Diabetes

Recruitment milestone reached in Diamyd® Phase 3 trial

2024-04-12T07:36:00.000-07:00

STOCKHOLM, April 12, 2024 - Diamyd Medical’s precision medicine Phase 3 trial for Type 1 Diabetes, DIAGNODE-3, has enrolled 100 patients. To date, no serious adverse events have been reported, and no patients have discontinued the trial.

“This is an important milestone in our Phase 3 trial and the notable zero dropout rate confirms our insights from previous trials regarding the safety and convinience of the treatment,” says Ulf Hannelius, President & CEO of Diamyd Medical. “We are deeply grateful to our participants for their continued commitment to the trial and to the dedicated staff at our participating clinics for their relentless efforts.”

DIAGNODE-3, being the first ever precision medicine Phase 3 trial in type 1 diabetes, is ongoing in eight European countries and in the United States. The trial specifically enrols patients that carry the genetic HLA DR3-DQ2 haplotype, a genetic subgroup of type 1 diabetes that in previous trials has been associated with positive clinical response to Diamyd® treatment. The antigen-specific immunotherapy Diamyd® was in February 2024 granted Fast Track designation by the FDA and has previously been granted Orphan Drug designation in the U.S.

About DIAGNODE-3

The confirmatory Phase III trial DIAGNODE-3 (www.diagnode-3.com), evaluating the safety and efficacy of the antigen-specific immunotherapy Diamyd® in individuals diagnosed with Type 1 Diabetes is ongoing in the United States and in eight European countries: Sweden, Spain, the Czech Republic, the Netherlands, Germany, Poland, Hungary and Estonia.

DIAGNODE-3 will enroll up to 330 individuals aged 12 to 29 years, recently diagnosed (within 6 months) with Type 1 Diabetes, who carry the HLA DR3-DQ2 haplotype, a certain genetic risk factor for Type 1 Diabetes. A further stratification for HLA haplotypes is included in order to evaluate the potential super responder group of individuals who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8. HLA testing is well established and widely available.

This patient population is based on clinical efficacy and safety results from the Phase IIa and Phase IIb trials DIAGNODE-1 and DIAGNODE-2, as well as on the large-scale meta-analysis encompassing data from more than 600 individuals from previous Phase II and Phase III trials using Diamyd®. The trial design provides a high probability to reach its co-primary endpoints of preservation of endogenous insulin producing capacity measured as stimulated C-peptide and improved blood glucose control as determined by HbA1c.

DIAGNODE-3 is supported in part by funding from JDRF, the leading global type 1 diabetes research and advocacy organization... Diamyd Medical's Press Release -

Medicare Coverage Significantly Expanded for the Eversense E3 CGM System

2024-02-13T05:57:00.000-08:00

The decision is further recognition of Eversense as an important option for people with diabetes.

12 February 2024, Parsippany, United States - Ascensia Diabetes Care, a global diabetes care company, and Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, announced that Medicare has significantly expanded access to the Eversense E3 CGM System, the longest lasting CGM available, with the implementation of Local Coverage Determinations providing access to implantable CGM for basal only patients, by the first three Medicare Administrative Contractors (MACs).

Medicare coverage has been expanded for implantable CGMs to include all people with diabetes using insulin, removing the previous requirement for multiple insulin administrations per day. The new policy has also been updated to cover non-insulin-users who have a history of problematic hypoglycemia. Noridian, Palmetto and National Government Services (NGS) are the first three MACs to publish final local coverage determinations (LCD). The earliest MAC expansion becomes effective on February 25, 2024 and the companies expect the remaining MACs to finalize their expansion in the near future.

“We welcome this policy change and look forward to bringing this differentiated CGM option to millions of more Americans through Medicare,” said Rudy Thoms, VP, CGM Commercial US of Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). “Eversense E3 is a truly unique technology and optionality is key in diabetes care, where what works for one person does not always work for all. In particular, our Medicare users love that this twice-yearly CGM offers them unparalleled reliability and flexibility, without the burden of regular self-insertions and the constant reordering of supplies. It is important that people with diabetes have the same access to the benefits of a fully implantable, long-term CGM, as they do to traditional CGMs [that have a much shorter lifespan], and so we are thrilled to see this expansion.”... Ascensia Diabetes Care's Press Release - Senseonics' Press Release -

RION Announces Initiation of Phase 2A Clinical Study for Purified Exosome Product™ (PEP™) in Diabetic Foot Ulcers

2024-02-07T02:39:00.000-08:00

RION's Phase 2A clinical trial focuses on evaluating the safety and efficacy of Platelet Exosome Product™ (PEP™) combined with TISSEEL fibrin sealant for treating Diabetic Foot Ulcers (DFU).
Diabetic Foot Ulcers, affecting 18.6 million people worldwide each year, significantly impact quality of life and impose substantial economic burdens on healthcare systems.
The trial is a key part of RION's broader efforts in regenerative medicine, aiming to address unmet needs in the treatment of chronic conditions such as DFU.

