Warum explodiert PDL ? - 500 Beiträge pro Seite
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weiß jemand, was los ist, Aktie steigt bei L&S um über 25%.
danke für Infos!!
danke für Infos!!
explodieren???
Gruss b2
Gruss b2
Protein Design Labs Reports Progress with Three Humanized Antibodies in Inflammatory Bowel Disease
Encouraging Interim Results Reported for Nuvion(R) in Ulcerative Colitis Daclizumab and HuZAF(TM) Begin Phase II Studies
FREMONT, Calif., May 19, 2003 /PRNewswire-FirstCall via COMTEX/ -- Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI) today reported progress with each of its three clinical programs focused on developing new therapies for the treatment of ulcerative colitis and Crohn`s disease, the principal forms of inflammatory bowel disease (IBD).
PDL said that encouraging interim data from a Phase I study of its humanized antibody Nuvion (visilizumab) were reported in an oral presentation Sunday, May 18 at the annual Digestive Disease Week meeting being held in Orlando, Fla. In the oral presentation, Dr. Scott Plevy of the University of Pittsburgh reported data from 10 patients with severe ulcerative colitis refractory to steroids, who were treated with one daily intravenous injection of visilizumab on two consecutive days.
Dr. Plevy reported that the clinical safety profile has been satisfactory to date, and that mild-to-moderate symptoms consistent with the cytokine release syndrome were observed in all 10 patients. The symptoms were transient in nature and were associated primarily with initial infusion. T-cell recovery occurred over a period of two to six weeks. Preliminary efficacy results were reported on eight patients treated in the initial dose cohort (15 microgram/kg) (n=8), in which a strong signal of activity was observed. All eight patients responded to treatment and seven of eight achieved remission. In the second dose cohort (10 microgram/kg) (n=2), one patient achieved a clinical response and the second has not yet been evaluated. In addition, responses appear to be durable, with a median duration of response of seven months. In the Phase I study, preliminary efficacy is evaluated as a reduction in the Modified Truelove and Witts Severity Index (MTWSI) score, with remission defined as achievement of an MTWSI score of less than four at 30 days following treatment. A clinical response is defined as achievement of an MTWSI score less than 10 at 30 days.
Dr. Plevy said, "The early data are extremely interesting and clearly are supportive of continued dose-finding and further study of this antibody in patients with severe ulcerative colitis. This study is being conducted in a very refractory group of patients who typically are candidates for surgery. Visilizumab potentially could enable a reduction in needed surgeries."
Steven Benner, M.D., M.H.S., Senior Vice President and Chief Medical Officer, PDL, said, "While we believe that the adverse event profile and degree of activity observed at the first dose level (15 microgram/kg) may be potentially appropriate for this patient population, the high degree of activity allows us to explore lower dosing regimens. These lower dose schedules give us an opportunity to potentially improve further the risk/benefit profile of Nuvion in ulcerative colitis."
PDL said that it has amended the initial study design to allow exploration of doses below the initial cohort dose of 15 microgram/kg. To further explore the dose-toxicity and dose-activity relationships for Nuvion, PDL will also initiate a second dose-ranging study to explore low doses of Nuvion in the same patient population. PDL currently expects to open the new Phase I trial later this year.
"Our current dataset is not sufficiently robust to allow for discussions of potential registration strategies with regulatory agencies at this time," Dr. Benner added. "We have, however, begun to outline possible pathways to registration in the event that with continued enrollment, visilizumab is shown to have significant activity and an appropriate safety profile. We believe that successful registration may be possible based on the results of adequate, well-controlled Phase II studies in this patient population that is refractory to intravenous steroids and for whom there are no approved alternative treatments. If Phase II studies could serve as the basis for regulatory approval, it is possible that a U.S. regulatory submission could occur by the end of 2006."
Daclizumab Begins Phase II in Ulcerative Colitis
PDL additionally reported that it has initiated a Phase II clinical trial of daclizumab in patients with moderate-to-severe ulcerative colitis. The Phase II study is a randomized, double-blind, placebo-controlled clinical trial in up to 150 patients to be conducted at up to 40 sites in North America and Europe.
Dr. Benner commented, "We had previously announced our intention to initiate this trial during the current quarter. I am pleased to confirm that enrollment in this PDL-sponsored study has begun on time. Our target is to complete the enrollment of this study during this year.
