ActiveSite Pharmaceuticals : Small Molecule Protease Inhibitor Blocks Retinal Blood Vessel Damage in Rodent Model of Diabetes

March 28, 2011 - ActiveSite Pharmaceuticals, Inc., announced the online publication of a study in the journal Diabetes that describes the effectiveness of its novel plasma kallikrein inhibitor ASP-440 in reducing blood-retinal barrier breakdown in a rodent model of diabetes. Diabetes-induced breakdown of the blood-retinal barrier results in leaky blood vessels in the eye, and the gradual buildup of fluid in the retina from the leakage can result in diabetic macular edema (DME), the primary cause of vision loss in diabetic individuals. DME affects more than 1 million individuals in the U.S. alone, and no FDA-approved medicines are currently available for its treatment.

In the study, co-authored by scientists from the Joslin Diabetes Center, an affiliate of Harvard Medical School, and ActiveSite Pharmaceuticals, the integrity of the blood-retinal barrier in diabetic rats was measured using a well-established technique that measures the leakage of the plasma protein albumin from the vascular compartment into the retina. Compared to non-diabetic healthy rats, diabetic animals demonstrated a 2.6-fold increase in the rate of albumin leakage into the retina. Treatment of diabetic animals with systemically-administered ASP-440 for four weeks reduced the excess rate of albumin leakage by more than 80%, without affecting blood glucose.

ASP-440 was also effective in preventing blood-retinal barrier breakdown in hypertensive rats, reducing excessive albumin leakage into the retina by 90% following systemic treatment for seven days, without affecting blood pressure. Hypertension is a known risk factor for development of DME... ActiveSite Pharmaceuticals' Press Release -

Sirona Biochem : Scale Up of Compounds to Accelerate Development of Diabetes Program

January 12, 2011 – Sirona Biochem Corp. (TSX-V: SBM) (the “Company”), a biotechnology company specializing in carbohydrate-based molecules, including therapeutics for diabetes and obesity, announced it has contracted Roowin to scale up a key intermediate for its lead diabetes drug candidate, a sodium glucose transporter (SGLT) inhibitor. Roowin is a privately owned Contract Research Organization (CRO) headquartered in Paris, France. Its core business is in high value-added fine chemistry. Roowin will bring expanded capabilities to Sirona Biochem’s research and help accelerate the preclinical development of its lead candidate for Type 2 diabetes.



“Recent positive preclinical data of our lead SGLT-2 inhibitor demonstrates that we are on the right track in developing a new Type 2 diabetes treatment and by scaling up this key intermediate we can speed up our preclinical process... Sirona Biochem's Press Release -

The Juvenile Diabetes Research Foundation and Selecta Biosciences : Research Collaboration for Vaccines for Type 1 Diabetes

June 9, 2011 – The Juvenile Diabetes Research Foundation (JDRF) and Selecta Biosciences, Inc. announced that they have established a research collaboration to support Selecta's development of a vaccine technology, which may subsequently help to better treat and potentially prevent type 1 diabetes.

Through the research partnership, JDRF will provide milestone-based financial support and expertise, with the goal of applying Selecta's vaccine technology toward the development of vaccines for type 1 diabetes.

Selecta's vaccine technology would ultimately be applied to create a therapeutic that would halt or prevent the autoimmune response that causes type 1 diabetes. Known as antigen-specific tolerogenic vaccines, these vaccines are designed to specifically stop the autoimmune response that causes the disease without damaging the immune cells that provide protection against infection. Antigen-specific therapies have shown promise to date in animal models of type 1 diabetes.

In addition to their potential in preventing type 1 diabetes, tolerogenic diabetes vaccines could have other benefits. For example, they could be used in conjunction with other therapies to preserve remaining beta cell function in individuals recently diagnosed with type 1 diabetes. This type of vaccine could also help with regeneration and replacement therapies, and be used to protect newly regenerated or transplanted insulin-producing beta cells in established type 1 diabetes. In addition, this class of vaccines may also have applicability for other autoimmune diseases... Selecta Biosciences' Press Release - The Juvenile Diabetes Research Foundation's Press Release -

LCT and Otsuka of Japan : Common DIABECELL ® Vision

April 12, 2011 ― Otsuka Pharmaceutical Factory, Inc. (head office: Naruto City, Tokushima, Japan; President: Ichiro Otsuka) (“OPF”) entered into a share subscription agreement on April 12, 2011 with Living Cell Technologies Limited (head office: Auckland, New Zealand, Managing Director & CEO：Ross Macdonald) (“LCT”) with respect to subscription for LCT’s new shares.
Under the agreement, OPF will invest AUD3 million in LCT for 25 million ordinary shares (A$0.12 per share). This investment will result in OPF holding 8.2% of LCT’s outstanding shares.
In addition to subscription for LCT’s new shares, OPF has earned an exclusive right to negotiate with LCT for research and development toward commercialization of LCT’s pancreatic islet “DIABECELL” and exclusive license and distribution right in Japan and other Asian countries (except for China).

