FDA OKs CLOTTING AGENT FOR CHRISTMAS DISEASEROCKVILLE, Md. H The Food and Drug Administration saidThursday that it approved a clotting agent for treatinghemophilia B, a rare form of hemophilia known as Christmasdisease.
Human coagulation factor IX, trade named AlphaNine, wasdeveloped by Alpha Therapeutic Corp. of Los Angeles, a whollyowned unit of Green Cross Corp. of Osaka, Japan.
Christmas disease, which each year affects about 2,800 peoplein the United States, is caused by a defect in the gene forproducing factor IX that is needed in blood clotting.
AlphaNine is a non-recombinant form of Factor IX purifiedfrom human plasma. It is expected to cause fewer cases ofexcessive blood clotting than existing pure factor IX complexdrugs, said Rani Stoddard, AlphaNine's product manager. Alphaprojects its potential market at $90 million.
The Factor IX gene has been cloned, but no company has said itplans to develop a genetically engineered form.
ALFACELL'S ANTI-CANCER DRUG BEGINS TRIALS
Alfacell Corp. of Bloomfield, N.J., said Thursday that a Phase IIclinical trial of its experimental Onconase anti-cancer drug wasstarted at the Thompson Cancer Survival Center in Knoxville,Tenn.
Phase I trials of Onconase, previously known as P-30, for thetreatment pancreatic cancer are continuing at Thompson and atthe New York Medical College in Valhalla, N.Y., said KuslimaShogen, Alfacell's president and chief operating officer.
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