EnteroMedics : Presentation of Maestro(R) RC System Clinical Data at the XVI World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders

09/02/11 -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases, and other gastrointestinal disorders, announced that data from the Company's VBLOC-DM2 ENABLE (DM2) trial evaluating the Company's second generation Maestro RC System in the treatment of obesity, diabetes and hypertension, was presented at the XVI World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), held August 31 to September 3 in Hamburg, Germany. The oral presentation, titled "Treatment of Obesity-Related Co-Morbidities with VBLOC Therapy," was delivered by Miguel Herrera Hernández, M.D., Instituto Nacional de la Nutrición, Mexico, an investigator in the DM2 trial.

DM2 trial results presented at IFSO reflect statistically significant, sustained improvement in glycemic control and blood pressure, as well as clinically meaningful weight loss in obese, diabetic patients using the Maestro RC System. The 18-month data presented at IFSO included: excess weight loss (EWL) of approximately 24.6% (n=22), a mean reduction in HbA1c of 1.2 percentage points from a baseline of 8.1% (n=13), a change in fasting plasma glucose of -38.4 mg/dl from a baseline of 151.4 mg/dl (n=12) and, in hypertensive patients (n=10), a reduction in mean arterial pressure of 13.0 mmHg from a baseline of 99.5 mmHg and a reduction in diastolic blood pressure of 15.9 mmHg from a baseline of 87.2 mmHg (n=10). Through 18 months, no change in mean arterial pressure was observed in patients that did not present with hypertension (n=10)... EnteroMedics' Press Release -

BioRestorative Therapies : License Agreement with University of Utah to Obtain Adipose (fat) Tissue for its Thermostem Program to Treat Obesity and ..

Aug. 25, 2011 - BioRestorative Therapies, Inc. (OTCQB: SCLZ) ("BRT") announced that it has entered into a Tangible Property License Agreement with the University of Utah. The two year license agreement enables BioRestorative Therapies to obtain adipose (fat) tissue that will be used for research purposes to develop and commercialize its ThermoStem Program, which is an adult derived stem cell-based program to treat metabolic and obesity related disorders, using the thermogenic or heat producing properties of brown fat.
The agreement marks the beginning of a strategic collaboration between BRT and the University of Utah, an institution recognized as a leader in translational stem cell-based therapies. This relationship offers BRT an opportunity to procure adipose tissues from donors (tissue and cells that are usually difficult to obtain) to be used for BRT's cellular research and characterization studies... [PDF] BioRestorative Therapies' Press Release -

GI Dynamics : Australian TGA Approval For the EndoBarrier® Gastrointestinal Liner for the Treatment of Type 2 Diabetes and Obesity

July 25, 2011 – GI Dynamics, Inc. (GI Dynamics), a company focused on the development and commercialization of effective, non-surgical approaches for the treatment of type 2 diabetes and obesity, announced that the Australian Therapeutic Goods Administration (TGA) has approved the EndoBarrier® Gastrointestinal Liner (the EndoBarrier) for inclusion on the Australian Register of Therapeutic Goods (ARTG). The TGA has approved the use of the EndoBarrier for up to 12 months for the treatment of type 2 diabetes and obesity. With this approval, GI Dynamics will be able to commercially launch the EndoBarrier in Australia.
“Gaining approval to commercialize the EndoBarrier in Australia is another important milestone for our company,” said Stuart A. Randle, chief executive officer of GI Dynamics. “We look forward to working with Australian diabetes experts and leading centers to bring the EndoBarrier to market in this country.”... GI Dynamics' Press Release -

Unigene : Positive Advanced Preclinical Data for UGP281 a Potent, Orally Delivered Anorexigenic Peptide

Jun 27, 2011 - UGP281 demonstrated significant and sustained weight reduction over several weeks using oral formulation - Unigene expects to file IND and commence Phase 1 studies in 1H 2012 - Unigene Laboratories, Inc. (OTCBB: UGNE) a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced that the Company presented positive preclinical data for UGP281, its potent, orally-delivered anorexigenic peptide as a late-breaking poster presentation at the American Diabetes Association (ADA) 71st Scientific Sessions being held June 24-28 in San Diego, California.

Poster Presentation

Titled: "Preclinical Studies with UGP281, a Potent, Orally Delivered, Anorexigenic Peptide", and authored by N. Mehta, W. Stern, A. Sturner, S. Carl, V. Ray, A. Conslavo, C. Sisk, F. Ritacco, N. Souders, S. Pennington, J. Jiacchi, K. Veintimilla, C. Meenan, A. Vryhoff and A. Bolat.

Summary

UGP281 is a peptide hormone analog that shows an acute dramatic reduction in food intake in a rat model at low doses. The peptide has been produced by recombinant expression in E. coli and has also been formulated in enteric-coated capsules for oral delivery. The effect of UGP281 on food intake and body mass has been investigated in several preclinical studies. In a 20 day chronic dosing study, young rats injected daily with UGP281 at doses of 5 ug/kg and 20 ug/kg exhibited an immediate acute dose dependent reduction in food intake of 55% and 84%, respectively and a sustained weight loss relative to placebo of 5.7% and 8.8%, respectively. A placebo-controlled study in Beagle dogs with enteric-coated capsules containing UGP281 demonstrated a sustained weight reduction of >8% compared to placebo for a period of 5 weeks. In comparative studies at comparable concentrations, UGP281 demonstrates greater reductions in body weight than other peptide drugs currently in development. Based on the results to date, UGP281 was well tolerated and offers the potential of a patient friendly orally dosed peptide therapy for the management of obesity... Unigene Laboratories' Press Release -

AMRI : Successful Completion of Phase I Clinical Study of Obesity Compound

May 31, 2011 - Phase 1 data support the continued development of ALB-127158(a) as a potential treatment for obesity — AMRI (NASDAQ: AMRI) announced the results from its Phase I clinical study on its novel MCH1 receptor antagonist, ALB-127158(a). The results indicate that ALB-127158(a) is well tolerated at the doses tested and shows preliminary evidence of efficacy.

The results were presented at the 18th European Congress on Obesity by Dr. Nicholas Moore, director of development and pharmacology at AMRI. The placebo-controlled study evaluated the safety, tolerability and efficacy of ALB-127158(a) in male volunteers. The study consisted of three components: a single ascending dose arm (SAD) in lean subjects (BMI ≤ 25), a fed/fasted crossover in overweight subjects (BMI ≥ 27) and a 14-day ascending dose arm (MAD) in overweight subjects. Standard safety assessments, ECG monitoring and PK measurements were conducted.

ALB-127158(a) was well tolerated in both the SAD and the MAD; reported events were mild and showed little dose relationship. One of the most common events reported in both the SAD and the MAD was loss of appetite. No drug-related changes in cardiovascular parameters or sleep were observed during any phase of the study. Reductions in “hunger,” “desire to eat,” and test meal consumption were observed. The study met both its primary and secondary objectives, demonstrating safety and tolerability. The data support the continued development of ALB-127158(a) as a potential treatment for obesity... AMRI's Press Release -