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 -

Echo Therapeutics : Symphony tCGM Demonstration Video

Aug. 9, 2011 - Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing the Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude™ SkinPrep System for transdermal drug delivery, announced the unveiling of a much anticipated demonstration video on the Company's website. The new video showcases the features and ease of use of the Symphony continuous glucose monitoring system in a home setting. The Company has released this demonstration video as a result of increasing demands from patients and investors for information regarding how the Symphony tCGM System works.

The launch of the video coincides with the final steps in the planning and preparation of the upcoming clinical study testing the next generation Symphony tCGM System design, which will commence in the near-term... Echo Therapeutics' Press Release -

Amarantus BioSciences and Generex Biotechnology : Collaboration on Cell Therapy for Late Stage Diabetes

Aug. 4, 2011 - Amarantus BioSciences (OTCBB: AMBS), a biotechnology company developing a first-in-class anti-apoptosis therapeutic protein known as MANF, and Generex Biotechnology Corporation (OTCBB: GNBT), a biotechnology company developing a buccal insulin spray technology known as Generex Oral-lyn™, currently in a Phase III trial, are making public the details of their intended third joint diabetes research collaboration. In this third research project, the companies will use Amarantus' proprietary PhenoGuard cell immortalization process to develop beta cell replacement therapies to aid diabetes therapy. The two companies are currently planning to develop a MANF-based diagnostic test to identify a sub-population at risk of developing Type 1 or Type 2 diabetes as well as a MANF-based therapeutic to be administered using the RapidMist™ delivery system for the treatment of diabetes and impaired glucose tolerance.


"The potential of Amarantus' proprietary PhenoGuard cell immortalization process to create a stable source of representative beta cells that can be used in cell replacement therapy in patients who have lost virtually all beta cell function represents a potential major breakthrough for the treatment of chronic, late-stage diabetes," said Dr. James Anderson, Senior Scientific Advisor and Director of Generex. "Patients whose beta cell function is most impaired are the ones most at-risk of developing life-threatening complications of diabetes. Beta cell replacement therapy taken together with the development of a diagnostic test able to track the progression of beta cell dysfunction, and the ability to administer MANF prophylactically and therapeutically to alter the course of beta cell apoptosis and dysfunction in patients with diabetes and pre-diabetes disorders, these three research collaboration programs represent major research and development initiatives that could dramatically alter the course of treatment in the diabetes space. The breadth and scope of this research collaboration provides Generex with an incredible opportunity to position itself as a long-term market leader in the treatment of diabetes-related metabolic disorders."... [PDF] Amarantus BioSciences' Press Release - Generex Biotechnology 's Press Release -

Axxam and Polyphor : Research Partnership for the Treatment of Type-2 Diabetes Funded by the EU

July 27, 2011 - The partnership between Axxam Spa and Polyphor Ltd receives a three-year EU grant under the Eurostars Program for the generation of innovative GLP-1R modulators - Axxam Spa and Polyphor Ltd announced a joint discovery research project for the generation of GLP-1R modulators. The partnership will receive funding from the EU as part of the Eurostars Program aimed at supporting innovation within the European Union.
The two companies will undertake a three-year research project with the objective of identifying and developing different classes of molecules as novel therapeutic agents to modulate the activity of the Glucagon-like-peptide 1 receptor (GLP-1R) for the treatment of Type-2 Diabetes.

“Axxam has developed several innovative technologies for drug discovery research of GPCRs including new functional readout systems, like Photina® and chAMPion that set the ground to develop smart screening assays for the identification of GLP-1R modulators,” said Dr. Chiara Liberati, Head of Discovery at Axxam.
Tailored functional assays will be developed to address the different mode of actions offered by the GLP-1R pharmacology like agonists, allosteric modulators as well as molecules reducing receptor desensitization and internalization.
“Polyphor’s innovative technology platforms, PEMfinder® and MacroFinder®, have proven to generate promising PEMdrug candidates and highly potent and selective novel molecular entities, even on challenging biological targets such as protein-protein interactions, GPCRs, ionchannels and the like... [PDF] Axxam's Press Release - [PDF] Polyphor's Press Release -

Eli Lilly India and Lupin : Strategic Collaboration to Help Fight the Battle Against Diabetes

July 29, 2011 - Eli Lilly India (Lilly) and Lupin Limited (Lupin)announced they have entered into a strategic collaboration to promote and distribute Lilly's Huminsulin range of products, including Huminsulin R(TM), Huminsulin NPH(TM), Huminsulin 50/50(TM), Huminsulin 30/70(TM) and Humapen Ergo II. Lupin's India formulations business will promote and distribute the range of products in India and Nepal, virtually doubling the number of sales representatives behind the diabetes care product. This collaboration will double the current customer base; approximately 45,000 doctors will now be called on as a result of the new partnership.

For Lilly, a company whose history in insulin production dates to 1923, caring for diabetes patients in India is clearly a priority. The country has an estimated 51 million people with diabetes currently and will have an estimated 85 million by 2030, or nearly one-fifth of all patients with diabetes globally. Lilly hopes to increase access to Huminsulin(TM) products through its relationship with Lupin India, bringing one of the most basic and proven therapies for diabetes treatment to more patients.

Lupin's India formulation business will deploy a sales force of medical representatives to provide education and resources to physicians and patients. Lupin has a vibrant presence in the Indian pharmaceuticals market and has over the past several years made major strides in expanding its therapy portfolio. Lupin has a robust promotion and distribution setup along with a strong presence in various therapeutic areas, including the fast growing diabetes market. This strategic collaboration will achieve major synergy arising from the strength of the product portfolio of Lilly and the promotion and distribution capabilities of Lupin... Eli Lilly's Press Release - Lupin's Press Release -

Concert Pharmaceuticals : Advancement of Novel Drug Candidates in Kidney Disease and Spasticity

June 20 , 2011 - Concert Pharmaceuticals, Inc. announced the advancement of two programs from its DCE Platform™ (deuterated chemical entity platform). CTP-499 is progressing into Phase 2 clinical trials for diabetic nephropathy and C-21191 has been selected as a lead candidate for spasticity.

