Oramed Pharmaceuticalsals, Phase 1B Clinical Trials of Oral Insulin Capsule

March 11, 2008 - Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB), a developer of oral delivery systems, has successfully completed Phase 1B clinical trials of its oral insulin capsule. The Phase 1B trial, which utilized healthy volunteers, was focused on finding the optimal dosage for the formulation of Oramed’s oral insulin product... [PDF] Oramed 's Press Release -

Abbott's FreeStyle Navigator Continuous Glucose Monitoring System : FDA approved

March 13, 2008 - The Food and Drug Administration (FDA) has approved the FreeStyle Navigator® Continuous Glucose Monitoring System in the United States for people with diabetes. Designed to discretely and continuously measure glucose levels through a sensor in the back of the upper arm or abdomen, Abbott's FreeStyle Navigator system provides minute-by-minute information about which way and how quickly blood sugar levels are changing. This information can lead to proactive adjustments that can result in tighter glucose ranges. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator system, traditional blood glucose tests must be performed... Abbott's Press Release -

Elixir Pharmaceuticals, new data on the role of ghrelin antagonism in the regulation of metabolism and as a potential treatment for Type 2 diabetes

02-22-08 - Elixir Pharmaceuticals, Inc., announced new data on the role of ghrelin antagonism in the regulation of metabolism and as a potential treatment for Type 2 diabetes. The data were presented by Dr. Yong Qi in a platform session during Keystone Symposia’s Neuronal Mechanisms Controlling Food Intake, Glucose Metabolism and Body Weight meeting being held this week in Banff, Alberta, Canada. Elixir’s small molecule ghrelin antagonists derive from the Company’s focus on pathways involved in the regulation of aging. Elixir identifies novel targets in these pathways leading to the development of compounds to treat a range of diseases of aging, including metabolic diseases such as diabetes and obesity... [PDF] Elixir Pharmaceuticals' Press Release -

Akesis Pharmaceuticals, First Patient in Phase IIa Trial of AKP-020 for Type 2 Diabetes

February 25, 2008 - Akesis Pharmaceuticals, Inc. (OTC/BB: AKES), an emerging diabetes drug-development company, announced it has initiated dosing of patients in its placebo controlled Phase IIa trial for AKP-020, a novel vanadium compound, to test its safety and efficacy in patients with Type 2 Diabetes.
"We are pleased to have reached this Phase IIa milestone," said Jay Lichter, president and chief executive officer of Akesis. "We are on track to complete enrollment and dosing according to schedule and anticipate announcing results when they become available."
dgd Research of San Antonio, TX, now a member of Cetero Research, is conducting the Phase IIa, controlled U.S. clinical trial. The trial will enroll a total of 21 diabetic patients at a single site measuring efficacy (using the gold-standard euglycemic-hyperinsulinemic clamping procedure), as well as pharmacokinetic parameters, safety and tolerability of AKP-020 in diabetic patients... Akesis Pharmaceuticals' Press Release -

Oculus Innovative Sciences, Phase II Data with Microcyn® Technology in Mildly Infected Diabetic Foot Ulcers

Feb 27, 2008 - Oculus Innovative Sciences, Inc. (Nasdaq:OCLS) announced positive top-line results from its U.S. Phase II clinical trial evaluating Microcyn® Technology as a topical antimicrobial treatment for mildly infected diabetic foot ulcers. Microcyn demonstrated a positive clinical response, defined as the clinical cure or improvement of infection, as a monotherapy and in combination with levofloxacin, a systemic antibiotic. The company plans to request an end-of-Phase II meeting with the FDA to discuss Phase II results and define the scope and parameters for advancing the clinical program... Oculus Innovative Sciences' Press Release -

