Pipex Pharmaceuticals : Oral Flupirtine Patent Estate for Diabetes, Diabetic Retinopathy, Retinitis Pigmentosa and Glaucoma

May 28, 2008 - Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced that it has entered into an option to acquire an exclusive worldwide license to issued and pending patent applications related to additional uses of oral flupirtine for the treatment of a range of ophthalmic, diabetes and diabetes-related therapeutic indications...
...The potential therapeutic indications covered by the additional intellectual property estate include glaucoma, age-related macular degeneration (AMD), retinitis pigmentosa (RP), diabetic maculopathy, and diabetic retinopathy and are supported by promising existing human clinical data generated in European countries where flupirtine has been commercially available for over 20 years and used by an estimated 1.5 million patients. The intellectual property is supported by promising multi-year clinical experience of oral flupirtine in over 100 patients with diabetic retinopathy, maculopathy, retinitis pigmentosa and glaucoma... Pipex Pharmaceuticals' Press Release -

Daiichi Sankyo : AZOR Reduces Blood Pressure in Difficult to Treat Special Populations

May 15, 2008 - Daiichi Sankyo, Inc., announced that data presented at the American Society of Hypertension's Twenty-Third Annual Scientific Meeting (ASH 2008) in New Orleans demonstrated that the powerful combination drug AZOR™ (amlodipine and olmesartan medoxomil) safely and effectively helped patients across several major subpopulations lower their blood pressure (BP). An analysis of patient subgroups from the pivotal registrational trial demonstrated the efficacy of AZOR in several key difficult to treat patient groups including people of African and Hispanic/Latino decent, people with high body mass index (BMI) and those with diabetes... [PDF] Daiichi Sankyo's Press Release -

DiaMedica : pre-IND FDA Guidance on DM-71

May 14, 2008 – DiaMedica Inc. (TSX-V:DMA), a drug discovery and development company focused on novel treatments for Type 2 diabetes, today announced that it has received feedback from the U.S. Food and Drug and Administration (FDA) on its pre-IND filing for DM-71, the Company’s lead compound.

The FDA has recommended a standard 90 day in vitro toxicology study comparing the combination product with each active component in separate arms to support the proposed phase IIb trial. This will provide further support for the safety of the compound which was well tolerated in the Company’s Phase IIa human study... DiaMedica's Press Release -

ALR Technologies : ECHO of Alabama Employer Coalition To Conduct New Diabetes Program Using The ALR Technologies Constant Health Companion...

May 27, 2008 - ALR Technologies Inc. (OTCBB: ALRT) announces that ECHO, Employers Coalition for Healthcare Options for corporations in Alabama, will start a program using ALRT’s Constant Health Companion™ (“CHC”) and its complementary Health ALRT Diabetes Management System.

The program will begin in June with the ECHO member companies and their employees or dependents with diabetes. ALRT’s CHC and the Health ALRT Diabetes System is a comprehensive patient compliance system and communications software platform that will enable health care professionals to remotely monitor the health progress specifically relating to diabetic patients. This will help diabetics reap the full therapeutic benefits of their medication by encouraging adherence to blood sugar testing and medications. Moreover, the system will facilitate effective and “real time” communication of blood sugar and other data to health professionals. This will facilitate timely intervention by health professionals as required and control complications due to diabetes. The program will also provide diabetic supplies from Health ALRT, LLC, an innovative health services company located in Kennesaw, GA... ALR Technologies' Press Release -

AtheroGenics : ARISE Trial Results Published in The Lancet

05/22/2008 -- AtheroGenics, Inc. (NASDAQ: AGIX), a pharmaceutical company focused on the treatment of chronic inflammatory diseases, announced that The Lancet, a peer-reviewed medical journal, will publish an article entitled, "Effects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomized, double-blind, placebo-controlled trial," in this week's May 24, 2008 issue. The article describes the results from AtheroGenics' 6,144-patient ARISE outcome trial of its novel diabetes drug candidate, AGI-1067.

