CLINICAL HOLD LIFTED FROM IMMUNOMEDICS' LUPUS TRIALS

Immunomedics announced that its partner, UCB, has received notification from FDA that the clinical hold on Phase III trials with epratuzumab in patients with lupus has been lifted. Amendments to trial protocol will be submitted to institutional review boards to seek approval to treat patients who remain on the currently suspended studies and who are in need of re-treatment.

The clinical hold resulted from observations by UCB after a routine audit of the end-stage manufacturing processes by Immunomedics, which resulted in UCB's concerns regarding sterility assurance of the final product, according to Immunomedics.

Epratuzumab is a naked humanized anti-CD22 antibody being evaluated in patients with moderate and severe systemic lupus erythmetosus (SLE) and other B-cell mediated autoimmune diseases. The ALLEVIATE A trial is enrolling patients with severe lupus, and the ALLEVIATE B trial is for patients with moderate lupus activity. Both trials are Phase III randomized, double-blinded, placebo-controlled studies. The FDA has granted fast-track designation to epratuzumab for the treatment of SLE.

Immunomedics licensed epratuzumab to UCB for the treatment of all autoimmune disease indications worldwide. The company retained the rights for epratuzumab in oncology indications, but UCB has been granted a buy-in option.