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Arena Pharmaceuticals Initiates Lorcaserin Phase 3 Obesity Clinical Trial

[The sheer size of this program is mind-boggling: 6,000 patients in all if subsequent phase-3 trials are commenced contingent on the first phase-3 trial showing no heart-valve problems after six months of treatment.]

http://biz.yahoo.com/prnews/060912/latu047.html?.v=69

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Tuesday September 12, 7:30 am ET

- First of Three Planned Phase 3 Trials Evaluating Lorcaserin for the Treatment of Obesity -

SAN DIEGO, Sept. 12 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA ) today announced the dosing of the first patient in the first of three planned Phase 3 clinical trials evaluating the efficacy and safety of its lead drug candidate, lorcaserin hydrochloride, for the treatment of obesity. Known as BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), this double-blind, randomized, and placebo-controlled trial will include about 100 centers in the United States and is expected to enroll approximately 3,000 overweight and obese patients. The proportion of patients with a 5% or greater weight reduction from baseline at week 52 is the primary endpoint.

"Based on the previously announced Phase 2b data demonstrating that treatment with lorcaserin resulted in statistically significant, progressive and dose-dependent weight loss with a generally favorable tolerability profile, we believe lorcaserin has the potential to be an attractive new therapy for obesity," commented William Shanahan, M.D., Arena's Vice President and Chief Medical Officer. "As we start the Phase 3 program, we are looking forward to the DSMB's review of the six-month echocardiographic data sometime around next summer as a significant safety milestone that will trigger the initiation of additional Phase 3 studies."

The BLOOM trial will evaluate a 20 mg dose (10 mg dosed twice daily) of lorcaserin versus placebo over a two-year treatment period in obese patients (BMI 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to 30) with at least one co-morbid condition. All patients will receive echocardiograms at baseline and follow-up echocardiograms at 6, 12, 18 and 24 months after starting the trial. Echocardiograms will be reviewed by an independent Data Safety Monitoring Board (DSMB) at 6 and 12 months. The DSMB will review echocardiographic data, and will make a judgment as to whether or not it is appropriate to proceed with the trial at the time of each review.

The complete lorcaserin Phase 3 program is designed to enroll a total of approximately 6,000 patients in three pivotal trials. Assuming a positive six-month safety assessment from the DSMB for the BLOOM trial, two additional Phase 3 trials enrolling a total of approximately 3,000 patients will be initiated. In these additional pivotal trials Arena plans to evaluate the 20 mg and 10 mg daily doses versus placebo over a one-year treatment period, with one of the trials evaluating patients with type 2 diabetes. Diet and exercise will be part of each of the pivotal trials in accordance with the FDA guideline. In addition to the above planned pivotal trial program, several other small studies, such as drug interaction and abuse potential studies, will be conducted.

"The initiation of Arena's first Phase 3 clinical program is a major achievement for the company," commented Jack Lief, Arena's President and Chief Executive Officer. "Working with our committed group of clinical investigators, we are hopeful that we will be able to provide a new and important therapeutic option for overweight and obese patients, who currently have limited treatment options."

About Lorcaserin

Lorcaserin, Arena's orally administered, internally discovered drug candidate for the treatment of obesity, is in an ongoing Phase 3 program. The compound is selective in stimulating the 5-HT2C serotonin receptor, located in the hypothalamus, which helps regulate satiety and influences metabolic rate. Results from a Phase 2 study demonstrate that treatment with lorcaserin produced highly statistically significant, progressive and dose-dependent weight loss over a 12-week period. In the study, which excluded diet and exercise, patients taking a daily 20 mg dose of lorcaserin recognized a mean weight loss of 7.9 pounds, while patients on placebo lost less than 1 pound. Lorcaserin was generally well tolerated at all doses and had no apparent effects on heart valves or pulmonary artery vasculature.

About Obesity

Obesity affects tens of millions of adults and children in the United States and poses a serious long-term threat to their health and welfare. The number of overweight and obese people has substantially increased over the past several decades. Approximately two-thirds of all adults in the United States are obese or overweight and medical and related costs of obesity were more than $117 billion in 2000. Being obese or overweight is associated with a number of conditions, including heart disease, stroke, diabetes, cancer and osteoarthritis. Medical treatment options for obese and overweight people are currently limited.

About Arena Pharmaceuticals

Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory, and metabolic diseases. Arena has a broad pipeline of novel compounds targeting G protein-coupled receptors, or GPCRs, an important class of validated drug targets. Arena has four internally discovered, clinical-stage drug candidates for major diseases and disorders. The most advanced, lorcaserin, is being investigated in a Phase 3 clinical trial program for the treatment of obesity. Arena's lead drug candidate for the treatment of insomnia, APD125, a compound with a novel mechanism of action to improve sleep maintenance, is expected to enter a Phase 2 clinical trial. Arena-discovered drug candidates are also being evaluated in two clinical-stage collaborations with major pharmaceutical companies: Merck & Co., Inc. and Ortho-McNeil, Inc., a Johnson & Johnson company.
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