Extavia, a form of interferon beta-1b, can be used in patients with early and relapsing forms of multiple sclerosis, Basel, Switzerland-based Novartis said in a statement today.

Selling the treatment is a strategic step that allows Novartis to establish itself in the multiple sclerosis community before introducing its potentially best-selling FTY720 MS pill. The company aims for at least $1 billion in sales for its multiple sclerosis franchise, Joe Jimenez, the head of Novartis’ drug unit, said in an interview before the approval. Novartis plans to set up a network of sales people, nurses, as well as support hotlines to help sell Extavia and “build our commercial capability,” Jimenez said.

Biogen Idec (NASDAQ: BIIB) today announced the U.S. Food and Drug Administration (FDA) has granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). Biogen Idec is currently enrolling patients in a global Phase III study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population.

“Early-stage clinical trials suggest that PEGylated interferon beta-1a has the potential to offer less frequent dosing without compromising efficacy, which would be a significant development for people living with multiple sclerosis,” said Michael Panzara, M.D., M.P.H., vice president and chief medical officer of neurology at Biogen Idec. “We look forward to working closely with the FDA to expedite the compound’s development and review process.”

The FDA’s Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

Biogen Idec plans to enroll more than 1,200 patients in the Phase III, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of PEGylated interferon beta-1a in patients with RMS. The global trial, called ADVANCE, will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients with RMS at one year. The study will also examine if, over time, treatment with PEGylated interferon beta-1a can slow disease progression and lead to a decrease in the number of T2 hyperintense brain lesions commonly seen in MS patients.

Patients interested in learning more about the ADVANCE trial may speak with their physician or e-mail ADVANCEstudy@biogenidec.com.

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June 26, 2009

A new electronic, multidose, autoinjection device improves subcutaneous delivery of interferon beta (IFNB)-1a in patients with relapsing multiple sclerosis (MS), according to a study presented here at the 19th Meeting of the European Neurological Society (ENS2009).

Virginia Devonshire, MD, Division of Neurology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, presented the results of a multicenter, single-arm, open-label, phase 3b study on June 24.

“Patients have problems with their adherence and initiation of therapies because these are injectable therapies, so we were looking at whether patients would find this device more suitable for injection,” said Dr. Devonshire.

She also indicated that the device enables adjustable injection depth and speed, has a hidden needle, provides visual and audio cues during the injection process, and records an accurate dosing history.

The study evaluated the suitability of the device for subcutaneous (SC) administration of the 3-times-weekly (TIW) formulation of IFNB-1a 44 mcg, as well as the incidence of injection-site reactions (ISRs), patient satisfaction with use, and impressions of the characteristics of the device.

Enrolled patients (n = 106) had received IFNB-1a 44 mcg SC TIW consistently for >=6 weeks before screening.

Patients who received regular injection of any other medication during the screening and study periods were excluded, as were patients with any physical/visual impairment that would preclude proper use of the device.

At baseline, patients were trained in the use of the new device and received IFNB-1a 44 mcg SC TIW for 12 weeks. Assessments were performed at baseline and weeks 2, 4, 8, and 12.

A total of 101 patients completed the study.

At week 12, 71.6% of patients indicated that this new device was suitable or very suitable. Most patients gave the same ratings for the various individual functions of the device (80.8%-95.2%), with most (95.2%) also rating these as easy or very easy to use.

In addition, 58.7% of the patients rated the device more or much more convenient than their previous device, and 60.2% requested to continue using it.

“We think that this is a good advance, and there will certainly be a group of patients who will prefer to have this kind of autoinjector,” said Dr. Devonshire.

“The main hurdle with new patients is often getting them onto a therapy, so this may offer something for that patient who is fairly needle phobic or is worried about going onto a therapy by injection,” he concluded

View entire post here: http://multiplesclerosis.blogharbor.com/blog/_archives/2009/6/29/4239965.html

Bravo is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod compared to placebo, and to provide risk-benefit data for laquinimod compared to a currently available injectable treatment, Avonex.

The Bravo study completed patient enrollment in June 2009, recruiting more than 1,200 patients at 156 sites in the US, Europe, Israel and South Africa.