"The ARISE trial has provided us with evidence that succinobucol may be a promising new therapy, based on clinical activity in a number of prespecified diabetes and cardiovascular endpoints... AtheroGenics' Press Release -

Daiichi Sankyo : Welchol, Combined With Metformin -- or Sulfonylurea-Based Therapy, Significantly Lowers Blood Glucose in Adults With Type 2 Diabetes

May 16, 2008 - Daiichi Sankyo, Inc. (DSI) announced today that data from two pooled analyses further demonstrate that Welchol™ (colesevelam HCl), in combination with metformin -- or sulfonylurea-based therapy, significantly lowers blood glucose (as measured by A1C) in patients with type 2 diabetes mellitus who had failed to achieve glycemic control (...). These findings, presented at the American Association of Clinical Endocrinologists' (AACE) 17th Annual Meeting and Clinical Congress, are the latest in a series of diabetes-related milestones for Welchol. In April, DSI announced that Welchol was added to the American College of Endocrinology (ACE)/AACE "Road Maps to Achieve Glycemic Control in Type 2 Diabetes Mellitus."... [PDF] Daiichi Sankyo's Press Release -

DiaMedica : Enrollment in Phase II Clinical Trial for DM-83

May 5, 2008 – DiaMedica Inc. (TSX-V:DMA), a drug discovery and development company focused on novel treatments for Type 2 diabetes, announces that it has enrolled the final patient in the phase II proof of concept clinical trial of DM-83...
...the twenty patient single-blind trial will demonstrate DM-83’s level of effectiveness in controlling blood glucose and insulin levels in Type 2 diabetic patients after they have consumed a standard meal. Changes in insulin and glucose levels are the study’s primary endpoints. Each patient will test both the effects of DM-83 as well as a placebo and therefore serve as their own control in this crossover study. All patients have now completed treatment and last patient is expect to complete the study in the second quarter with results to be analyzed and released shortly thereafter. The results of this trial will be used to optimize the design of the next stage of clinical development for DM-83... DiaMedica's Press Release -

Allon : potential of AL-309 as a new neuropathy treatment

May 1, 2008 — Allon Therapeutics Inc. (TSX:NPC) presented preclinical data that demonstrate the potential of the Company’s proprietary product candidate AL-309 as a treatment for peripheral neuropathy. AL-309 is the lead candidate in Allon’s second neuroprotection technology platform, derived from Activity Dependent Neurotrophic Factor (ADNF)...
...AL-309 was tested in two independent studies where diabetes was chemically-induced in rats. As in humans, diabetes in rats leads to progressive development of neuropathy characterized by hypersensitivity to pain, touch, warm and cold stimuli. AL-309 produced a dose-dependent and statistically significant prevention of all of these behavioural end-points showing that it has broad potential for treating the symptoms of nerve damage. In addition, pathology data showed a statistically significant effect on intra-epidermal nerve fiber density demonstrating the capacity to dramatically reduce the loss of nerve fibre... Allon Therapeutics' Press Release -

Entelos : Agreement with Lilly

April 30, 2008 - Entelos, Inc. (LSE:ENTL) a leading life sciences company building predictive computer models of human physiology and "virtual patients" for drug discovery and development, announced that Eli Lilly and Company (“Lilly”) has signed an agreement with Entelos to conduct in silico research in the field of diabetes using the Entelos® Metabolism PhysioLab® platform. Financial terms were not disclosed.

The Entelos Metabolism PhysioLab platform is an innovative and predictive computer model that simulates diabetic patients and can accurately predict the effects of drugs, changes in diet and exercise, and other interventions... Entelos' Press Release -

FivePrime and Pfizer : Diabetes Collaboration

May 20, 2008 - Five Prime Therapeutics, Inc. and Pfizer Inc. (NYSE:PFE) announced the initiation of a worldwide collaborative research and license agreement. The collaboration will focus on the discovery of antibody targets and novel therapeutic protein products to treat certain areas of cancer and diabetes. Under the collaboration, FivePrime will screen its comprehensive protein library in both cell-based assays and primary in vivo screens directed toward finding potential therapeutic protein products and antibody targets... [PDF] Five Prime Therapeutics' Press Release - Pfizer's Press Release -

Diasome Pharmaceuticals : at the 68th Annual American Diabetes Association Meeting

