- April 14, 2018
- Posted by: PharmaScroll
- Category:
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, announced that the data for Cladribine Tablets, an investigational treatment for multiple sclerosis (MS), and Rebif® (interferon beta-1a) will be presented at the American Academy of Neurology (AAN) 70th Annual Meeting, April 21-27, 2018, in Los Angeles.
Cladribine Tablets data to be presented includes poster presentations highlighting post-hoc analyses of the CLARITY, CLARITY Extension and ORACLE-MS trials evaluating safety and use in patients with MS, as well as the impact on B- and T-cells. Cladribine Tablets, marketed as MAVENCLAD® in the European Union (EU), is an investigational short-course oral therapy that is thought to preferentially target lymphocytes which may be integral to the pathological process of relapsing forms of MS (RMS). Cladribine Tablets is currently under clinical investigation and is not approved in the US.
MAVENCLAD® has received marketing authorization in 35 countries including European Union member countries, Canada, Australia, Argentina, Israel, and the United Arab Emirates. MAVENCLAD® is now available in Germany, UK, Canada, Netherlands, Norway, Denmark, Sweden, Israel, and other markets. The Company is planning additional filings for regulatory approval including the United States.
Rebif data includes presentations analyzing no evidence of disease activity (NEDA), long-term disease activity assessed by the Magnetic Resonance Imaging in MS (MAGNIMS) score, new data on pregnancy outcomes for women being treated with interferon beta, as well as real-world evidence evaluating treatment adherence rates for patients treated with Rebif compared with dimethyl fumarate.
“We look forward to presenting data demonstrating advancement in our knowledge of MS, including further scientific information about Rebif, an important treatment option for relapsing forms of MS, and potential treatment options, such as investigational Cladribine Tablets, at the 2018 AAN Annual Meeting,” said Luciano Rossetti, MD, Executive Vice President, Global Head of R&D for EMD Serono. “We are committed to better understanding MS and developing innovative solutions to improve the lives of patients and those affected by this disease.”
Meeting attendees can learn more about the Company and participate in the following MS-specific interactive activities by visiting booth #1847:
- “I’m Balancing MS”: Individuals can understand the balance between healthcare and lifestyle for those facing MS through a mobile art activity. For each participant, we will donate $100 to MS Fitness Challenge, a charity organization dedicated to educating and training people with MS on the benefits of exercise and nutrition.
- “Shine a Light”: Individuals can create their own Light Trail art symbolizing what drives their commitment to fighting MS. Participation in the activity will drive a donation to MS Fitness Challenge.
Additionally, Exhibit Hall booth #1957 will host hands-on activities which will allow attendees to gain a better understanding of what it’s like to have MS through virtual reality pods and simulation stations.
EMD Serono will also be hosting an Industry Therapeutic Update event entitled Evolving Perspectives and Innovations in Multiple Sclerosis on Wednesday, April 25 from 7:00 p.m.-10:00 p.m. PDT at the Platinum Ballroom in the JW Marriott Hotel in Los Angeles. Speakers include, Professor Amit Bar-Or, University of Pennsylvania, Philadelphia, PA, Professor Dusan Stefoski, Rush University Medical Center, Chicago, IL and Professor Anthony Traboulsee, University of British Columbia, Vancouver, CA.
AAN Brain Health Fair
EMD Serono will exhibit its MS InsideOut experience at the AAN Brain Health Fair, a one-day-only event where attendees can learn about the brain and the field of neurology. The event takes place on Friday, April 20 from 10:00 a.m.-4:00 p.m. PDT at the Los Angeles Convention Center.
