Tandem Diabetes Care : FDA Clearance of the t:slim™ Insulin Delivery System

November 16, 2011 - Tandem Diabetes Care Announces FDA Clearance of the t:slim™ Insulin Delivery System -


Smallest Insulin Pump System and First-Ever with a Touch Screen -

Tandem Diabetes Care, Inc. announced that the U.S. Food and Drug Administration has granted the Company clearance to market the t:slim™ Insulin Delivery System.—

Tandem Diabetes Care, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to market the t:slim™ Insulin Delivery System (t:slim). This new full-featured pump is the first-ever with a color touch screen, and is the smallest insulin pump system currently available. The t:slim is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative.

“With the clearance of t:slim, Tandem Diabetes Care has an opportunity to set a new standard in insulin infusion therapy,” said Kim Blickenstaff, president and CEO, Tandem Diabetes Care. “In creating t:slim, we spoke with more than 4,000 healthcare professionals and people with diabetes, and the clear message we heard was, ‘make it cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort.’ The t:slim’s touch screen interface has been proven in extensive user studies to be easy to learn and to use by new and experienced pump users alike.”

Of approximately 1.5 million people in the U.S. with type 1 diabetes,1 industry estimates indicate that only 20 to 30 percent use an insulin pump, despite clinical evidence that pump use can improve glycemic control and quality of life2. Tandem Diabetes Care believes that enhanced ease of use and attractive design will encourage more patients to consider the clinical benefits of insulin pump therapy... Tandem Diabetes Care's Press Release -

Servier : Type 2 Diabetes partnership with Canadian firm Prognomix Inc.

Nov. 8, 2011 - Les Laboratoires Servier, France (Servier) and Prognomix Inc., Canada (Prognomix) announced that they have entered into a research and development agreement aimed at identifying novel targets as part of programs meant to develop innovative type 2 diabetes and metabolic disease treatment.

This collaboration will rest on the discovery platform developed by Prognomix. This platform comprises genomic and bioinformatic technologies, a database of phenotypic and genotypic data and an assembly of results of the analysis of these data that are at the foundation of a knowledge base that will be exploited by the partners. This knowledge base was developed using, among other, the data collected during ADVANCE, the largest clinical study ever conducted on Type 2 diabetes and of which Servier was the main sponsor.

As part of the agreement, Servier will make a contract signature fee payment and will be granted options to obtain rights to use the results of the collaboration.

According to Dr. Pavel Hamet, President of Prognomix, « Closing of this agreement represents an important step in the development of Prognomix and confirms the value of the knowledge base that we have developed. We are happy to initiate this collaboration with Servier, a well known and very innovative pharmaceutical company and we are excited by the opportunities it represents ».

According to Dr. Emmanuel Canet, President of Research and Development at Servier, « This partnership confirms Servier interest for well validated biomarkers, allowing for the identification of the patients who will benefit the most from Servier therapeutic innovations »... [PDF] Prognomix's Press Release - Servier's Press Releases -

Poxel : New Clinical Results for an Anti-Diabetic Compound in Development

LYON, FRANCE - Oct. 26, 2011 - Poxel's Novel Compound Imeglimin Shows Significant Benefits in Type 2 Diabetes When Added to Metformin -

Poxel SA announced that Imeglimin, a novel compound in development for Type 2 diabetes, showed incremental efficacy as an add-on therapy to metformin, the reference first-line treatment, in patients inadequately controlled by metformin monotherapy. The study achieved its primary endpoint of superiority in HbA1c reduction versus placebo (p<0.001), and the decrease in FPG (Fasting Plasma Glucose) was also statistically significant (p<0.001). Reduction in HbA1c and FPG are two important measure of diabetes control.

Data from this Phase II trial assessing the clinical benefit of adding imeglimin to metformin demonstrate that in 12 weeks, patients in the imeglimin-metformin treatment group experience a -0.65 % reduction in HbA1c versus baseline. Moreover, the initial results indicated a trend towards reduced BMI (body mass index) and waist circumference, further indications of diabetes control. The overall safety and tolerability profile in the Imeglimin-metformin group was good.

