Sanofi-aventis : Newly Published Study Results Showed that Two Mealtime Insulin Dosing Algorithms were Effective for Patients with Type 2 Diabetes

July 22, 2008: The results from the “Adjust to Target in Type 2 Diabetes: Comparison of a Simple Algorithm to Carbohydrate Counting for Adjustment of Mealtime Insulin Glulisine” studyi, were published in the American Diabetes Association’s (ADA) medical journal, Diabetes Care. This study, using a basal-bolus insulin regimen with Lantus® (insulin glargine [rDNA origin] injection) once daily (basal insulin) and rapid-acting Apidra® (insulin glulisine [rDNA origin] injection) at mealtime (bolus insulin) demonstrated significant reductions in postprandial blood glucose and A1c using two different dosing algorithms.
The 24-week, multicenter, randomized, controlled study compared two algorithms for adjusting mealtime insulin (Apidra®) in 273 intent-to-treat patients with type 2 diabetes. Apidra® and Lantus® were adjusted weekly in both groups based on the previous week’s Self-Monitored Blood Glucose (SMBG) results... [PDF] Sanofi-aventis' Press Release -

Allon Therapeutics : U.S. patent for lead product in new technology platform

July 09, 2008 - Allon Therapeutics Inc. (TSX: NPC), announced that it has been granted a United States patent covering composition, delivery and method of use for AL-309, the lead product candidate in the Company’s second neuroprotection technology platform, called Activity Dependent Neurotrophic Factor (ADNF).

Gordon McCauley, President and CEO of Allon, said the Company plans to begin human clinical trials in 2009 to evaluate AL-309 as a treatment for peripheral neuropathy, a condition suffered by millions of people resulting from nerve damage that leads to pain, discomfort, numbness and muscle weakness. Among the major causes of neuropathy are diabetes and cancer chemotherapy... Allon Therapeutics' Press Release -

UCB : not-approvable letter from FDA for lacosamide for diabetic neuropathic pain

July 29, 2008 - UCB announced that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for lacosamide for the treatment of diabetic neuropathic pain in adults.

The company will seek clarification from the FDA of its position and of the additional information required to obtain final marketing approval.

UCB confirmed that lacosamide (Vimpat®) is also currently under active review by the FDA for the adjunctive treatment of partial onset seizures in patients with epilepsy, age 16 and over.

In June 2008, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending that the European Commission grant a marketing authorization for Vimpat® (lacosamide) for the adjunctive treatment of partial onset seizures with or without secondary generalization in patients with epilepsy, age 16 and over. Vimpat® is also under review by the EMEA for the treatment of diabetic neuropathic pain in adults.

About Vimpat® (lacosamide) Vimpat® is an investigational therapy for the reduction of pain and discomfort in patients with diabetic neuropathic pain - a common and painful complication of diabetes... UCB's Press Release -

MicroIslet : Safety and Efficacy Data Update

July 2, 2008 - MicroIslet Inc. (OTCBB: MIIS), a biotechnology company engaged in the development and commercialization of cell therapies for diabetes, is pleased to report recent safety and efficacy data.

To date, MicroIslet has seen no adverse events attributable to MicroIslet-P(TM) in its animal models. The Company has tested hundreds of rodents and is currently completing a trial with nineteen non-human primates. Eighteen of the nineteen have been tested, and the last primate has received its final dose. Importantly, the primates have been subjected to one, two, or even three, separate transplant procedures, with no observed ill effects.

MicroIslet also has efficacy data demonstrating that MicroIslet-P(TM) can produce normoglycemia in both immune comprised and immune competent rodents. Additionally, all primates tested to date, post-implant, have demonstrated decreases in insulin requirements needed to maintain their blood glucose levels at a healthy concentration. Finally, post-implant, the primates have been primarily managed with long-acting insulin as opposed to acute insulin treatment, indicating improved glucose homeostasis (control)... MicroIslet's Press Release -

