individuals soldiered on despite the bad news and found ways to overcome the failings of the early versions of the drugs. Now many are hoping that 2001 will be the Year of the Monoclonals, when their perseverance will pay off in the form of lots of effective monoclonal antibody-based drugs approved or under evaluation by the U.S. Food and Drug Administration. "Antibodies will be surging ahead," says Franklin M. Berger, a biotech analyst with JP Morgan Securities. He predicts that soon there will be so many monoclonal antibodies awaiting approval by the FDA that they will cause a bottleneck in the review process.
Ten monoclonals have reached the market, and three await FDA approval, including the first two that would be equipped to deliver a dose of radiation [see table]. Another 100 or more antibodies are being tested in humans, having already shown promise in tests involving animals. But this summer the FDA sent a message that could slow the monoclonal juggernaut. In July the agency told Genentech, located in South San Francisco, Calif., that it would have to present additional data from human (clinical) trials to prove the long-term safety of its monoclonal antibody for asthma, Xolair, which mops up the antibodies that play a role in asthma and allergies. Some observers have interpreted the move as an indication that the FDA might be particularly rigorous in scrutinizing the side effects of monoclonal antibodies, especially those that patients would take for years for chronic conditions. The announcement sent a brief chill through investors, who drove down the stocks of monoclonal developers for a week or so.
Read Full Story
If only things had been so simple. Monoclonal antibodies are highly pure populations of immune system proteins that attack specific molecular targets. Unfortunately, people who received infusions of the early therapeutic monoclonal antibodies tended to develop their own antibodies against the foreign ones, which caused them to become even sicker for reasons that are not entirely clear. And the liver showed a predilection for these early monoclonals, sopping them up before they could target their quarries. Clinical trials failed. Stocks plunged. Millions of dollars were lost. And a generation of scientists and biotechnology businesspeople developed the skepticism shared only by the once burned, twice shy.
Luckily, some of those individuals soldiered on despite the bad news and found ways to overcome the failings of the early versions of the drugs. Now many are hoping that 2001 will be the Year of the Monoclonals, when their perseverance will pay off in the form of lots of effective monoclonal antibody-based drugs approved or under evaluation by the U.S. Food and Drug Administration. "Antibodies will be surging ahead," says Franklin M. Berger, a biotech analyst with JP Morgan Securities. He predicts that soon there will be so many monoclonal antibodies awaiting approval by the FDA that they will cause a bottleneck in the review process.
Ten monoclonals have reached the market, and three await FDA approval, including the first two that would be equipped to deliver a dose of radiation [see table]. Another 100 or more antibodies are being tested in humans, having already shown promise in tests involving animals. But this summer the FDA sent a message that could slow the monoclonal juggernaut. In July the agency told Genentech, located in South San Francisco, Calif., that it would have to present additional data from human (clinical) trials to prove the long-term safety of its monoclonal antibody for asthma, Xolair, which mops up the antibodies that play a role in asthma and allergies. Some observers have interpreted the move as an indication that the FDA might be particularly rigorous in scrutinizing the side effects of monoclonal antibodies, especially those that patients would take for years for chronic conditions. The announcement sent a brief chill through investors, who drove down the stocks of monoclonal developers for a week or so.
Read Full Story
