Protein Design Labs Begins Phase II Trial of Nuvion(TM) In Steroid-Refractory Graft-Versus-Host Disease
FREMONT, Calif., March 11 /PRNewswire-FirstCall/ -- Protein Design Labs, Inc. (Nasdaq: PDLI - news; PDL) today announced that it has initiated a Phase II clinical study to evaluate its humanized antibody Nuvion (visilizumab) in patients with steroid-resistant, acute graft-versus-host disease (GvHD), a potentially fatal complication of hematopoietic cell transplantation.
The Phase II single-arm, multicenter clinical trial will be conducted at up to 20 centers in the United States with a target enrollment of 80 patients. A single dose of visilizumab at 3.0 mg/m2 will be administered to patients who have developed acute, steroid-refractory GvHD within 100 days following allogeneic hematopoietic cell transplantation. If GvHD recurs within 14 to 42 days after a response, a second dose may be administered. The study is designed to determine the proportion of patients surviving at 180 days after treatment with visilizumab.
``The objective of this trial is to obtain additional safety and efficacy data for Nuvion in patients with acute graft-versus-host disease who have failed steroid therapy,'' said Daniel J. Levitt, M.D., Ph.D., President, Research and Development, PDL. ``We are pleased to continue the development of a humanized antibody that may represent a life-saving opportunity for severely ill patients for whom there currently are no acceptable treatment options. Patients who develop steroid-refractory GvHD are the most severely ill, with life expectancies of less than three months.''
Graft-versus-host disease is a major complication following allogeneic hematopoietic cell transplantation, occurring in 30% to 80% of all recipients, depending upon the degree of donor matching. Manifestations of GvHD can include severe skin blistering, diarrhea and jaundice. Steroids are the standard primary therapy for acute GvHD; however, responses to steroid therapy frequently are not sustained and patients experience high mortality rates.
Nuvion is a humanized, monoclonal antibody directed at the CD3 antigen, a receptor for stimulating T cells. PDL previously reported results from a Phase I study of Nuvion in steroid-resistant GvHD in which patients received either seven low daily doses of Nuvion or a single higher dose. The results indicated that doses of up to 3.0 mg/m2 were well tolerated, and that Nuvion achieved a partial and complete response rate of 100%. In the group of 12 patients receiving a single dose at 3.0 mg/m2, seven patients had a complete response and all seven are alive with a median survival of more than one year.
PDL also plans to initiate a Phase I/II trial of visilizumab in primary graft-versus-host disease in the near future. PDL additionally believes that visilizumab may be appropriate for the treatment of certain autoimmune diseases, and expects that additional Phase I trials of visilizumab will be conducted in ulcerative colitis, myelodysplastic syndrome and systemic lupus erythematosis.
The foregoing contains forward-looking statements involving risks and uncertainties and PDL's actual results may differ materially from those in the forward-looking statements. Factors that may cause such differences are discussed in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2001, and our Annual Report on Form 10-K for the year ended December 31, 2000, and other filings made with the Securities and Exchange Commission. In particular, we may be unable to complete the described trials, and the results of the Phase I trial of visilizumab in steroid-refractory GvHD may not be indicative of the results we obtain in the Phase II trial... |