CombinatoRx : Progress in Key Programs at 2008 R&D Day

Jul 23, 2008 - CombinatoRx, Incorporated (NASDAQ: CRXX) provided a detailed review of selected therapeutic programs and a general company update at its annual Research and Development (R&D) day at its corporate headquarters in Cambridge, MA.
Presentation highlights included:...
CRx-401
The company conducted a comprehensive review of the ongoing Phase 2a clinical trial of CRx-401 as "add-on" to metformin therapy in Type-2 diabetes. The presentation also included a discussion of the potentially favorable positioning of CRx-401 with respect to the new FDA guidelines related to cardiovascular outcomes. With dozens of years of clinical experience behind the components and positive cardiovascular outcomes data previously demonstrated with bezafibrate in particular, CRx-401 may offer a reduced risk development pathway. Clinical data from this trial are expected in the second half of 2008... CombinatoRx's Press Release -

Metabolon : Collaboration with the University of Texas Health Science Center at San Antonio

July 22, 2008 - Partnership to Accelerate Pre-Diabetes Diagnostic Development— Metabolon, Inc., the leader in metabolomics-driven biomarker discovery and analysis, today announced that it is collaborating with Ralph A. DeFronzo, M.D. and colleagues at The University of Texas Health Science Center at San Antonio. The partnership will help drive development of Metabolon’s pre-diabetes diagnostic products as well as provide valuable data for insulin resistance and diabetes-related research...
... Metabolon will be analyzing samples from various studies conducted by Dr. DeFronzo’s team to discover and validate biochemical biomarkers reflective of insulin resistance and beta cell dysfunction. These markers will be used to help further develop Metabolon’s diagnostic tests in the area of insulin resistance, and how this relates to risk of developing metabolic diseases such as diabetes... Metabolon's Press Releases -

Santarus and Depomed : U.S. Promotion Agreement for GLUMETZA Prescription Products

July 22, 2008-- Santarus, Inc. (NASDAQ: SNTS) and Depomed, Inc. (NASDAQ: DEPO) announced that they have entered into a promotion agreement granting Santarus exclusive rights to promote Depomed's GLUMETZA(R) (metformin hydrochloride extended release tablets) prescription products in the U.S. GLUMETZA is a once-daily, extended-release formulation of metformin that incorporates patented drug delivery technology and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Santarus expects to train its field sales representatives in the third quarter and to begin promotion of GLUMETZA brand products in the fourth quarter of 2008. Depomed reported GLUMETZA net sales of $5.2 million in the first quarter of 2008.


Metformin is widely used for the treatment of type 2 diabetes, but many patients do not achieve optimal dosing levels due to gastrointestinal (GI) side effects. The advantage of GLUMETZA's delivery system is that it allows physicians to rapidly titrate dosing up to 2000 mg a day, which results in a more optimal level of glycemic control without significantly increasing GI side effects compared to a daily dose of 1500 mg of immediate-release metformin... Depomed's Press Release - Santarus' Press Release -

International Stem Cell and Novocell : Collaboration to Test Human Parthenogenetic Stem Cells for production of Pancreatic Islet Cells...

July 17, 2008 - International Stem Cell Corporation and Novocell, Inc. Collaborate to Test Human Parthenogenetic Stem Cells for production of Pancreatic Islet Cells that may be useful in the Treatment of Diabetes — International Stem Cell Corporation (OTCBB: ISCO) announced a collaboration with Novocell Inc. (La Jolla, CA) to use ISCO’s human parthenogenetic stem cell lines for differentiation to Human pancreatic islet cells. The studies will be directed by Nikolay Turovets, PhD, Director, Research and Therapeutic Development at ISCO in collaboration with Novocell scientists.
ISCO’s unique stem cells offer a solution for two of the most difficult problems facing stem cell therapy. They are the first step in preventing the rejection of implanted cells by the patient’s own immune system and they provide an alternative to embryonic stem cells that does not involve destroying human embryos...


...Novocell has developed technology to direct embryonic stem cells to become pancreatic islet cells that have been shown to be effective in treating diabetes in animals. The combined technologies of the two companies may therefore result in therapeutic cells with improved immune properties for eventual treatment of larger segments of the diabetic population.
A description of ISCO’s human parthenogenetic stem cells and their potential to improve transplantation was reported in ISCO’s peer review paper published December 19, 2007 in the online edition of Cloning and Stem Cells Journal... International Stem Cell Corporation's Press Releases -

XOMA 052 Phase 1 Data to be Presented At European Association for the Study of Diabetes Annual Meeting

Jul 15, 2008 - XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of antibody therapeutics, announced that results from two ongoing Phase 1 studies of XOMA 052 in Type 2 diabetes will be presented at the 44th European Association for the Study of Diabetes (EASD) Annual Meeting that will be held in Rome, Italy on September 7-11, 2008.

