Derma Sciences : Continued Healing at 24 Weeks in Patients with Diabetic Foot Ulcers Treated with DSC127 in Phase 2 Trial

May 25, 2011 - Healing spread widens between DSC127 0.03% group and placebo group compared with 12-week data - Wounds up to five times more likely to heal at 24 weeks with DSC127 0.03% versus placebo - Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, announced that in the follow-up portion of its Phase 2 clinical trial in patients with diabetic foot ulcers, the percentage of patients treated with the therapeutic (0.03%) dose of DSC127 with complete healing at 24 weeks following trial enrollment was 73% in the intent-to-treat (ITT) population and 85% in the per-protocol population (PP), a difference of 27 and 33 percentage points, respectively, compared with patients treated with placebo/standard of care (placebo). DSC127 is a patented, topically applied novel angiotensin analog that targets receptors that are up-regulated upon injury to tissue.

Healing was defined as 100% epithelialized with no drainage. The Company previously announced that the 0.03% dose of DSC127 exceeded the trial's goal of an improvement of 15 percentage points in complete healing of wounds at 12 weeks for both the ITT (21 percentage point increase) and PP (27 percentage point increase) populations, compared with placebo. With today's announcement, the improvement at 24 weeks between patients treated with DSC127 0.03% and patients treated with placebo is even more pronounced. There were no drug-related adverse safety events during the entire 24-week study period.

The double-blind, placebo-controlled, multi-center Phase 2 clinical trial randomized 80 patients to receive one of two dose strengths of DSC127 (0.03% or 0.01%) or vehicle placebo control. After 14 days of best standard-of-care to evaluate ulcer healing and ensure the wounds were chronic, those patients randomized into the study received four weeks of active treatment followed by eight weeks of observation and assessment. Although the primary endpoint of the trial was healing at 12 weeks, patients continued to be followed for an additional 12 weeks to gain further information on the drug and its effects. Consistent with what was seen at week 12, the 0.01% dose of DSC127 continued to be comparable to placebo at week 24, and therefore non-therapeutic. The table below shows the percentage of patients healed at weeks 12 and 24, with the 0.03% dose of DSC127 and placebo... Derma Sciences' Press Release -

Metabolic Solutions Development : Launches Phase 2a Trial of its Second Compound to Treat Type 2 Diabetes

March 29, 2011 – Metabolic Solutions Development Company (MSDC), a drug discovery and development company exploiting novel molecular targets to treat metabolic diseases, announced that it has launched a Phase 2a trial for MSDC-0602, the company’s second drug candidate for the treatment of type 2 diabetes. The 28-day, randomized, double-blind, comparator- and placebo-controlled clinical trial will involve approximately 125 patients at 15 planned sites throughout the United States.
MSDC-0602 is a selective modulator of mitochondrial metabolism that modifies nutrient-sensing pathways leading to improved insulin action without direct activation of nuclear transcription factors. “Because this novel mechanism of action does not depend on direct activation of nuclear transcription factors, type 2 diabetic patients treated with MSDC-0602 are not expected to experience fluid retention or weight gain as do patients treated with the currently marketed PPARγ agonists,” said Dr. Jerry Colca, president and chief scientific officer of MSDC.
In addition to gathering additional safety and tolerability data, the Phase 2a trial will evaluate the reduction in fasting plasma glucose following once-daily dosing for 28 consecutive days in patients with type 2 diabetes. Patients taking MSDC-0602 will be compared to those taking 45 mg of pioglitazone and placebo... [PDF] Metabolic Solutions Development's Press Release -

Stempeutics Research : DCGI nod to start Phase II clinical trial...

January 20 th, 2011 – Stempeutics Research a group company of Manipal Education & Medical Group announced that Drug Controller General of India (DCGI) has granted clearance of the company’s Investigational Medicinal Product “Stempeucel” for conducting Phase II clinical trials in patients with Osteo Arthritis, Diabetes Mellitus – Type 2, Liver Cirrhosis and Chronic Obstructive Pulmonary Disease. Stempeucel product is developed from allogeneic mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology. Earlier the company has received approval from DCGI for Phase I/II clinical trial for Acute Myocardial Infarction and Critical Limb Ischemia in March 2009. Stempeutics is funded by Manipal Group and Cipla...


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Diabetes Mellitus – Type2

Diabetes mellitus Type2 is a disease in which a person has high blood sugar, either because the body does not produce enough insulin, or because cells do not respond to the insulin that is produced. Current therapies for diabetes include oral hypoglycaemic drugs and insulin injections in addition to dietary management. They do not address the root cause i.e. lack of functional cells in pancreas and peripheral insulin resistance. This study is planned to see if stem cells injected into patients with diabetes, can trigger pancreatic resident stem cells / progenitors to form new cells. If successful, stem cell therapy possibly may result in permanent cure for diabetes. The objective of this study is to evaluate the safety and efficacy of a single intravenous dose of “Stempeucel” in type 2 diabetes mellitus and to find out the most suitable dose of stem cells... [PDF] Stempeutics Research's Press Release -