January 30, 2024 - ROCHESTER, Minn.--RION, a clinical-stage regenerative medicine company, at the forefront of the exosome therapeutic revolution, has officially commenced a Phase 2A study aimed at assessing the efficacy and safety of its exclusive exosome regenerative therapeutic, known as Purified Exosome Product™ (PEP™), for the management of Diabetic Foot Ulcers (DFU).

Diabetic Foot Ulcers affect approximately 18.6 million people worldwide each year1 and are associated with increasing rates of amputation and death. The economic burden of DFUs is substantial, imposing $13 billion in cost on the US public and private healthcare systems.2 The trial is a key part of RION's broader efforts in regenerative medicine, aiming to address unmet needs in the treatment of chronic conditions such as DFU.

Building on the success of the Phase 1B study conducted at Mayo Clinic, RION's Phase 2A trial represents a significant step forward in the development of a regenerative biologic for Diabetic Foot Ulcers. This prospective, randomized, multi-center study will involve 40 patients across the United States. Patients will be divided into two cohorts: one receiving standard care and the other treated with PEP™ exosomes, enabling a thorough comparison of outcomes.

A positive outcome in the Phase 2A trial has the potential to pave the way for a pivotal study followed by the submission of a Biologics License Application (BLA). PEP™ addresses a significant unmet medical need in the realm of diabetic wound care... RION's Press Release -

Modular Medical Announces 510(k) Submission of MODD1 Insulin Pump

2024-01-25T05:23:00.000-08:00

SAN DIEGO, CA / January 19, 2024 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company"), a development-stage, insulin delivery technology company seeking to launch the next generation of user-friendly and affordable insulin pump technology, announced the premarket submission of its MODD1 next-generation insulin pump to the FDA for 510(k) clearance.

"This is an exciting milestone for the Company, as we seek to change the diabetes market. Almost 30 years after the introduction of the first insulin pump, more than three quarters of those who could benefit from wearing a pump do not wear one. It is our belief that our simplified design will encourage many "almost-pumpers" to adopt technology to aid in their diabetes management, without the complexity and expense required by many of the current solutions," said Paul DiPerna, Chairman and CTO of Modular Medical.

Jeb Besser, CEO of Modular Medical, stated "Getting a person who requires daily insulin to adopt a pump instead of multiple daily injections can reduce healthcare costs and improve long-term patient outcomes. Pump adoption has been impeded by the ‘three-Cs:' they are too complex, cumbersome and costly. The MODD1 was designed to be simple and affordable with an attractive form factor. We believe our two-part patch pump design, easy to learn interface and scalable manufacturing will all contribute to a differentiated and lower cost marketing approach."... Modular Medical's Press Release -

PolTREG receives US Patent Office Notice of Allowance for Treg cell therapy to treat Type-1 Diabetes

2024-01-16T07:12:00.000-08:00

Gdańsk, Poland – 16 January 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG), a clinical-stage biotechnology company in Europe developing cell therapies for use in a wide range of autoimmune diseases, announced it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO), covering the manufacturing of T-regulatory cells (T-reg) to treat Type-1 Diabetes (T1D), and ways the therapy is administered. The US allowance constitutes an important addition to the intellectual property portfolio covering PolTREG’s autoimmune therapies.

“This USPTO decision complements our extensive intellectual property portfolio in the US and EU, paving the way for rapid, unimpeded commercialization of PolTREG’s cell therapies,” said PolTREG CEO Prof Piotr Trzonkowski. “Together with our 17 years of experience with patients at our own facilities in Poland, our dominant intellectual property portfolio demonstrates that we are leading pioneers in the field of T-reg therapeutics for autoimmune disorders. Indeed, we are the first ever to have administered Treg cell therapies to patients and the first company to begin receiving revenues from sales of our lead product; so far, 27 patients have been successfully treated commercially under the Hospital Exemption program in Poland.”

