GI Dynamics' EndoBarrierTM Gastrointestinal Liner : Significant HbA1c Reduction in Obese People Living with Type 2 Diabetes

November 11, 2009 – GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and obesity, announced data which demonstrate that obese patients with uncontrolled type 2 diabetes using the EndoBarrier™ Gastrointestinal Liner achieved near normalization of glycemic control in just one week, as compared to a sham control group. In addition, patients treated with EndoBarrier achieved a mean reduction of 2.4% in HbA1c glucose levels versus 0.8% for the sham arm at 24 weeks. Patients treated with EndoBarrier also achieved reductions in other diabetic factors including fasting blood glucose and weight. The results of the pilot study were published today in the current advance online issue of Diabetes Technology & Therapeutics.



“Studies show that every one percent decrease in HbA1c reduces health risks by 21 percent and as the rates of obesity and type 2 diabetes continue to reach epidemic proportions around the globe, patients are in urgent need of new therapeutic solutions that overcome the limitations associated with pharmaceutical regimens and invasive surgery,... GI Dynamics' Press Release -

First Diabetes Patient Adherence Program for Foot Ulcer Treatment

November 3, 2009 – Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine and the maker of Dermagraft®, launched during American Diabetes Month the Heal2gether Partnership Program for diabetes patients and their physicians. Focused on patient adherence, Heal2gether aims to increase awareness and proper care of diabetic foot ulcers (DFUs), enhance the effective use of living cell technologies in treating DFUs, and encourage patients to take an active role in their healing process... Advanced BioHealing's Press Release -

Compugen : Discovery of Genetic Biomarker for Predisposition to Type 2 Diabetes

November 9, 2009 - Compugen Ltd. (NASDAQ: CGEN) announced the discovery and experimental confirmation of a genetic biomarker, CGEN-40001 for predisposition to type 2 diabetes, the most common form of diabetes. This new biomarker was discovered using Compugen’s GeneVa® platform, which consists of an in silico database of approximately 350,000 predicted genetic variations in the human genome, with each predicted variation consisting of multiple consecutive nucleotides.

Predisposition markers are of particular value in diseases like type 2 diabetes, where specific lifestyle and health factors are known to play an important role. Following diagnosis, high-risk patients may benefit from more aggressive management either through lifestyle modification or drug treatment. There are an estimated 24 million people in the U.S. with diabetes, 90% of whom are affected by type 2 diabetes.During the past few years, extensive efforts by others searching for genetic markers for type 2 diabetes have utilized numerous genome-wide association studies, involving thousands of patients globally. Several validated genetic markers have been found; however, combining all the discovered biomarkers still explains only a small fraction of the heritability of the disease, so the need for additional markers continues to exist... Compugen's Press Release -

Ossulin, a Novel Oral Insulin : Promising Bioavailability for Advancing Diabetes Therapy

9th November 2009 - New data from Puredel Limited, presented at the 9th Annual Diabetes Technology Meeting in San Francisco, California, suggest that higher blood levels of insulin were achieved by Ossulin than had been prevously demonstrated by other products. In a series of experiements in a range of doses and models, Ossulin consistently delivered around 20% of the insulin dose into the bloodstream.

The authors concluded that:

'Ossulin provides an efficient way to deliver insulin to the body by oral administration, resulting in blood levels higher than those previously observed with other oral insulin products.'... CM&D Pharma' Press Release -

CPEX’s Nasulin Insulin Therapy Featured in an Oral Presentation and Four Abstracts at the Ninth Annual Diabetes Technology Meeting

November 05, 2009 -CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) announced that its intranasal insulin product candidate, NasulinTM, will be featured in an oral presentation and four abstracts at the Ninth Annual Diabetes Technology Meeting, November 5-7, 2009 at the Hyatt Regency Airport in San Francisco, California. Dr. Lance Berman, Senior Vice President and Chief Medical Officer, is scheduled to deliver an oral presentation entitled “The Technology and Clinical Aspects of Nasal Insulin Therapy” at 9:30 a.m. PST on Saturday, November 7. Further details on the abstracts are provided below.
A Randomized 6-Way Crossover Study of NasulinTM, Saline and Lispro in Subjects with Type 2 Diabetes to Determine Optimum Dose Timing
A similar glucose-lowering effect may be achieved by administering Nasulin either just before or at the end of the meal offering more flexibility of dosing than with injectable insulins.
Two Randomized Crossover Glucose Clamp Studies of NasulinTM and Lispro
In both Type1 diabetic patients and healthy volunteers, peak glucose metabolism rates occurred earlier with ultra-rapid acting Nasulin than with rapid acting lispro. The pharmacodynamic profile indicates Nasulin has optimum activity when glucose levels rise during a meal with less potential for hypoglycemia in the hours after the meal has ended.