Professor Valdis Pirags, Principal Investigator, commented, "I am pleased to see how positive these findings are. The results are exciting and we wait to further contribute to the development of this compound."

"The results from this add-on study are extremely encouraging, and I am confident that further development trials will reinforce the conclusion that Imeglimin is a safe and efficacious treatment option for diabetic people. There is still a need for new medications to control their disease," said Professor Harold Lebovitz, a distinguished member of Poxel's scientific advisory board... [PDF] Poxel's Press Release -

Boston Therapeutics : to Start Clinical Trial in Type 2 Diabetes

October 11, 2011 - Boston Therapeutics, Inc., a public company registered with the SEC and a developer of diabetes therapeutics, announced the initiation of its first clinical trial to evaluate the Safety and Efficacy of PAZ320 when added to oral agents or Insulin regimen in Patients with Type 2 Diabetes Mellitus.

“We have already seen significant reduction of post-meal elevation of glucose in preclinical models with PAZ320,” said David Platt, Ph.D., Chief Executive Officer of Boston Therapeutics. “We are excited about our collaboration with Endocrinologist Sushela Chaidarun, M.D., Ph.D. and Dr. Laura E. Trask at Dartmouth Hitchcock Medical Center and the possibility to help millions of people with high blood sugar and diabetes.” 

PAZ320 is a chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. It is a proprietary polysaccharide designed to be taken before meals and works in the gastrointestinal system to block the action of carbohydrate-hydrolyzing enzymes which break down carbohydrates into glucose and release it into the bloodstream. This clinical study will evaluate the safety and efficacy of PAZ320 when added to oral diabetes agents or insulin. The study population will consist of adults aged 18-75 years with Type 2 diabetes, either on oral agents or insulin with a BMI of 25-35 kg/m2 and with A1c of less than 9.0%... [PDF] Boston Therapeutics' Press Release -

Merck : FDA Approves Merck's JUVISYNC™ (sitagliptin and simvastatin) Tablets, a Once-Daily Therapy for Patients with Type 2 Diabetes Who Need to Lower Blood Sugar and Cholesterol, Known Risk Factors for Cardiovascular Disease

Oct. 7, 2011 - Multiple National Guidelines Recommend that Patients with Type 2 Diabetes be Treated for Cholesterol - Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved JUVISYNC™ (sitagliptin and simvastatin), a new treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of JANUVIA® (sitagliptin), with the cholesterol-lowering medication ZOCOR® (simvastatin). JUVISYNC is the first treatment option for healthcare providers to help patients who need the blood sugar-lowering benefits of a DPP-4 inhibitor and the cholesterol-lowering benefits of simvastatin, with the convenience of a single tablet once daily. "Although clinical guidelines put people with type 2 diabetes who need glycemic and lipid therapy at the same risk level as those with coronary heart disease, nearly 40 percent of eligible patients do not receive statin treatment," said Barry J. Goldstein, M.D., Ph.D., vice president, Diabetes and Endocrinology, Merck. "We are proud to bring forward a treatment option that can help these patients who need both glycemic and lipid therapy."

Indications and usage for JUVISYNC

JUVISYNC is indicated in patients for whom treatment with both sitagliptin and simvastatin is appropriate. Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet... Merck' s Press Release -

Furiex Pharmaceuticals Confirms Takeda Launches LIOVEL® LD and LIOVEL® HD, a Fixed Dose Combination of NESINA® and ACTOS® for Type 2 Diabetes in Japan

September 20, 2011 - Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) confirmed that Takeda Pharmaceutical Company Limited ("Takeda") has launched two dosages of LIOVEL®, a fixed dose combination tablet of NESINA® (alogliptin) and ACTOS® (pioglitazone HCL), in Japan for the treatment of Type 2 diabetes.

Furiex developed NESINA, which is a member of the dipeptidyl peptidase IV (DPP-4) inhibitor class, in collaboration with Takeda's wholly-owned subsidiary, Takeda San Diego, Inc. LIOVEL LD and LIOVEL HD contain 25 mg alogliptin/15 mg pioglitazone and 25 mg alogliptin/30 mg pioglitazone, respectively.