Presentations at AAN 2018 include the following accepted abstracts:
|
Cladribine Tablets Presentations |
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|
Title |
Lead Author |
Abstract/Poster # |
Presentation |
|
Effects of Cladribine Tablets on CD4+ T-cell Subsets in the ORACLE-MS Study: Results from an Analysis of Lymphocyte Surface Markers |
Leist T. |
402 |
Session P1: Biomarkers and Experimental Studies for Multiple Sclerosis on April 22, 2018
On Display: 11:30 a.m. to 5:30 p.m. PDT
Present: 4:00 p.m. to 5:30 p.m. PDT |
|
Integrated Safety Analysis of Infections during Periods of Grade 3 or 4 Lymphopenia in Patients Taking Cladribine Tablets 3.5mg/kg |
Cook S. |
407 |
Session P3: MS Therapeutics in Development on April 24, 2018
On Display: 11:30 a.m. to 7:00 p.m. PDT
Present: 5:30 p.m. to 7:00 p.m. PDT |
|
Effectiveness of Lymphocyte-based Re-treatment Criteria in Minimizing the Incidence of Severe Sustained Lymphopenia During Treatment with Cladribine Tablets 3.5mg/kg |
Cook S. |
370 |
Session P5: MS Therapies: MOA, Safety and Complications on April 26, 2018
On Display: 11:30 a.m. to 7:00 p.m. PDT
Present: 5:30 p.m. to 7:00 p.m. PDT |
|
Long-term Lymphocyte Counts in Patients with RRMS Treated with Cladribine Tablets 3.5 mg/kg: Total Lymphocytes, B-, and T-cell Subsets |
Soelberg-Sorensen P. |
364 |
Session P5: MS Therapies: MOA, Safety and Complications on April 26, 2018
On Display: 11:30 a.m. to 7:00 p.m. PDT
Present: 5:30 p.m. to 7:00 p.m. PDT |
|
Selective and Discontinuous Reduction of B and T Lymphocytes and NK cells in Patients with Early and Relapsing MS (ORACLE-MS, CLARITY and CLARITY Extension) After Administration of Cladribine Tablets |
Stuve O. |
351 |
Session P5: MS Therapies: MOA, Safety and Complications on April 26, 2018
On Display: 11:30 a.m. to 7:00 p.m. PDT
Present: 5:30 p.m. to 7:00 p.m. PDT |
|
Rebif® (interferon beta-1a) Presentations |
|||
|
Title |
Lead Author |
Abstract/Poster # |
Presentation |
|
Relapse in Patients with Multiple Sclerosis Newly Initiating scIFNβ1a Compared with Oral Disease-Modifying Drugs: A Real-World Assessment |
Bowen J. |
353 |
Session P1: Comparative Efficacy of Disease Modifying Therapies on April 22, 2018
On display: 11:30 a.m. to 5:30 p.m. PDT
Present: 4:00 p.m. to 5:30 p.m. PDT |
|
A Panel Survey Analysis of Adherence in Patients with Multiple Sclerosis Treated with scIFNβ1a or Dimethyl Fumarate |
Perrin Ross A. |
354 |
Session P1: Comparative Efficacy of Disease Modifying Therapies on April 22, 2018
On display: 11:30 a.m. to 5:30 p.m. PDT
Present: 4:00 p.m. to 5:30 p.m. PDT |
|
Disease Activity as Assessed by the Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS) Score Predicts Long-Term Clinical Disease Activity (CDA)-Free Status and Disability Progression in Patients Treated with Subcutaneous Interferon beta-1a (scIFNβ-1a) |
Sormani M.P. |
005 |
Session S24: MS Outcome Measures and Biomarkers on April 24, 2018, 4:18 p.m.-4:30 p.m. PDT |
|
Evolution of New Lesions and its Temporal Patterns in Patients with Clinically Isolated Syndrome (CIS) Treated with Subcutaneous Interferon beta-1a (scIFNß-1a) |
Vrenken H. |
370 |
Session P3: MS and CNS Inflammatory Disease: Neuroimaging on April 24, 2018
On display: 11:30 a.m. to 7:00 p.m. PDT
Present: 5:30 p.m. to 7:00 p.m. PDT |
|
Risk of Stroke in Patients with Multiple Sclerosis Treated with Subcutaneous Interferon beta-1a |
Sabidó-Espin M. |
008 |
Session S36: MS Therapeutics and Clinical Research on April 25, 2018
4:54 p.m. to 5:06 p.m. PDT |
|
Cumulative Data from the European Interferon Beta Pregnancy Registry |
Hellwig K. |
357 |
Session P4: Pregnancy and Multiple Sclerosis on April 25, 2018
On display: 11:30 a.m. to 7:00 p.m. PDT
Present: 5:30 p.m. to 7:00 p.m. PDT |
|
Impact of the Presence of Gadolinium-Enhancing (Gd+) Lesions at Baseline on No Evidence of Disease Activity (NEDA) Status in Patients Treated with Subcutaneous Interferon beta-1a (scIFNß-1a): A Post-hoc Analysis of REFLEXION |
Freedman M. |
387 |
Session P6: MS Therapeutics: Extension Studies on April 27, 2018
On display: 11:30 a.m. to 5:30 p.m. PDT
Present: 4:00 p.m. to 5:30 p.m. PDT |
|
Analysis of 6-month Confirmed Disability Progression in RRMS Patients Treated with Subcutaneous Interferon beta-1a |
Wong S.L. |
361 |
Session P6: MS Therapeutics III on April 27, 2018
On display:11:30 a.m. to 5:30 p.m. PDT
Present: 4:00 p.m. to 5:30 p.m. PDT |
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News Source: EMD Serono Website
Image Source: https://multiplesclerosisnewstoday.com/2016/04/15/14146/