The US patent application covers the manufacturing of Treg cells, the formula of the cellular medicinal product containing Treg cells, and the ways the therapy is administered in T1D patients... PolTREG's Press Release -

OcuTerra Therapeutics Announces Last Patient Completes Final Visit in Nesvategrast (OTT166) Eye Drop Phase 2 DR:EAM Clinical Trial in Diabetic Retinopathy

2024-01-09T07:40:00.000-08:00

- Topline results from study expected in Q1 2024

- Nesvategrast is a novel small molecule, potential first-in-class selective RGD integrin inhibitor specifically engineered for ocular delivery

- Addresses critical need for non-invasive, more accessible therapy for millions of patients worldwide suffering from diabetic retinopathy, a progressive, vision-threatening eye disease

January 03, 2024 - BOSTON-- OcuTerra Therapeutics, Inc. (“OcuTerra”), a clinical stage ophthalmology company developing innovative drugs to treat ophthalmic diseases for which the current standard of care of “watch-and-wait” does not prevent or control the progression of disease, announced the completion of the last patient’s final visit in the Phase 2 DR:EAM (Diabetic Retinopathy: Early Active Management) clinical trial of nesvategrast (OTT166). Nesvategrast, OcuTerra’s novel, selective RGD integrin inhibitor delivered via eye drop, is being developed as a possible treatment for the millions of patients with diabetic retinopathy who currently have no active, non-invasive therapies approved for this potentially devastating disease.

“The final patient visit in OcuTerra’s Phase 2 DR:EAM clinical trial brings us one step closer to providing an acceptable, non-invasive, active treatment to patients with diabetic retinopathy who are not actively managed due to the invasive nature of approved therapies, namely injections and/or laser,” said David Tanzer, M.D., board-certified ophthalmologist and Chief Medical Officer of OcuTerra Therapeutics. “We are incredibly pleased that this study has been a smooth process from start to finish. I would like to thank all of the clinical trial site staff, investigators, and study participants for their support of our work, and I am proud of the amazing clinical team that has achieved this latest study milestone.”

Topline data for the DR:EAM study are expected in the first quarter of 2024. These data will show the percentage of patients that have a ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) when treated with nesvategrast vs. placebo. The 24-week study enrolled 225 adult patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) with minimal vision loss.

“The forthcoming data from the DR:EAM trial represents a significant step forward in our mission. We look forward to reviewing the data from the DR:EAM clinical trial and sharing our insights on how nesvategrast could benefit millions of patients living with DR,” said Kerrie Brady, President and CEO of OcuTerra Therapeutics. “Nesvategrast epitomizes our commitment to patient-centric innovation. This achievement marks a significant advancement in the development of what could be the first non-invasive therapy for diabetic retinopathy, a condition that currently lacks proactive, patient-friendly treatment options. We are excited to begin planning the next phase of development for nesvategrast.”... OcuTerra Therapeutics' Press Release -

Enable Biosciences Receives $3M Phase IIB SBIR Award from NIDDK for Advanced T1D Testing Technology

2024-01-02T05:54:00.000-08:00

Enable Biosciences Inc., a leader in diagnostic technologies, is elated to announce its receipt of a Phase IIB Small Business Innovation Research (SBIR) award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The $3 million grant is a significant boost in the company's development of its innovative dried blood spot test for Type 1 Diabetes (T1D) autoantibodies, utilizing the patented Antibody Detection by Agglutination-PCR (ADAP) technology. A key objective of this funding is to pursue FDA clearance for the T1D test, a critical step towards commercialization.

Type 1 diabetes is a life-altering autoimmune disease affecting millions, characterized by the destruction of insulin-producing pancreatic cells, necessitating lifelong insulin therapy. Early detection of T1D is essential for effective management and reducing the risk of severe complications. The importance of early detection is highlighted by recent therapeutic developments that suggest the possibility of delaying the onset of type 1 diabetes through early intervention.

Dr. Jason Tsai, PhD, Chief Technical Officer at Enable Biosciences, shared his enthusiasm: “This Phase IIB SBIR award from NIDDK is a testament to our dedication to transforming T1D testing. With this funding, we are a step closer to achieving FDA clearance for our ADAP technology, which is crucial in the context of new therapies capable of delaying T1D onset.”

The project, supported by the NIDDK award, aims to achieve three primary goals:

1. Developing a Comprehensive Quality System: Critical to ensuring the high-quality production of test components, this system will comply with FDA guidelines, ensuring safety and effectiveness.

2. Laboratory Analytical Validation: This phase will evaluate the assay for consistency, sensitivity, and resistance to common interferences, setting a new standard in T1D testing accuracy.

3. Clinical Validation: Collaborating with top clinical specimen collection sites globally, Enable Biosciences seeks to validate the effectiveness of its testing method, benchmarking it against current diagnostics.

