Metabolex : Phase 1 clinical trial of MBX-2982, Potential First-in-Class Treatment for Type 2 Diabetes

March 26, 2008 : Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced that it has dosed the first cohort of healthy subjects in a Phase 1 clinical trial of MBX-2982, a potential first-in-class treatment for type 2 diabetes.

The Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of MBX-2982. Investigators expect to enroll a total of 60 healthy volunteers in the 6-cohort ascending-dose study.

MBX-2982 is an agonist of GPR119, a G-protein coupled receptor (GPCR) that is expressed in pancreatic islets and the gastrointestinal tract. Pre-clinical studies conducted by Metabolex and others show that GPR119 agonists can stimulate glucose-dependent insulin secretion... Metabolex's Press Release -

Takeda : ACTOS® (pioglitazone HCl) Prevented Progression of Atherosclerotic Plaque Volume in Patients with Type 2 Diabetes

March 31, 2008 – New data from a clinical trial using intravascular ultrasound (IVUS) technology found that in patients living with type 2 diabetes, ACTOS^® (pioglitazone HCl) reduced the atherosclerotic burden in the coronary arteries compared to glimepiride, and prevented progression compared to baseline. These data stem from the PERISCOPE (Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation) trial.

The PERISCOPE trial was presented today as a late breaker at the 57th Annual Scientific Session of the American College of Cardiology in Chicago. This trial adds to the body of cardiovascular data for ACTOS. ACTOS studies, conducted over the past 10 years in more than 16,000 patients, including short- and long-term trials, as well as prospective and observational studies, have shown no evidence that ACTOS is associated with an increased risk of heart attack, stroke, or death... Takeda's Press Release -

Cardium and Tissue Repair Company's Excellarate : Healing Diabetic Wounds Gains Media Focus in Multiple Regions Across U.S.

March 17, 2008 - Cardium Therapeutics (Amex: CXM) and its subsidiary, Tissue Repair Company (TRC) reported that the Phase 2b MATRIX clinical study has been the focus of media attention in multiple regions across the U.S., including television news features in Florida, Pennsylvania, Arizona and Southern California. The MATRIX study is evaluating the safety and efficacy of Excellarate(TM) for the potential treatment of non-healing diabetic foot ulcers. Excellarate is a DNA-based topical gel that is being developed to be physician-administered once or twice to stimulate wound healing... Cardium Therapeutics' Press Release -

Smiths Medical MD : voluntary recall of specific serial numbers of the Deltec Cozmo Insulin Pump

March 10, 2008 - Smiths Medical MD, Inc. issued a voluntary recall of specific serial numbers (see below) of the Deltec Cozmo® Insulin Pump.

Only 1023 recently manufactured pumps have been affected by this recall. These pumps were manufactured between November 2007 and January 2008. We have only been notified of 2 occurrences by customers, none of which have required any medical intervention... Smiths Medical's Press Release -

Owen Mumford Ltd : to discontinue Unilet GP and Unilet Superlite in UK market

02 April 2008 - As of the 1st of June 2008, Owen Mumford will be discontinuing two variants from their range of lancets within the UK market: Unilet Superlite (23G) and Unilet GP (21G)... Owen Mumford's Press Release -

CV Therapeutics : New Data Shows Ranexa Increases Glucose-Stimulated Insulin Secretion

March 31, 2008 - CV Therapeutics, Inc. (Nasdaq: CVTX) announced that preclinical research presented at the American College of Cardiology 57th Annual Scientific Session in Chicago showed that ranolazine increased glucose-stimulated insulin secretion (GSIS) in pancreatic islets isolated from animals and humans.

