[ PDLI/anti-CD3/ulcerative colitis ]
(these guys must have an incredible regulatory group)
Tuesday July 9, 4:00 pm Eastern Time
Press Release
SOURCE: Protein Design Labs, Inc.
Protein Design Labs Begins Phase I Clinical Trial of Nuvion(R) in Ulcerative Colitis
FREMONT, Calif., July 9 /PRNewswire-FirstCall/ -- Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI - News) today announced that it has initiated a Phase I clinical trial to evaluate the safety and tolerability of its humanized antibody Nuvion (visilizumab) in patients with ulcerative colitis.
The Phase I, dose-escalation pilot study of visilizumab will be conducted in patients whose ulcerative colitis has failed to respond to steroid therapy. The study is targeted to enroll up to 20 patients at eight centers in the United States. Visilizumab will be administered as one daily intravenous injection administered on two consecutive days at one of four dose levels. Patients will continue to receive steroids according to their current regimen for a period of at least seven days after receiving visilizumab. After seven days, steroid regimens may be continued or tapered.
"Increasing evidence implicates T lymphocytes as the primary immune cells mediating the induction and progression of inflammatory bowel disease," said Cary L. Queen, Ph.D., Senior Vice President, PDL. "We believe that an antibody such as visilizumab, which induces apoptosis or programmed cell death of activated T cells, could provide therapeutic benefit in ulcerative colitis. Visilizumab has previously shown evidence of activity in early stage trials in graft-versus-host disease and kidney transplantation, in which steroids also are a concomitant therapy."
Nuvion is a humanized, monoclonal antibody directed at the CD3 antigen, a component of the T-cell receptor complex. PDL currently is conducting a Phase II clinical trial of Nuvion in steroid-refractory graft-versus-host disease (GvHD) and a Phase I/II clinical trial in primary GvHD. 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 more than one year later.
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 PDL's Quarterly Report on Form 10-Q for the quarter ended March 31, 2002, and in its Annual Report on Form 10-K for the year ended December 31, 2001, as amended, and in 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 to be obtained in the Phase I/II trial in primary GvHD, or in the Phase II trial in steroid-refractory GvHD, or in the pilot trial in ulcerative colitis.
Protein Design Labs, Inc. is a leader in the development of humanized antibodies to prevent or treat various disease conditions. PDL currently has antibodies under development for autoimmune and inflammatory conditions, asthma and cancer. PDL holds fundamental patents for its antibody humanization technology. For further information, visit www.pdl.com.
NOTE: Protein Design Labs and Nuvion are registered U.S. trademarks and the PDL logo is a trademark of Protein Design Labs, Inc.
SOURCE: Protein Design Labs, Inc. |
