PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI) today announced that the company will advance its Nuvion(R) (visilizumab) antibody in patients with intravenous steroid- refractory ulcerative colitis (IVSR-UC) into a phase 3 program.
FREMONT, CA, USA | Apr 26, 2007 | PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI) today announced that the company will advance its Nuvion(R) (visilizumab) antibody in patients with intravenous steroid- refractory ulcerative colitis (IVSR-UC) into a phase 3 program. Advancement of the program follows guidance from an independent external Data Monitoring Committee (DMC) based on a planned safety and futility assessment of data from 60 patients enrolled in an ongoing phase 2/3 clinical trial of the Nuvion antibody in patients with IVSR-UC. As a result, the company will continue with enrollment in this ongoing phase 2/3 trial, known as RESTORE 1, while starting a second pivotal trial in the same patient population, known as RESTORE 2.
"We are pleased to continue development of Nuvion in this important indication," said Mark A. McCamish, M.D., Ph.D., senior vice president and chief medical officer, PDL BioPharma. "There is a significant unmet medical need in patients with IVSR-UC, as patients at this stage of the disease have exhausted other treatment options and are facing surgery to remove their colons."
Nuvion is a humanized monoclonal antibody designed to target and modulate the action of T cells, the cells believed to cause inflammation leading to ulcerative colitis (UC), with the aim of significantly reducing the symptoms of the disease and potentially delaying the need for colectomy, or surgical removal of the colon. An estimated 60,000 UC patients a year in both the U.S. and Europe undergo colectomies.
Long-term follow-up data from PDL’s earlier Nuvion studies in this patient population will be presented at the upcoming Digestive Disease Week congress, which will be held from May 19 – 24, 2007 in Washington, D.C.
About Ulcerative Colitis
Ulcerative colitis is a chronic disease caused by an abnormality in the body’s immune system that leads to inflammation and ulceration of the innermost lining of the colon (or large intestine), which can cause diarrhea, pain and bleeding. In severe cases, individuals may have diarrhea 10 to 20 times a day, which may lead to dehydration, fever, hospitalization and the need for blood transfusions. More than one million people worldwide suffer from UC, which primarily affects men and women in their 30s, but can occur at any age. An estimated 25 to 40 percent of these patients eventually fail to respond to standard medical therapy of oral and intravenous steroids.
About PDL BioPharma
PDL BioPharma, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative therapies for severe or life-threatening illnesses. Commercially focused in the acute-care hospital setting, PDL markets and sells its portfolio of leading products in the United States and Canada. A pioneer of antibody humanization technology, PDL promotes this technology through licensing agreements and clinical development of its own diverse pipeline of investigational compounds. PDL’s research platform centers on the discovery and development of antibodies to treat cancer and autoimmune diseases. For more information, please visit www.pdl.com.
Forward-looking Statements
The information in this press release should be considered accurate only as of the date of this press release. PDL has no intention of updating and specifically disclaims any duty to update the information in this press release for any reason, except as required by law, even as new information becomes available or other events occur in the future. This press release contains "forward-looking statements" that are based on current expectations and assumptions that are subject to risks and uncertainties. The actual results may differ materially from those in the forward-looking statements because of various factors, risks and uncertainties. In particular, the advancement of the Nuvion program following the guidance of the DMC may not be predictive of continued advancement of the program or predictive of results that would need to be obtained in the additional evaluations and studies that would be necessary to demonstrate the Nuvion antibody to be safe and effective in the treatment of patients with IVSR-UC. There can also be no assurance that PDL will initiate or complete the RESTORE 2 trial or any other subsequent clinical trials which would be necessary to support marketing approval of the Nuvion antibody by the United States Food and Drug Administration. For further information regarding factors, risks and uncertainties that may cause such differences, please refer to the filings PDL has made with the Securities and Exchange Commission, including the "Risk Factors" sections of PDL’s Quarterly and Annual Reports, copies of which may be obtained at the "Investors" section on PDL’s website at www.pdl.com. All forward- looking statements in this press release are qualified in their entirety by this cautionary statement.
SOURCE: PDL BioPharma, Inc.
