A class-action lawsuit over a new Medicaid law that would require beneficiaries and applicants to provide proof of citizenship to receive benefits beginning July 1 is expected to be filed Wednesday, the Atlanta Journal-Constitution reports (Kemper, Atlanta Journal-Constitution, 6/28). The measure is included in the Deficit Reduction Act of 2005, which was signed into law by President Bush in February. Under the law, individuals seeking care through Medicaid as of July 1 will be required to show proof of U.S. citizenship, such as a birth certificate, passport or another form of identification. The law’s intent is to prevent undocumented immigrants from claiming to be citizens in order to receive benefits only provided to legal residents (Kaiser Daily Health Policy Report, 4/11). The Congressional Budget Office estimates that the requirement will save the federal government $220 million over five years and $735 million over 10 years. CBO says that by 2015, about 35,000 people — mostly undocumented immigrants — will lose coverage because of the new requirement. However, the Center on Budget and Policy Priorities estimates that three million to five million low-income citizens could lose Medicaid coverage because they do not have birth certificates or passports (Kaiser Daily Health Policy Report, 4/18). The lawsuit — to be filed on behalf of at least four Medicaid beneficiaries who are unable to provide documentation of their citizenship — alleges that current enrollees who already have been declared eligible for Medicaid would be put “through a complex, costly and difficult administrative process to prove the same thing all over again.” Many U.S. residents — including blacks in the South who were denied access to hospital maternity wards during periods of segregation — cannot provide such documentation, according to the lawsuit. Ron Pollack, executive director of Families USA, which is aiding those involved in the lawsuit, said the stricter Medicaid requirement is “part of the backlash and — if I may say — the pandering of members of Congress” as they debate how to deal with the estimated 12 million undocumented immigrants living in the U.S (Atlanta Journal-Constitution, 6/28).

NPR’s “Talk of the Nation” on Tuesday included a discussion of the Medicaid law. The segment includes comments from Leslie Norwalk, deputy administrator of CMS, and Pollack (Conan, “Talk of the Nation,” NPR, 6/27). The complete segment is available online in RealPlayer.

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

Allon Therapeutics Inc. (TSX:NPC) announced today that a Phase 1 clinical trial of its lead neuroprotective drug, davunetide , which began patient enrolment January 28, 2010, has been completed. The results demonstrated that the intranasal dose range can be broadened and provided additional information on the pharmacokinetic profile of davunetide.

Gordon McCauley, President and CEO of Allon, said the results confirm davunetide’s safety and expands the doses that can be used in future clinical trials. The Company’s previous Phase 2a clinical trials successfully demonstrated human efficacy in patients with schizophrenia and in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer’s disease.

“These Phase 1 results fully support our dosing plans for a Phase 2 clinical trial that will evaluate davunetide as a treatment for Progressive Supranuclear Palsy (PSP), a rapidly-progressing and fatal degenerative brain disease,” McCauley said.

The randomized, double-blind, placebo-controlled Phase 1 study evaluated the multi-dose safety, tolerability and pharmacokinetic profile of davunetide in 10 healthy adult subjects aged 45 to 65 years. Davunetide was administered at a dose up to 60 mg per day, and was found to be generally well tolerated with no serious adverse events reported. The number of treatment emergent AEs were small with a similar number reported in the placebo and the high dose groups. These clinical results support the advancement of davunetide at higher dosage levels in the treatment of neurodegenerative diseases such as Alzheimer’s disease, schizophrenia and PSP.

Allon announced January 12, 2010 that the United States Food and Drug Administration (FDA) granted Orphan Drug Designation to davunetide for the treatment of PSP. PSP is a one of several dementias classified as a frontotemporal dementia (FTD).

Approximately half of dementias diagnosed as FTD, including PSP, have a common pathology in which brain cells are damaged by impairment of the brain protein tau. Allon’s preclinical studies and Phase 2a clinical trials have shown that davunetide is active in treating diseases known to have impaired tau function, leading to restoration of brain cell health. Allon expects that efficacy in PSP would define the opportunity to use davunetide in other FTD subtypes that are tauopathies.

