The 23% lower annual relapse rate among the laquinimod patients versus the placebo ones is “statistically significant”, the researchers said. There was also a 36% reduction in disability progression as measured by Expanded Disability Status Scale, and 33% less brain atrophy among the laquinimod participants.

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

Oral cladribine (EMD Serono) reduced the relapse rate significantly more than inactive placebo in the phase 3 “CLARITY” study of 1,326 people with relapsing-remitting MS. These initial results – the first from any phase 3 study of oral therapy for MS — are reported in a press release from EMD Serono dated January 23, 2009. Additional study results will be submitted for presentation at an upcoming scientific meeting. Oral cladribine has been designated by the U.S. Food and Drug Administration as a “Fast Track Product,” which should expedite its future review. The company plans to file for FDA approval of oral cladribine in mid-2009.

Background: Cladribine can interfere with the activity of white blood cells that underlie the immune attacks that cause the unpredictable symptoms of MS. Injectable cladribine is used to treat hairy cell leukemia. Studies have suggested a benefit in MS. In addition to the completed CLARITY study, other ongoing studies of oral cladribine funded by EMD Serono include:
• The ONWARD study, an investigation of the safety and effectiveness of adding high or low doses of oral cladribine to interferons in a trial recruiting 260 people with relapsing forms of MS (this study is currently recruiting participants); and
• The ORACLE MS study, designed to evaluate the safety and effectiveness of oral cladribine in people who have experienced a neurological episode that puts them at risk for developing MS (this study is currently recruiting participants).

The CLARITY Study: For the first year of the study, 1,326 participants were randomly assigned to receive a low dose of cladribine (two treatment cycles per year, each cycle consisting of one tablet per day for four to five consecutive days), a high dose (four cycles) of cladribine, or inactive placebo. In the second year, both treatment groups received a low dose of cladribine. The primary endpoint was the drug’s effect on relapse rate at two years compared with placebo. Secondary endpoints included effects on disease activity, as detected by MRI scans, the proportion of relapse-free participants, and disability progression.

The relapse rate was reduced significantly more than placebo in both treatment groups (by 58% in the low-dose group and by 55% in the high-dose group). The company reports that secondary endpoints of the CLARITY study were also met, although the details of these are not provided in the press release. Additional study results will be submitted for presentation at an upcoming scientific meeting.

Lymphopenia – a reduction of white blood cells – was the most frequent adverse event, and occurred more frequently in the groups on cladribine. Other adverse events reported in all three groups were headaches and cold symptoms.

“These are exciting initial results, and we look forward to seeing the full data,” says John Richert, MD, Executive Vice President of Research and Clinical Programs at the National MS Society. “If this pill proves to be safe and effective for people with relapsing MS, it represents a major treatment breakthrough – hopefully the first of many more in the pipeline.”

View full post here: http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=650

Teva’s laquinimod for MS gets fast tracked
February 12, 2009 — 3:34pm ET | By Calisha Myers

Israel-based Teva Pharmaceutical announced today that the FDA has granted the Fast Track designation to laquinimod, its investigational treatment for relapsing-remitting multiple sclerosis (RRMS). Laquinimod is a once-daily treatment administered orally. Teva licensed the compound from Swedish developer Active Biotech in 2004.

The first phase III clinical trials–Allegro–were completed in November 2008 and Teva is now enrolling patients globally for Bravo, the second Phase III study. Teva said that with the FDA’s decision, the drug could enter the market as soon as late 2011. “We are pleased that the FDA has awarded laquinimod with a Fast Track designation, and are hopeful it will be part of our growing portfolio of innovative therapies,” Moshe Manor, Vice President, Global Innovative Resources Group at Teva, said in a statement.

Shares of Teva rose 75 cents to $43.88 in afternoon trading on Thursday, while Active Biotech’s shares jumped $3.40 to $38.30.

ALSO: It seems that Teva is trying to make 2009 the year of generics. The company’s new campaign, “Year of Affordable Healthcare,” employs social media–including YouTube, Twitter and possibly Second Life– and various other tools to build its largest ever PR campaign. Teva tells PRWeek that 2009 is “a critical year for the future of both healthcare in America and the generic drug industry.” Report

The companies are to commence two global Phase III trials of laquinimod during this year. The Phase III trials will take place in centers in the United States, Europe, and other locations worldwide, to further confirm the results of the Phase II trials.

“We are extremely excited about initiating the Phase III clinical program for oral laquinimod, as we believe laquinimod is a potential new and convenient treatment option for MS patients,” said Shlomo Yanai, President and CEO of Teva Pharmaceutical Industries Ltd. “The accelerated development of oral laquinimod is part of our commitment to MS patients to develop additional improved therapies that combine superior efficacy and excellent safety.”

“Laquinimod has the potential to be a novel, orally-administered disease modifying treatment for people suffering from multiple sclerosis,” said Sven Andréasson, President and CEO of Active Biotech. “Laquinimod would represent a milestone for patients as it would provide them with an efficacious and safe treatment, as well as a new drug delivery option that is suitable for long-term treatment.”

About Phase II Laquinimod Trials

Results from a 36-week, randomized, double-blind, placebo-controlled Phase IIb trial evaluating the effect of oral daily 0.3 and 0.6 mg doses of laquinimod on magnetic resonance imaging (MRI) -monitored disease activity in patients with RRMS were recently presented at the American Academy of Neurology (AAN) Annual Meeting in May, 2007. Data from the trial demonstrated that an oral 0.6 mg dose of laquinimod given daily significantly reduced MRI disease activity by 40 percent in RRMS patients and was well tolerated. In addition, there was a favorable trend towards reducing annual relapse rates, the number of relapse-free patients and time to first relapse compared with placebo. Treatment with both 0.3 and 0.6 mg doses of laquinimod were well tolerated with only some transient and dose-dependent increases in liver enzymes.

A previous 24-week Phase IIa trial conducted by Active Biotech demonstrated that oral 0.3 mg laquinimod given daily was well tolerated and reduced the formation of active lesions in RRMS.

About Laquinimod

Laquinimod is a novel once-daily, orally administered immunomodulatory compound that is being developed as a disease modifying treatment for multiple sclerosis (MS). Active Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries, Ltd. in June 2004. To date, 460 MS patients have received laquinimod in various clinical trials.

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