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This excerpt taken from the PDLI 8-K filed May 4, 2005. Clinical Development Update
Nuvion® (visilizumab, anti-CD3). On March 22, PDL reported that it had discussed with the U.S. Food and Drug Administration (FDA) the future development pathway for Nuvion for the treatment of intravenous steroid-refractory ulcerative colitis.
Following these discussions, PDL now expects to conduct two pivotal clinical trials and a retreatment study of Nuvion in the setting of intravenous steroid-refractory ulcerative colitis. The first pivotal study will be a Phase II / III clinical trial and is expected to begin this year. Assuming certain protocol-defined criteria are met at the time of the interim analysis, the second pivotal trial would be initiated. PDL anticipates initiating the retreatment study at the time of the Phase II / III study. The proposed protocols are expected to be reviewed in detail by the FDA. PDL expects to provide a further development update by the end of May 2005.
Additional data from an ongoing Phase I / II study of Nuvion will be presented in an oral presentation by Stephan A. Targan, M.D., Director, Cedars-Sinai Division of Gastroenterology and Professor, UCLA School of Medicine, on May 17 beginning at 11:30 a.m. at the Digestive Disease Week meeting to be held in Chicago.
Daclizumab (Zenapax®, anti-CD25). PDL began in the first quarter of 2005 a single-dose Phase I study of PDL-manufactured daclizumab administered subcutaneously in healthy volunteers. This trial is expected to be followed by a multiple-dose study in healthy volunteers anticipated to be initiated this summer. A Phase II dose range-finding study of subcutaneously administered, PDL-manufactured daclizumab in asthma patients remains on schedule to begin in the first quarter of 2006. PDL also continues to evaluate the opportunity to develop daclizumab further in the setting of solid organ transplantation.
A randomized, placebo-controlled, Phase II study of daclizumab in patients with multiple sclerosis is pending initiation. We anticipate the first patient accrual in the second quarter of 2005. In this study, patients with active relapsing forms of MS will receive subcutaneous daclizumab at one of two dosage levels, or placebo, for six months in addition to their current beta-interferon treatment. The three-arm study is planned to enroll a total of 270 patients.
Ularitide. PDL on April 18 reported positive results from a Phase II clinical study, known as the SIRIUS II trial, of the atrial natriuretic peptide ularitide in patients with decompensated congestive heart failure (DHF).
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The SIRIUS II trial was a randomized, double-blind, placebo-controlled clinical trial conducted at 19 centers in Europe. Primary endpoints in the study were change of pulmonary capillary wedge pressure (PCWP) and change in dyspnea (shortness of breath) score, both at six hours. A total of 221 patients were randomized equally to receive ularitide 7.5, 15, or 30 ng/kg/min given intravenously as a 24-hour infusion, or placebo. In the assessment of the primary endpoints, ularitide significantly reduced PCWP (p<0.05) and improved dyspnea score (p<0.05) in all three dose groups compared to placebo. The main adverse events through day three were dose-dependent decreases in blood pressure compared to placebo. Serum creatinine levels were unchanged during and after ularitide treatment when compared to placebo. The incidence of serious adverse events was similar for all three treatment groups and the placebo group.
The SIRIUS II clinical trial was conducted by CardioPep Pharma GmbH. Through the ESP Pharma acquisition, PDL acquired from CardioPep exclusive rights to conduct all subsequent development and exclusive marketing rights for ularitide for all indications in the United States, Canada, the European Union and Switzerland. To date, the clinical development of ularitide has taken place in Europe. A U.S. Investigational New Drug (IND) application has not yet been filed by CardioPep.
M200 (volociximab, anti-alpha5beta1 integrin antibody). Currently, M200 is being developed as an anti-angiogenic therapy for the treatment of solid tumors in open-label pilot Phase II studies. These trials, each of up to 40 patients, will further assess the tolerability of prolonged administration of M200 and look for evidence of clinical activity. Three clinical trials have now been opened and are enrolling patients. An additional pilot Phase II study is expected to open in the second quarter of 2005. Data from at least two of the initial Phase II studies is expected to be available for presentation during the ASCO meeting in June 2006.
In addition, PDL is planning a pilot Phase II trial of M200 administered intravenously in patients with age-related macular degeneration (AMD), which is expected to begin during the second half of 2005.
