Protein Design Labs is enrolling patients in a Phase II/III clinicaltrials of its humanized antibody, Smart M195, for the treatmentof acute myeloid leukemia. The randomized, open-label trials,which may take several years, will focus on patients who have beentreated with chemotherapy and are in remission. The clinical endpoints of the test are extending the duration of the remissionand the survival of the patients. The trials will be conductedat eight to 12 medical centers in the U.S.Peter Dworkin, Protein Design's director of corporate communications,said that acute myeloid leukemia patients in remission afterchemotherapy typically relapse within six to nine months. Dworkinsaid Protein Design ultimately expects to show that post-chemotherapytreatments of M195 antibody can double the time of remission.The first part of the trial will involve 150 patients receivingtreatment with chemotherapy and granulocyte-colony stimulatingfactor. In the second part, about 50 of the patients who are inremission will receive Smart M195 for eight months. Those patientswill be given injections twice a week for three weeks of thefirst month. In the subsequent seven months, patients will receivetwo doses during one week of each month. All 20 doses will be atthe same level. The patients will be evaluated for up to 10 months.Dworkin said the overall length of the trials will be determinedby the time it takes to enroll patients, who must be at least60 years old.If successful, Dworkin said, Protein Design, of Mountain View,Calif., will file a new drug application for the antibody withthe FDA specifically to treat acute myeloid leukemia patients whoare in remission.The disease is most common among the elderly and usually is fatalwithin a year. The company estimated 15,000 new cases are reportedannually."The significance of this trial is that it's the second of ourcompounds to go into Phase II/III trials," Dworkin told BioWorld,"and we think it's a novel way of using the antibody. By using itin this minimal residual disease setting it may have the greatestchance to be an effective therapeutic."The other Protein Design compound in Phase II/III trials is aSmart Anti-Tac antibody for graft-versus-host disease. n

-- Charles Craig

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