"Results of this ongoing Phase II trial will serve as the basis for further discussions with regulatory agencies concerning the additional clinical trials that would be necessary to support a successful registration," Dr. Benner continued. "We hope to have these discussions, pending positive findings in the current Phase II study, during 2004. The additional trials needed to support registration would be initiated as soon as possible following these discussions. We believe it is likely that well-controlled, randomized Phase III trials will be needed to support the registration of daclizumab in this disease setting. Such a trial may take the form of randomization to standard therapy, with and without daclizumab."
High-Dose Phase II Trial of HuZAF
PDL also announced that it has initiated the second of its planned Phase II clinical trials to define the activity of HuZAF (anti-gamma interferon antibody) in patients with Crohn`s disease. Up to 120 patients will be randomized into one of two treatment groups or placebo. Patients will receive two intravenous doses at 4.0 mg/kg, 10.0 mg/kg or placebo, at a 28-day interval.
"Our intention is to submit abstracts of results from the two Phase II trials for presentation at the Digestive Disease Week meeting next year," Dr. Benner said. "These two trials should define the activity of HuZAF in Crohn`s disease. Our registrational strategy will depend on the level of activity observed in the Phase II studies and subsequent discussions with regulatory agencies. Because our information about the role of HuZAF in Crohn`s disease is currently limited, we are not yet able to describe the study design for subsequent trials."
PDL to Host Webcast at 4:30 p.m. Eastern time
PDL will host a webcast beginning at 4:30 p.m. Eastern time today, May 19, 2003, to discuss research and development strategies for its programs in inflammatory bowel disease, including the visilizumab interim Phase I clinical results. The webcast will be hosted by Mark McDade, Chief Executive Officer, PDL, and by Dr. Benner. Dr. Plevy and Dr. Gert Van Assche, University of Leuven, Belgium, also will participate.
The live webcast will be available through the PDL website: www.pdl.com. Please connect to this website at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be needed to hear and view the webcast. A replay will be available at www.pdl.com starting approximately one hour after completion of the webcast.
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 the Company`s Quarterly Report on Form 10-Q for the period ended March 31, 2003, and in its Annual Report on Form 10-K for the year ended December 31, 2002, and in its other filings with the Securities and Exchange Commission. In particular, there can be no assurance that the interim data from the Phase I study of Nuvion in ulcerative colitis are indicative of results to be obtained in the completed study, or in the additional studies that would be required to show the antibody to be safe and effective. Nor can there be any assurance that we will be able to base a successful registration of Nuvion on Phase II studies without conducting Phase III studies. Moreover, there can be no assurance that the possible timing for filing for regulatory approval of Nuvion will be realized. In addition, there can be no assurance that PDL will complete the Phase II studies of daclizumab in ulcerative colitis or HuZAF in Crohn`s disease, or that results in the Van Assche study of daclizumab in ulcerative colitis are indicative of results that may be obtained in the PDL Phase II study. Nor can there be any assurance that the data to be obtained in these clinical trials will support the initiation of additional clinical trials or that such trials will be initiated within the estimated timeframes.
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 and HuZAF are trademarks of Protein Design Labs, Inc. Zenapax is a registered U.S. trademark of Hoffmann-La Roche.
SOURCE Protein Design Labs, Inc.
James R. Goff, Senior Director, Corporate Communications of
Protein Design Labs, Inc., +1-510-574-1421, or jgoff@pdl.com
http://www.pdl.com
Copyright (C) 2003 PR Newswire. All rights reserved.
Encouraging Interim Results Reported for Nuvion(R) in Ulcerative Colitis Daclizumab and HuZAF(TM) Begin Phase II Studies
FREMONT, Calif., May 19, 2003 /PRNewswire-FirstCall via COMTEX/ -- Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI) today reported progress with each of its three clinical programs focused on developing new therapies for the treatment of ulcerative colitis and Crohn`s disease, the principal forms of inflammatory bowel disease (IBD).
PDL said that encouraging interim data from a Phase I study of its humanized antibody Nuvion (visilizumab) were reported in an oral presentation Sunday, May 18 at the annual Digestive Disease Week meeting being held in Orlando, Fla. In the oral presentation, Dr. Scott Plevy of the University of Pittsburgh reported data from 10 patients with severe ulcerative colitis refractory to steroids, who were treated with one daily intravenous injection of visilizumab on two consecutive days.
