DARA BioSciences : Phase I Clinical Study of DB959 for the Treatment of Type 2 Diabetes

Mar 25, 2010 - DB959 is a Highly Selective, Non-TZD First-In-Class Dual PPAR-Delta/Gamma Agonist - DARA BioSciences, Inc. (Nasdaq:DARA) announced that it has initiated a Phase I clinical study for DB959, its PPAR (peroxisome proliferator activated receptor) delta/gamma agonist, an oral drug in development for the treatment of Type 2 Diabetes. The study will enroll approximately 75 volunteers and will be conducted at Quintiles' Overland Park facility. This study's main objectives are to determine the safety and pharmacokinetics of single ascending oral doses of DB959. The Company expects to report the results of the study during the second half of 2010.

The results of preclinical studies demonstrated that DB959 controlled glucose while raising HDL and the HDL:LDL ratio and lowering triglycerides. These beneficial effects on glucose and lipids were observed without causing the weight gain which is seen with other PPAR agonists... DARA BioSciences' Press Release -

iCo Therapeutics : Phase 1 DME Clinical Trial Update and Phase 2 Trial Guidance

December 11, 2009 - iCo Therapeutics (“iCo”) is pleased to announce that its Phase 1 clinical trial of iCo-007, having enrolled all patients in four cohorts of increasing concentration (110ug, 350ug, 700ug, 1000ug), has to date demonstrated a positive safety profile. A Safety Evaluation Committee recently convened to review early data from the fourth and final cohort, which represented an approximately 10-fold increase in concentration from the first dosing level and concluded there were no drug-related serious adverse events. Based on the safety profile and additional encouraging data seen so far, iCo has now entered the planning stage for Phase 2 clinical studies. Stated Dr. David Boyer: “I am pleased with the results of the Phase I clinical trial to date. The Safety Evaluating Committee’s experience with iCo-007 indicates that the drug has been well tolerated by patients and there were no drug-related significant adverse events noted to date even at the highest dosing level. I look forward to working with iCo in the planning and design of Phase 2 trials for iCo-007”. In early Q1 2010 iCo expects a last patient visit (month six) followed by data lock and analysis. iCo expects to present final data in Q2 2010.

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About iCo-007
Designed and discovered by ISIS Pharmaceuticals Inc., (NASDAQ: ISIS), iCo-007 is a second-generation antisense inhibitor targeting c-Raf kinase mRNA for the treatment of DME and Diabetic Retinopathy (DR)... iCo Therapeutics' Press Release -

MacuSight : Fast Track Designation from FDA for Perceiva™ in Treatment of Diabetic Macular Edema

October 21, 2009 - MacuSight, a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, announced that it has received Fast Track designation from the United States Food and Drug Administration (FDA) for Perceiva, the company's proprietary ocular sirolimus product, for the treatment of diabetic macular edema (DME). MacuSight is currently advancing Perceiva in a broad Phase 2 clinical program across multiple large ocular indications. The company recently announced that it had completed enrollment in four separate Phase 2 studies which are evaluating Perceiva as a treatment for DME, neovascular (wet) age-related macular degeneration (wet AMD) and dry eye syndrome. The company plans to announce data from these studies in the first half of 2010.

FDA's process for providing Fast Track designation is intended to facilitate the development and expedite the review of drugs that treat serious or life-threatening diseases and address an unmet medical need. With this designation, MacuSight will be provided the opportunity to submit portions of a New Drug Application (NDA) for Perceiva as they are completed instead of filing all completed portions of the NDA at one time. As a result, FDA may begin its review of the application as portions are received, potentially accelerating the review and approval process.

"By granting Fast Track status to Perceiva for the treatment of DME, the leading cause of vision loss among working-age adults, FDA is providing an accelerated pathway for delivering this potentially important therapeutic to patients in need of effective treatment options... MacuSight's Press Release -

ThromboGenics : results from a Phase IIa trial evaluating microplasmin for the treatment of Diabetic Macular Edema

5 October, 2009 - Data presented at the American Society of Retina Specialists (ASRS) Conference in New York – ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative medicines for eye disease, vascular disease and cancer, announces results of a Phase IIa trial evaluating microplasmin intravitreal injection for the treatment of Diabetic Macular Edema (MIVI II DME). The data from this trial were presented at the ASRS (American Society of Retina Specialists) Conference in New York on 3 October, 2009 by Professor Peter Stalmans, University Hospitals Leuven, Belgium.
The MIVI II DME trial was designed to be the initial step in evaluating microplasmin in patients with diabetes, a group which is more prone to eye disease, and specifically diabetic retinopathy. Diabetic retinopathy is a major cause of visual loss and the leading cause of blindness in patients aged 20-60. Previous studies in this advanced patient population have shown that, given the underlying condition, the adhesion between the vitreous and retina tends to be much stronger, as evidenced during vitrectomy. This level of adhesion makes it more challenging to achieve a total PVD in patients with advanced DME, as opposed to earlier stage diabetic retinopathy... [PDF] ThromboGenics' Press Release -

