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Ocr } 225 | THE UNBRIDLED OPTIMISM THAT SURROUNDED MONOCLONAL ANTIBODIES in the 1980s was infectious, You had to be the world’s toughest cynic not ta 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 abort an jatcerious disease? All ‘would be well, Monnaclonals would sue- round searaucing viruses ard bocteria Hike goombaks From Cony Soprano’s snuscling therm isto secluded by- ways where killer cells of the immare system would make chem en offer they soul's reise, Tr only chings had been so imp Monoclonal antibodies are highly pure popuarions of immune system proteins that attack specificmolecularrarge, Une runerely, peaple who roccived ial of tie tarly therapeusic monostonal iver showed « predilection for these early monoclonals, sopping them up be- forethey could targer their quarries, Cline ical cizls failed, Stocks plunged. Millions ofdollars were lost. Anda generation of scientists sad biotechnolegy business- veloped the skepricism shared only by the once bumed, ewice sky. Luckily, some of those individuals soldiered on despite the bad news and found ways to overcome the failings af the early sersions of the drags. Now many are hoping chat 2001 will be che Year o! the Monoelonals, when thei per- sererance wil pay of in she form of lots of elfective mozoclonal anaibody-besed hugs approved o- under evaluation by the U.S, Food and Doug Administarion, Ant: s+ Anritogies erelarge, Y-shaped molecules that cel of the immune system called 3 lymphcoyses prosiuce tefight invaders, Menacional antibodies ate made by 108, orclonas, ofono single 8 lmphazyte, ethey atteckonly ene people al entibadies nowon thernarker, ts do everything fom preventing organ-traneplantrejactian to treating cancer, Thies nuie are waiting in the wings or Food and Crvg Administration agpraval 5 Athough monocional antibaties ere usually preduced ay mammalian ceils called hypridemas, ssienticre are warking toderive them fram the milkf genetically engineered anyma's ane from transgente plants. 2159 called MAbs~are cheaperan faster to ready for rraldrugs, hich are maze cf small inerganic moieeales: 20 sp evnieic avenican “Antibodies will be surging ahead,” says Franklin M. Berger, 2 biorech analyst with JP Morgan Secucicies. He predicts hat soon there will be so many mono clonal antibodies aviting approval ly the FDA thet they will cause a borteacck inthe review process. “Ten monoclonals have reached the marker, and three awaieFDS approval = clading the first two char would equipped 10 deliver a dove of radiation [sce table o7 page 35). Another 100 or more antibodies are being tested in hu ‘mans, having already shown promise in tests iovelving enimals, Bur this summer the FDA senca mes- sage that could slewethe monoclonal jug gorau. In July the agency tld Genen- tech, located in Somth San Francisc Calif, that ir would have to prosent ad

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