About davunetide

Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP). Allon’s laboratory and animal studies have shown that davunetide improves cognition in a number of disease models through a mechanism believed to involve effects on structures in the brain – known as microtubules which are critical to communication between brain cells and the structure of individual cells.

In 2008, Allon reported Phase 2a clinical trial results showing that davunetide had a statistically significant positive impact on memory function in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer’s disease (AD). The data was presented July 28 and July 30, 2008 to the International Conference on Alzheimer’s Disease and Related Disorders (ICAD 2008).

On December 7, 2009, Allon reported Phase 2a clinical trial results showing that davunetide improved memory function of schizophrenia patients and had a positive impact on the ability of these patients to carry out important activities in their daily lives. The data was presented at the annual meeting of the American College of Neuropsychopharmacology.

About Allon’s neuroprotective platforms

Allon’s two neuroprotective technology platforms are based on two naturally occurring proteins produced by the brain in response to a range of insults. The platforms are activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF).

Because the two platforms are based on different proteins, the drugs from each are different molecules with different therapeutic mechanisms and distinct commercial opportunities. Clinical-stage drugs based on davunetide are derived from ADNP, while preclinical stage drug AL-309 is derived from ADNF. Davunetide is focused on Alzheimer’s disease, cognitive impairment in schizophrenia, and frontotemporal dementia.

ADNF drug candidate AL-309 is being developed for the treatment of peripheral neuropathies and is administered orally or subcutaneously.

Source
Allon Therapeutics Inc. Continue reading →

Kids aren’t the only ones who smile when the words “snack time” are heard. We are obsessed with snacking. Aisle after aisle in the grocery store is filled with sweet, salty, savory and, yes, even healthy snacks. Do we live in an oversnacked society? Is this fixation adding to the dangerous level of childhood obesity and playing a role in the growing number of poorly nourished kids in our country?

“Despite the increase in weight of our children, there are still critical nutrient gaps,” said Gina Bucciferro, registered dietician and pediatric nutrition expert at Loyola University Medical Center. “Snacks can either make or break the nutritional quality of a kid’s daily intake.”

Research has shown that 88 percent of U.S. children do not meet the recommended daily intake for fruit and 92 percent do not meet the same for vegetables. Though obesity is a major concern for kids with poor nutrition, there are other health risks as well. These include heart disease, depression, high blood pressure, tooth decay, anemia, osteoporosis and diabetes.

According to Bucciferro, snacks are a great way to bridge the nutritional gap. Parents need to be aware of what is being served and when it takes place to help keep snack time a good time.

When to snack:

1. After physical activity. In addition to needing high-quality energy for growth and development, children involved in sports and other physical activities need to replace the extra energy they are burning. Whole grains, fruits, vegetables and low-fat dairy can provide the carbohydrates needed to replenish little athletes without added sugar and fat. Fluids also are important in making sure active kids stay hydrated. According to the American Dietetic Association, school-age children need to drink six 8 ounce cups of water per day and another 8 ounces for every half-hour of strenuous activity. A sports drink is only necessary for activities lasting longer than 60 minutes.

2. Scheduled between meal times. Children do have increased nutrition needs, so providing snacks between meals can help them stay focused and healthy. The goal should be to offer as much nutrition as possible without providing excessive sugar, fat and calories. Fruits, vegetables and low-fat dairy are an easy way to meet this goal. These types of foods, eaten two to three hours before a meal will not spoil an appetite, whereas high-fat foods might.

When not to snack:

1. As a reward. Our relationship with food is formed at a very young age. When food is provided as a reward an unhealthy relationship with food can be formed. Rewarding children with playtime or fun, educational activities can form much better habits than indulging in high-fat, high-sugar fare. Also, providing these types of foods after an accomplishment can lead the child to place a higher value on low-nutrition food items. Also, don’t treat these foods as forbidden. Encourage everything in moderation.