The NIDDK's support is pivotal for Enable Biosciences in its pursuit of FDA clearance for its innovative T1D test. This development comes at a crucial time, aligning with the advent of new therapies that show promise in delaying the onset of type 1 diabetes when administered early.

Enable Biosciences is dedicated to utilizing this grant to make significant strides in T1D diagnostics, potentially changing the lives of millions affected by this disease. The company's commitment to pioneering diagnostic solutions aligns with the evolving landscape of diabetes management, promising a future where early detection and intervention lead to improved health outcomes for individuals at risk of or living with type 1 diabetes.

Porosome Therapeutics Announces Groundbreaking Approach to Advance Diabetes Treatment

2023-11-15T05:31:00.000-08:00

October 30, 2023 (BOSTON) – Porosome Therapeutics, Inc. (Porosome Therapeutics) has announced a new and distinctive therapy for Type 1 Diabetes (T1D) and Type 2 Diabetes (T2D) targeting the insulin secretory defects found in beta cells associated with the disease. Porosome Therapeutics’ approach addresses the cell's secretory machinery.

Porosome Therapeutics Founder and Chairman Professor Bhanu P. Jena discovered a new cellular structure called the porosome nearly three decades ago. After its discovery, the porosome was isolated and its structure and composition determined before porosomes were successfully inserted into cells to enhance secretion. This groundbreaking discovery provides a platform for diabetes treatments, as well as other secretory disorders such as cystic fibrosis, Alzheimer’s, and certain cancers. This approach is novel in that it provides the ability to target undruggable proteins, which make up almost 85% of the human proteome.

“Identifying effective approaches to find therapeutic solutions to undruggable proteins is our major focus,” said Jena. “By targeting beta cells and incorporating additional insulin-secreting porosomes, we are able to restore the cell’s ability to secrete insulin. Similarly, a major issue in treating T1D using beta cells derived from induced pluripotent stem cells (iPSC), is the inability of these beta cells to optimally secrete insulin in response to a glucose challenge. Consequently, a large number of such beta cells derived from iPSC are required for a transplant, a major issue. This can be overcome by reconstituting insulin-secreting porosomes to the iPSC derived beta cells prior to a transplant. Our solution is a promising advancement in treating diabetes.”

Porosome Therapeutics' has two novel therapeutic approaches. The first is the proprietary approach of “porosome-reconstitution therapy,” where insulin-secreting porosomes are introduced into the cell plasma membrane of stem cell-derived beta cells. This approach has been demonstrated in published studies to enhance glucose-stimulated insulin secretion. The second proprietary approach is the use of a porosome-targeted small molecule capable of both insulin synthesis and secretion from beta cells. When combined with Metformin, a widely used medication for T2D, it could offer a powerful therapeutic approach to manage and treat T2D...Porosome Therapeutics' Press Release -

Bayer closes on divestiture of Diabetes Care business to Panasonic Healthcare Holdings Co., Ltd. for around EUR 1 billion

2016-02-01T09:23:00.001-08:00

Transaction includes blood glucose monitoring systems and lancing devices for people with diabetes

January 5, 2016 – Bayer AG closed on its previously announced agreement to sell its Diabetes Care business to Panasonic Healthcare Holdings Co., Ltd., a company which is backed by funds sponsored by leading global investment firm KKR and the Panasonic Corporation. The total consideration for the transaction is around EUR 1 billion (JPY 132 billion). The new stand-alone Diabetes Care business is named Ascensia Diabetes Care Holdings and is headquartered in Basel, Switzerland.

The sale includes the leading Contour™ portfolio of blood glucose monitoring meters and strips, as well as other products such as Breeze™2, Elite™ and Microlet™ lancing devices. Bayer’s Diabetes Care business accounted for EUR 909 million in sales in 2014... Bayer's Press Release - Panasonic Healthcare's Press Release

FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) for Treatment of Diabetic Retinopathy in People with Diabetic Macular Edema

2015-04-21T09:21:00.000-07:00

South San Francisco, Calif. -- February 6, 2015 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10 percent of people with DR.

The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials.

"While there are various options for treating diabetic macular edema, before today none were approved showing improvement in retinopathy," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "With today's approval, people with diabetic macular edema now have a FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision."... Genentech's Press Release -

CSL : drug candidate in diabetes research breakthrough

2012-11-23T02:23:00.003-08:00

27/09/2012 - CSL Limited has developed a new drug candidate that is able to prevent the development of type 2 diabetes and reverse its progression in animal models of the disease.

The drug candidate blocks signalling by a protein known as Vascular Endothelial Growth Factor B (VEGF-B) and this prevents fat from accumulating in the “wrong” places, such as in muscles and in the heart. As a result, cells within these tissues are once again able to respond to insulin and blood glucose is restored to normal levels.