The oral presentation, titled "XOMA 052, an Anti-IL-1beta Antibody, in a Double-Blind, Placebo-Controlled, Dose Escalation Study of the Safety and Pharmacokinetics in Patients with Type 2 Diabetes Mellitus - A New Approach to Therapy" will examine safety and pharmacokinetics of XOMA 052 in addition to certain markers of activity such as hemoglobin A1c and C-reactive protein.

In the two studies, XOMA 052 was well tolerated without any evidence of serious drug-related adverse events. Clearance of XOMA 052 was consistent with that of a human antibody with a terminal half-life of 15-21 days. This drug profile, when combined with XOMA 052's high binding affinity of 300 femtomolar, could support potential dosing of once per month or longer in Type 2 diabetes patients... XOMA's Press Release -

Hollis Eden Pharmaceuticals : Phase II Clinical Trial with TRIOLEX(TM) (HE3286) in Type-2 Diabetes Patients; Expands Sites to Accelerate Enrollment

July 16, 2008 - Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH), the world leader in the development of a new class of small molecule compounds based on endogenous adrenal steroid hormones, announced that it has commenced a Phase II clinical trial with its oral drug candidate TRIOLEX(TM) (HE3286) in type 2 diabetes patients, and that it is expanding the number of clinical sites to accelerate enrollment. The Phase II, double-blinded placebo controlled 12-week dosing trial will enroll approximately 90 patients who are stable on metformin treatment only, the current first-line therapy for type 2 diabetes, with a hemoglobin A1c (HbA1c) level in excess of 7.5 percent. The primary endpoints for the trial will be safety and a reduction in HbA1c. Hollis-Eden plans to release preliminary interim data from this trial in the fourth quarter of 2008, and to completely enroll by the end of the year.

TRIOLEX may represent a novel, first-in-class insulin sensitizer that Hollis-Eden believes acts by modulating inflammatory pathways. Recently announced interim data from the Company's on-going Phase I/II clinical trial with TRIOLEX demonstrate that the compound is safe and well tolerated to date, and that it significantly improved insulin sensitivity and lowered fasting blood glucose, insulin and triglyceride levels in obese insulin resistant subjects treated orally with the compound for 28 days when compared to placebo-treated subjects. As would be expected in a population of insulin resistant subjects, blood levels of the chemokine monocyte chemoattractant protein (MCP-1) were elevated at baseline, before initiating treatment. MCP-1 plays a central role in the evolution of insulin resistance because it causes increased migration of macrophages into adipose tissue (and other tissues), leading to low-grade chronic inflammation and gradual loss of insulin sensitivity. Subjects treated with TRIOLEX at the highest dose showed a significant drop in MCP-1 in blood and IL-6 production by peripheral blood mononuclear cells, compared to placebo-treated subjects. This finding is consistent with what the Company believes is the anti-inflammatory mechanism of action of TRIOLEX... Hollis-Eden Pharmaceuticals' Press Release -

Genaera : Data on Mechanism of Inhibition of PTP-1B for Trodusquemine (MSI-1436) at Federation of American Societies for Experimental Biology

July 14th, 2008 - Genaera Corporation (NASDAQ: GENR) announced the presentation of new preclinical data on trodusquemine (MSI-1436), a novel inhibitor of PTP-1B and Genaera’s lead drug candidate for the treatment of type 2 diabetes and obesity, during the 10th Biennial FASEB Summer Research Conference Protein Phosphatases in Snowmass Village, Colorado. The poster presentation entitled, “Trodusquemine (MSI-1436), An Allosteric Inhibitor of Protein Tyrosine Phosphatase 1B,” concluded that MSI-1436 is a selective, reversible and noncompetitive inhibitor of PTP-1B that enhances insulin signaling through potent PTP-1B inhibition both in vivo and in vitro.
“The search to discover PTP-1B inhibitors as a therapeutic target for the treatment of obesity and type 2 diabetes has long been a goal of drug development but achieving the selectivity necessary to demonstrate safety has been a significant hurdle. The new information on the mechanism by which MSI-1436 inhibits PTP-1B supports its first-inclass status... Genaera's Press Release -