ZymoGenetics says phase 1 TACI-Ig study in multiple myeloma has early, promising results

By E. Janene Geiss

Philadelphia, Dec. 12 - ZymoGenetics, Inc. said Monday that preliminary data from a phase 1 study of TACI-Ig in nine patients with multiple myeloma and Waldenstrom's macroglobulinemia show early promising results.

Investigators said TACI-Ig reduced circulating polyclonal immunoglobulin levels and had an acceptable tolerability profile with few treatment-related adverse events, according to a company news release.

The ongoing open-label, dose-escalation study was designed to determine the maximum tolerated dose and the optimal biological dose of TACI-Ig in these patients.

Patients are receiving five weekly subcutaneous injections of TACI-Ig at either 2, 4, 7 or 10 mg, officials said.

Preliminary results of the first three cohorts with patients who received 2, 4 and 7mg, consisting of six patients with multiple myeloma and three patients with Waldenstrom's macroglobulinemia, have shown no dose-limiting toxicity. TACI-Ig was well tolerated with few adverse events and fewer drug-related adverse events, officials said.

Two patients with multiple myeloma and two patients with Waldenstrom's macroglobulinemia demonstrated a stabilization of disease at the end of the first treatment cycle, officials said.

Two of the four patients continue to have stable disease after three treatment cycles, and one patient is undergoing extension treatment and will be evaluated at a later date, officials said.

Investigators concluded that these early results were encouraging and that higher doses up to 10mg or prolonged treatment might be necessary to obtain more sustained responses. Patients are being recruited for treatment at higher doses of TACI-Ig, officials said.

These results were presented at the annual meeting of the American Society of Hematology in Atlanta.

ZymoGenetics is a Seattle biopharmaceutical company focused on the development and commercialization of therapeutic proteins for the prevention or treatment of human diseases.

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