2. To cure boredom. Starting a habit of eating when bored can become a slippery slope. If you notice your child requesting snacks at off-times, make sure to assess the situation. If your child’s normal meal times have been thrown off due to a hectic schedule or if they’ve had increased activity, provide them with a small, low-calorie snack such as fruit and low-fat yogurt or veggies and light ranch dip. However, if it’s been a typical day and you notice your child is just antsy, provide a fun activity instead. Depending on your child’s age coloring and other activity books can be a good option for minimal supervision while not encouraging increased television time.

“Snack time can be beneficial for kids. Just make sure kids are snacking at the right time and that snack items are closing the nutrient gaps, not worsening a child’s nutrient deficit which be detrimental to a child’s health,” said Bucciferro.

Source:
Loyola University Health System Continue reading →

Alzheimer’s disease and its precursor, mild cognitive impairment, appear to be associated with an increased risk of death among both white and African American older adults, according to a report in the June issue of Archives of Neurology, one of the JAMA/Archives journals.

Alzheimer’s disease reduces life expectancy and has emerged as a leading cause of death in the United States, according to background information in the article. “Data from two national surveys suggest that life expectancy among patients with Alzheimer’s disease may be greater for African Americans than for whites,” the authors write. “However, not all surveys have reported this difference. Furthermore, in these surveys, the diagnosis of Alzheimer’s disease is not based on a uniform clinical evaluation but derived from medical records, increasing the likelihood of substantial variation in the quality of diagnostic classifications.”

Robert S. Wilson, Ph.D., and colleagues at Rush University Medical Center, Chicago, studied 1,715 older adults (average age 80.1, 52.5 percent African American) from four adjacent neighborhoods in Chicago. Each participant had a clinical evaluation that included medical history, a neurological examination and cognitive (thinking, learning and memory) function testing. Based on these evaluations, an experienced physician diagnosed 296 (17.3 percent) of the participants with Alzheimer’s disease, 597 (34.8 percent) with mild cognitive impairment and 20 (1.2 percent) with other forms of dementia, while 802 (46.8 percent) had no cognitive impairment.

During up to 10 years of follow-up (average observation period, 4.7 years) 634 individuals died (37 percent), including 25.8 percent of those without cognitive impairment, 40.4 percent of those with mild cognitive impairment, 59.1 percent of those with Alzheimer’s disease and 60 percent of those with other forms of dementia. “Compared with people without cognitive impairment, risk of death was increased by about 50 percent among those with mild cognitive impairment and was nearly three-fold greater among those with Alzheimer’s disease,” the authors write. “These effects were seen among African Americans and whites and did not differ by race.”

Among individuals with mild cognitive impairment, risk of death increased as cognitive impairment became more severe, another association that did not differ by race. A similar association between disease severity and survival was seen among patients with Alzheimer’s disease, although that effect was slightly stronger for African Americans than for whites.

“Overall, these results do not suggest strong racial differences in survival for persons with mild cognitive impairment and Alzheimer’s disease,” the authors conclude.

Arch Neurol. 2009;66[6]:767-772.

Source
Archives of Neurology Continue reading →

In many cases persons with limited mobility in their upper limbs; those with muscular dystrophy, those suffering from certain nervous and muscular disorders such as cerebral palsy, lose the ability of moving their wrists and arms and, thereby, may have difficulties handling certain devices, such as a computer mouse or keyboard or a TV remote control pad. In the COMPORTA project, work is being carried out with these people severely disabled in the upper limbs. The aim of the project is to adapt a portable communicator that will have various applications for these persons.

Xmadina Tecnolog?­a Adaptativa, S.L.; Eleka Ingeniaritza linguistikoa, S.L.; Robotiker; Minos 97 and the Bidaideak association have all participated in this project.

COMPORTA is based on the use of PDAs (Personal Digital Assistant), also known as electronic agendas. Given their small size and weight, they are totally portable and are easy to use anywhere. This is why PDAs are so useful for persons with neurophysical disabilities, and can help with greater personal autonomy; in effect, they enhance one??s quality of life. This is because they can be used to communicate anywhere, listen to music of one??s choice, search the Web or control the television set.

