Recruitment milestone reached in Diamyd® Phase 3 trial

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 -

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

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 - 

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

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

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 -

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

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®

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

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 -

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 -

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 -

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 -

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 -

ZenBio : Awarded Phase I SBIR Grant to Develop Adipose Stem Cells into Insulin Producing Cells

July 1, 2010 - ZenBio, Inc. announced that it has been awarded a Phase I SBIR grant to identify and characterize an adult stem cell population from human fat stroma that has the therapeutic potential to differentiate into insulin-secreting “beta-like” cells.
Human adult stem cells derived from adipose tissue are a practical source of stem cells from which to launch work on deriving beta-like cells for autologous transplantation. The medical need for new therapies to manage type 1 and type 2 diabetes is well known and appreciated by physicians and patients alike. A plentiful and convenient source of cells that release appropriate amounts of insulin in response to changes in glucose would be a major advancement for diabetes therapy, particularly if the cells were provided by the patient (i.e. autologous transplantation). “In type 1 and long-term type 2 diabetes, the failure of the beta cells in the pancreas to produce sufficient insulin results in eventual insulin dependence for survival.”... [PDF] ZenBio's Press Release -

MannKind : Study Showing AFREZZA(TM) Provides Comparable Glycemic Control with Less Weight Gain and Hypoglycemia than Standard of Care

Jun 24, 2010 - American Diabetes Association/The Lancet Symposium Will Highlight Study Showing AFREZZA(TM) Provides Comparable Glycemic Control with Less Weight Gain and Hypoglycemia than Standard of Care - Findings on ultra rapid acting insulin also published in The Lancet - AFREZZA (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, investigational ultra rapid acting mealtime insulin, combined with basal insulin is comparable to standard insulin therapy in controlling post-meal blood sugar levels in adult patients with Type 2 diabetes, and offers the added benefits of significantly less weight gain and lower risk of hypoglycemia. These study findings will be presented on Saturday, June 26, at a special symposium co-hosted by The Lancet and the American Diabetes Association (ADA), at the American Diabetes Association's 70th Scientific Sessions(R). The study will also be published in the June 26 issue of The Lancet, one of the world's leading medical journals...

[...]

...AFREZZA is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycemia. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder pre-metered into single use dose cartridges and the light, discreet and easy- to-use AFREZZA Inhaler. Administered at the start of a meal, AFREZZA dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals. To date, the AFREZZA clinical program has involved 50 different studies and over 5,000 adult patients... MannKind Corporation's Press Release -

Diamyd Medical and Ortho-McNeil-Janssen Pharmaceuticals : Agreement for Diabetes Therapy

June 22, 2010 - Diamyd Medical AB has signed an agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company, to develop and commercialize the Diamyd® diabetes therapy.
The agreement relates to the development and world-wide commercialization of the GAD65 antigen-based therapy (Diamyd®) for the treatment and prevention of type 1 diabetes and associated conditions.
OMJPI will make an upfront payment of USD 45 million, and under the terms of the agreement, Diamyd has the potential to receive additional development and sales milestone payments of up to USD 580 million, as well as tiered royalties on future sales. The parties will equally share costs for the development program until results from the ongoing EU Phase III study, expected in the first half of 2011. OMJPI has the right to fully assume responsibility for the development program upon reviewing the results.

Following its strategy, Diamyd has secured exclusive rights for commercialization in the Nordic countries. Diamyd also retains the rights to the therapeutic use of the GAD65 gene and derivatives, fragments and variants of the GAD65 protein... Diamyd's Press Release - Johnson & Johnson's Press Release -

Omni Bio Pharmaceutical : FDA IND Clearance for Alpha-1 antitrypsin (AAT) Type 1 Diabetes Clinical Trial

June 8, 2010 - Screening Underway at Barbara Davis Center for Childhood Diabetes at University of Colorado Denver Anschutz Medical Campus - Management to Present at Jefferies 2010 Global Life Sciences Conference – Omni Bio Pharmaceutical, Inc.(“OMNI”), (OTCBB: OMBP) announced that the Barbara Davis Center for Childhood Diabetes has received IND regulatory clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial evaluating Alpha-1 antitrypsin (“AAT”) in Type I diabetics.
Dr. Charles A. Dinarello, Acting Chief Executive Officer of OMNI stated, “We are pleased to announce IND Clearance for a Phase I/II clinical trial in Type 1 diabetics. Although this is the first time AAT will be evaluated in humans with Type 1 diabetes, AAT already has an excellent safety track record as an FDA-approved biological. We are confident that this outstanding safety profile was a significant factor in the FDA’s IND clearance.”
AAT is an FDA-approved, off-patent drug currently indicated for the treatment of pulmonary emphysema among those with genetic deficiency of AAT. Preclinical studies demonstrate that AAT may be effective in treating a variety of medical disorders. The decision to pursue a clinical trial of AAT in Type 1 diabetics was based on promising animal study data... [PDF] Omni Bio Pharmaceutical's Press Release -

