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 -

Emisphere Technologies : Data From Independent Clinical Study of Effects of Oral GLP-1 on Glucose and Insulin Concentrations

July 8, 2008 - GLP-1 Has Potential to Treat Type 2 Diabetes Using Emisphere's Eligen(R) Technology - Emisphere Technologies, Inc. (Nasdaq: EMIS) announced findings from a clinical study assessing the oral delivery of GLP-1 peptide safely and effectively. The study used a delivery-agent-based approach using Emisphere's Eligen(R) technology, and was conducted at University Hospital in Basel, Switzerland by Christoph Beglinger, M.D., of the Clinical Research Center, Department of Biomedicine Division of Gastroenterology, and Department of Clinical Pharmacology and Toxicology at the hospital.

Prof. Beglinger's study, conducted in 16 healthy male subjects, was designed to explore the pharmacodynamic effects of a single oral dose of GLP-1 administered 15 minutes prior to an oral glucose tolerance test.

For the study, GLP-1 was formulated as a tablet with Emisphere's delivery agent known as SNAC. This was Prof. Beglinger's second clinical study of the compound, and it confirmed his earlier results that SNAC allows for rapid oral absorption of GLP-1. Prof. Beglinger's study also showed that pharmacological levels were achieved after a 2 mg oral dose. The study demonstrated that the oral formulation of GLP-1 stimulated an early increase in fasting insulin and a decrease in fasting glucose as compared to placebo... Emisphere Technologies' Press Release -

Animas Corporation : OneTouch Ping Glucose Management System Cleared by FDA

July 1, 2008 – Animas Corporation announced the clearance of its OneTouch® Ping™ Glucose Management System by the U.S. Food and Drug Administration (FDA). OneTouch Ping is the first full-feature insulin pump that wirelessly communicates with a blood glucose meter-remote. Using the OneTouch Ping meter-remote, a person can calculate insulin doses and opt to wirelessly instruct the pump to deliver them without touching the pump at all, giving patients more freedom and flexibility in using their insulin pump... Animas Corporation's Press Release -

Echo Therapeutics : Clinical Study of Its Symphony™ Transdermal Continuous Glucose Monitoring System in Patients with Type 1 and Type 2 Diabetes

July 1, 2008 – Echo Therapeutics, Inc. (OTCBB: ECTE) announced that it has initiated a clinical study of its Symphony™ Transdermal Continuous Glucose Monitoring System (tCGM System) in patients with Type 1 and Type 2 diabetes. The Company expects to complete and announce the results of the study in the third quarter of 2008. Echo’s non-invasive Symphony tCGM System consists of its Prelude™ SkinPrep System, which incorporates patented and leading-edge skin permeation control technology, and wireless transmission and proprietary transdermal biosensor technologies. Echo’s Symphony tCGM System is designed to provide both diabetes and hospital patients with a reliable, needle-free, easy-to-use, affordable and comfortable-to-wear continuous glucose monitoring device... [PDF] Echo Therapeutics' Press Release -

BodyTel : to Launch GlucoTel System in August

July 8, 2008 - BodyTel Scientific Inc. (OTCBB:BDYT), a developer and manufacturer of wireless telemedical systems, announces that it has finalized the mass production of all GlucoTel Starter Kit components including GlucoTel Blood Glucose Test Strips and is now preparing the kitting of its first market ready product. After having obtained CE approval on May 28th 2008, BodyTel has already commenced supplies of its innovative blood glucose monitoring and management system GlucoTel to selected partners in CE sensitive countries. GlucoTel will be commercially available in Germany, the Netherlands and the United Arab Emirates (U.A.E.) by August 18th... BodyTel Scientific's Press Release -

Axis-Shield : AFINION HbA1c patent granted in USA

27 June, 2008: Axis-Shield (LSE:ASD, OSE:ASD), the international in-vitro diagnostics company, announces that it has received notice of approval of its US patent application governing the measuring methodology for HbA1c within the Afinion™ cassette for detection of this important marker of diabetic patient compliance. The patent protects technology which improves HbA1c stability, precision and accuracy and has resulted in a longer product shelf-life with improved performance. The invention may also have utility for the well-established NycoCard™ product for the same marker... Axis-Shield's Press Release -

AgaMatrix : New WaveSense Presto and Pro Glucose Meters to Simplify Testing

June 6, 2008 – The makers of the WaveSense™ line of blood glucose monitoring products (AgaMatrix, Inc.) announce the launch of the WaveSense Presto and WaveSense KeyNote Pro Blood Glucose Monitoring Systems (BGMS). The Presto is a no code meter with premium features that consumers can buy at a value price. The Pro is designed for use in institutional settings with added features for increased safety.
The Presto has all the market-leading features of AgaMatrix’s first product, the WaveSense KeyNote®, but does not require coding and is priced considerably less than no code products from the major brands. The system also has improved ergonomics and a brighter backlit display. Like the KeyNote, it requires a small sample size (0.5µl), is As Fast As 1-2-3®, and has alternate site testing. Presto builds on the existing base of WaveSense customers that is expected to exceed 1,000,000 by this fall... AgaMatrix's Press Release -