This represents an entirely new approach to the treatment of type 2 diabetes and a paper outlining this breakthrough has just been published in the prestigious scientific journal Nature.

The research is a joint effort by an international team led by Professor Ulf Eriksson from the Karolinska Institute in Sweden, and involving scientists from CSL‟s research laboratories in Melbourne, The University of Melbourne and the Ludwig Institute for Cancer Research.

“The results seen in these laboratory studies are very promising for the millions of people around the world who are affected by type 2 diabetes,” said Dr Andrew Nash, Senior Vice President of Research at CSL... CSL's Press Release -

Midatech and MonoSol Rx : Positive Phase 1 Clinical Results for their Novel Transbuccal Oral Insulin Film Product

2012-05-22T14:15:00.000-07:00

3 May 2012 – Midatech Ltd., a global leader in the design, synthesis and manufacture of nanomedicines based on its passivated gold-nanoparticle technology, and MonoSol Rx LLC, the developer of PharmFilm® drug delivery technology, announced positive bioavailability and pharmacokinetic results from a first-in-human Phase 1 clinical study of their Midaform™ Insulin PharmFilm product in 27 healthy volunteers. The companies have licensed to their joint venture company, MidaSol Therapeutics LLC, a proprietary nanoformulated transbuccal insulin film product, which delivers monomeric insulin through the use of a rapidly dissolving mucoadhesive film that is placed onto the inside of the cheek.

Insulin, stabilized on a nanoparticle and delivered transbuccally, has the potential to offer diabetic patients a viable oral alternative to injectable insulin. The Phase 1 study established Midaform Insulin PharmFilm as a safe, novel, non-injectable insulin delivery system, which closely mimicked the delivery characteristics of monomeric insulin from the pancreas. Importantly, MidaSol’s product showed a faster onset of action compared to subcutaneous insulin. Top-line results, including PK and bioavailability elements, from the study will be presented at the European Summit for Clinical Nanomedicine (CLINAM) in Basel, Switzerland by Prof.Dr. med. Fritz R. Bühler, Chief Medical Officer and member of the Board of Midatech Ltd... [PDF] Midatech's Press Release - MonoSol Rx's Press Release -

Orgenesis : Agreement to Commence Advanced Studies for Proposed Diabetes Treatment

2012-04-26T15:44:00.001-07:00

Apr 11, 2012 - Orgenesis Inc. (OTCBB: ORGS), a development stage company with a novel therapeutic technology dedicated to convert a patient's own liver cells into functional insulin-producing cells as a treatment for diabetes, is pleased to announce entry into an agreement to commence a comprehensive research study into the efficacy of its treatment in order to more efficiently move the technology towards future human clinical trials.

Effective March 22, 2012, Orgenesis Inc. has entered into an agreement with Tel Hashomer - Medical Research, Infrastructure and Services Ltd. ("THM"). In exchange for certain fees, licensing rights and other considerations, THM is to perform a study at the facilities and using the equipment and personnel of the Chaim Sheba Medical Center of Israel under the direct supervision of Orgenesis Chief Science Officer, Prof. Sarah Ferber.

THM will conduct the study, through the services of the Medical Research Infrastructure Development and Health Services Fund established by the Sheba Medical Center pursuant to the Research Program under the direct supervision of Prof. Ferber, who will conduct and supervise the study with the assistance of the employees, researchers and/or associates of the Hospital and/or the Fund. The study itself shall be performed pursuant to the laws, regulations and guidelines as applicable in Israel with respect to clinical research on human subjects... Orgenesis' Press Release -

NGM and Daiichi Sankyo Collaborate to Discover and Develop Innovative Therapeutics for Diabetes

2012-04-05T12:01:00.004-07:00

March 28, 2012) – Daiichi Sankyo Company, Ltd. (hereafter, Daiichi Sankyo) and NGM Biopharmaceuticals, Inc. (hereafter, NGM) announced that they have entered into a research collaboration and license agreement to discover and develop novel therapeutics that modulate beta-cell regeneration for the treatment of diabetes. The loss or decline of beta-cell function contributes to the pathogenesis of diabetes, a chronic disease that ultimately necessitates insulin therapy for the majority of sufferers. A therapeutic providing for beta-cell regeneration could potentially be disease-modifying and represent a significant advance for patients suffering from Type 1 or Type 2 diabetes.

