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 -

VIVUS : Additional Data From QNEXA Clinical Trials Presented at the European Congress on Obesity

May 31, 2011 - Presentations to European Medical Community Highlight the Benefits of QNEXA Treatment Including:
- Prevention of Progression to Diabetes
- Sustained Weight Loss over Two Years, and
- Reduction in Cardiometabolic Risk

- VIVUS, Inc. (NASDAQ: VVUS) announced that multiple abstracts were presented over the weekend at the European Congress on Obesity (ECO) in Istanbul, Turkey. ECO is the official obesity congress of The European Association for the Study of Obesity (EASO). ECO is regularly attended by more than 2500 participants from over 75 countries and is considered to be the most important annual scientific event on obesity in Europe.

Highlights from the ECO presentations were as follows:

A poster presentation authored by W. Timothy Garvey, MD from the University of Alabama at Birmingham reported reductions in progression to type 2 diabetes and improvement in glycemic status in CONQUER patients that were ADA-defined as prediabetics at baseline. Of the 2,487 patients in the CONQUER study, 1,119 were determined to have prediabetes. In the prediabetics treated with QNEXA, hemoglobin A1c, fasting glucose and fasting insulin were significantly improved at week 56 (ITT-LOCF p<0.005 vs. placebo). In the prediabetic population significantly more QNEXA treated patients achieved normal blood sugar levels (p=0.0016) and significantly more patients on placebo were progressed to type 2 diabetics as compared to the QNEXA treated patients (p=0.0253).

"For this set of patients, QNEXA treatment led to benefits above and beyond losing weight. The results highlighted by Dr Garvey showed that weight loss after 56 weeks of treatment led to an improvement in glycemic status and reduction of progression to type 2 diabetes. This clinically important finding further strengthens the QNEXA benefit profile," added Barbara Troupin, MD, senior director of medical affairs for VIVUS.

The CONQUER study included 2,487 patients that had two or more comorbidities studied over 56 weeks. Patients were randomized to receive mid-dose QNEXA (498), top-dose QNEXA (995) or placebo (994). All patients received lifestyle modification instruction. QNEXA patients had significant weight loss at week 56 as compared to placebo (p<0.0001). Least squares mean percent weight loss at week 56 was 9.8% top-dose, 7.8% mid-dose, and 1.2% placebo. The most common side effects were dry mouth, tingling, constipation, upper respiratory infection and runny nose.

Dr Garvey also authored a poster that included the results of the SEQUEL study which showed that QNEXA treatment led to significantly greater weight loss as compared to placebo (p<0.0001, IIT-LOCF LS mean weight loss of 10.5% top-dose, 9.3% mid-dose, 1.8% placebo). The differences between both treatment groups and placebo were significant starting at week 8. Significantly more patients treated with QNEXA achieved greater than 5%, 10%, 15%, 20% weight loss in a dose-related fashion than placebo (p<0.0072). Specifically categorical weight loss over two years was as follows...VIVUS' Press Release -