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To date, the only M.S. treatments on the market come in the form of an injection or an infusion.   Excitingly, laquinimod, the potentially first-ever oral therapy for M.S. is undergoing its second Global Phase III Trial.  And — they are looking for qualified patients to join the trial. Enrollments began on July 17th.

The following information was supplied to me by Erica Tursi, who represents the firm promoting Iaquinimod (etursi@rxmosaic.com).  I’ve agreed to post the information here for readers. (This is lengthy information, but it all seemed important and relevant and I certainly didn’t want to be the one to edit out some important clause). If you like what you read and want to enroll in the Bravo Trial, call 1-800-840-5601.  More information will come soon on how to enroll in the Allegro Trial, although there is a number supplied below as well.  Deep breath — and read on, and on, and on! 

TEVA ENROLLS PATIENTS FOR A SECOND LARGE GLOBAL PHASE III TRIAL OF ORAL LAQUINIMOD

 

The BRAVO trial, together with the ongoing ALLEGRO trial will investigate oral laquinimod in more than 2,000 relapsing-remitting-multiple-sclerosis (RRMS) patients worldwide

 

Jerusalem, Israel and Lund, Sweden, July 16, 2008 – Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech AB (OMX NORDIC: ACTI) announced today that patients are being enrolled for the BRAVO (benefit-risk assessment of Avonex® and laquinimod) Phase III pivotal trial. The BRAVO is a global, 24-month, double-blind study designed to evaluate the efficacy, safety and tolerability of the oral compound laquinimod versus placebo, and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex®. The BRAVO trial, which was initiated in April this year, aims to enroll approximately 1,200 patients with relapsing-remitting multiple sclerosis (RRMS). A second global Phase III trial of laquinimod including 1,000 patients, ALLEGRO, is already ongoing and recruiting patients globally.

 

“All currently approved multiple sclerosis (MS) treatments are administered via injection or infusion. The ability to provide a safe and effective oral treatment option would be a significant advancement for the treatment of MS,” said Dr. Timothy Vollmer, Medical Director, Rocky Mountain MS Center, Denver, Colorado, and principal investigator of the BRAVO study. “Additionally, the mode of action for laquinimod is unlike any other MS compound, existing or experimental. We are hopeful that this research will expand our abilities to combat the disease through novel targeting.”

 

Data recently published in The Lancet* demonstrated that oral dose of laquinimod significantly reduced magnetic resonance imaging (MRI) disease activity by a median of 60 percent, compared to placebo and was well tolerated in RRMS patients. The majority of patients from the study are still receiving treatment with laquinimod in an open-label extension trial.

 

“The safety profiles of oral therapies are of increasing interest to the MS community; We are hopeful that laquinimod will be both efficacious and safe thus providing patients with an optimal risk-benefit profile,” said Dr. Per Soelberg Sorensen, Danish Multiple Sclerosis Research Center, Department of Neurology, Copenhagen University Hospital, and prinicipal investigator of the BRAVO study.

 

About Bravo

BRAVO (benefit-risk assessment of Avonex® and laquinimod) is a pivotal, multinational, multi-center, randomized, double-blind, parallel-group, placebo-controlled study designed to compare the safety and efficacy of laquinimod with placebo and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex®. The enrollment goal is approximately 1,200 patients with RRMS. The globally conducted study will include centers in the United States, Europe, and Israel. To learn more about BRAVO visit
www.TevaClinicalTrials.comor call 1-800-840-560.

 

About Allegro

Allegro is a pivotal, global, 24/30-month, double-blind, Phase III study designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo in the treatment of relapsing-remitting multiple sclerosis (RRMS). The Allegro trial aims to enroll approximately 1,000 patients with RRMS. The globally conducted study will include centers in the United States as well as centers throughout Canada, Europe, and Israel. To learn more about Allegro, visit
www.TevaClinicalTrials.comor call +1 866 550 0614        .

 

About Laquinimod

Laquinimod is a novel once-daily, orally administered immunomodulatory compound that is being developed as a disease-modifying treatment for RRMS. Active Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries, Ltd. in June 2004. A Phase IIb study in 306 patients was recently published in The Lancet and demonstrated that an oral 0.6 mg dose of laquinimod, administered daily, significantly reduced MRI disease activity by a median of 60 percent versus placebo in RRMS patients. Laquinimod also showed consistent and robust effect on all secondary MRI endpoints. In addition, the study showed a favorable trend toward reducing annual relapse rates and the number of relapse-free patients compared with placebo. Treatment was well tolerated, with only some transient and dose-dependent increases in liver enzymes reported. Over 460 MS patients have received laquinimod in various Phase I-II clinical trials.

