Phase II study with ocrelizumab shows significant reduction in disease activity for multiple sclerosis patients

Basel, --

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Biogen Idec (NASDAQ: BIIB) today announced 24-week results1 from a phase II study of ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS), the most common form2 of the disease. Ocrelizumab demonstrated a significant reduction in disease activity as measured by brain lesions and relapse rate. Patients with RRMS suffer from relapses and disabling symptoms caused by nerve damage which can significantly affect their quality of life.

Reductions in total number of brain lesions detected by magnetic resonance imaging (MRI) scans (the primary endpoint of the study) were highly significant at 96% for 2000mg ocrelizumab and 89% for 600mg ocrelizumab compared to placebi . Disease activity was also measured by reduction in annualised relapse rate (ARR), the rate of attacks or flare-ups per patient-year. At week 24, ARR was significantly lowered versus placebo with a reduction of 73% for ocrelizumab 2000mg and 80% for ocrelizumab 600mg .ii

“These efficacy results are amongst the most remarkable seen in a phase II RRMS study, and show that ocrelizumab may have the potential to offer benefits to patients with this disease”, said Professor Ludwig Kappos, lead investigator of the study, from the Department of Neurology, University Hospital Basel, Switzerland.

“We are strongly encouraged by these data and the possibility that ocrelizumab could become a new option for patients with MS”, commented Hal Barron, M.D, Head of Global Development and Chief Medical Officer for Roche. “We believe in the potential of ocrelizumab and look forward to exploring it further in the final phase of clinical development”.

Both ocrelizumab doses were generally well tolerated and no opportunistic infections were reported. Serious adverse events (SAEs) were similar in all treatment groups. Infusion-related events during first infusion, predominantly mild to moderate, were more common with ocrelizumab (34.5% and 43.6%) than placebo (9.3%). However, these reports decreased during the second ocrelizumab infusion and were comparable to those initially reported with placebo.
About the study

* A phase II randomised, multicenter, 220-patient study investigating ocrelizumab compared to placebo in patients with RRMS. Open-label, rater-blinded, interferon beta-1a (30 mcg IM) was also included as a study arm.
* Efficacy and safety profile of two dose regimens of ocrelizumab (600mg and 2000mg) were evaluated. Patients were treated for 24 weeks and received two ocrelizumab intravenous infusions of 300mg or two intravenous infusions of 1000mg given at day 1 and day 15.
* Primary endpoint was efficacy measured by gadolinium-enhancing T1 lesions observed by magnetic resonance imaging (MRI) scans of the brain at weeks 12, 16, 20 and 24 compared with placebo.
* Secondary endpoints included ARR at week 24; total number of new gadolinium-enhancing T1 lesions at four-weekly intervals; safety and tolerability of the two ocrelizumab dose regimens compared to placebo and interferon beta-1a.
* In the double-blinded treatment groups (ocrelizumab 600mg, ocrelizumab 2000mg vs. placebo) SAEs included: systemic inflammatory response syndrome [SIRS] (0.0%, 1.8% vs. 0.0%), hypersensitivity (1.8%, 0.0% vs. 0.0%), oral herpes (0.0%, 0.0% vs. 1.9%), squamous cell carcinoma of the skin (pre-existing lesion) (0.0%, 1.8% vs. 0.0%) and anxiety (0.0%, 1.8% vs. 0.0%). One death related to the consequences of a systemic acute inflammatory reaction was recorded in the 2000mg ocrelizumab treatment arm. A causal relationship with ocrelizumab has not been established.
* Patients will be treated according to study protocol for up to 96 weeks, receiving ocrelizumab infusions every 24 weeks.

About ocrelizumab

Ocrelizumab is an investigational humanised monoclonal antibody designed to selectively target CD20-positive B-cells, which are believed to play a critical role in multiple sclerosis (MS). It then interacts with the body’s immune system to eliminate CD20-positive B-cells.
About multiple sclerosis

Multiple sclerosis (MS) is a highly debilitating autoimmune disease of the central nervous system (CNS) and is one of the leading causes of neurological disability in young adults3,4. The immune system incorrectly attacks healthy nerve tissue in the CNS which affects the transfer of messages from the CNS to the rest of the body5. Symptoms are unpredictable and vary between patients, but include tingling, numbness, pain, slurred speech, and blurred or double vision. Some patients may experience muscle weakness, poor balance or coordination and tremors as well as altered sensation, memory and concentration problems. In severe MS, patients have permanent symptoms, including partial or complete paralysis and difficulties with vision, speech and memory. According to estimates of the World Health Organisation, approximately 1.3 million people worldwide have been diagnosed with multiple sclerosis6. Most people experience their first symptoms between the ages of 20 and 40 years7. Relapsing-remitting multiple sclerosis (RRMS) is the most common form of MS and accounts for around 85% of all cases2. RRMS is characterised by acute exacerbations with full or partial recovery between attacks.
About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients worldwide benefit from Biogen Idec’s significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80’000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

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References:
1) ‘Efficacy and Safety of Ocrelizumab in Patients with Relapsing-Remitting Multiple Sclerosis: Results of a Phase II Randomized Placebo-Controlled Multicenter Trial’, Kappos et al., ECTRIMS 2010
2) Multiple Sclerosis Society (MSS) UK’s information page, What is relapsing and remitting MS? http://www.mssociety.org.uk/about_ms/types_of_ms/what_is_rrms.html#
3) Ford HL, Gerry E, Johnson M, et al. A prospective study of the incidence, prevalence and mortality of multiple sclerosis in Leeds. J Neurol 2002; 249:260–265
4) Sloka JS, Pryse-Phillips WE, Stefanelli M. Incidence and prevalence of multiple sclerosis in Newfoundland and Labrador. Can J Neurol Sci 2005; 32:37–42
5) NINDS multiple sclerosis information page, National Institute of Neurological Disorders and Stroke, http://www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm, last accessed 30/10/09
6) MS Atlas, World Health Organisation, 2008
7) NINDS multiple sclerosis information page, National Institute of Neurological Disorders and Stroke, http://www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm, last accessed 30/10/09