Dr. Plevy reported that the clinical safety profile has been satisfactory to date, and that mild-to-moderate symptoms consistent with the cytokine release syndrome were observed in all 10 patients. The symptoms were transient in nature and were associated primarily with initial infusion. T-cell recovery occurred over a period of two to six weeks. Preliminary efficacy results were reported on eight patients treated in the initial dose cohort (15 microgram/kg) (n=8), in which a strong signal of activity was observed. All eight patients responded to treatment and seven of eight achieved remission. In the second dose cohort (10 microgram/kg) (n=2), one patient achieved a clinical response and the second has not yet been evaluated. In addition, responses appear to be durable, with a median duration of response of seven months. In the Phase I study, preliminary efficacy is evaluated as a reduction in the Modified Truelove and Witts Severity Index (MTWSI) score, with remission defined as achievement of an MTWSI score of less than four at 30 days following treatment. A clinical response is defined as achievement of an MTWSI score less than 10 at 30 days.
Dr. Plevy said, "The early data are extremely interesting and clearly are supportive of continued dose-finding and further study of this antibody in patients with severe ulcerative colitis. This study is being conducted in a very refractory group of patients who typically are candidates for surgery. Visilizumab potentially could enable a reduction in needed surgeries."
Steven Benner, M.D., M.H.S., Senior Vice President and Chief Medical Officer, PDL, said, "While we believe that the adverse event profile and degree of activity observed at the first dose level (15 microgram/kg) may be potentially appropriate for this patient population, the high degree of activity allows us to explore lower dosing regimens. These lower dose schedules give us an opportunity to potentially improve further the risk/benefit profile of Nuvion in ulcerative colitis."
PDL said that it has amended the initial study design to allow exploration of doses below the initial cohort dose of 15 microgram/kg. To further explore the dose-toxicity and dose-activity relationships for Nuvion, PDL will also initiate a second dose-ranging study to explore low doses of Nuvion in the same patient population. PDL currently expects to open the new Phase I trial later this year.
"Our current dataset is not sufficiently robust to allow for discussions of potential registration strategies with regulatory agencies at this time," Dr. Benner added. "We have, however, begun to outline possible pathways to registration in the event that with continued enrollment, visilizumab is shown to have significant activity and an appropriate safety profile. We believe that successful registration may be possible based on the results of adequate, well-controlled Phase II studies in this patient population that is refractory to intravenous steroids and for whom there are no approved alternative treatments. If Phase II studies could serve as the basis for regulatory approval, it is possible that a U.S. regulatory submission could occur by the end of 2006."
Daclizumab Begins Phase II in Ulcerative Colitis
PDL additionally reported that it has initiated a Phase II clinical trial of daclizumab in patients with moderate-to-severe ulcerative colitis. The Phase II study is a randomized, double-blind, placebo-controlled clinical trial in up to 150 patients to be conducted at up to 40 sites in North America and Europe.
Dr. Benner commented, "We had previously announced our intention to initiate this trial during the current quarter. I am pleased to confirm that enrollment in this PDL-sponsored study has begun on time. Our target is to complete the enrollment of this study during this year.
"Results of this ongoing Phase II trial will serve as the basis for further discussions with regulatory agencies concerning the additional clinical trials that would be necessary to support a successful registration," Dr. Benner continued. "We hope to have these discussions, pending positive findings in the current Phase II study, during 2004. The additional trials needed to support registration would be initiated as soon as possible following these discussions. We believe it is likely that well-controlled, randomized Phase III trials will be needed to support the registration of daclizumab in this disease setting. Such a trial may take the form of randomization to standard therapy, with and without daclizumab."
High-Dose Phase II Trial of HuZAF
PDL also announced that it has initiated the second of its planned Phase II clinical trials to define the activity of HuZAF (anti-gamma interferon antibody) in patients with Crohn`s disease. Up to 120 patients will be randomized into one of two treatment groups or placebo. Patients will receive two intravenous doses at 4.0 mg/kg, 10.0 mg/kg or placebo, at a 28-day interval.
