PROLOR Biotech : Positive Results of Its Obesity/Diabetes Drug Candidate in Preclinical Weight Loss Study

April 17, 2012 - PROLOR Biotech, Inc. (NYSE Amex: PBTH) reported positive preclinical results from an animal study of its long-acting obesity/Type II diabetes drug candidate MOD-6030. The study was designed to measure the potential therapeutic effect of MOD-6030 injected once weekly as measured by weight loss, reduction in food intake, glycemic control and cholesterol levels. The study results will be presented at GTC's 5th Diabetes Drug Discovery and Development Conference on April 19, 2012 in Boston, MA.

In the study, MOD-6030 administered to diet-induced obese (DIO) mice once weekly over a 30-day period demonstrated significant efficacy in reducing weight, lowering blood glucose levels, increasing insulin sensitivity and reducing cholesterol levels as compared to a group that received placebo. Animals in the placebo group showed minimal changes in the study parameters, while the animals receiving MOD-6030 achieved on average a 28% reduction in weight, a 29% reduction in food intake, a 19% reduction in blood glucose levels and a 57% reduction in cholesterol levels. Body composition analysis showed that the weight loss resulted specifically from reductions in body fat... [PDF] PROLOR Biotech's Press Release -

LATITUDE Pharmaceuticals : Stable Liquid Glucagon Formulation

April 03, 2012 - LATITUDE Pharmaceuticals, Inc. (LPI) announced that its scientists have developed the first ever, ready-to-inject, stable liquid glucagon formulation (Nano-G). A glucagon formulation with these properties had been a highly sought after Holy Grail of drug developers for decades.

Currently, glucagon is indicated for emergency treatment of insulin-induced hypoglycemia and as a diagnostic aid for radiological examinations. Researchers have long been interested in evaluating glucagon for hypoglycemia prevention, the bi-hormonal insulin/glucagon pump and the treatment of obesity but have been thwarted by the absence of a stable injectable glucagon formulation.

Glucagon is a notoriously insoluble and unstable molecule and is therefore provided as a dried powder. Before use, the glucagon is dissolved in an acid solution by following a cumbersome, eight-step procedure that becomes an outsized task during life-threatening hypoglycemia.

Nano-G is a pH-neutral, isotonic, detergent-free, aqueous formulation that contains only FDA-approved injectable ingredients. Results from rigorous 6-month real-time and accelerated ICH stability testing predict a 2-yr shelf-life. Nano-G is also stable at body temperature, making it highly suitable for subcutaneous infusion pump delivery.

“Nano-G fulfills the long overdue need for a rapidly self-administered, auto-injector delivered glucagon for hypoglycemia rescue and is the missing piece needed for the bi-hormonal pump and novel combination therapies for obesity... LATITUDE Pharmaceuticals' Press Release -

AMA : Free ‘Weigh What Matters’ App to Help People Achieve Healthier Lifestyles

Jan. 30, 2012 – Many Americans resolved to become healthier in the new year, but are having trouble monitoring their progress to achieve their goals. Now there's an app for that. The American Medical Association (AMA) released a free app today to help patients improve their overall health as part of the AMA Healthier Life Steps program, which promotes healthy choices and healthy lives.

"Every January, Americans implement New Year's resolutions that involve healthy eating and increased physical activity," said AMA President Peter W. Carmel, M.D. "This new app encourages people to work with their physicians to set healthy goals, and it allows users to track their progress and accomplish their goals."

The Weigh What Matters app is free, easy to use and encourages users to consult with their physician to establish personal health goals for three categories: weight, eating and activity. Once goals are established, users can track their weight, physical activity and nutrition with daily entries. It also calculates a user's Body Mass Index (BMI) and provides a mechanism to view progress reports and email them to the user's physician.

"The AMA Healthier Life Steps program offers tools and information to help physicians and patients work together to promote longer, healthier lives," said Dr. Carmel. "Physicians and their staff can use this new app as a resource to work with patients to address challenging behavioral changes."...American Medical Association's Press Release -

Oragenics : Positive Clinical Results for its Proprietary Weight Loss Agent, LPT3-04

February 14, 2012 - Oragenics, Inc. (OTCBB:ORNI) announced that a recently completed randomized, double-blind, placebo-controlled, human clinical study with 32 enrolled subjects resulted in a statistically and clinically significant reduction in body weight when healthy, overweight and mildly obese adult volunteers were given daily supplementation of Oragenics’ Weight Loss Agent LPT3-04 over a twelve-week period. This study, sponsored by Oragenics, was conducted at the Miami Research Associates (MRA) clinical research facilities in Miami, Florida. MRA investigators also confirmed that there were no safety concerns with daily supplementation of LPT3-04 over the 12-week duration of the trial, and that no reports of serious adverse events, including depression, occurred during this trial. This human study result confirms the extensive results obtained from animal safety and efficacy studies completed to date by Oragenics, and suggests that LPT3-04, a natural occurring dietary substance with an excellent safety and tolerance profile, can support weight loss in overweight men and women.

The World Health Organization estimated that by 2015, there will be more than 1.5 billion overweight consumers. Further, according to a 2012 healthcare market research report published by Markets and Markets, the total global weight loss market is expected to be worth US$586.3 billion by 2014, with a compound annual growth rate of 10.9% from 2009 to 2014. These reports suggest that the opportunities for a scientifically-substantiated weight management product are impressive...[PDF] Oragenics' Press Release -

Hanmi : license agreement for a new anti-obesity botanical drug

16, Feb. 2012 - Hanmi pharmaceuticals announced that it has entered into a licensing agreement with AngioLab for a new anti-obesity botanical drug, ALS-L1023.