Allegro, the first global Phase III trial of laquinimod, completed enrollment in November 2008, after recruiting more than 1,000 patients at 152 sites in North America, Europe and Asia, said Teva. The trial is currently ongoing.

Moshe Manor, Teva’s group vice president of global branded products, said: “Teva and Active Biotech are encouraged by the potential of laquinimod to address patients’ unmet need for an oral immunomodulating multiple sclerosis therapy that provides efficacy while maintaining safety. We look forward to continuing our clinical Phase III program of laquinimod, and hope it will offer enhanced quality of health for relapsing-remitting multiple sclerosis patients.”

View full article here: http://www.tmcnet.com/usubmit/2009/06/26/4246746.htm

MILAN, Italy — June 26, 2009 — Patients with relapsing-remitting multiple sclerosis (RRMS) who receive glatiramer acetate (GA) or interferon (IFN) beta show a reduction in cognitive impairment and relative stability of cognitive and affective variables at 2 years, according to the results of an observational study presented here at the 19th Meeting of the European Neurological Society (ENS).

The aim of the observational study was to evaluate the long-term effects of first-line disease-modifying therapies with GA or IFN beta on cognitive functions, affective status, fatigue and quality of life in patients with RRMS (ITACA study).

“A total of 752 patients with RRMS and a mean age of 36 years were enrolled in 79 Italian centres,” explained principal investigator Monica Falautano, PhD, Functional Unit of Psychology, IRCCS H. San Raffaele Milano, Milan, Italy, on June 24. Study patients were treated with either GA or IFN beta.

At baseline and 6, 12, 18, and 24 months, a fatigue and physical disability evaluation was performed. Cognitive and affective assessments were performed at baseline and 12 and 24 months.

A significant reduction [P < .0001] in cognitive impairment was observed at the 24-month follow-up, Dr. Falautano noted.

At baseline, 40% of all patients showed mild cognitive impairment, and 16% showed severe cognitive impairment, which the researchers said was reduced to 30% and 11%, respectively, at 2 years.

A higher proportion of GA than IFN patients had been affected by severe cognitive impairment (20% vs 12%). At the 24-month follow-up, the percentage of severe impairment was reduced to similar amounts in both treatment groups (12% and 10%, respectively).

According to the mean Montgomery-Asberg Depression Rating Scale score, significant depressive symptoms were missing both at baseline and at the 24-month follow-up.

Physical and mental health assessed with the Multiple Sclerosis Quality of Life 54 questionnaire correlated highly significantly at baseline and at the 24-month follow-up (P < .001).

Patients did not report any changes in perception of their quality of life after 2 years of treatment. No changes were observed in Kurtzke’s Functional Systems Scores.

“The immunomodulatory treatment may have an impact on cognitive function,” Dr. Falautano summarised the primary result of the study. “Nevertheless, a longer follow-up is advisable to confirm our results.”

Funding for this study was provided by Sanofi-Aventis.

[Presentation title: Affective and Cognitive Aspects in Relapsing-Remitting Multiple Sclerosis Patients: 24-Month Follow-Up of the ITACA Study. Abstract P696]

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In the 96-week phase 3, randomised, double-blind, placebo-controlled Cladribine Tablets Treating MS Orally (CLARITY) trial, cladribine tablets demonstrated significant efficacy in the treatment of patients with relapsing-remitting MS.

Vissia Viglietta, MD, Merck Serono, Inc., Rockland, Massachusetts, presented the safety results of the study at a poster presentation on June 22.

The trial assessed 2 dosing regimens of the immunomodulatory drug and compared them with placebo. A total of 1,326 patients were randomised to either cladribine 5.25 mg/kg total dose, cladribine 3.5 mg/kg total dose, or placebo.

As expected based on the mechanism of action of cladribine, lymphopenia occurred more frequently with active treatment. The association was dose related; patients in the highest-dose group showed the highest incidence (31.5% vs 21.6% and 1.8% in the 3.5-mg/kg and placebo groups, respectively).

“This finding was not associated with any clinical outcomes,” Dr. Viglietta emphasised. “Furthermore, the vast majority of patients recovered quickly during the 96-week period.”

Infections/infestations occurred with similar incidence across treatment groups (48.9%, 47.7%, and 42.5% with cladribine 5.25 mg/kg, cladribine 3.5 mg/kg, and placebo, respectively), suggesting that first-line immune defence mechanisms remained adequate.