ARKRAY USA : National Launch of GLUCOCARD X-METER

June 16, 2008 - ARKRAY USA, Inc. nationally launched GLUCOCARD™ X-METER Blood Glucose Monitoring System at the ADA (American Diabetes Association) annual meeting June 7, 2008. GLUCOCARD™ X-METER is well-received internationally and has been cleared by the FDA for sale in the U.S.
GLUCOCARD™ X-METER
This intuitive system requires no coding, displays results in 5 seconds, requires a tiny 0.3 µL sample size, and has a 360-count test memory with time and date stamp. The choice of palm, forearm, upper arm or fingertip testing, combined with the ability to reapply blood within 10 seconds if the first drop is too small (double dosing), makes testing simple and accommodating. It also features a large, easy-to-read display for better viewing of test results. The GLUCOCARD™ X- METER is distinguished by its leading edge design and technology. "The diabetes community has never seen such a sleek meter with all the necessary features. We have received tremendous feedback on how discreet the GLUCOCARD™ X-METER is. It is not your ordinary meter... ARKRAY's Press Release -

Georgetown University Teams with Gentag and SAIC : to Develop New Glucose Sensor Technology with Wireless Connection to Cell Phones,No More Needles?

June 18, 2008 - Georgetown University, Gentag,Inc., and Science Applications International Corporation (SAIC, NYSE: SAI), have combined forces to develop a non-invasive method for glucose measurement. The three technology leaders agreed to combine their respective intellectual property (IP) and expertise to create a new method to monitor glucose, using disposable skin patches with wireless sensors and cell phones.
The resulting products could eliminate the need for finger pricking with lancets to draw blood for people of all ages with diabetes... Georgetown University's Press Release -

Emisphere : License Agreement With Novo Nordisk to Develop Oral Formulation of GLP-1 Receptor Agonists for Diabetes

June 23, 2008 - Emisphere Technologies, Inc. (Nasdaq: EMIS) and Novo Nordisk A/S (NYSE: NVO) have entered into an exclusive Development and License Agreement to develop and commercialize oral formulations of Novo Nordisk's proprietary GLP-1 receptor agonists, which have the potential of treating Type 2 diabetes, using Emisphere's eligen(R) technology. The agreement includes at least $87 million in product development and sales milestone payments to Emisphere, of which $10 million will be the minimum first year payment, as well as royalties on sales. The agreement also provides Novo Nordisk with the option to develop oral formulations of Novo Nordisk compounds other than GLP-1 receptor agonists using Emisphere's proprietary carrier technology. Further financial details of the agreement were not made public.

Under the new agreement, Novo Nordisk is responsible for the development and commercialization of the product candidates. Novo Nordisk and Emisphere have collaborated since 2007 on early-stage pre-clinical research that has preliminarily confirmed the utility of Emisphere's carriers to provide bioavailable oral formulations of GLP-1 receptor agonists... Emisphere Technologies' Press Release -

Debiotech and STMicroelectronics : First Prototypes of Disposable Insulin Nanopump

June 23, 2008 – Debiotech and STMicroelectronics (NYSE: STM) introduced first evaluation prototypes of a unique miniaturized insulin-delivery pump. The tiny device can be mounted on a disposable skin patch to provide continuous insulin infusion, enabling substantial advancements in the availability, treatment efficiency and the quality of life of diabetes patients. The breakthrough Nanopump, which relies on microfluidic MEMS (Micro-Electro-Mechanical System) technology, has successfully passed initial testing stages and is now ready to enter volume manufacturing.
The highly miniaturized disposable insulin pump combines Debiotech’s expertise in insulin delivery systems with ST’s strengths in manufacturing high-volume silicon-based microfluidic devices. The Nanopump is less than one fourth the size of existing insulin-pump devices and can be worn as a nearly invisible patch on the skin... Debiotech's Press Release - STMicroelectronics's Press Release -

Abbott : Phase III Sub-Group Analysis Shows Investigational TriLipix™ in Combination with CRESTOR Improves Key Lipids in Patients with Mixed ...

June 7, 2008 — New data from a sub-group analysis of patients with mixed dyslipidemia and type 2 diabetes that were enrolled in a Phase III study showed that the use of Abbott's (NYSE: ABT) investigational TriLipix™ (ABT-335) in combination with AstraZeneca's CRESTOR® (rosuvastatin calcium), demonstrated similar improvements in LDL "bad" cholesterol, HDL "good" cholesterol and triglycerides compared to the overall study population. These data were presented at the American Diabetes Association's (ADA) 68^th Annual Scientific Sessions in San Francisco.

Abbott evaluated the efficacy and safety of TriLipix in combination with rosuvastatin in a Phase III study of more than 1,400 patients with mixed dyslipidemia. This study, presented at the National Lipid Association annual meeting on May 31, 2008, met its primary endpoints. TriLipix in combination with rosuvastatin significantly improved HDL and triglycerides compared to rosuvastatin alone, and significantly improved LDL compared to TriLipix alone.