Nevertheless, those with disabilities in the arms and hands may have problems in handling the buttons and tactile screens of the usual PDAs. In order to provide a solution to this, an adaptation has been made of Etsedi, a PC application created for the Xmadina company.

Editing text

Etsedi created a virtual keyboard on the PC screen, reducing the complete virtual keyboard of the commercially available variety to just eight keys. Taking into account that many people with limited mobility are capable of handling the control pad for a wheelchair with great precision and skill, the distribution of the 8 keys has been designed so that they can be selected by means of movements similar to those of these control pads. That is to say, the virtual keys are selected with movements carried out in one plane, in different directions.

The Etsedi application edits texts in Windows. Having a choice of various menus, the user may write numbers, text or special characters. Each virtual key has a set of characters that have been grouped together on the basis of an analysis of combination frequencies, while taking into account that these combinations never occur and, thus, introducing the text is facilitated and optimised. Besides, the application predicts the words that the user wishes to write. As the user keys in a word, the programme automatically comes up with up to 16 possible words around the 8 virtual keys, in such a way that a simple movement can directly select the desired word. The dictionary used by the application for this prediction can be updated and adapted by the user to his or her needs.

The COMPORTA project has adapted this application to PDAs and has developed the same system of prediction for the Basque language. Further, they wish to extend the functions so the device can be used for electronic mail, surfing the Net, and so on.

Giving a voice to the text

People disabled in the upper limbs often have problems in speaking. This is why COMPORTA, by means of a virtual keyboard, adds a voice to the written text. Using voice synthesisers and text-to-speech technology, the text keyed in by the end-user is heard through the speakers

This part of the project has been the task of Eleka Ingeniaritza Linguistikoa and, although applications of this technology exist in other languages, this is the first time in Euskara.

Thus, it will be a bilingual PDA, voice synthesising in both Basque and Spanish, enabling the end-user to use either language. Moreover, different tones of voice are available, the user being able to employ the tone of their choice and which best befits their personality, sex, age, etc.

Remote Control

The PDA can also be useful for controlling various everyday devices. This is why, at COMPORTA, they want the PDA also to be a remote control one for various utilities controlled through the PC. This means the PC would have the software necessary to control the TV, the music centre, the DVD, etc., and the PDA would send the corresponding commands to the PC to control this software.

Wheelchair tuning

So that the PDA is genuinely portable, a support will be designed which will be an articulated arm adaptable to different models of wheelchair and which can also be used to support other items.

The device will have small speakers incorporated which will have sufficient power and quality to be used in noisy environments, such as the street. Current PDAs have inbuilt speakers but they are not very powerful; the new, reinforced system will guarantee quality in communication.

And all this, for how much?

There currently exist a number of devices for the disabled on the market. However, unfortunately many disabled persons are denied access to these because, according to the INE (Instituto Nacional de Estad?­stica) their price is prohibitive. This is why COMPORTA have focused on the final product being accessible for this target group of people.

The solution adopted was the use of commercial hardware with adapted software. In most cases, the hardware is specialised. In this case, however, it is one that is manufactured in great numbers, thus reducing the price considerably. Moreover, in choosing a PDA amongst mobile communicators, the economic factor was also taken into consideration, as these are also cheaper than other communicators.

Internet reference
eleka/

Contact: Ibon Aizpurua

Elhuyar Fundazioa Continue reading →

AngioDynamics (NASDAQ:ANGO) announced the launch of a new family of micro-introducer kits, featuring a stiffened introducer option.

“Our broad range of kits gives physicians a comprehensive set of options to treat their patients and allows healthcare institutions to source all micro-introducer needs from a reliable and trusted provider.”

AngioDynamics’ micro-introducers allow physicians to perform percutaneous introduction of a guidewire or catheter into the peripheral vasculature during minimally invasive percutaneous procedures, utilizing a 21 gauge needle.