NephroGenex : Full Enrollment in New PYR 210Pyridorin™ Clinical Trial

September 9, 2009 - 317 diabetic kidney disease patients enrolled in Phase 2b trial – NephroGenex, Inc., a privately held drug development company focusing on kidney disease, announced the completion of patient enrollment in its Phase 2b clinical trial (PYR‐210) studying the safety and efficacy of its lead drug candidate Pyridorin™ (pyridoxamine dihydrochloride) in type 2 diabetic patients with overt diabetic nephropathy. Three hundred and seventeen (317) patients have been randomized.
The study is being conducted by the Collaborative Study Group (CSG) at approximately 65 sites in the United States, Australia and Israel. The CSG is a site management organization of nephrologists that has conducted notable landmark studies in diabetic nephropathy in the past, including studies leading to approval of drugs for this indication.
The trial is evaluating two doses of Pyridorin™ against placebo in approximately 300 patients for a one year treatment period. Recruited type 2 diabetic patients have elevated serum creatinine levels and significant proteinuria. The estimated study completion date is August 2010... [PDF] NephroGenex's Press Release -

Salix : FDA Marketing Approval for Metozolv™ ODT (Orally Disintegrating Tablets) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD

September 8, 2009 - The First Available Orally Disintegrating Metoclopramide Tablet Designed to Offer Improved Convenience – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV™ ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets. METOZOLV ODT is indicated for the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short–term therapy (4–12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapyi.

"METOZOLV ODT is the first available treatment for both diabetic gastroparesis and symptomatic documented GERD that offers physicians and patients the similar safety and efficacy of metoclopramide with the added convenience of an orally disintegrating tablet formulation... Salix Pharmaceuticals' Press Release -

Intrinsic Bioprobes : discovery and exclusive licensing of novel biomarkers for diabetes

January 21, 2010 – Intrinsic Bioprobes announced the exclusive licensing of two novel biomarkers for diabetes to Ortho-Clinical Diagnostics, Inc. (Raritan, NJ). The biomarkers are modified forms of blood-circulating proteins and have been linked with the presence of pre-diabetes and type 2 diabetes. The financial terms of the licensing agreement were not disclosed.

“The biomarkers were discovered using Intrinsic Bioprobes’ unique Mass Spectrometric Immunoassay technologies”... [PDF] Intrinsic Bioprobes' Press Release -

Intuity Medical : $64M Series D Financing

January 5, 2010 – Intuity Medical, Inc., a privately-held company developing innovative technologies in diabetes management, announced that it has secured a $64M Series D financing round. The funds were contributed by new investors Venrock and Emergent Medical Partners; and existing investors Investor Growth Capital, Thomas, McNerney and Partners, U.S. Venture Partners, and Versant Ventures.
Intuity will utilize the proceeds for the U.S. commercialization and distribution of its All-in-One System, following regulatory clearance. All-in-One is the world’s first fully integrated blood glucose monitor, providing greater convenience, ease of use and discretion in glucose testing... [PDF]Intuity Medical's Press Release -

Insulet and Ypsomed : International Distribution Agreement for the OmniPod Insulin Management System

Jan 05, 2010 -- Insulet Corporation (Nasdaq: PODD), the leader in tubing-free insulin pump technology with its OmniPod(R) Insulin Management System, and Ypsomed AG (SIX Swiss Exchange: YPSN), a leading independent diabetes specialist and technology provider of innovative injection systems for self-medication in Europe, announced an exclusive agreement for the distribution of the OmniPod Insulin Management System in nine countries across Europe, as well as China and Australia.Ypsomed has been a leader in the diabetes industry for over 25 years... Insulet's Press Release - [PDF] Ypsomed's Press Release -

Dr. Reddy's and Rheoscience : headline results from First Phase III clinical trial of Balaglitazone (DRF 2593)

January 04, 2010, Hyderabad: Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) and Rheoscience, a subsidiary of Nordic Bioscience A/S, announced the headline results from the first phase III study for their investigational agent, Balaglitazone. The study (Study 307) was a phase III, randomized, double blind, parallel-group placebo- and active comparator-controlled clinical study to determine the efficacy and safety of balaglitazone. The study showed that the trial met its primary endpoint of reduction in HbA1c.

The study explored the impact of adding placebo, Balaglitazone 10mg, Balaglitazone 20mg or Pioglitazone 45mg to a background treatment regimen of stable insulin therapy for a period of 26 weeks. The primary endpoint was HbA1c reduction, while several secondary endpoints including fasting plasma glucose, oedema, weight gain, and body composition were considered.

In all, 409 patients were randomized in roughly equal proportions across the four arms of the study. All three active arms (Balaglitazone 10mg, 20mg and Pioglitazone 45mg) showed similar levels of efficacy with respect to both HbA1c and fasting plasma glucose... Dr. Reddy’s Press Release -

Betagenon : its lead AMPK activator drug candidate BG8702 has started IMP enabling studies in the UK

Jan 29, 2009 - Betagenon announced that its lead AMPK activator drug candidate BG8702 aimed for the treatment of type2 diabetes has started Investigational Medicinal Product enabling studies in the UK. The selected compound is derived from the in-house drug discovery AMPK activator program. Treatment with BG8702 leads to significant improvement of insulin sensitivity, glucose and triglyceride lowering in diabetic mouse models... Betagenon's Press Releases -