The Company believes that the increase in GSIS seen with ranolazine may contribute to the statistically significant reductions in hemoglobin A1c (HbA1c) levels observed with Ranexa in cardiovascular patients with diabetes from the phase 3 CARISA (n=189 with angina and diabetes) and MERLIN-TIMI 36 (n=2,220 with acute coronary syndromes and diabetes) clinical trials. In CARISA, Ranexa reduced HbA1c levels by an average of up to 0.7 percentage points. In MERLIN-TIMI 36, Ranexa lowered HbA1c versus placebo by an average of 0.43 percentage points at four months in patients with a mean baseline HbA1c level of 7.5%... CV Therapeutics' Press Release -

Senesco : Preclinical Pancreatic Islet Data to be Presented at Upcoming Conferences

April 2, 2008 - Senesco Technologies, Inc. ("Senesco" or the "Company") (AMEX:SNT) announced that Dr. Raghavendra Mirmira, one of the Company’s funded researchers will be presenting his findings regarding preclinical pancreatic islet cell data at two conferences in April, 2008. Dr. Mirmira, who conducted this preclinical research while at the University of Virginia, is presently the Eli Lilly Endowed Chair in Pediatric Diabetes in the Departments of Pediatrics, Medicine, and Cellular and Integrative Physiology at Indiana University School of Medicine... Senesco Technologies' Press Release -

Aegera : Phase 1 Clinical Trial of AEG33773 - a Small Molecule in Development for Diabetic Neuropathic Pain

March 18, 2008 - Aegera Therapeutics announced today the initiation of a Phase 1, first-in-man, clinical trial for AEG33773, a novel, orally bioavailable small molecule in development for the treatment of painful diabetic neuropathy. The Phase I study will evaluate the safety, tolerability and pharmacokinetic profile of AEG33773 using a randomized, double blind, placebo controlled, single ascending dose design in healthy male volunteers.
Aegera completed a comprehensive pre-clinical development program on AEG33773, culminating in regulatory clearance from Health Canada and treatment of a first patient, in less than 12 months... [PDF] Aegera Therapeutics' Press Release -

Oculus Innovative Sciences : Chinese SFDA Regulatory Approval of Microcyn Technology

Mar 27, 2008 - Oculus Innovative Sciences, Inc. (NASDAQ:OCLS) announced that the Chinese State Food and Drug Administration (SFDA) has approved Microcyn® Technology for use in China. The Chinese agency approved Microcyn Technology for treatment of various acute and chronic wounds including ulcers, cuts, contusions and burns. This approval allows Oculus' Chinese partner to market Microcyn Technology as a technology that provides a moist environment for wounds and accelerates wound healing through the reduction of microorganisms in wounds.
This approval follows the completion and submission of two randomized controlled Chinese clinical trials of Microcyn in December of 2007--a burn wound study with 162 patients and a chronic wound treatment study with 35 patients. The Microcyn Technology will be marketed by Oculus' Chinese partner, China Bao Tai... Oculus Innovative Sciences' Press Release -

BioMimetic Therapeutics Addresses FDA Communication on Regranex Safety Review

March 27, 2008 - BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) addressed a communication the U.S. Food and Drug Administration ("FDA") released on its website this afternoon regarding the agency's ongoing safety review of Regranex®, a Johnson & Johnson product. Regranex is composed of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) (becaplermin) in a non-sterile ointment, which has been approved since 1997 for the chronic treatment of non-healing diabetic foot ulcers. The FDA communication specifically addresses Regranex use and does not address other rhPDGF-BB containing products. BioMimetic has not received any communications from the FDA related to today's web posting regarding Regranex.The FDA communication provided information regarding a study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who applied the product Regranex (a topical medicine) daily, directly to their dermal ulcers for up to 140 consecutive days. According to the communication, "posting this information does not mean that FDA has concluded a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing this product."... BioMimetic Therapeutics' Press Release -

Novo Nordisk : FDA Approves NovoLog for Use in Insulin Pumps by Children and Adolescents

March 18, 2008 - Novo Nordisk (NYSE: NVO) announced that the U.S. Food and Drug Administration has approved NovoLog® (insulin aspart [rDNA origin] injection) for continuous subcutaneous insulin infusion (CSII) by external insulin pump in pediatric patients between the ages of 4 and 18 years. NovoLog® is the first and only insulin analog approved for this use.

Data from a trial published in the February issue of Diabetes Care in support of this approval demonstrated that compared to insulin lispro CSII, NovoLog® CSII achieved similar levels of glycemic control and safety. Results came from a 16-week, open-label, multi-center, parallel group study of 298 patients (aspart, n= 198; lispro, n = 100) (aged 4-18 years; type 1 diabetes duration greater than or equal to 1 year; CSII therapy treatment greater than or equal to 3 months; A1C less than or equal to 10% at screening)... Novo Nordisk's press Release -