MannKind Corporation : Follow-up Safety Data Show AFREZZA(TM) Comparable to Standard Antidiabetic Therapy in Lung Function Tests

Apr 23, 2010 - Follow-up Study with Investigational Diabetes Therapy Presented at the American Association of Clinical Endocrinologists 19th Annual Meeting -Pulmonary function test results (PFTs) in patients treated with AFREZZA TM (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, at follow-up measurements were similar to PFT results observed in patients receiving standard antidiabetic therapy, according to data presented today at the American Association of Clinical Endocrinologists 19th Annual Meeting (Poster #267). Results from the follow-up study suggest that the pattern and magnitude of changes in lung function associated with the use of AFREZZA in patients with Type 1 and Type 2 diabetes are not likely due to any structural alterations in the lungs and are not clinically meaningful.

"Our findings add to the growing body of clinical evidence that indicates AFREZZA is comparable to standard of care insulin therapy in terms of lung safety," ...

...

...AFREZZA is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycemia. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder pre-metered into single use dose cartridges and the light, discreet and easy-to-use AFREZZA Inhaler. Administered at the start of a meal, AFREZZA dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals. To date, the AFREZZA clinical program has involved 49 different studies and over 5,000 adult patients... MannKind's Press Release -

Cetero Research : More Than 500 Diabetes Studies Completed

April 13, 2010 - Full-Service Options Help Move Treatments Through Proof-of-Concept More Quickly – Cetero Research, the leading early-stage contract research organization (CRO), announced it has completed more than 500 diabetes research studies in the past three years for both Type 1 and Type 2 diabetics, including complex clamp studies and studies in Phase I, II, III and IV. Cetero is the only CRO that can combine both pivotal pharmacokinetic studies and proof-of-concept studies in one study, saving up to six months of development time.

“Approximately eight percent of the U.S. population struggles with diabetes, and the numbers continue to grow. Our ability to provide researchers with the support they need to expedite new drug development is extremely important,”... Cetero Research's Press Release -

CureDM Partners Novel Diabetes Treatment with Sanofi-Aventis

April 8, 2010 – CureDM, LLC announced that an agreement has been signed with Sanofi-Aventis (EURONEXT: SAN and NYSE: SNY) for the exclusive worldwide license of Pancreate™, a novel islet neogenesis agent for the treatment of type 1 and type 2 diabetes. CureDM is a privately held biopharmaceutical company whose scientists discovered Pancreate™, a first-in-class human peptide therapeutic. Several key Composition of Matter and Use patents have been issued to CureDM for this potentially transforming treatment approach for diabetes.

“We are extremely pleased to have the opportunity to partner with one of the most innovative global pharmaceutical companies,”... [PDF] CureDM's Press Release - [PDF] Sanofi-Aventis' Press Release -

CPEX’s Nasulin Insulin Therapy Featured in an Oral Presentation and Four Abstracts at the Ninth Annual Diabetes Technology Meeting

November 05, 2009 -CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) announced that its intranasal insulin product candidate, NasulinTM, will be featured in an oral presentation and four abstracts at the Ninth Annual Diabetes Technology Meeting, November 5-7, 2009 at the Hyatt Regency Airport in San Francisco, California. Dr. Lance Berman, Senior Vice President and Chief Medical Officer, is scheduled to deliver an oral presentation entitled “The Technology and Clinical Aspects of Nasal Insulin Therapy” at 9:30 a.m. PST on Saturday, November 7. Further details on the abstracts are provided below.
A Randomized 6-Way Crossover Study of NasulinTM, Saline and Lispro in Subjects with Type 2 Diabetes to Determine Optimum Dose Timing
A similar glucose-lowering effect may be achieved by administering Nasulin either just before or at the end of the meal offering more flexibility of dosing than with injectable insulins.
Two Randomized Crossover Glucose Clamp Studies of NasulinTM and Lispro
In both Type1 diabetic patients and healthy volunteers, peak glucose metabolism rates occurred earlier with ultra-rapid acting Nasulin than with rapid acting lispro. The pharmacodynamic profile indicates Nasulin has optimum activity when glucose levels rise during a meal with less potential for hypoglycemia in the hours after the meal has ended.

Dose-Exposure for Single and Dual Nostril Administration of Nasal Insulin (NasulinTM)
The findings from this study demonstrated significantly enhanced insulin absorption when a 50 IU dose is administered as 2 sprays of 25 IU given in the same nostril rather than one spray in each nostril. In addition, the study also demonstrated that nasal administration of up to 200 microliters per nostril was well tolerated allowing the administration of doses up to 100 IU. Together these findings provide an improved dosing methodology and a higher maximum dose for evaluation in future clinical trials.

Dose-Exposure for Two Dose Strengths of Nasal Insulin (NasulinTM)
These data demonstrated that the original Nasulin concentration (1.0%) and the new concentration (0.7%) revealed proportional dose-dependent increases in insulin exposures... [PDF] CPEX Pharmaceuticals' Press Release -