CTP-499 is a novel anti-inflammatory, anti-oxidant and anti-fibrotic agent that Concert is developing for the potential treatment of diabetic nephropathy associated with chronic kidney disease (CKD). The company has successfully completed two Phase 1 clinical trials and expects to report results at a future scientific meeting. Concert intends to advance the CTP-499 clinical program into an approximately 170 patient Phase 2 proof-of-concept clinical study by year-end.

Concert also announced that C-21191 has been selected as a lead candidate. C-21191 is a non-sedating subtype-selective GABAA modulator that represents a new therapeutic modality for the potential treatment of spasticity, neuropathic pain and anxiety. Recently, the U.S. Patent and Trademark Office issued a notice of allowance for Concert’s patent application claiming C-21191 and other deuterium-containing GABAA modulators as novel compositions of matter. Concert expects to complete preclinical dose ranging studies during 2011 to support the potential advancement of C-21191 into human clinical testing... Concert Pharmaceuticals' Press Release -

Regeneron and Bayer HealthCare : Start of Phase 3 Clinical Program in Diabetic Macular Edema

April 8, 2011 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare announced that they have initiated the first of two Phase 3 clinical trials evaluating the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution), an investigational new agent for the treatment of certain eye diseases, in the treatment of Diabetic Macular Edema (DME). The companies are extending their development program for VEGF Trap-Eye in DME after promising results in the global Phase 2 DME program.

The first Phase 3 trial in DME, named VIVID-DME, is being led by Bayer HealthCare and has started in Australia. The trial will also be conducted in Europe and Japan. A second study led by Regeneron, named VISTA-DME, is expected to begin later in 2011 in the United States, Canada, and other countries.


"Clinically significant DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes," said Dr. Kemal Malik, Head of Global Development and member of the Bayer HealthCare Executive Committee. "After reporting positive results from our global Phase 3 program (VIEW 1 and VIEW 2 studies) for the treatment of the neovascular form of age-related macular degeneration (wet AMD), we are pleased to start a Phase 3 program with VEGF Trap-Eye in DME which may help to address this significant unmet medical need."

The Phase 3 program in DME expands the companies' global development collaboration for VEGF Trap-Eye. The companies announced positive data for two Phase 3 studies in patients with wet AMD in November 2010 and for the first of two Phase 3 studies in patients with Central Retinal Vein Occlusion (CRVO) in December 2010... Regeneron Pharmaceuticals's Press Release - Bayer HealthCare's Press Release -

Arcion Therapeutics : data from the Phase 2b trial of ARC-4558 for the treatment of pain associated with painful diabetic neuropathy (PDN)

June 14, 2011 -...Arcion previously announced positive top-line results from a Phase 2b double-blind, randomized, placebo-controlled clinical trial of ARC-4558 in adult patients with PDN. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to ARC-4558 for the treatment of pain associated with PDN. The Company also held an End of Phase 2 meeting with the FDA and the ARC-4558 program is now poised to enter Phase 3 studies.

About ARC-4558

ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride (HCL) for topical administration to the painful area in order to manage the neuropathic pain associated with painful diabetic neuropathy (PDN). Topical clonidine, through its agonist effects on (a2)-adrenergic receptors, is believed to reduce pain in PDN via local actions on the nociceptors that innervate the affected skin. Based on the results of clinical trials to-date, Arcion believes that ARC-4558 has a level of efficacy comparable to systemic therapies in the target population, but with substantially fewer side effects. The 0.1% gel formulation avoids the treatment area limitations and undesirable aesthetic and skin reaction issues associated with analgesic patches. Furthermore, the ARC-4558 gel has been shown to provide analgesia without numbing or anesthetizing the skin... [PDF] Arcion Therapeutics' Press Release -

Cebix : Long-Acting C-Peptide Ersatta Has Potential in Multiple Chronic Complications of Diabetes

June 24, 2011 – Cebix Incorporated announced that preclinical data for its long-acting form of C-peptide, ErsattaTM (CBX129801), demonstrated a half-life of three days as compared to one hour for native C-peptide. Ersatta halted the impairment in nerve conduction velocity, a measure of the rate at which electrical signals travel through the nerves, in an animal model of diabetic peripheral neuropathy. Additionally, clinical data showed that native C-peptide replacement therapy improved erectile function in 46% of type 1 diabetes patients as compared to 9% of patients receiving placebo. These preclinical and clinical data will be presented during two poster sessions at the 71st Annual Meeting of the American Diabetes Association in San Diego starting on Saturday, June 25.

“C-peptide replacement therapy is a clinically-validated approach to treating multiple serious long-term complications of diabetes, including erectile dysfunction, peripheral neuropathy, and nephropathy,” said John Wahren, M.D., Ph.D., Chief Scientific Officer of Cebix. “We see tremendous potential in Ersatta to treat all of these diseases, because its biological activity is comparable to that seen in the native peptide, and the long-acting form will require less frequent dosing, thereby improving patient convenience and compliance.”

Cebix has an established database of 19 clinical studies evaluating native C-peptide in more than 300 patients with type 1 diabetes. These studies demonstrate that C-peptide replacement therapy increases nerve blood flow and mitigates peripheral and autonomic neuropathy and nephropathy, as well as improves erectile function. To date, native C-peptide replacement therapy has an excellent safety profile... Cebix's Press Release -

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 -