TRIMETREXATE APPROVED FOR TREATMENT OF PCP

News 12/20/1993 TRIMETREXATE APPROVED FOR TREATMENT OF PCP
NOTE TO CORRESPONDENTS                        Arthur Whitmore
Dec. 20, 1993                                 (301) 443-4177

           
     FDA has approved trimetrexate glucuronate for the treatment of
moderate to severe Pneumocystis carinii pneumonia (PCP), a
potentially fatal infection that often strikes people with AIDS. 
     Trimetrexate is the first drug approved for severe PCP,
although three other drugs are approved for treatment of patients
with milder forms of the disease.  A substantial number of PCP
patients fail to respond to, or are intolerant of, these other
drugs  -- trimethoprim/sulfamethoxazole, injectable pentamidine and
atovaquone. 
     Trimetrexate must be administered concurrently with leucovorin
(folinic acid) to protect against potential toxic effects of
tremetrexate in human cells.  Patients must be monitored carefully
and must continue leucovorin therapy for 72 hours past the last
dose of trimetrexate. 
     The drug was given expanded distribution prior to approval
under a "treatment IND" in February 1988 -- the first AIDS-related
drug to have been granted this status.  Treatment IND regulations
provide a mechanism for making promising experimental drugs
available to patients with certain serious or life-threatening
conditions before all clinical trials required for approval have
been completed.        
     U.S. Bioscience Inc. of West Conshohocken, Pa., manufactures 

trimetrexate and will market it under the name NeuTrexin.   

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