“The new family of micro-introducer kits with the stiffened introducer option was developed based on the physician feedback we continue to draw on to spur innovation,” said Shawn McCarthy, Senior Vice President and General Manager of the Peripheral Vascular business unit. “Our broad range of kits gives physicians a comprehensive set of options to treat their patients and allows healthcare institutions to source all micro-introducer needs from a reliable and trusted provider.”

The new kits include a needle, micro-introducer, and .018″ guidewire. They feature stiffened and standard introducer options with various needle configurations, including super-sharp needles and echogenic tip options. The guidewire has a range of configurations, including stainless steel, nitinol, and tungsten; tungsten-coiled tips allow for enhanced radiopacity while the nitinol wire helps resist against kinking.

The micro-introducer kits are available in 4 and 5 French sizes, in both standard and stiffened configurations, which facilitate smooth entry into difficult vessels. All feature a quarter-twist cam connection, which verifies a secure lock, and seamless dilator-to-sheath transitions.

Source
AngioDynamics Continue reading →

California Stem Cell, Inc. (CSC) and Families of Spinal Muscular Atrophy (FSMA) announced that CSC has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for approval to commence a Phase I safety study on a jointly-developed stem cell-derived motor neuron transplantation therapy for Spinal Muscular Atrophy (SMA) Type I.

SMA is the leading genetic cause of death of infants. It is a disorder that results from a chronic deficiency in the production of the SMN protein, which is essential to the proper functioning of the motor neurons in the spinal cord. SMA is typically marked by the deterioration of the muscles that control crawling, walking, swallowing and breathing. Approximately 1 in every 6000 babies born is affected. 1 in 40 people, or approximately 7.5 million people in the US, are genetic carriers. SMA Type I, the most severe form of the disease, progresses very rapidly and is often fatal in the affected infants. To date, there are no treatments for this disease.

CSC, a leading stem cell therapeutics company, has developed a stem cell-derived motor neuron transplantation therapy, MotorGraft™, for the treatment of SMA Type I. Pre-clinical studies completed in collaboration with the Hans Keirstead Research Group at the University of California, Irvine have shown functional benefit and safety in animal models. CSC’s MotorGraft™ was granted orphan drug status for treatment of SMA by the FDA in late 2009.

Filing of this application is the first step in a multi-phase clinical development pathway aimed ultimately at approval of a novel therapy. The approval process for cutting-edge therapeutic approaches such as cell products may present unique regulatory challenges compared to conventional drugs, so companies and the FDA must work in close partnership to ensure safety and efficacy of these first in-human products. A cautious regulatory approach has been the norm in cell therapy applications submitted to date in other disease areas.

The trial will study the safety of MotorGraft™ and the surgical procedure required to deliver these cells directly into the spinal cords of patients with SMA Type I and will enroll a very limited number of patients. This IND filing is a major milestone in the search for a treatment for SMA patients.

Source:

Families of Spinal Muscular Atrophy

California Stem Cell, Inc. Continue reading →

Coffee and tea drinkers may not need to worry about indulging – high and moderate consumption of tea and moderate coffee consumption are linked with reduced heart disease, according to a study published in Arteriosclerosis, Thrombosis, and Vascular Biology: Journal of the American Heart Association.

Researchers in The Netherlands found:
Drinking more than six cups of tea per day was associated with a 36 percent lower risk of heart disease compared to those who drank less than one cup of tea per day.
Drinking three to six cups of tea per day was associated with a 45 percent reduced risk of death from heart disease, compared to consumption of less than one cup per day.

And for coffee they found:
Coffee drinkers with a modest intake, two to four cups per day, had a 20 percent lower risk of heart disease compared to those drinking less than two cups or more than four cups.
Although not considered significant, moderate coffee consumption slightly reduced the risk of heart disease death and deaths from all causes.

Researchers also found that neither coffee nor tea consumption affected stroke risk.

“While previous studies have shown that coffee and tea seem to reduce the risk of heart disease, evidence on stroke risk and the risk of death from heart disease was not conclusive,” said Yvonne T. van der Schouw, Ph.D., study senior author and professor of chronic disease epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands. “Our results found the benefits of drinking coffee and tea occur without increasing risk of stroke or death from all causes.