May 20, 2008 - Diasome Pharmaceuticals, a clinical stage diabetes therapeutics company, announced that four abstracts were accepted for publication at the 68^th Annual Meeting of the American Diabetes Association, being held June 6 through June 10 at the Moscone Convention Center in San Francisco, Ca.
All of the abstracts highlight HDV-Insulin, the Company’s proprietary oral and injectable insulin products. ...
...A 2-Week Randomized Active Comparator Study of Two HDV-Insulin Routes (SC and Oral) and SC Human Insulin in Patients with Type 1 Diabetes Mellitus....
...Single-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral HDV-Insulin in Patients with Type 2 Diabetes Mellitus...
...Hepatic-Directed Vesicle Insulin: Evaluation of a Novel Oral and Subcutaneous Insulin Delivery System in Animal Models of Diabetes... [PDF] Diasome Pharmaceuticals' Press Release -

Phenomix : PHX1149 Phase 2b Clinical Trial Results for Type 2 Diabetes

May 16, 2008 — Phenomix Corporation announced that PHX1149, a dipeptidyl peptidase-4 (DPP-4) inhibitor, demonstrated positive results in a Phase 2b clinical trial for the treatment of Type 2 diabetes.
The 12-week, double-blind, placebo-controlled clinical trial involving 422 randomized patients compared PHX1149 in once-daily oral doses of 200 milligrams and 400 milligrams to placebo. Patients were allowed to continue selected anti-diabetic drugs, either metformin or a thiazolidinedione, or a combination of the two, at a constant dose during the trial. PHX1149 demonstrated statistically significant reductions in hemoglobin A1c (HbA1c) in both the 200 milligram and 400 milligram dose groups... Phenomix's Press Release -

Aradigm : Data Showing No Occurrence of Primary Lung Cancer in Patients Treated with AERx Insulin Diabetes Management System (iDMS)

April 30, 2008 - Aradigm Corporation (OTCBB:ARDM) announced that review of the clinical data by Novo Nordisk a/s , with whom the Company had a collaboration for inhaled insulin, revealed no occurrence of primary lung cancer in patients inhaling insulin using the AERx(R) insulin Diabetes Management System (iDMS). AERx iDMS uses an aqueous formulation of insulin delivered by a hand-held electronic inhaler. Review of the clinical trial data for AERx iDMS revealed no cases of primary lung cancer either in the 2,307 patients treated with AERx iDMS or in the 1,218 patients treated with comparator treatments... Aradigm's Press Release -

MicroIslet : Collaboration With DiaKine Intended To Expand MicroIslet's Product Pipeline

April 24, 2008 - MicroIslet, Inc. (OTCBB: MIIS), a biotechnology company engaged in the development and commercialization of cell transplantation therapies for diabetes, and DiaKine Therapeutics, Inc., a biopharmaceutical company developing new, proprietary drugs for unmet medical needs in diabetes and complications related to diabetes, announced the award of an NIH grant for "Improving porcine islet function and in vivo survival."
Under the NIH grant, MicroIslet will lead studies utilizing DiaKine's proprietary compounds designed to develop agents capable of enhancing the immunocompatibility and survival of encapsulated porcine islets in vivo... MicroIslet's Press Release - [PDF] DiaKine's Press Release -

CytRx : Discovery of Novel Compounds that Amplify Chaperone Response to Cell Stress

April 23, 2008 - CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that scientists at its San Diego laboratory have discovered a novel series of compounds that amplify the natural cellular chaperone response to toxic misfolded proteins in cell culture, providing potential pipeline leads for next generation drug candidates in a number of disease indications, including cancer, cardiovascular disease, diabetes and neurodegenerative diseases... CytRx's Press Release -

RegeneRx : Ophthalmic Patent in Hong Kong

April 22, 2008 - REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) announced that it has received official notice from the Hong Kong Intellectual Property Department granting a patent using TB4, analogues, isoforms and derivatives to accelerate corneal wound healing and reverse or inhibit eye degeneration. The patent claims are based on a significant body of data supporting the use of TB4 for wound healing of the cornea and other areas in and around the eye.

TB4's corneal wound healing properties are being tested in a RegeneRx-sponsored Phase II clinical trial using an ophthalmic formulation, RGN-259, in diabetic vitrectomy patients, where a portion of the outer layer of the cornea is sometimes removed in order for surgeons to perform the procedure. Due to their diabetes, these patients often have problems healing quickly or at all... RegeneRx 's Press Release -

Elixir Pharmaceuticals : Issuance of SIRT Patent Covering Development of New Therapies Based on Breakthrough Science.