As part of this collaboration, NGM will apply its integrated discovery technology and in vivo screening platform to identify and validate physiologically-relevant metabolic targets that modulate beta-cell growth and function. Daiichi Sankyo and NGM will jointly conduct research on selected targets with the goal of identifying and optimizing drug candidates for further development. Daiichi Sankyo will assume responsibility for preclinical studies, clinical development, manufacturing and commercialization on a worldwide basis.

Under the terms of the agreement, NGM will receive an upfront payment and committed research funding for the duration of the collaboration. In addition, NGM is eligible to receive payments upon the achievement of research, development, regulatory and commercial milestones, as well as royalties on product sales. Daiichi Sankyo will receive an exclusive worldwide license to develop and commercialize compounds resulting from the collaboration... Daiichi Sankyo's Press Release - [PDF] NGM Biopharmaceuticals' Press Release -

ADOCIA : positive phase IIa clinical results on its fast-acting human insulin, HinsBet®

2012-03-23T10:45:00.000-07:00

28th of February 2012 - The first clinical results are confirmed on diabetic patients - The main results of this clinical trial are a rapid reduction of glycemia, an excellent local tolerance and an inter-patient and intra-patient variability, all comparable to NovoLog® (Novo Nordisk) -

ADOCIA (ISIN: FR0011184241, Ticker: ADOC), a biotechnology company specialized in the formulation of therapeutic proteins for treating diabetes and chronic wounds (diabetic foot ulcers, venous ulcers), announces positive results from a Phase IIa clinical trial evaluating the safety and efficacy of HinsBet®, its fast-acting human insulin, in type 1 diabetic patients. This program is supported by OSEO.

This phase IIa study was a single center, double-blinded, randomized, cross-over trial conducted on 20 type 1 diabetic patients under euglycemic clamp procedure. The aim of the study was to compare pharmacokinetics, pharmacodynamics and safety of HinsBet® to the fast-acting insulin analog NovoLog®, after 3 consecutive injections of each study medication to each patient.

The hypoglycemic effect of HinsBet® is as rapid as the one of NovoLog®, one of the modern prandial insulins. Furthermore, neither serious adverse event nor clinically significant change in laboratory safety parameters occurred in this study. On local tolerance, HinsBet® was as good as NovoLog®. Finally, the inter and intra patients variabilities of the two medications after 3 consecutive injections are also similar on pharmacological parameters... [PDF]ADOCIA's Press Release - PDF du communiqué de presse ADOCIA -

Medistem : Exclusive Worldwide License With Yale University for Treatment of Type 1 Diabetes Using Stem Cells

2012-03-14T09:24:00.000-07:00

March 7, 2012 - Medistem Inc. (MEDS.PK) and Yale University have signed an exclusive worldwide licensing agreement covering the generation of pancreatic islets from stem cells such as the Endometrial Regenerative Cell (ERC). These pancreatic islets have effectively treated diabetes in animal models.

Professor Hugh Taylor of Yale University, inventor of the technology, made international headlines in September 2011 when he published his findings in the peer-reviewed journal Molecular Therapy.

“Medistem is the first company to develop clinical-grade endometrial-derived stem cells and initiate trials in humans,” said Professor Taylor. “Since Medistem’s Endometrial Regenerative Cells are manufactured inexpensively, can be used as an ‘off the shelf’ product, and to date appear safe in human subjects, I am very excited to see diabetes added to the list of diseases that can potentially be treated with Medistem’s ERCs.”... Medistem's Press Release -

China Nuokang Bio-Pharmaceutical Inc. Broadens Product Portfolio by Acquiring Alpha Lipoic Acid Capsule for Diabetic Patients

2012-02-14T14:05:00.000-08:00

Jan. 11, 2012 - China Nuokang Bio-Pharmaceutical Inc. (Nasdaq:NKBP) ("Nuokang" or the "Company"), a fully integrated, China-based biopharmaceutical company focused on the research, development, manufacture, marketing and sales of hospital-based medical products, announced that it has acquired from Shandong Qidu Pharmaceutical Co., Ltd. ("Qidu Pharma") for a cash consideration of RMB18 million the manufacturing license and marketing rights for Alpha Lipoic Acid Capsule ("ALA"), also known as Thioctic Acid, an antioxidant product that addresses diabetic neuropathy. Upon the transfer of the manufacturing license from Qidu Pharma, the Company will be one of the two pharmaceutical companies in China licensed to manufacture ALA. ALA will be in the new drug monitoring period through October 2014, during which period there will be no additional market entrants due to current Chinese government regulations.