Post Views: 130
PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI) today announced that the company will advance its Nuvion(R) (visilizumab) antibody in patients with intravenous steroid- refractory ulcerative colitis (IVSR-UC) into a phase 3 program.
FREMONT, CA, USA | Apr 26, 2007 | PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI) today announced that the company will advance its Nuvion(R) (visilizumab) antibody in patients with intravenous steroid- refractory ulcerative colitis (IVSR-UC) into a phase 3 program. Advancement of the program follows guidance from an independent external Data Monitoring Committee (DMC) based on a planned safety and futility assessment of data from 60 patients enrolled in an ongoing phase 2/3 clinical trial of the Nuvion antibody in patients with IVSR-UC. As a result, the company will continue with enrollment in this ongoing phase 2/3 trial, known as RESTORE 1, while starting a second pivotal trial in the same patient population, known as RESTORE 2.
"We are pleased to continue development of Nuvion in this important indication," said Mark A. McCamish, M.D., Ph.D., senior vice president and chief medical officer, PDL BioPharma. "There is a significant unmet medical need in patients with IVSR-UC, as patients at this stage of the disease have exhausted other treatment options and are facing surgery to remove their colons."
Nuvion is a humanized monoclonal antibody designed to target and modulate the action of T cells, the cells believed to cause inflammation leading to ulcerative colitis (UC), with the aim of significantly reducing the symptoms of the disease and potentially delaying the need for colectomy, or surgical removal of the colon. An estimated 60,000 UC patients a year in both the U.S. and Europe undergo colectomies.
Long-term follow-up data from PDL’s earlier Nuvion studies in this patient population will be presented at the upcoming Digestive Disease Week congress, which will be held from May 19 – 24, 2007 in Washington, D.C.
About Ulcerative Colitis
Ulcerative colitis is a chronic disease caused by an abnormality in the body’s immune system that leads to inflammation and ulceration of the innermost lining of the colon (or large intestine), which can cause diarrhea, pain and bleeding. In severe cases, individuals may have diarrhea 10 to 20 times a day, which may lead to dehydration, fever, hospitalization and the need for blood transfusions. More than one million people worldwide suffer from UC, which primarily affects men and women in their 30s, but can occur at any age. An estimated 25 to 40 percent of these patients eventually fail to respond to standard medical therapy of oral and intravenous steroids.
About PDL BioPharma
PDL BioPharma, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative therapies for severe or life-threatening illnesses. Commercially focused in the acute-care hospital setting, PDL markets and sells its portfolio of leading products in the United States and Canada. A pioneer of antibody humanization technology, PDL promotes this technology through licensing agreements and clinical development of its own diverse pipeline of investigational compounds. PDL’s research platform centers on the discovery and development of antibodies to treat cancer and autoimmune diseases. For more information, please visit www.pdl.com.
Forward-looking Statements
The information in this press release should be considered accurate only as of the date of this press release. PDL has no intention of updating and specifically disclaims any duty to update the information in this press release for any reason, except as required by law, even as new information becomes available or other events occur in the future. This press release contains "forward-looking statements" that are based on current expectations and assumptions that are subject to risks and uncertainties. The actual results may differ materially from those in the forward-looking statements because of various factors, risks and uncertainties. In particular, the advancement of the Nuvion program following the guidance of the DMC may not be predictive of continued advancement of the program or predictive of results that would need to be obtained in the additional evaluations and studies that would be necessary to demonstrate the Nuvion antibody to be safe and effective in the treatment of patients with IVSR-UC. There can also be no assurance that PDL will initiate or complete the RESTORE 2 trial or any other subsequent clinical trials which would be necessary to support marketing approval of the Nuvion antibody by the United States Food and Drug Administration. For further information regarding factors, risks and uncertainties that may cause such differences, please refer to the filings PDL has made with the Securities and Exchange Commission, including the "Risk Factors" sections of PDL’s Quarterly and Annual Reports, copies of which may be obtained at the "Investors" section on PDL’s website at www.pdl.com. All forward- looking statements in this press release are qualified in their entirety by this cautionary statement.
SOURCE: PDL BioPharma, Inc.
Post Views: 130