Van der Schouw and colleagues used a questionnaire to evaluate coffee and tea consumption among 37,514 participants. They followed the participants for 13 years for occurrences of cardiovascular disease and death.

Study limitations included self-reported tea and coffee consumption, and the lack of specific information on the type of tea participants drank. However, black tea accounts for 78 percent of the total tea consumed in The Netherlands and green tea accounts for 4.6 percent. Coffee and tea drinkers have very different health behaviors, researchers note. Many coffee drinkers tend to also smoke and have a less healthy diet compared to tea drinkers.

Researchers suggest that the cardiovascular benefit of drinking tea may be explained by antioxidants. Flavonoids in tea are thought to contribute to reduced risk, but the underlying mechanism is still not known.

Co-authors are: J. Margot de Koning Gans, M.D.; Cuno S.P.M. Uiterwaal, M.D., Ph.D.; Joline W.J. Beulens, Ph.D.; Jolanda M.A. Boer, Ph.D.; Diederick E. Grobbee, M.D., Ph.D.; and W.M. Monique Verschuren, Ph.D. Author disclosures and funding sources are in the study.

Source:
Karen Astle
American Heart Association Continue reading →

If you use anabolic steroids to help your muscles get bigger you should bear in mind that you could also be destroying your brain cells in a big way, say researchers from the Yale School of Medicine, who found that steroids, which cause testosterone levels to go up, destroy nerve cells.

You can read about this new study in the Journal of Biological Chemistry.

Hyperexcitability, a condition not uncommon among bodybuilders who become aggressive and even suicidal, may occur as a result of steroid use, suggest the researchers.

Professor Barbara Ehrlich, head of the research team, said “Next time a muscle-bound guy in a sports car cuts you off on the highway, don’t get mad, just take a deep breath and realise that it might not be his fault.”

The researchers found that apoptosis was triggered when cultured nerve cells were exposed to testosterone. Apoptosis is a form of “cell suicide” in which damaged cells eliminate themselves with less harm to their neighbors – in other words ‘programmed cell death’. This process has been linked to such diseases as Alzheimer’s and Hutington’s disease.

Previous studies on hamsters have shown they become much more aggressive when given anabolic steroids.

“Elevated Testosterone Induces Apoptosis in Neuronal Cells”
Manuel Estrada, Anurag Varshney, and Barbara E. Ehrlich
J. Biol. Chem., Vol. 281, Issue 35, 25492-25501, September 1, 2006
Click here to view abstract online

Continue reading →

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that lorcaserin will be featured in multiple presentations at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society in Washington, DC.

The line-up includes a late-breaking abstract oral presentation of results from BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), a Phase 3 trial for which Arena reported positive, highly significant top-line results in September. Arena will also present new data analyses from lorcaserin’s successful Phase 3 pivotal program in oral and poster sessions. In an independent clinical symposium, expert academic scientists and physicians will spotlight the 5HT-2C mechanism for weight management.

“The positive results from our Phase 3 pivotal program highlight lorcaserin’s potential to provide physicians with a treatment option that combines three important attributes – efficacy, safety and tolerability – critical to broad applicability in the majority of their patients to help manage weight and improve cardiometabolic health,” stated William R. Shanahan, M.D., Arena’s Vice President and Chief Medical Officer. “The breadth of presentations featuring lorcaserin at The Obesity Society’s annual scientific meeting speaks to the strong interest physicians have in this drug candidate.”

Obesity 2009: Presentation Schedule

Saturday, October 24, 2009

– Pre-Conference Session: Pharmacotherapy Update

Time: 1:00 – 3:45 p.m. Eastern Time (ET)

Chairs: Ken Fujioka, M.D., Louis J. Aronne, M.D., and Richard

Pratley, M.D.

Presenter: Christen M. Anderson, M.D., Ph.D.

Sunday, October 25, 2009

– Poster Session

Time: on display 1:00 – 7:00 p.m. ET; presenters will be available to address questions from 1:00 – 2:00 p.m. and 6:30 – 7:30 p.m. ET

Presenters: William R. Shanahan, M.D., Christen M. Anderson, M.D.,

Ph.D., and Meredith Fidler, Ph.D.