The Company expects to begin manufacturing ALA in its production facilities in Penglai, China in 2014 when the transfer of the ALA manufacturing license is expected to be completed. Until that time, Qidu Pharma has agreed to fulfill the full production needs for ALA for the Company on a contractual basis at a pre-determined, fixed price. The Company has begun to actively participate in provincial tendering processes for the drug and expects to begin recognizing meaningful revenues from it in the second half of 2012... China Nuokang Bio-Pharmaceutical's Press Release -

Actavis and Bioton : new alliance to shake up diabetes market

2012-02-08T16:22:00.000-08:00

30 JAN 2012 - Global managed-care offering to help bring down treatment costs for 366 million diabetics -

Actavis and Bioton (WSE:BIO) announced today that they have formed a joint venture company for the development and registration of insulins, including analogue insulins. Within the framework of the joint-venture, Bioton will be responsible for the development and manufacture of insulin products, while Actavis will be granted an exclusive licence to commercialise those products under the Actavis brand throughout the European Union and the United States of America, as well as in Albania, Bosnia & Herzegovina, Croatia, Iceland, Japan, Kosovo, Lichtenstein, Macedonia, Montenegro, Norway, Serbia and Switzerland. In Poland, both companies will offer the insulin products under their respective brands, Bioton being a Polish company.

The announcement, at a press conference in Warsaw today, was made jointly by Ryszard Krauze, Chairman of the Supervisory Board of Bioton, and Claudio Albrecht, CEO of the Actavis Group and Chairman of the Actavis Board of Directors.

Actavis has agreed to remunerate Bioton with the aggregate amount of EUR 55.5 million, of which EUR 22.25 million at signing today. The remainder (EUR 33.25 million) will be paid in instalments in accordance with agreed milestones relating to the registration process involving recombined human insulin (RHI)...Actavis' Press Release -

Roche : clearance from the U.S. Food and Drug Administration for the new ACCU-CHEK® Nano SmartView blood glucose monitoring system

2012-01-31T14:05:00.000-08:00

01.11.2012 - Innovative, small, no code device will be available to people with diabetes in the U.S. in first half of 2012

Roche announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its ACCU-CHEK® Nano SmartView blood glucose monitoring system.The new ACCU-CHEK Nano meter, which is smaller than a standard credit card, employs a large brilliant backlit display and does not require any manual coding or code key for enhanced ease of use. It also offers improved functions such as customizable test reminders, pre- and postmeal markers and average glucose calculation. The ACCU-CHEK Nano meter uses ACCU-CHEK® SmartView test strips and will be available to customers in the first half of 2012.

“We are very excited to bring this latest blood glucose monitoring technology to the United States,” said Luc Vierstraete, Global Head of Roche Diabetes Care. “The ACCU-CHEK Nano meter is the newest advancement in Roche’s more than 35-year commitment to bring state-of-the-art innovations to people with diabetes and their caregivers, and continues our promise to enabling optimal diabetes management. This new system will help us to further leverage and enhance our position in this important market.”... Roche's Press Release -

Eisai and EIDIA : Launch of LIFE CHECK, a Self-monitoring Blood Glucose Meter That is Easy for Elderly Diabetes Patients to Use

2012-01-23T15:49:00.000-08:00

January 19, 2012 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) and its diagnostics subsidiary EIDIA Co., Ltd. (Headquarters: Tokyo, President & CEO: Keisuke Watanabe, “EIDIA”) announced that EIDIA will launch LIFE CHECK, a self-monitoring blood glucose meter manufactured by Gunze Limited (Headquarters: Osaka, President & CEO: Hiroshi Hirata, “Gunze”), on January 27, 2012.

LIFE CHECK is a personal self-monitoring blood glucose meter with which diabetes patients can monitor their own blood glucose level by simply inserting a dedicated sensor known as the LIFE CHECK SENSOR into the meter. The meter was developed as a next-generation model of the blood glucose monitor G-CHECK currently manufactured by Gunze and marketed by EIDIA. While Gunze received approval to manufacture and market LIFE CHECK in August 2011, the system will be distributed and marketed by EIDIA and co-promoted by Eisai.

The LIFE CHECK meter employs a color liquid crystal screen that displays step-by-step operational instructions and easy-to-read graphs of measured data. After measurement, the dedicated sensor can be easily and safely removed from the meter with the push of a button without the patient having to touch the part to which their blood has been applied... Eisai's Press Release -

GE Selects Bionime to Launch Innovative Diabetes Solutions

2012-01-18T15:34:00.000-08:00

17 January 2012 - Bionime will offer innovative GE-branded clinical and home-based patient care products for the rapidly growing global diabetes population -

GE (NYSE: GE) announced it has entered into a new worldwide licensing agreement with Bionime, a global leader in biotechnology medical testing, to provide new GE-branded solutions for the diabetes market.

