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Results From Phase 1 Clinical Study of PEG-PAL in PKU and Update on Phase 2 Clinical Study
Date:6/9/2009

NOVATO, Calif., June 9 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced results from the Phase 1 clinical study of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment of phenylketonuria (PKU). The company expects to initiate the Phase 2 clinical study in late June or early July, pending institutional review board (IRB) approval from the clinical trial sites. The U.S. Food and Drug Administration (FDA) has reviewed the Phase II clinical trial protocol.

Key findings from the Phase 1 study:

  • Substantial blood Phe level reductions in the range of 36% to 97% (mean of 62%) were observed in all patients in the fifth dosing cohort (0.1 mg/kg) with a mean baseline blood Phe level of 1113 umol/L. No notable blood Phe level reductions were observed in the first four dosing cohorts (0.001 to 0.03 mg/kg).
  • No serious immune reactions, including hives or anaphylactoid reactions, were observed.
  • Seven out of 25 patients developed late mild to moderate injection-site reactions, of which two also developed skin rashes without other symptoms and two patients developed reactions to Depo-Provera (medroxyprogesterone acetate).

Click here for graph: Correlation between blood Phe level and plasma concentration of PEG-PAL in Cohort 5.

"We are encouraged to see significant reductions in blood Phe levels in all patients in the fifth dosing cohort of the Phase 1 trial. Importantly, there were no serious reactions, and both the number and severity of the mild to moderate reactions were in-line with expectations of an enzyme of this nature," said Hank Fuchs, M.D., Chief Medical Officer of BioMar
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SOURCE BioMarin Pharmaceutical Inc.
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