"Our intention is to submit abstracts of results from the two Phase II trials for presentation at the Digestive Disease Week meeting next year," Dr. Benner said. "These two trials should define the activity of HuZAF in Crohn`s disease. Our registrational strategy will depend on the level of activity observed in the Phase II studies and subsequent discussions with regulatory agencies. Because our information about the role of HuZAF in Crohn`s disease is currently limited, we are not yet able to describe the study design for subsequent trials."
PDL to Host Webcast at 4:30 p.m. Eastern time
PDL will host a webcast beginning at 4:30 p.m. Eastern time today, May 19, 2003, to discuss research and development strategies for its programs in inflammatory bowel disease, including the visilizumab interim Phase I clinical results. The webcast will be hosted by Mark McDade, Chief Executive Officer, PDL, and by Dr. Benner. Dr. Plevy and Dr. Gert Van Assche, University of Leuven, Belgium, also will participate.
The live webcast will be available through the PDL website: www.pdl.com. Please connect to this website at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be needed to hear and view the webcast. A replay will be available at www.pdl.com starting approximately one hour after completion of the webcast.
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 the Company`s Quarterly Report on Form 10-Q for the period ended March 31, 2003, and in its Annual Report on Form 10-K for the year ended December 31, 2002, and in its other filings with the Securities and Exchange Commission. In particular, there can be no assurance that the interim data from the Phase I study of Nuvion in ulcerative colitis are indicative of results to be obtained in the completed study, or in the additional studies that would be required to show the antibody to be safe and effective. Nor can there be any assurance that we will be able to base a successful registration of Nuvion on Phase II studies without conducting Phase III studies. Moreover, there can be no assurance that the possible timing for filing for regulatory approval of Nuvion will be realized. In addition, there can be no assurance that PDL will complete the Phase II studies of daclizumab in ulcerative colitis or HuZAF in Crohn`s disease, or that results in the Van Assche study of daclizumab in ulcerative colitis are indicative of results that may be obtained in the PDL Phase II study. Nor can there be any assurance that the data to be obtained in these clinical trials will support the initiation of additional clinical trials or that such trials will be initiated within the estimated timeframes.
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 and HuZAF are trademarks of Protein Design Labs, Inc. Zenapax is a registered U.S. trademark of Hoffmann-La Roche.
SOURCE Protein Design Labs, Inc.
James R. Goff, Senior Director, Corporate Communications of
Protein Design Labs, Inc., +1-510-574-1421, or jgoff@pdl.com
http://www.pdl.com
Copyright (C) 2003 PR Newswire. All rights reserved.
#3 danke dir !!!
#2 naja, du hasr recht, wenn ich deinen chart ansehe
happy trades
#2 naja, du hasr recht, wenn ich deinen chart ansehe
happy trades
die entwickeln medikament, bzw antikörper.
gute ergebnisse gab es bei einem stoff der gegen colitis ulcerosea wirken soll. ist einen erkrankung des dickdarms, hab da meine doktorarbeit drüber gemacht.
ich hab mir den wert vor ein paar wochen in amerika gekauft. zu ca 11,37 $. würde nur dort kaufen, da der markt wesentlicih liquider ist. außer du willst nur für 2-3000 € einsteigen dann hier.
der chart ist super interessant. wenn wir die 14$ signifikant überspringen hat der wert schnell luft bis ca 20$. ist aber ne riskante sache. stellt sich raus das deren stoffe hochwirksam sind, kannste dein geld vervielfachen. wenn nicht gehts genauso schnell berg ab.
gute ergebnisse gab es bei einem stoff der gegen colitis ulcerosea wirken soll. ist einen erkrankung des dickdarms, hab da meine doktorarbeit drüber gemacht.
ich hab mir den wert vor ein paar wochen in amerika gekauft. zu ca 11,37 $. würde nur dort kaufen, da der markt wesentlicih liquider ist. außer du willst nur für 2-3000 € einsteigen dann hier.
der chart ist super interessant. wenn wir die 14$ signifikant überspringen hat der wert schnell luft bis ca 20$. ist aber ne riskante sache. stellt sich raus das deren stoffe hochwirksam sind, kannste dein geld vervielfachen. wenn nicht gehts genauso schnell berg ab.