04.28.08 - Elixir Pharmaceuticals, Inc., announced today issuance of U.S. Patent No. 7,351,542, which covers the discovery of new and existing chemical entities that modulate the activity of a human sirtuin, SIRT 2. Elixir's rights to this patent were made possible through an exclusive license.
Sirtuins are a class of enzymes believed to play a significant role in diseases of aging, including type 2 diabetes and obesity. SIRT 2 is one of the seven human SIRT (or sirtuin) enzymes. Elixir co-founder Dr. Lenny Guarente of MIT and others have shown that the down-regulation of SIRT 2 elicits positive effects on metabolism. Therefore, pharmaceutical compounds that block the activity of this enzyme could have clinical utility to treat a range of metabolic diseases, such as diabetes and obesity. This new patent adds to Elixir's broad portfolio of issued patents and patent applications related to the development of sirtuin-based therapeutics... [PDF] Elixir Pharmaceuticals' Press Release -

OXiGENE : Active Metabolite of ZYBRESTAT Improves Glucose Metabolism through Similar Mechanism as a Sirtuin Agonist

April 30, 2008--OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN) a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced the publication by Zhang et al. of a paper demonstrating that combretastatin-A4, like its structural analog, resveratrol, activates cellular pathways (AMP-activated protein kinase and PPAR) involved in glucose regulation and improves glucose metabolism in a preclinical model of diabetes. Resveratrol is a stilbene compound found in red wine and other plant products that has been shown to increase healthy lifespan in animals and reduce blood glucose levels in humans with type-2 diabetes. Combrestatin-A4, a stilbene compound originally isolated from the African bush willow tree and similar in structure to resveratrol, is the active metabolite of ZYBRESTAT(TM) (fosbretabulin)... OXiGENE's Press Release -

Incyte : Positive Clinical Progress

April 30, 2008--Incyte Corporation (Nasdaq:INCY) reported first quarter 2008 financial results and reviewed recent clinical accomplishments in multiple programs...
...

11beta-HSD1 Inhibitor Program

INCB13739: Type 2 Diabetes

• Confirmed that results from the 28-day Phase IIa trial will be presented by the principal investigator at the American Diabetes Association meeting on June 9, 2008
• Finalized the protocol for the three-month Phase IIb trial which is scheduled to initiate in May 2008

INCB20817: Type 2 Diabetes

• Initiated Phase I trials

HM74a Agonist Program

INCB19602: Type 2 Diabetes

• Completed Phase I trials in which the compound was well tolerated, lowered free fatty acids without rebound and did not produce the flushing seen with niacin and its derivatives
• Results from the Phase I trials support the initiation of a 28-day Phase IIa trial in type 2 diabetics that is expected to provide top-line proof-of-concept data later this year or early next year...
  

Incyte's Press Release -

Merck's JANUMET (sitagliptin/metformin HCl) Recommended for Approval in the European Union to Treat Type 2 Diabetes

April 24, 2008 - Merck & Co., Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended two medicines for marketing approval in the European Union (EU)...
... JANUMET helps many patients lower blood sugar levels through the powerful efficacy of sitagliptin, a DPP-4 inhibitor, and metformin, a mainstay of diabetes therapy. For patients uncontrolled on metformin alone, JANUMET provides weight loss comparable to metformin alone, with no increased risk of hypoglycemia, edema, or gastrointestinal (GI) disturbances beyond metformin alone.