In almost all cases in each group, infections were considered mild or moderate by the investigators.

“Three isolated solid malignancies occurred in the 3.5-mg/kg group,” Dr. Viglietta reported. “They were unrelated to the mechanism of action of cladribine.” One choriocarcinoma was noted in the highest-dosage group approximately 9 months after the completion of the study.

In the 5.25-mg/kg, 3.5-mg/kg, and placebo groups, 7.9%, 3.5%, and 2.1% of patients discontinued treatment because of adverse events (AEs). Lymphopenia was the reason for discontinuation in 2.0%, 0.5%, and 0%.

Apart from blood and lymphatic system disorders, AEs leading to treatment discontinuation were comparable across the treatment groups. In the same group order, 9.0%, 8.4%, and 6.4% of patients experienced serious AEs.

“We are acquiring more safety data with the 4-year extension trial,” Dr. Viglietta concluded. At the same time, a safety registry is being established. “Every patient who has been treated with cladribine even once will be followed for a total of 8 years.”

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JERUSALEM–New data presented today provided evidence that long-term treatment with COPAXONE^® (glatiramer acetate injection) may offer sustained protection from neuronal/axonal injury. This protective effect was reflected biologically by a significant increase in N-acetylaspartate (NAA), a specific marker of neuronal mitochondrial function, in treated versus non-treated relapsing-remitting multiple sclerosis (RRMS) patients. These six-year results augment previously published findings suggesting that treatment with COPAXONE^® may provide a neuroprotective effect in RRMS patients^{1, 2}.

The study, “Six-Year Prospective Multi-Voxel Brain MRS Study of Two Cohorts in RRMS To Examine the Effect of Glatiramer Acetate on Neuronal/Axonal Metabolic Injury,” is the largest (n=46) and longest study of its kind to date. In the study, patients taking COPAXONE^® for six years experienced an improvement in neuronal mitochodrial function, as quantified by an increase in neuronal NAA levels and evaluated by ¹H- Magnetic Resonance Spectroscopy (¹H-MRS). Decreased neuronal NAA levels are reflective of neuronal/axonal injury.

“The potential ability to prevent or repair brain tissue damage in RRMS patients is an important treatment consideration given the degenerative pathology of this life-long condition,” said Omar Khan, M.D., Professor of Neurology, Director, Multiple Sclerosis Center, Wayne State University and lead investigator of the study. “These data further substantiate our previous research into the potential neuroprotective effect of COPAXONE^®, as well as the use of NAA measures as a reliable marker for assessing a patient’s disease progression and response to treatment.”

Similar results were reported from a different study examining the effect of COPAXONE^® in Clinically Isolated Syndrome (CIS) patients. The study demonstrated patients who received COPAXONE^® improved in their cerebral neuroaxonal integrity relative to patients treated with placebo. Patients on placebo showed a decline in NAA consistent with that demonstrated in historical control studies.

About the Study

Forty-nine patients, divided into two cohorts of previously treatment-naïve RRMS patients, underwent serial brain ¹H-MRS scanning. Group 1 (n=22) included patients who started COPAXONE^® therapy at enrollment (n=18) and during the course of the study (n=4). Mean age, disease duration and Expanded Disability Status Scale (EDSS) were 43.5 years, 8.2 years and 2.77, respectively. Mean NAA/Cr at baseline was 1.97 + 0.24 and 2.20 + 0.16 (+11.6 percent) at year 6 (p<0.05). Group 2 (n=31) included patients who started GA therapy at enrollment. Mean age, disease duration and EDSS were 35.1 years, 5.8 years and 2.53, respectively. Mean NAA/Cr at baseline was 1.99 + 0.1 and 2.12 + 0.08 (+6.53 percent) at year 6 (p<0.05). Twelve untreated RRMS patients were also scanned for two years and showed a significant decline in NAA/Cr over the two years of follow-up. Additionally four untreated patients initiated COPAXONE^® during the course of the study and demonstrated considerable improvement in the mean NAA/Cr ratio, as well as clinical stability during total study observation. Finally, nine healthy volunteers were scanned annually for controls. Further analysis is ongoing. The study was in part supported by Teva Neuroscience.

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