According to the World Health Organization, an estimated 346 million people worldwide have diabetes. Type 2 diabetes is the fastest growing chronic disease in the world. Through this agreement, Bionime will deliver GE-branded blood glucose monitors, test strips, kits and related diabetes accessories.

The first product to be launched is the GE100 Blood Glucose Monitoring System, available now through durable medical equipment suppliers and on retail shelves in 2012. The GE100 utilizes advanced patented strip technology to achieve a high level of accuracy and precision and a unique, innovative strip design that makes it easier to use and more sanitary for the consumer than current similar offerings. In addition, patented True Auto Coding Technology eliminates the need to code each strip lot without sacrificing the accuracy of the readings. The GE100 provides an easy, clean and accurate way to test blood glucose levels of people living with diabetes... GE Healthcare's Press Release - Bionime's Press Release -

PhaseBio : Positive Clinical Results with its Once Weekly GLP-1 analogue, Glymera

2012-01-11T14:26:00.000-08:00

November 15, 2011 - For the Treatment of Hyperglycemia in Patients with Type 2 Diabetes -

PhaseBio Pharmaceuticals, Inc., announced positive results from its Phase I/IIa single and multiple ascending dose clinical study with Glymera™, a recombinant glucagon-like peptide-1 (GLP-1) analogue for the treatment of hyperglycemia in patients with type 2 diabetes. In a dose dependent manner, Glymera™ demonstrated highly statistically significant reductions in fasting glucose glycemic load following meal tolerance testing, and average daily glucose measured through continuous glucose monitoring following 4 weeks of dosing.

“Currently approved GLP-1 analogues in the US need to be given at least once a day. Our intent was to develop a long acting product that would provide full 24/7 coverage and we are extremely pleased to have such robust results this early in the development of Glymera™ that supports a weekly dosing regimen and plan to aggressively move Glymera™ through the development process” said Lynne Georgopoulos, Senior Vice President Clinical Development at PhaseBio...PhaseBio Pharmaceuticals' Press Release -

AstraZeneca : Option Agreement to Acquire New Class of Diabetes Assets from Prosidion

2012-01-04T16:36:00.000-08:00

20th December, 2011 – AstraZeneca and Prosidion Limited, a fully-owned subsidiary of Astellas Pharma Inc. (Tokyo: 4503,”Astellas”), announced that they entered into an option agreement, under which Prosidion grants to AstraZeneca an exclusive option to acquire the Phase II clinical and pre-clinical assets, PSN821 and PSN 842 respectively, for the treatment of type 2 diabetes. Both PSN821 and PSN842 are orally administered G protein-coupled receptor GPR119 agonists, a potential new class of medicines for diabetes.

PSN821 is currently in a Phase-II clinical trial for the treatment of type 2 diabetes. It has been shown in pre-clinical disease models to substantially lower blood glucose, reduce food intake and bodyweight and therefore has the potential to be a valued addition to the future treatments for type 2 diabetes. PSN842 is currently poised to enter clinical trials to treat type 2 diabetes.

Under the terms of the agreement, AstraZeneca will pay Prosidion an undisclosed, non-refundable option fee. The exercise of the option will be dependent upon the successful results of the Phase-IIa clinical trial of PSN821 and the evaluation of pre-clinical work. In the event that AstraZeneca exercises the option, AstraZeneca would acquire the assets from Prosidion and would pay an undisclosed, pre-specified upfront payment and milestone payments... AstraZeneca's Press Release - [PDF] Astellas' Press Release -

Grove Instruments : Noninvasive Glucose Monitor

2011-12-08T09:19:00.001-08:00

September 2011 – Grove has received $998K for an SBIR Phase II grant titled “Development of a Fiberless Transflectance Noninvasive Glucose Monitor” from the NIDDK NIH... Grove Instruments' news -

About Grove Instruments

Grove Instruments,Inc. is a privately held pre-market medical device company developing the world's first noninvasive glucometer with the potential to exceed the ISO standard for blood glucose meters.

Grove's patented technology is based on the seminal concept of the Optical Bridge and is unique among all NIR spectroscopic approaches to noninvasive blood glucose determination.

The Company has been recognized for its innovation, technology development and clinical results on 10 separate occasions by the NIH NIDDK with funded SBIR Grants.

In 2011, Grove was also recognized by the Massachusetts Life Sciences Center with an Accelerator Award – one of only 4 recipients out of all Boston-area life sciences companies applying in that round. [About Grove Instruments]

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

2011-11-23T11:41:00.001-08:00

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 -