 

In addition to the efficacy that laquinimod has shown in Phase II RRMS clinical trials, laquinimod has demonstrated potent therapeutic efficacy in preclinical models of other autoimmune diseases such as rheumatoid arthritis, insulin-dependent diabetes mellitus, Guillain Barré Syndrome, lupus and Inflammatory Bowel Disease. The broad profile of efficacy in animal models of inflammatory diseases suggests that laquinimod affects a pivotal pathway of inflammation and autoimmunity. Teva expects to initiate the clinical development of laquinimod for Crohn’s disease and Lupus Nephritis in the near future.

 

About Active Biotech

Active Biotech AB (OMX NORDIC: ACTI), headquartered in Sweden, is a biotechnology company with R&D focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, as well as ANYARA for use in cancer targeted therapy, primarily renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex® for RA. Please visit
www.activebiotech.comfor more information

 

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva’s sales are in North America and Western Europe. Please visit
www.tevapharm.comfor more information on Teva Phermaceutical Industries Ltd.

 

Teva’s Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: Teva’s ability to accurately predict future market conditions, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra®, Neurontin®, Lotrel®, Famvir® and Protonix®, Teva’s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, the effects of competition on our innovative products, especially Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, Teva’s ability to successfully identify, consummate and integrate acquisitions (including the pending acquisition of Bentley Pharmaceuticals, Inc.), potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in Teva’s Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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“NEW ORAL DRUG LAQUINIMOD REDUCES MULTIPLE SCLEROSIS DISEASE ACTIVITY AND IS SAFE AND WELL TOLERATED.”

 

A new treatment for multiple sclerosis (MS) reduces MRI disease activity* and is well-tolerated in patients with the relapse-remitting form of the condition. The treatment is also oral and thus offers advantages to patients over conventional injected treatments. The promising results from this phase II study are reported in an Article in this week’s edition of The Lancet.

 

MS is an immune-mediated disease of the central nervous system, affecting predominantly ‘white matter’—ie, the tissues in the brain and the other parts of the nervous system which transmit messages between ‘gray matter’ where nerve bodies are found. Drugs available at the moment focus on the inflammatory aspects of MS, which predominate in the relapse-remitting form of the disease. These drugs include glatiramer acetate, interferon β, natalizumab, and mitoxantrone, and all are injectable, Thus the availability of an oral agent could be a major advantage for patients in terms of convenience. Professor Giancarlo Comi, Institute of Experimental Neurology, University Vita-Salute, Milan, Italy and colleagues did a randomised phase II trial to test the efficacy, safety, and tolerability of two doses of laquinimod versus placebo.

 

The trial involved 51 centres in nine countries, and patients were eligible if they had had one or more relapses in the year before entry and at least one gadolinium enhancing (GdE) lesion† on screening MRI. A total of 306 patients aged 18–50 years were enrolled, with 102 randomly assigned to placebo, 98 to laquinimod 0·3 mg daily, and 106 to laquinimod 0·6 mg daily. Brain MRI scans and clinical assessments were done four weeks before the trial started, at the start (baseline), then every four weeks for nine months. Numbers of GdE lesions were measured at weeks ,12, 16, 20, 24, 28, 32 and 36.

 

The researchers found that, compared with placebo, laquinimod 0·6 mg per day showed a 40·4% reduction of the mean number of GdE lesions over the last four scans compared with baseline, while laquinimod 0·3 mg per day showed no statistically significant effects vs placebo. Both doses of laquinimod were well tolerated, with only two serious but reversible adverse events connected with the drug, but with no clinical consequences. Two patients stopped treatment as one had persistent elevations in liver enzymes, while another had inherited thrombophilia and experienced an event of Budd-Chiari syndrome—a partial blockage of the venous outflow from the liver.

 

The authors conclude: “Overall, the efficacy and safety profile emerging from this and from a previous phase II clinical trial, in combination with the oral route of administration, make laquinimod a promising therapeutic opportunity for patients with relapse remitting multiple sclerosis. The benefits and risks of laquinimod treatment are now being further assessed in a large-scale phase III trial.”

 

In an accompanying Comment, Dr B Mark Keegan and Dr Brian G Weinshenker, Department of Neurology, Mayo Clinic, Rochester, MN, USA, say laquinimod will need to go through head-to-head trials with other multiple sclerosis drugs to demonstrate superiority or at least equivalence.

 

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