Of the patients enrolled in this study, a sub-group of 276 patients were identified as having type 2 diabetes... Abbott's Press Release -

ProStrakan : Novel Testosterone Gel Significantly Improves Insulin Sensitivity and Sexual Function in Hypogonadal Men with Type 2 Diabetes and ...

June 17, 2008 - New data from a 12-month, international, multi-center study showed that treatment for low testosterone with Tostran(R), a topical, metered dose 2% testosterone gel, significantly improves insulin sensitivity and sexual function among hypogonadal men with Type 2 diabetes and/or Metabolic Syndrome. These data were presented at the Endocrine Society's 90th Annual Meeting in San Francisco. Tostran, also marketed as Fortigel, Tostrex and Itnogen, is available in 13 countries across Europe, and ProStrakan (LSE: PSK), an international specialty pharmaceutical company, plans to file Tostran with U.S. regulatory authorities later this year.
The Testosterone replacement In hypogonadal men with either MEtabolic Syndrome or type 2 diabetes (TIMES 2) study looked at the effects of Tostran on insulin resistance, diabetic control, lipids, quality of life and symptoms of hypogonadism... [PDF] ProStrakan's Press Release -

Isis : Robust Drug Portfolio for Diabetes and Obesity at ADA Conference

June 10, 2008 - Oral presentation on the potent blood glucose lowering effect of SGLT2 antisense inhibitors in multiple preclinical models - Eight additional presentations highlight significant activity in eight new metabolic disease targets utilizing antisense - Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced the presentation of new preclinical data showing that antisense drugs potently reduce levels of sodium dependent glucose transporter type 2 (SGLT2), a key component in controlling glucose re-absorption in the kidney and the target of ISIS 388626. In addition, Isis presented results from eight research programs on novel targets that offer new mechanisms to treat metabolic diseases. The nine presentations (including two late-breaking abstracts) were presented during the American Diabetes Association's (ADA) 68th Scientific Sessions in San Francisco by Isis and its collaborators.
...

The presentation titled "Long Term Safety and Efficacy of ISIS 388626, an Optimized SGLT2 Antisense Inhibitor, in Multiple Diabetic and Euglycemic Species," showed that antisense reduction of SGLT2 produced the following results in preclinical models:

    --  Lowered HbA1c, a measure of average blood glucose over time in
     diabetic animals, and reduced fed and fasted blood glucose levels,
     while also ameliorating diabetic complications, including slowing
     progression of cataract formation.
 --  Lowered SGLT2 mRNA levels in the kidney by approximately 80% in all
     species tested, with doses as low as 1-2 mg/kg/week with no effect on
     SGLT1, a related protein, where levels of activity is desirable.
 --  Showed no changes in urinary or plasma markers of renal function and
     no harmful effects such as low blood glucose.
... Isis Pharmaceuticals' Press Release -

Sangamo BioSciences : Presentation of Phase 1b ZFP Therapeutic Data at American Diabetes Association Meeting

June 8, 2008 - Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced the presentation of encouraging Phase 1b clinical data from its ZFP Therapeutic(TM) program at the 68th Scientific Sessions of the American Diabetes Association (ADA). As disclosed in an oral presentation entitled, "Evidence of Neuroregeneration Using Vascular Endothelial Growth Factor (VEGF) Zinc Finger Protein Activator (SB-509) in Diabetic Neuropathy: A Chronic Degenerative Polyneuropathy," results of Sangamo's Phase 1b clinical trial (SB-509-401) demonstrated statistically significant improvements in measurements of nerve health and function in subjects with diabetic neuropathy... Sangamo BioSciences' Press Release -

HemoCue : First FDA CLIA Waiver in Diagnostics Industry for Quantitative Point-of-Care Test for Microalbuminuria, a Kidney and Cardiovascular Disease

June 18, 2008 - HemoCue(R) AB, a global point-of-care diagnostic test manufacturer and wholly owned subsidiary of Quest Diagnostics Incorporated (NYSE: DGX), announced that its HemoCue Albumin 201 System is the first quantitative point-of-care test for screening for, diagnosing and monitoring microalbuminuria to be granted a CLIA waiver by the U.S. Food and Drug Administration (FDA). With the FDA CLIA waiver, non-laboratory trained physicians and other health care professionals in any health care facility with a CLIA Certificate of Waiver in the U.S. will be able to use the HemoCue Albumin 201 System to screen patients for microalbuminuria and begin treatment based on the test's results during a single office visit.


Microalbuminuria may indicate the presence of chronic kidney disease (CKD), a life-threatening condition that affects approximately 26 million Americans. Diabetes and hypertension are the two leading risk factors for developing CKD. Microalbuminuria also is an independent risk factor for developing cardiovascular disease in patients with or without diabetes or hypertension... Quest Diagnostics' Press Release -