– Oral Abstract Presentation: Clinical Studies, Pharmacotherapy

Time: 6:00 – 6:15 p.m. ET

Presenter: Steven Smith, M.D.

Monday, October 26, 2009

– Related Symposium: Spotlight on 5HT-2C

Time: 8:30 – 10:00 a.m. ET

Chairs: Jonathan Purnell, Ph.D., and Robert Berkowitz, M.D.

Speakers: Laurence Tecott, M.D., Ph.D.: Neuroscience of 5HT-2C;

Steven Smith, M.D.: Lorcaserin – Clinical Results; Neil Weissman

M.D., F.A.C.C.: A Primer of Valvulopathy in Obesity

Tuesday, October 27, 2009

– Oral Abstract Presentation: Late-Breaking Clinical Trial Symposium

Time: 10:40 – 11:00 a.m. ET

Presenter: Lee Kaplan, M.D.

Phase 3 Program Overview

The lorcaserin Phase 3 program consists of three trials: BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus). Enrollment in the lorcaserin Phase 3 program is complete with approximately 7,800 patients. Positive results from BLOOM were presented at the 69th Scientific Sessions of the American Diabetes Association in June 2009 and positive top-line results from BLOSSOM were reported in September 2009. BLOOM and BLOSSOM comprise the Phase 3 pivotal registration program and will be the basis for the lorcaserin NDA submission. BLOOM-DM, which is planned as a supplement to the NDA, is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes at about 60 sites in the US.

A standardized program of moderate diet and exercise guidance is included in the Phase 3 program. The program’s hierarchically ordered co-primary efficacy endpoints are: the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. Arena is also studying several key secondary endpoints, including changes in serum lipids, markers of inflammation and insulin resistance, and in the BLOOM-DM trial, other indicators of glycemic control.

About Lorcaserin

Lorcaserin is a novel single agent that represents the first in a new class of selective 5HT-2C receptor agonists. The 5HT-2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.

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’s most advanced drug candidate, lorcaserin, is being investigated in a Phase 3 clinical trial program for weight management. Arena has a broad pipeline of novel compounds targeting G protein-coupled receptors, an important class of validated drug targets, which includes compounds being evaluated independently and with partners, including Merck & Co., Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Arena Pharmaceuticals® and Arena® are registered service marks of the company. “APD” is an abbreviation for Arena Pharmaceuticals Development.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the significance of the lorcaserin results and the success of the lorcaserin Phase 3 program; lorcaserin’s commercial and other potential; the importance of efficacy, safety and tolerability and the combination of such attributes; interest in lorcaserin; the development, advancement, therapeutic indication, tolerability, safety, selectivity and efficacy of lorcaserin; the protocol, design, scope, enrollment and other aspects of the lorcaserin trials; the Phase 3 pivotal registration program; the potential of the lorcaserin Phase 3 program and its results to satisfy the FDA’s approval requirements; future activities, results and announcements relating to lorcaserin, including submitting an NDA for lorcaserin and the BLOOM-DM results as a supplement to the NDA; lorcaserin’s patent coverage; and Arena’s strategy, internal and partnered programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena’s expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Arena’s lorcaserin program and other of its research and development programs; results of clinical trials or preclinical studies may not be predictive of future results; clinical trials and studies may not proceed at the time or in the manner Arena expects or at all; Arena’s ability to partner or commercialize lorcaserin or other of its compounds or programs; the timing and ability of Arena to receive regulatory approval for its drug candidates; Arena’s ability to obtain additional funds; Arena’s ability to obtain and defend its patents; and the timing and receipt of payments and fees, if any, from Arena’s collaborators. Additional factors that could cause actual results to differ materially from those stated or implied by Arena’s forward-looking statements are disclosed in Arena’s filings with the Securities and Exchange Commission. These forward-looking statements represent Arena’s judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Source: Arena Pharmaceuticals, Inc Continue reading →