Alkermes, Eli Lilly, Termination of AIR (Inhaled) Insulin Program

March 7, 2008--Alkermes, Inc. (NASDAQ: ALKS) announced that it has received a letter terminating the development and license agreement between Eli Lilly and Company (Lilly) and Alkermes dated April 1, 2001 thereby terminating the AIR(R) Inhaled Insulin (AIR(R) Insulin) program. The termination will become effective in 90 days. The termination of the agreement also results in the termination of the AIR Insulin supply agreement... Alkermes' Press Release - Lilly's Press Rlease -

PLC Systems' RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy

Feb. 15 , 2008 - PLC Systems Inc. (Amex: PLC) announced that it has submitted an Investigational Device Exemption (IDE) supplement with the U.S. Food & Drug Administration (FDA) for its RenalGuard Therapy™ and RenalGuard System™. This supplement seeks approval to move to a pivotal trial to study the effectiveness of the Company's RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy. According to the current timetable, PLC expects to commence the pivotal trial after receipt of FDA approval. Contrast-Induced Nephropathy, or CIN, is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre-existing renal impairment -- all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media... PLC Systems' Press Release -

Novocell, Successful Use of Stem Cells to Generate Insulin in Mice

San Diego, CA / February 20, 2008 – Novocell, Inc., a stem cell engineering company, announced data demonstrating for the first time that human embryonic stem (hES) cells can be turned into pancreatic cells capable of producing insulin in mice. The findings are reported in an article appearing on-line today, in advance of print publication, in the journal Nature Biotechnology. This research provides evidence supporting the potential future use of hES cells to replace insulin-producing pancreatic cells that are destroyed in people with Type 1 diabetes, requiring them to receive regular insulin treatment... Novocell's Press Release -

Novartis Eucreas combination of Galvus® and metformin, set for launch in first EU countries as new treatment for type 2 diabetes

Basel, February 25, 2008 - European health authorities have approved Eucreas®, an oral tablet combining Galvus® (vildagliptin) and metformin, as a new treatment for patients with type 2 diabetes. Eucreas is the first single-tablet combination of a member of the new DPP-4 inhibitor class with metformin to be approved in the European Union.

The approval comes after Novartis proposed changes to the EU label recommending that liver monitoring should be conducted at the start of treatment, every three months for the first year, and periodically thereafter. The Eucreas approval closely follows European approval of the updated label for Galvus announced earlier this month.

The decision applies in all 27 countries of the EU as well as in Norway and Iceland, and both medicines will be available in the first European countries within the next few weeks... Novartis' Press Release -

Johnson & Johnson Diabetes Institute, New Center To Provide State-of-The-Art Education, Training to Health Professionals

Milpitas, CA (February 29, 2008) – With mounting evidence that many health professionals lack the training and skills to combat the nation’s growing epidemic of diabetes, the Johnson & Johnson Diabetes Institute, LLC today opened its first training center in the U.S. to improve how practitioners deliver diabetes care in local communities.The new facility, based in Silicon Valley, will provide comprehensive training each year for thousands of community-based nurses, physician assistants, diabetes educators and other health professionals using a curriculum developed with national diabetes organizations and academic centers. It addresses an acute shortage of skills training in diabetes management at the community level, which practitioners cite as one of the major obstacles to improving patient outcomes... Johnson & Johnson Diabetes Institute's Press Release -

Metabasis Therapeutics, Proof-of-Concept Clinical Trial for MB07803, Its Product Candidate for the Treatment of Type 2 Diabetes

Feb. 28, 2008--Metabasis Therapeutics, Inc. (Nasdaq:MBRX) announced the completion of patient enrollment in its Phase 2a clinical trial for MB07803, a product candidate being studied as a treatment for patients with type 2 diabetes. With this trial fully enrolled and the final patients undergoing dosing, the Company expects to be able to announce top line results in the second quarter of 2008, as planned. MB07803 is a member of a new class of drugs discovered by Metabasis that is designed to regulate glucose production in the liver by inhibiting an enzyme known as fructose-1,6-bisphosphatase (FBPase), a key enzyme in the gluconeogenesis pathway which is responsible for the excessive production of glucose in patients with type 2 diabetes... Metabasis Therapeutics' Press Release -