Annual European Congress of Rheumatology
TARRYTOWN, N.Y.--(BUSINESS WIRE)--June 10, 2005—Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) a annoncé aujourd’hui les résultats préliminaires positifs d’une étude pilote actuellement en cours sur le dosage hebdomadaire de l’Interleukin-1 (IL-1) Trap sur des patients présentant un syndrome périodique associé CIAS1 (CAPS), une famille de pathologies auto-inflammatoires.
IL-1 Trap Shows Positive Results in Study of Patients with Inflammatory Disease; Results Presented at the Annual European Congress of Rheumatology
Pharmaceutical Writers/Business Editors/Health/Medical Writers
Annual European Congress of Rheumatology
TARRYTOWN, N.Y.--(BUSINESS WIRE)--June 10, 2005--Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced today positive preliminary results from an ongoing pilot study of once-weekly dosing of the Interleukin-1 (IL-1) Trap in patients with CIAS1-associated periodic syndrome (CAPS), a family of autoinflammatory diseases.All four patients enrolled in the study to date experienced a positive response to a subcutaneous loading dose regimen of the IL-1 Trap, including a sizable reduction in daily patient diary scores and acute phase reactant levels.
In the ongoing chronic dosing phase of the study, these patients continue to demonstrate a positive response to the IL-1 Trap
The study was conducted under a Cooperative Research and Development Agreement (CRADA) with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health.
The senior investigators in this study are Raphaela Goldbach-Mansky, M.D., Staff Clinician with NIAMS, and Daniel Kastner, M.D., Ph.D., Chief, Genetics and Genomics Branch with NIAMS
The United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to the IL-1 Trap in CAPS disorders.
Currently, there are no approved therapies for CAPS disorders
"Treatment with the IL-1 Trap led to an immediate clinical and laboratory improvement in all patients," the NIAMS investigators reported.
"These results will allow us to further investigate the role of IL-1 blockade in treating patients with CAPS and other inflammatory diseases."
Objectives and Study Design
The ongoing pilot study is designed to evaluate the effect of the IL-1 Trap, a long-acting IL-1 inhibitor, in patients with autoinflammatory disease, a spectrum of diseases characterized by spontaneous systemic inflammation, but no evidence of immune dysregulation (e.g., the formation of antibodies directed against a person's own body tissue).
One well-recognized group of autoinflammatory diseases is caused by mutations in the CIAS1 gene
These clinical syndromes are known as Familial Cold Autoinflammatory Syndrome (FCAS), Muckle Wells Syndrome (MWS) and Neonatal Onset Multisystem Inflammatory Disease (NOMID).
All four subjects evaluated in the study so far were adults with FCAS or FCAS-MWS overlap syndrome.
In this study, subjects were observed prior to treatment during a baseline period and then were administered a loading dose regimen of IL-1 Trap (100 mg per day for three days).
Subjects' signs and symptoms were observed without further therapy in order to determine the onset of therapeutic effects and to measure how long those effects lasted.
After return of signs and symptoms (flare), subjects were entered into an extension phase with once-weekly IL-1 Trap dosing
Results
All four patients experienced a sizable reduction in daily patient diary scores and acute phase reactant levels.
Clinical response was determined in part by measuring values of specific inflammatory indicators, such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and serum amyloid A (SAA) protein.
The results are detailed in the chart below.
Offset of therapeutic effect and return of signs and symptoms (flare) occurred in all patients at a median of 21 days (range 9-26) and resumption of dosing with the IL-1 Trap led to another immediate therapeutic response.
On weekly administration of the IL-1 Trap, all four patients have maintained those favorable responses.
No significant adverse events or injection site reactions have occurred thus far.
Further results from this study are expected to help identify the optimal dose for future IL-1 Trap studies in inflammatory diseases
| | Baseline | Maximal Efficacy | Flare |
| | median (range) | median (range) | median (range) |
| Daily Diary | | | |
| Score | 6.06 (2.2-7.56) | 1.67 (0-3.3)(a) | 4.5 (2-7.33) |
| CRP | 7.28 (2.32-8.65) | 0.72 (0.07-1.15)(b) | 2.94 (0.08-6.21) |
(a) statistically significant difference from previous timepoint at p less than 0.1;
(b) p less than 0.05
In many cases, IL-1 acts as a messenger to help regulate immune and inflammatory responses by attaching to cell-surface receptors in cells that participate in the body's immune system.
In excess, it can be harmful and has been linked to a variety of inflammatory diseases
Blocking IL-1 is a proven therapeutic approach in rheumatoid arthritis, and IL-1 represents an important target for pharmaceutical development in other inflammatory conditions
The IL-1 Trap is designed to attach to and neutralize IL-1 in the blood stream before it can attach to cell-surface receptors and generate signals that can trigger disease activity in body tissue
Once attached to the Trap, IL-1 cannot bind to the cell surface receptors and, together with the Trap, is flushed from the body.
The IL-1 Trap has a long duration in the body, and can be delivered by weekly injection
About Regeneron Pharmaceuticals
Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions.
Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, inflammatory diseases, and asthma, and has pre-clinical programs in other diseases and disorders
This news release discusses historical information and includes forward-looking statements about Regeneron and its products, programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of drugs and biologics, determinations by regulatory and administrative governmental authorities, competitive factors, technological developments, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement to be canceled or to terminate without any product success, and other material risks.
A more complete description of these risks can be found in Regeneron's filings with the United States Securities and Exchange Commission (SEC), including its Form 10-K for the year ended December 31, 2004 and the Form 10-Q dated March 31, 2005.
Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise unless required by law
CONTACT:
Investor Relations: Charles Poole, 914-345-7640
[email protected] or
Media Relations: Lauren Tortorete, 212-845-5609
[email protected]
KEYWORD: NEW YORK
INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY PRODUCT
SOURCE: Regeneron Pharmaceuticals, Inc
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