Dose-Exposure for Single and Dual Nostril Administration of Nasal Insulin (NasulinTM)
The findings from this study demonstrated significantly enhanced insulin absorption when a 50 IU dose is administered as 2 sprays of 25 IU given in the same nostril rather than one spray in each nostril. In addition, the study also demonstrated that nasal administration of up to 200 microliters per nostril was well tolerated allowing the administration of doses up to 100 IU. Together these findings provide an improved dosing methodology and a higher maximum dose for evaluation in future clinical trials.

Dose-Exposure for Two Dose Strengths of Nasal Insulin (NasulinTM)
These data demonstrated that the original Nasulin concentration (1.0%) and the new concentration (0.7%) revealed proportional dose-dependent increases in insulin exposures... [PDF] CPEX Pharmaceuticals' Press Release -

GlycoMimetics : Awarded NIH Grant to Study Drug Candidate in Diabetes

August 16, 2009 -- GlycoMimetics, Inc., a clinical-stage biotechnology company that is developing a new class of glycobiology-based therapies for a broad range of indications, announced it has been awarded a grant from The National Heart, Lung, and Blood Institute (NHLBI) of The National Institutes of Health (NIH) to evaluate its E-selectin small molecule antagonists in animal models of vascular complications of diabetes.

The grant is based upon substantial data in the scientific literature suggesting an important role for E-selectin in the chronic inflammation associated with diabetes. The company has developed a family of potent small molecule E-selectin antagonists which it is currently optimizing for oral availability... GlycoMimetics' Press Release -

EXSULIN : PUBLICATION OF PHASE 2 TRIAL RESULTS FOR NOVEL ISLET REGENERATION TREATMENT IN TYPE 1 & TYPE 2 DIABETES

(August 18, 2009) – Exsulin Corporation announced milestones achieved and immediate plans to move forward as a well supported Minnesota-based company dedicated to the development of regeneration therapies for the treatment of diabetes mellitus. Exsulin’s focus is on development of a drug with potential to become a breakthrough therapy for patients suffering from type 1 (T1DM) and type 2 diabetes (T2DM). Phase II human clinical trial data of ExsulinTM (INGAP peptide), a peptide drug product aimed at restoring the ability of the pancreas to produce insulin normally in people with diabetes mellitus, have just been published online by Diabetes/Metabolism Research and Reviews.




Exsulin Corporation, founded by diabetes industry professionals, is supported by a proven clinical, development and regulatory management team and is advised by globally recognized diabetes experts. To follow on and support the results documented in the recent trial data publication, Exsulin has received clearances for a trial in patients with established (not newly diagnosed) T1DM, a population subset with no other currently active clinical trials. Other milestones achieved by Exsulin include reformulation and procurement of drug product, support of key independent laboratory research, and securing regulatory authorization to initiate a new clinical trial... Exsulin's Press Release -

Lexicon : Phase 1 Clinical Trial and Phase 2 Clinical Trial of LX4211 in Patients with Type 2 Diabetes

September 15, 2009 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, obtained favorable results from recently completed Phase 1 studies of LX4211 and announced that it has initiated a Phase 2 clinical trial of the drug candidate in patients with type 2 diabetes mellitus. LX4211 is an orally-delivered, small molecule drug candidate that inhibits the sodium glucose transporter 2 (SGLT2). LX4211 is Lexicon’s fourth drug candidate currently being tested in Phase 2 clinical trials... Lexicon Pharmaceuticals' Press Release -

Intarcia Therapeutics : Enrollment of ITCA 650 Phase 2 Study in Type 2 Diabetes

September 17, 2009 - Intarcia Therapeutics, Inc. announced the start of enrollment for a phase 2 study comparing its proprietary drug candidate ITCA 650 (DUROS continuous delivery of exenatide) with Byetta, an FDA-approved twice-daily injection form of exenatide. Building upon the successful completion of a 28-day phase 1b study of ITCA 650 in May of this year, the phase 2 study is intended to evaluate the doses achieving the best results in the phase 1b in a larger study population and for a longer duration of treatment. In addition, an extension phase of the phase 2 study will evaluate dose response of ITCA 650. Patients receiving Byetta for the first 12 weeks will be switched from Byetta to one of two doses of ITCA 650 to evaluate the potential for improving treatment effect... Intarcia Therapeutics' Press Release -

Medarex : Milestone Payment from FibroGen for the Initiation of a Phase 2 Study of FG-3019 in Patients with Diabetic Kidney Disease

Jul. 13, 2009-- Medarex, Inc. (NASDAQ:MEDX) announced it will receive a milestone payment of an undisclosed amount from its licensing partner, FibroGen,Inc., in connection with a recently initiated Phase 2 clinical trial of FG-3019 in patients with type 2 diabetes and advanced kidney disease as announced by FibroGen on June 15, 2009.



FG-3019 is a fully human monoclonal antibody generated using Medarex's UltiMAb(R) technology against connective tissue growth factor(CTGF). Under the agreement with FibroGen, Medarex could receive future milestone payments and sales-based royalty payments... Medarex's Press Release -