The CHMP has recommended JANUMET to be indicated to improve glycemic control in patients with type 2 diabetes inadequately controlled on diet and exercise plus their maximally tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. The CHMP also recommended JANUMET to be indicated in combination with a sulfonylurea as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea... Merck's Press Release -

Pfizer : Research Consortium to Expand Understanding of Diabetes and Obesity Pathobiology

April 25, 2008 - Pfizer has entered into a collaboration agreement with four major research universities – University of California, Santa Barbara (UCSB); Caltech; the Massachusetts Institute of Technology; and University of Massachusetts – and Entelos, a physiological modeling company, to re-examine the regulatory mechanisms of human energy metabolism.
Pfizer is funding the three-year and $14 million Insulin Resistance Pathway (IRP) Project to look at insulin signaling in adipose (fat) cells to increase understanding of diabetes and obesity, inextricably linked conditions that affect 7 percent of the U.S. population... Pfizer's Press Release -

NOVAGALI : First Patient in U.S. Phase I Clinical Study with CORTIJECT for Diabetic Macular Edema

April 24th, 2008 - Novagali Pharma, an emerging ophthalmic pharmaceutical company today announced that it has successfully injected the first patient in a Phase I clinical trial using CORTIJECT®, an ophthalmic injectable emulsion based on EYEJECT® technology platform containing a corticosteroid prodrug for the treatment of Diabetic Macular Edema (DME). This trial, which will enroll a total of 15 patients, is designed to evaluate the safety and to observe the efficacy trend of CORTIJECT®. The patients will be monitored for a period of twelve months following injection... Novagali Pharma's Press Release -

Solianis Monitoring : Non-Invasive Glucose Monitoring

May 5, 2008 - The research for non-invasive glucose monitoring has found new investors: The Zürich Cantonal Bank will invest in Solianis; together with a research grant from the European Union and private investors a total of CHF 2.5 Mio is raised...
..."With this capital increase we can continue the current clinical work to demonstrate that our technology is applicable in the daily life of patients". Solianis Monitoring AG is developing a device for the non-invasive monitoring of blood glucose for patients with diabetes to improve their quality of life... [PDF] Solianis Monitoring's Press Release -

Nektar Terminates All Negotiations With Potential Partners for Inhaled Insulin; Increased Number of Lung Cancer Cases Observed in Ongoing Clinical...

April 9, 2008 - Nektar Therapeutics (Nasdaq: NKTR) announced that it has ceased all negotiations with potential partners for its inhaled insulin programs as a result of new data analysis from ongoing clinical trials conducted by Pfizer Inc. An increase in the number of new cases of lung cancer was observed in inhaled insulin patients as compared to the control group. All new incidences of lung cancer were in patients that are former smokers... Nektar's Press Release -

CureDM : Diabetes Therapy Major Development Achieved

April 30, 2008 - CureDM, Inc., a biopharmaceutical company developing new therapies that prevent, ameliorate, or reverse both type 1 and 2 diabetes, announces its achievement of a major drug development milestone for Human proIslet Peptide (HIP). CureDM has successfully stabilized HIP to improve its bioavailability with recent dose response studies indicating that the dosage used in man may be as much as 100-fold lower than the native form. HIP is a 14-amino acid human peptide derived from a specific human gene responsible for populating the pancreas with islets, which contain the cells that secrete insulin and other hormones necessary to prevent diabetes... [PDF] CureDM's Press Release -

Biocon Limited : Phase IIa Clinical Trials for IN105

April 22, 2008 - ... Biocon commences Phase IIa Clinical Trials for IN105 : An open label, multi-centric, placebo controlled, single ascending dose study designed to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of IN105 under fed conditions in type II diabetic patients currently on Metformin therapy has been commenced at 5 investigation sites. The study is expected to be completed in August 2008 and will provide the data necessary to commence Phase IIb clinical trials... Biocon's Press Release -

Toumaz Technology and Consortium Partners : Major EU Funding To Develop Personal Blood Glucose Predictor For Diabetes Patients

10 April 2008 – Toumaz Technology Limited, the leading provider of ultra-low power wireless infrastructure for body monitoring solutions, announces its participation in a major collaborative research project that has been granted 7.1 million Euros to develop a unique personalised blood glucose prediction tool aimed at improving the lives of millions of diabetes patients. The grant award, made under the Seventh Framework Programme (FP7) of the European Community, will fund a four-year research and development project into the “DIAdvisor™” portable glucose prediction system, that will utilise Toumaz’s breakthrough Sensium™ wireless body monitoring technology. The large-scale project is being coordinated by Novo Nordisk A/S, a world leader in diabetes care, and will be delivered by a consortium of 13 medical, industrial and academic partners, including the European region of the International Diabetes Federation (IDF)...Toumaz Technology 's Press Release -