Trading Spotlight
der link des bildes ist
http://www.technical-investor.de/cmy/forum/image.asp?id=2431…
komisch dass das bild ned geht
http://www.technical-investor.de/cmy/forum/image.asp?id=2431…
komisch dass das bild ned geht
#5 wie wahr, wie wahr,
bei Biotech-Aktien gibt es relativ wenige, du profitabel arbeiten. da ist (auch heute noch) viel Phantasie bereits im Kurs mit eingepreist.
Aber interessant, wenn ich da z.B. an resorbierenden Hautimplataten denke von Macropore.
Habe allerdings bei Biotechs auch schon einiges in den Sand gesetzt
Lui
bei Biotech-Aktien gibt es relativ wenige, du profitabel arbeiten. da ist (auch heute noch) viel Phantasie bereits im Kurs mit eingepreist.
Aber interessant, wenn ich da z.B. an resorbierenden Hautimplataten denke von Macropore.
Habe allerdings bei Biotechs auch schon einiges in den Sand gesetzt
Lui
Luitschi,
Gruss b2
Gruss b2
Neue News von heute:
FREMONT, Calif., June 2 /PRNewswire-FirstCall/ -- Protein Design Labs, Inc. (PDL) today reported progress in a program aimed at developing new therapies for the treatment of cancer, announcing a new study of a direct anti-endothelial cell antibody that inhibits angiogenesis (formation of new blood vessels to a tumor). The antibody is being evaluated for the treatment of solid tumors, such as colorectal or kidney cancers.
PDL said that it has initiated a Phase I clinical trial of the anti-a5B1 integrin antibody in patients with advanced solid tumors for whom there is no standard treatment. The dose-escalation trial is designed to explore the safety associated with the infusion of the anti-a5B1 integrin antibody. The primary study objective is to define the dose-limiting toxicities and maximum tolerated dose associated with the antibody. Patients will receive two intravenous infusions at a 14-day interval, and three subsequent infusions at weekly intervals, for a total of five doses.
Steven Benner, M.D., M.H.S., Senior Vice President and Chief Medical Officer, PDL, said, "We are pleased to have started this trial on schedule in the second quarter. This trial is in keeping with our strategy to expand our focus in oncology. We look forward to our initial clinical experience with this antibody that targets activated endothelial cells, a novel approach to inhibiting the growth of tumors that are dependent on new blood vessel formation."
Agents that inhibit angiogenesis are intended to block formation of blood vessels in tumors, thereby leading to slower tumor growth, death or inhibition of metastasis. The anti-a5B1 integrin antibody targets the activated subset of endothelial cells, which are found in the lining of blood vessels undergoing angiogenesis, by inhibiting binding of a5B1 integrin receptors to fibronectin. In preclinical experiments, treatment with the antibody led to apoptosis of activated, but not normal, endothelial cells. In vitro studies have shown that the anti-a5B1 integrin antibody inhibits angiogenesis, including vessel formation induced by vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), as well as other pro-angiogenic growth factors. As a result, the antibody may prove effective in treating tumors in which one or more growth factors contribute to angiogenesis. PDL obtained the chimeric anti-a5B1 integrin antibody program in connection with the company``s April 2003 acquisition of Eos Biotechnology, Inc. PDL also has an anti-a5B1 integrin antibody fragment in preclinical development for certain ocular indications, including age-related macular degeneration.
PDL additionally reported that it will discontinue its studies aimed at treatment of steroid-refractory graft-versus-host disease (GvHD) following bone marrow transplantation as a potential indication for Nuvion (visilizumab). Accrual to the company-sponsored, multi-institution Phase II trial, previously acknowledged as slow in accruing, has been stopped.
Dr. Benner commented, "While most patients had improvement in symptoms of GvHD, the treatment with visilizumab was not, on average, associated with a significant prolongation of survival relative to historic controls. PDL will now concentrate our near-term development efforts for Nuvion as a potential therapy for patients with steroid-refractory ulcerative colitis, a more common condition than GvHD."
On May 19, PDL reported partial data from a Phase I dose-ranging study of Nuvion in patients with severe ulcerative colitis that is refractory to treatment with steroids. In that study, all eight patients in the initial dose cohort responded and seven of eight achieved remission. The clinical safety profile has been satisfactory to date. PDL expects to open later this year a second Phase I/II dose-ranging study to explore lower doses of visilizumab in this disease setting.
