Seragen Inc. announced Thursday that it has started the PhaseI/II clinical trial of its interleukin-2 (IL-2) receptor-targetedfusion protein DAB389IL-2 for the early treatment of HIVinfection.
To catch the infection in its early stages, Seragen(NASDAQ:SRGN) of Hopkinton, Mass., has defined the patientpopulation as those people whose CD4 lymphocyte count isbetween 300 and 600 per cubic millimeter. As well, theindividuals should test seropositive for the HIV-associatedprotein p24 and have not had opportunistic infections, saidThasia Woodworth, Seragen's vice president for clinical affairs.
But because the protocol also requires that the subjects not becurrently taking anti-retroviral therapy, patient enrollment hasbeen difficult. Patients with a CD4 count of about 300 "don'twant to go off anti-virals," explained Helen Maslocka, thecompany's director of corporate communications.
In fact, Seragen enrolled its first -- and so far only -- patienton May 3, although FDA approved the trial protocol on Jan. 21.Ultimately, Seragen is hoping to recruit about 15-20 people forthis safety trial, which is being conducted at Boston CityHospital, Beth Israel Hospital's Division of Infectious Diseases inBoston and Johns Hopkins Hospital's Division of ClinicalPharmacology in Baltimore.
-- Jennifer Van Brunt Senior Editor
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