"We are very pleased with Takeda's launch of LIOVEL in Japan, a new product using the drug NESINA," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "This launch adds to Furiex's revenue stream and confirms our strategy of partnering drug candidates in return for royalty payments." 

Under Furiex's agreement with Takeda, this launch does not trigger a milestone payment to Furiex. However, Furiex is entitled to receive royalty payments on sales of LIOVEL... Furiex Pharmaceuticals' Press Release - Takeda Pharmaceutical's Press Release -

Bristol-Myers Squibb and Ambrx : Collaboration for Novel Biologics Programs in Diabetes and Heart Failure

September 22, 2011 - Bristol-Myers Squibb Company (NYSE: BMY) and Ambrx, Inc. announced a collaboration under which Bristol-Myers Squibb will receive exclusive worldwide rights to research, develop and commercialize biologics based on Ambrx’s research surrounding the Fibroblast Growth Factor 21 (FGF-21) protein, for potential use in treating type 2 diabetes, and the Relaxin hormone, for potential use in treating heart failure. Derivatives of FGF-21 and Relaxin were developed using Ambrx’s unique ReCODE™ platform technology to modify the native proteins with amino acid building blocks beyond the common 20 to engineer enhanced versions for investigation for therapeutic use.

Under the terms of the agreement, Bristol-Myers Squibb will make an upfront payment of $24 million to Ambrx. In addition, Bristol-Myers Squibb will make potential milestone payments and royalty payments on worldwide sales for both programs. Bristol-Myers Squibb and Ambrx will also enter research collaborations for both programs.

FGF-21 is a naturally occurring protein that has been characterized as a potent metabolic regulator, and has been shown to lower blood glucose, elevate good cholesterol and promote weight loss in preclinical studies. The lead compound in this program, ARX618, or PEG-FGF-21, is in the final stages of preclinical development.

Relaxin is a naturally occurring hormone known for its role in pregnancy and childbirth. Preclinical studies suggest Relaxin may aid in the treatment of heart failure by improving cardiac function. This program is in preclinical development... Bristol-Myers Squibb's Press Release - Ambrx's Press Release -

Kuros : Patient Recruitment in a Phase IIb Clinical Trial With KUR-211 for Diabetic Foot Ulcers

01.09.2011 - Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced that it has completed recruitment in a Phase IIb clinical trial designed to investigate KUR-211 (Viz.I-020201) in the treatment of diabetic foot ulcers.

 This Phase IIb clinical trial is a randomised, multi-center, controlled, parallel group dose-finding study to evaluate the efficacy and safety of KUR-211 used as an adjunct to standard of care in patients with diabetic foot ulcers. KUR-211 is a bioactive therapy intended for topical treatment of diabetic foot ulcers, stimulating the granulation tissue formation, that aids wound closure. The study evaluates the effects of KUR-211 applied twice a week for maximum 16 weeks in addition to standard of care versus standard of care (SOC) alone.

 KUR-211 consists of a modified variant of platelet-derived growth factor (PDGF) incorporated into a fibrin sealant and is applied to the wound as a foam. The innovative Kuros "TG-hook" technology enables the PDGF to be retained at the site for local exposure to migrating cells and for sustained delivery of PDGF on enzymatic cleavage of the matrix. It is believed that this novel approach may improve the frequency and speed of healing... [PDF] Kuros Biosurgery's Press Release -

KalVista Pharmaceuticals Launched with £8 Million in Series A Funding to Develop Novel Class of Drugs for Diabetic Macular Edema

23 August 2011 – KalVista Pharmaceuticals (“KalVista”), a new ophthalmology company with a focus on diabetic macular edema (DME), has raised £8 million in a series A round from leading life sciences investors Novo A/S and SV Life Sciences. The Company is developing novel, small molecule plasma kallikrein inhibitors, which represent a new approach to the treatment of DME, a leading cause of adult visual loss in developed countries and a major unmet medical need. KalVista’s advanced pre-clinical product pipeline is targeting both intravitreal injection and oral administration routes. KalVista acquired these inhibitors plus all relevant intellectual property from Vantia Therapeutics.