ALS-L1023 is a Melissa leaf (Lemon Balm) ethyl acetate dried extract, having excellent angiogenesis and MMP inhibitory activities. The inhibition of angiogenesis in the growing adipose tissue is a novel approach for the prevention and treatment of obesity having a high specificity to visceral fat (intra-abdominal fat).

A randomized, double-blind, placebo-controlled, phase II human trial was completed in ASAN Medical Center and Inje University Seoul Paik Hospital. The statistically significant reduction of visceral fat by 15% was observed in comparison with the baseline after 12 weeks. In safety assessment, there was no statistically significant Adverse Events. Furthermore, plasma adiponectin level has increased, while plasma free fatty acid level has decreased... Hanmi pharmaceuticals' Press Release -

Bridge Bioresearch : Completion of Preclinical Trials of 2hydroxyoleic Acid - a Novel Treatment of Obesity

LONDON, January 11, 2012 - Bridge Bioresearch PLC (BBR) announces that the company has completed the preclinical efficacy and safety trials of 2hydroxyoleic acid (2OHOA) a novel treatment of obesity and other metabolic disorders.

BBR has in- licensed 2OHOA from the University of the Balearic Islands (Spain) in 2006 and has continued research in animal models verifying the pharmacological properties as well as safety profile of the 2OHOA molecule. This is an important milestone for the further development of 2HOA and the move from pre-clinical to clinical development of the molecule as all the tests completed to-date have shown the molecule to be biologically active and safe in the standard animal models.

Søren Stenderup, CEO of BBR commented: "The successful completion of the pre-clinical programme is a significant milestone for this molecule. The fact that the product shows good biological activity and no observed toxicity gives us the confidence to commit time and resource to undertaking a full clinical development programme. The observation, in the animal models examined, that the product appears to improve other conditions associated with obesity such as hypertension and the onset of type 2 diabetes is an additional benefit that we will seek to quantify in the clinical trial programme as this will give the product benefits over other treatments for the growing problem of obesity."

About the 2hydroxyoleic acid molecule: 

2OHOA has a granted patent (PCT/ES02/00475) and the clinical development process as drug for the treatment of obesity has already been initiated following the encouraging results from the pre-clinical studies... Bridge Bioresearch's Press Release -

Arena Pharmaceuticals and Eisai : FDA Accepts Resubmission of Lorcaserin New Drug Application

Jan. 10, 2012 - Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced that the US Food and Drug Administration (FDA) has accepted for filing and review Arena's resubmission of the New Drug Application (NDA) for lorcaserin. The FDA considers the resubmission a complete, class 2 response, and assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012.

Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, > 30) or patients who are overweight (BMI > 27) and have at least one weight-related co-morbid condition. Arena submitted the original NDA for lorcaserin in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. Arena submitted a response to the lorcaserin CRL in December 2011.

About Lorcaserin

Lorcaserin is an investigational new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain... Arena Pharmaceuticals' Press Release - [PDF] Eisai's Press Release -

Ember Therapeutics : Nature Publication of Brown Fat Biology Data

January 11, 2012 - Program Exclusively Licensed from the Dana-Farber Cancer Institute -


Novel Hormone Identified that Augments Brown Fat, Increases Energy Expenditure, and Reduces Obesity and Insulin Resistance -

Ember Therapeutics, Inc., a company harnessing breakthroughs in brown fat biology and insulin sensitization to revolutionize the treatment of metabolic disease, announced the publication of key data supporting its lead brown fat biology program in the journal Nature. The paper details for the first time the discovery and identification of a new hormone, irisin, which is present and identical in mice and humans and has been shown to act on white fat cells in culture and in vivo to stimulate UCP1 expression and brown fat development. The publication outlines how even relatively short treatments of obese mice with irisin caused an increase in energy expenditure with no changes in activity levels or food intake, resulting in improved glucose homeostasis and weight loss.

This research was led by Bruce Spiegelman, Ph.D., professor of cell biology, Dana-Farber Cancer Institute, Harvard Medical School, and a co-founder of Ember, and was funded by the National Institutes of Health. Ember recently entered into an exclusive license agreement with Dana-Farber Cancer Institute for this irisin technology and is optimizing and developing a proprietary molecule designed to augment and activate the body’s brown fat... [PDF] Ember Therapeutics' Press Release -

Isis : Phase 1 Clinical Trial of ISIS-FGFR4Rx a Peripherally Acting Drug to Treat Obesity

Calif., Dec. 20, 2011 - Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 1 study of ISIS-FGFR4Rx, an antisense drug designed to treat obesity. ISIS-FGFR4Rx specifically reduces the production of fibroblast growth factor receptor 4 (FGFR4) in the liver and fat tissues, which decreases the body's ability to store fat while simultaneously increasing fat burning and energy expenditure. Because ISIS-FGFR4Rx does not distribute to the brain or central nervous system (CNS), ISIS-FGFR4Rx should not produce any CNS side effects. Many anti-obesity drugs primarily work to suppress appetite by acting in the brain, commonly resulting in CNS side effects.

"Obesity is an epidemic in the United States and much of the rest of the industrialized world. Obesity is a serious condition that increases the risk of diabetes, heart disease, stroke, arthritis and some cancers. Severely obese patients make up the most rapidly growing part of the obese population. In these severely obese patients, bariatric, or weight-loss, surgery is a preferred therapeutic option; however long-term weight loss remains a challenge for these patients," said Richard Geary, Ph.D., Senior Vice President of Development at Isis. "Many of the recent therapies under development or on the market to treat obesity have unacceptable safety profiles. Clearly there is a significant need for a treatment approach that can cause weight loss without deleterious side effects."... Isis Pharmaceuticals' Press Release -