>>Phase 2 Data Show Daclizumab Significantly Reduced Multiple Sclerosis Lesions in Patients Receiving Interferon Beta Therapy
Thursday October 11, 4:26 pm ET
- Phase 2 monotherapy trial to be initiated by end of 2007 -
PRAGUE, Czech Republic, Oct. 11 /PRNewswire-FirstCall/ -- Biogen Idec Inc. (Nasdaq: BIIB - News) and PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI - News) announced today that Phase 2 data demonstrated a significant reduction in new or enlarged gadolinium-enhancing lesions when daclizumab is added to interferon beta therapy in patients with active relapsing multiple sclerosis (MS). These data will be presented tomorrow at the 23rd Congress of the European Committee for Treatment and Research of Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic.
The ongoing Phase 2, randomized, double blind, placebo-controlled clinical study, known as the CHOICE trial, studies MS patients who continue to have active MS disease while receiving interferon beta therapy. The study patients who received daclizumab 2 mg/kg subcutaneously every two weeks showed a statistically significant 72% reduction in the number of new or enlarged gadolinium-enhancing lesions (Gd+) at week 24, compared to patients on interferon beta therapy alone. Patients from the CHOICE study were followed for an additional 48 weeks after the daclizumab treatment period to further assess safety and efficacy.
"Patients who received daclizumab every two weeks experienced far fewer new or enlarged gadolinium-enhancing lesions than the control group, which indicates that the antibody may be a promising option for patients with MS," said Dr. Xavier Montalban, Director of the Unit of Clinical Neuroimmunology at the Hospital Val D'Hebron in Barcelona, Spain. "In addition, we were encouraged to see a trend in the reduction of the number of relapses, or exacerbations, that these MS patients experienced. Further study is warranted."
Daclizumab is a humanized monoclonal antibody that targets the IL-2 receptor on activated T cells. Biogen Idec and PDL plan to initiate the SELECT study, a Phase 2 trial of daclizumab alone in the same relapsing patient population, by the end of 2007.
"We are very pleased to see positive results from the CHOICE study, the first randomized trial of daclizumab in patients with relapsing MS," said Mark A. McCamish, M.D., Ph.D., chief medical officer, PDL BioPharma. "We recognize how monoclonal antibodies have changed modern medicine and see great potential in their ability to treat serious diseases, including cancer and select immunological diseases such as MS. We're very excited to move development of daclizumab forward with our partner Biogen Idec, the acknowledged leader in the MS field."
"Daclizumab represents an exciting opportunity within our growing MS portfolio," said Alfred Sandrock, M.D., Ph.D., senior vice president, neurology research and development, Biogen Idec. "MS is a complex disease that requires an arsenal of treatment options for patients. We look forward to advancing the daclizumab development program and initiating the SELECT trial by the end of the year."
Study Results
The CHOICE trial is evaluating the efficacy and safety of daclizumab or placebo added to interferon beta therapy in 230 patients with active MS who were enrolled at study centers in the U.S. and Europe. Patients were randomized to receive daclizumab 2 mg/kg every two weeks, daclizumab 1 mg/kg every four weeks, or placebo added to ongoing interferon beta treatment.
The primary efficacy analysis showed that at 24 weeks, the 75 patients in the 2 mg/kg group experienced 72% fewer new or enlarged Gd+ on average compared to the 77 patients who received a placebo (p=0.004). The 78 patients in the 1 mg/kg group experienced a 25% reduction in new or enlarged lesions compared with placebo but that measurement did not achieve statistical significance.
Based on data up to week 24, analysis of the relapse rate, which was a secondary endpoint, indicates that both daclizumab regimens revealed a trend in reducing the annualized relapse rate compared to placebo (an approximately 35% reduction), but these observations did not reach statistical significance.
Preliminary safety data showed similar rates of infection across all treatment groups with an overall greater incidence of serious infections in the daclizumab treated groups. (4.6% versus 1.3% placebo). Urinary tract infections were slightly higher with the 2 mg/kg dose (17% vs 13% placebo). The incidence of cutaneous events was higher in the combined daclizumab groups (34% daclizumab vs. 27% placebo) but was mild to moderate and most resolved with little or no treatment.