It is OPF’s objective, through obtaining the rights for development and commercialization of this pancreatic islet DIABECELL, to offer additional therapeutic options for patients with diabetes, and to strengthen its R&D in the field of regenerative medicine and further actively expand its business not only in Japan but also on the international stage... [PDF] Otsuka Pharmaceutical Factory's Press Release - [PDF] Living Cell Technologies' Press Release -

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 -

Asante Solutions : CE Mark for Pearl™ Insulin Pump

April 12, 2011 – Asante Solutions, Inc. (Asante), a medical device company focused on diabetes care, announced it received the CE mark for its Pearl Insulin Pump, the only insulin pump that uses a pre-filled insulin cartridge. The CE mark is a European proof of conformity that certifies the product meets EU safety, health and environmental requirements. Asante has begun discussions with potential distribution partners in Europe.
“This important regulatory milestone brings us one step closer to our goal of delivering a sensible solution to the growing but underserved insulin pump market,” said Phil Hopper, Asante CEO and President. “Once available, we believe the small and sleek Pearl will be the simplest-to-operate pump on the market. The Pearl is a fully featured insulin pump addressing the imperatives of safety, reliability, and ease of use required to meet the needs of people with diabetes using intensive insulin therapy.”

The Pearl Insulin Pump is designed to simplify diabetes care for the more than 500,000 people worldwide who use an insulin pump and those considering insulin pump therapy. Unlike the insulin pumps currently available, which require users to manually fill an insulin reservoir using a vial of insulin and syringe, the Pearl Insulin Pump uses a 300-unit, pre-filled insulin cartridge that simplifies the process of loading the pump and filling the infusion set by reducing the number of steps required and thereby creating a less time-consuming and more convenient process... [PDF] Asante Solutions' Press Release -

Diartis Pharmaceuticals : New Biotech Company Will Focus on Clinical Development of Novel Diabetes Drug

February 16, 2011 - INDEX VENTURES AND AMUNIX INVEST IN DIARTIS PHARMACEUTICALS – Diartis Pharmaceuticals, Inc., a newly founded biotechnology company, announced that it has received initial funding from Index Ventures, Amunix Inc., a U.S. based biotechnology company, and private investors. The company has also acquired a clinical-stage diabetes drug candidate from Versartis, Inc., VRS-859 (exenatide-XTEN), and with this initial funding will continue its development for type 2 diabetes mellitus (T2DM).

A Phase 1a multi-center, blinded, placebo-controlled, single-ascending dose study is ongoing to evaluate the safety and ability of VRS-859 to maintain glycemic control for one month in T2DM patients after a single dose. The results of the Phase 1a study are anticipated in Q2 2011. The Phase 1a study will be followed later this year by a repeat dose (3 month) Phase 1b study comparing VRS-859 to Byetta® (exenatide injection) in T2DM patients. VRS-859 is intended as a once-monthly form of the GLP-1 analog, exenatide.

Commenting on the investment, Kevin Johnson, London based partner at Index Ventures said, “We are delighted to invest in Diartis Pharmaceuticals Pharmaceuticals. The company will focus on moving this exciting compound rapidly through early clinical development. Given the dramatic rise in the number of people with type 2 diabetes, there is a significant market need for a longer acting form of the GLP-1 analog exenatide.”... Diartis Pharmaceuticals' Press Release -

Genentech : Second Lucentis Phase III Study Meets Primary Endpoint for Improved Vision in Patients with Diabetic Macular Edema (DME)

March 25, 2011 - -- Results Consistent with Data Released Last Month Showing Patients with DME Who Received Lucentis Achieved Significant Improvement in Vision - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the second of two Phase III trials evaluating Lucentis® (ranibizumab injection) in patients with diabetic macular edema (DME) met its primary endpoint. The primary endpoint of the study, known as RIDE, showed that after 24 months a significantly greater number of patients who received Lucentis, compared to those who received placebo (sham) injections, were able to read at least 15 additional letters on an eye chart than they could at the start of the study. The safety results were consistent with previous Lucentis Phase III trials and no new significant safety findings were observed. Further analyses of the data are ongoing. Topline results from the RIDE study will be presented at the EURETINA Congress in London on May 29, 2011.

DME is an eye condition characterized by swelling of the retina, which can occur in patients with type 1 or type 2 diabetes and can cause blurred vision, severe vision loss and blindness.1 DME is a leading cause of blindness among the working-age population in most developed countries,2 and there are currently no U.S. Food & Drug Administration (FDA) approved medications to treat DME.
"This data adds to the considerable body of clinical evidence showing that patients with DME who received Lucentis had significant improvement in vision," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Lucentis may provide physicians and patients with a potential option for DME, and we look forward to sharing the data from this study and a previous Phase III trial with the FDA and medical community."... Genentech's Press Release -

Mylan Pharmaceuticals : Approval for Generic Version of Precose® Tablets

Jan. 18, 2011 -- Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Acarbose Tablets, 25 mg, 50 mg and 100 mg, the generic version of Bayer's Precose® Tablets, a treatment to be used with diet and exercise to improve glycemic control in adults with type 2 diabetes.

Acarbose Tablets had U.S. sales of approximately $23 million for the 12 months ending Sept. 30, 2010, according to IMS Health. The product is available for immediate shipment.

Currently, Mylan has 169 ANDAs pending FDA approval representing $99.5 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $24 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health... Mylan's Press Release -