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 the Company``s Quarterly Report on Form 10-Q for the period ended March 31, 2003, and in its Annual Report on Form 10-K for the year ended December 31, 2002, and in its other filings with the Securities and Exchange Commission. In particular, there can be no assurance that PDL will complete the Phase I study of the anti-a5B1 integrin antibody, nor can there be any assurance that the trial will determine a dose regimen that can be tolerated by patients with advanced solid tumors.
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 http://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.
Protein Design Labs, Inc.
© PR Newswire
FREMONT, Calif., June 2 /PRNewswire-FirstCall/ -- Protein Design Labs, Inc. (PDL) today reported progress in a program aimed at developing new therapies for the treatment of cancer, announcing a new study of a direct anti-endothelial cell antibody that inhibits angiogenesis (formation of new blood vessels to a tumor). The antibody is being evaluated for the treatment of solid tumors, such as colorectal or kidney cancers.
PDL said that it has initiated a Phase I clinical trial of the anti-a5B1 integrin antibody in patients with advanced solid tumors for whom there is no standard treatment. The dose-escalation trial is designed to explore the safety associated with the infusion of the anti-a5B1 integrin antibody. The primary study objective is to define the dose-limiting toxicities and maximum tolerated dose associated with the antibody. Patients will receive two intravenous infusions at a 14-day interval, and three subsequent infusions at weekly intervals, for a total of five doses.
Steven Benner, M.D., M.H.S., Senior Vice President and Chief Medical Officer, PDL, said, "We are pleased to have started this trial on schedule in the second quarter. This trial is in keeping with our strategy to expand our focus in oncology. We look forward to our initial clinical experience with this antibody that targets activated endothelial cells, a novel approach to inhibiting the growth of tumors that are dependent on new blood vessel formation."
Agents that inhibit angiogenesis are intended to block formation of blood vessels in tumors, thereby leading to slower tumor growth, death or inhibition of metastasis. The anti-a5B1 integrin antibody targets the activated subset of endothelial cells, which are found in the lining of blood vessels undergoing angiogenesis, by inhibiting binding of a5B1 integrin receptors to fibronectin. In preclinical experiments, treatment with the antibody led to apoptosis of activated, but not normal, endothelial cells. In vitro studies have shown that the anti-a5B1 integrin antibody inhibits angiogenesis, including vessel formation induced by vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), as well as other pro-angiogenic growth factors. As a result, the antibody may prove effective in treating tumors in which one or more growth factors contribute to angiogenesis. PDL obtained the chimeric anti-a5B1 integrin antibody program in connection with the company``s April 2003 acquisition of Eos Biotechnology, Inc. PDL also has an anti-a5B1 integrin antibody fragment in preclinical development for certain ocular indications, including age-related macular degeneration.
PDL additionally reported that it will discontinue its studies aimed at treatment of steroid-refractory graft-versus-host disease (GvHD) following bone marrow transplantation as a potential indication for Nuvion (visilizumab). Accrual to the company-sponsored, multi-institution Phase II trial, previously acknowledged as slow in accruing, has been stopped.
Dr. Benner commented, "While most patients had improvement in symptoms of GvHD, the treatment with visilizumab was not, on average, associated with a significant prolongation of survival relative to historic controls. PDL will now concentrate our near-term development efforts for Nuvion as a potential therapy for patients with steroid-refractory ulcerative colitis, a more common condition than GvHD."
On May 19, PDL reported partial data from a Phase I dose-ranging study of Nuvion in patients with severe ulcerative colitis that is refractory to treatment with steroids. In that study, all eight patients in the initial dose cohort responded and seven of eight achieved remission. The clinical safety profile has been satisfactory to date. PDL expects to open later this year a second Phase I/II dose-ranging study to explore lower doses of visilizumab in this disease setting.
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 the Company``s Quarterly Report on Form 10-Q for the period ended March 31, 2003, and in its Annual Report on Form 10-K for the year ended December 31, 2002, and in its other filings with the Securities and Exchange Commission. In particular, there can be no assurance that PDL will complete the Phase I study of the anti-a5B1 integrin antibody, nor can there be any assurance that the trial will determine a dose regimen that can be tolerated by patients with advanced solid tumors.
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 http://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.
Protein Design Labs, Inc.
© PR Newswire
Siehe PDL-Thread!
Powerbulls
Powerbulls
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