KalVista’s scientific founders include world-leading experts in ophthalmology, diabetes and diabetes-related complications, Dr Lloyd Paul Aiello and Dr Edward P. Feener. Dr Aiello is Professor of Ophthalmology at Harvard Medical School, Director of the Joslin’s Beetham Eye Institute and Inaugural Chair of the National Eye Institute Diabetic Retinopathy Clinical Research Network. Dr Feener is Associate Professor of Medicine at Harvard Medical School and an Investigator in Vascular Cell Biology at the Joslin Diabetes Center, where his team led the discovery of plasma kallikrein in the vitreous fluid from people with DME and has shown that inhibition of plasma kallikrein decreases pathological retinal vascular permeability in pre-clinical studies. Dr Aiello has guided the clinical development programs for a wide range of recent ophthalmology drugs, and has been a lead investigator in the trials determining the benefit of VEGF (vascular endothelial growth factor) inhibitors for the treatment of DME... KalVista Pharmaceuticals' Press Release -

Lpath Addresses Diabetic Neuropathic Pain With Financial Support by National Institutes of Health

Aug 15, 2011 - Lpath to Conduct In Vivo Studies in Diabetic Neuropathy With Lpathomab(TM), Its Monoclonal Antibody Against Lysophosphatidic Acid (LPA) -- Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based therapeutics, announced the Type 1 Diabetes Preclinical Testing Program of the National Institutes of Health (NIH) will provide financial support for the further study of Lpathomab's efficacy in animal models of disease, particularly diabetic neuropathy.

"Bristol Myers Squibb's recent $325 million acquisition of Amira, whose lead program is an LPA-receptor antagonist with Phase 1 results, underscores the potential value of a compound that neutralizes the LPA signaling pathway," said Lpath's CEO Scott Pancoast. "With assistance from the NIH for neuropathic pain and from various partners/collaborators for other central-nervous-system disorders and for fibrosis, we believe we can generate compelling data that validates Lpath's unique approach to neutralizing LPA with Lpathomab." As a monoclonal antibody, Lpathomab functions like a 'molecular sponge' that binds to and neutralizes the bioactive lipid signaling molecule, lysophosphatidic acid (LPA), thus silencing LPA receptors associated with the transmission of pain through the nervous system. Lpathomab was generated using Lpath's proprietary ImmuneY2(TM) technology... Lpath's Press Release -

Telcare : First-in-class mHealth Connected Glucose Meter Cleared by FDA

August 03, 2011 - Telcare, Inc., an exhibitor at this year’s annual meeting of the American Association of Diabetes Educators, has just received clearance from the US Food and Drug Administration to market the Telcare BGM, the first cellular-enabled glucose meter, combined with an FDA-cleared database (Telserve) to aid in the management of diabetes. The device allows patients to transmit their blood glucose readings to caregivers and family members, and receive immediate coaching and clinical feedback relayed to the screen of the glucose meter. The patient does not have to take any additional steps to transmit the data and the cost of the wireless connectivity is included in the price of the device and its accompanying test strips. Thus, users will have a much richer clinical experience at no additional cost when compared to standard glucose meters.
Telcare’s objective is to transform the management of diabetes, from a condition where patients feel cut off from their caregivers and don’t know what to do from day to day, to a model in which the patient is continually empowered to manage his or her condition through continual feedback from caregivers, family members, and even other patients.
The Telcare glucose meter aims to bridge the last mile between patient and caregiver. Real time information is transmitted to the electronic medical record, personal health records, such as Microsoft HealthVault, and a variety of smartphone apps designed to connect patients to family members and to each other. While other marketplace solutions have relied on Bluetooth transmission to cellphones, connections of glucose meters to personal computers and cradles, or requiring the patient to manually enter results into a phone app, Telcare’s solution requires no additional steps on the part of the patient... Telcare’s Press Release -