Terlipressin. PDL and privately held Orphan Therapeutics, LLC on April 20 reported that the FDA had granted Fast Track status to the development of terlipressin for the treatment of patients with type 1 hepatorenal syndrome (HRS).
Designation as a Fast Track product indicates that the FDA will facilitate the development and expedite the review of a new drug that is intended to treat a serious or life-threatening condition and that demonstrates the potential to address an unmet medical need. However, Fast Track designation does not mean that the FDA will expedite approval of the product nor does it increase the likelihood of approval of the product.
Through its acquisition of ESP Pharma, PDL acquired from Orphan Therapeutics exclusive marketing, sales and distribution rights for terlipressin in the United States and Canada. Orphan Therapeutics holds the U.S. IND for terlipressin and is conducting a Phase III clinical trial in the United States and Europe. Orphan Therapeutics has obtained Orphan Drug status for this program.
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This excerpt taken from the PDLI 8-K filed Mar 17, 2005. Clinical Development UpdateDr. Steven Benner, Senior Vice President and Chief Medical Officer, PDL, said, “PDL is committed to the development of new antibody-based treatments. We have continued to make progress on our clinical programs and look forward to exciting new antibody programs leading to future INDs coming from our research efforts. Now, with the anticipated acquisition of ESP Pharma, we expect to add additional clinical programs that we hope will expand our product portfolio over the next few years.”
Nuvion (visilizumab, anti-CD3). Nuvion remains PDL’s highest development priority. PDL expects to meet with the FDA in late March. At this end-of-Phase I meeting, PDL will discuss its plans to move Nuvion into a Phase III program. PDL hopes to move into registrational trials with Nuvion in intravenous corticosteroid-refractory ulcerative colitis late this year. If the discussions with the FDA are positive, PDL intends to use the FDA’s Special Protocol Assessment process to continue to develop the protocol and plan the analysis of the Phase III program.
PDL expects to publicly update the status of its Nuvion program and the outcome of the discussion with the FDA by early April. Additional data from the Phase I / II study of Nuvion is expected to be presented during the Digestive Disease Week meeting to be held in Chicago from May 14-19.
Daclizumab (Zenapax, anti-IL-2 receptor). PDL is on schedule to begin in this quarter a single-dose Phase I study of PDL-manufactured daclizumab administered subcutaneously for asthma. This trial will be followed by a multiple-dose study in healthy volunteers expected to be initiated this summer. A Phase II dose range-finding study of subcutaneously administered, PDL-manufactured daclizumab in asthma patients remains on schedule for the first quarter of 2006. PDL also continues to evaluate the opportunity to develop daclizumab further in the setting of solid organ transplantation.
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A randomized, placebo-controlled, Phase II study of daclizumab in patients with multiple sclerosis is pending initiation. We anticipate the first patient accrual in late March or early in the second quarter. In this study, patients with active relapsing forms of MS will receive subcutaneous daclizumab at one of two dosage levels, or placebo, for six months in addition to their current beta-interferon treatment. The three-arm study is planned to enroll a total of 270 patients.
M200 (volociximab, anti-alpha5beta1 integrin antibody). Currently, M200 is being developed as an anti-angiogenic therapy for the treatment of solid tumors in open-label pilot Phase II studies. These trials, each of up to 40 patients, will further assess the tolerability of prolonged administration of M200 and look for evidence of clinical activity. Two clinical trials are now open. Two additional pilot Phase II studies will open in the first and second quarters, respectively. Data from at least two of the initial Phase II studies is expected to be available for presentation during the ASCO meeting in June 2006.
In addition, PDL is planning a pilot trial of M200 administered intravenously in patients with age-related macular degeneration (AMD). M200 administered intravenously has shown activity in animal models and this approach reflects PDL’s belief that the treatment of this disease will evolve to systemic therapies. Consequently, given the attractiveness of this approach relative to intra-vitreal injections, we intend to proceed with development of M200 in place of F200 in this indication. F200 is a fragment of the M200 antibody and was a pre-IND candidate for the intra-vitreal treatment of AMD. We are planning a Phase II trial of M200 administered intravenously in patients with AMD, expected to begin during the second half of 2005.
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