PDL and Biogen Idec entered into a collaboration agreement in 2005 to co- develop and commercialize daclizumab in MS and indications other than transplant and respiratory diseases. Under the collaboration, the companies are also co-developing volociximab (also known as M200), an antibody in Phase 2 development for the treatment of various solid tumors. PDL and Biogen Idec share equally the costs of all development activities and all operating profits for both products within the U.S. and Europe. The companies jointly oversee development, manufacturing and commercialization plans for collaboration products and divide implementation responsibilities to leverage each company's capabilities and expertise. Each party will have co-promotion rights in the U.S. and Europe. Outside the U.S. and Europe, Biogen Idec will fund all incremental development and commercialization costs and pay a royalty to PDL on sales of collaboration products.
About Multiple Sclerosis
MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and more than one million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age. MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, which interferes with messages from the brain to the body. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.
About Daclizumab
Daclizumab is a humanized monoclonal antibody that binds to the IL-2 receptor on activated T cells, inhibiting the binding of IL-2 and the cascade of pro-inflammatory events contributing to organ transplant rejection and autoimmune-related diseases. Hoffmann-La Roche, Inc. currently markets daclizumab under the name Zenapax® under a license from PDL. Zenapax is indicated for intravenous use for the prophylaxis of acute organ rejection in patients receiving renal transplants. To conduct the CHOICE study, PDL prepared a high concentration formulation of Roche-produced daclizumab for subcutaneous administration. PDL has also developed a high yield manufacturing process and formulation for subcutaneously delivered daclizumab, which is in clinical development for MS by PDL and Biogen Idec. PDL has retained the rights for development of daclizumab for asthma and transplant maintenance.<<
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GENZ/BAY's alemtuzumab data coming in a couple of days:
>>CAMBRIDGE, Mass. and BERLIN /PRNewswire-FirstCall/ -- Genzyme Corporation and Bayer Schering Pharma AG, Germany announce that important, new clinical data will be presented this weekend from two studies regarding alemtuzumab use in patients with multiple sclerosis (MS) at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) underway in Prague.
Charcot Award Lecture
Top-line, three-year data from a completed international, multi-center, Phase 2 clinical trial known as CAMMS223 that compared alemtuzumab with Rebif® (interferon beta-1a) for the treatment of multiple sclerosis will be presented on Sunday, Oct. 14 at 10 a.m. The data will be presented by Professor Alastair Compston during the prestigious Charcot Award lecture. The study results, taken at 36 months, compare alemtuzumab-treated patients with Rebif®-treated patients in the risk for sustained accumulation of disability and the risk for relapse. The data come from a pre-specified analysis conducted after three years of treatment for 334 patients in the study.
Details on two poster presentations
-- Alemtuzumab Improved Multiple Sclerosis Functional Composite Scores and
Delayed Time to First Relapse at 2-Year Interim Analysis Compared to
Subcutaneous Interferon Beta 1-a.
Sat. October 13 from 3:30-5:00 p.m. Alasdair J. Coles, M.D.
A further analysis of disability in CAMMS223, as measured by the Multiple Sclerosis Functional Composite Scale (MSFC), will be reported at ECTRIMS. Data from this scale, including quantitative tests on ambulation, manual dexterity, and cognition, will be presented along with new analyses of relapse events. These results build on the two-year analyses of the co-primary endpoints presented at the American Academy of Neurology annual meeting in May, 2007, which demonstrated that the risk of sustained accumulation of disability as well as the annualized relapse rate were markedly reduced in alemtuzumab-treated patients compared to Rebif-treated patients. Data from CAMMS223 provide the rationale for the newly initiated Phase 3 CARE-MS I clinical trial in untreated patients with relapsing-remitting multiple sclerosis.
-- Two-year Results with Alemtuzumab in Patients with Active Relapsing-
Remitting Multiple Sclerosis Who Have Failed Licensed Beta-Interferon
Therapies.
Saturday, October 13 from 3:30-5:00 p.m. Ed Fox, M.D.
In another poster presentation, data from an investigator-sponsored study demonstrate the benefits of alemtuzumab in previously treated MS patients. Data from this two-year study evaluate the effect of two annual cycles of alemtuzumab on patients with relapsing-remitting MS who had failed prior treatment with licensed beta-interferons. Reported at ECTRIMS will be new data on patient functioning as measured by the Multiple Sclerosis Functional Composite Scale cited above. Data from this study provides the basis for the second Phase 3 clinical trial, CARE-MS II, in patients who have continued to relapse while using a licensed therapy. This study is also open to enrollment.<<
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Cheers, Tuck |
