Glucose-Responsive Insulin Advances Toward Clinical Development

Main Category: Diabetes
Also Included In: Pharma Industry / Biotech Industry
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Pharmaceutical company, Merck & Co., Inc. has announced that it will acquire SmartCells, Inc., a private biotech developing a glucose-responsive insulin whose proof-of-concept preclinical trials were partially funded by the Juvenile Diabetes Research Foundation (JDRF). SmartCells' product for the treatment of diabetes is designed to be a once-a-day injection that will maintain continuous, tight control of blood glucose levels while reducing the risk of hypoglycemia - like the pancreas does automatically in the absence of diabetes.

"This is exciting news for the diabetes research field and for JDRF. We believe this novel technology may lead to a practical solution to the real needs of people with diabetes," said Dr. Richard Insel, Chief Scientific Officer at JDRF. "We are pleased to see that SmartCells' technology has attracted the support of a leading pharmaceutical company that has the capacity to translate this opportunity to patients," added Insel.

JDRF funds critical gaps in the type 1 diabetes drug and device pipeline by supporting discovery and proof-of-concept research for innovative ideas that might otherwise remain unexplored. This is the sixth time that an early-stage product supported by JDRF has attracted the attention of industry, which has the expertise and resources to bring novel technologies to patients as quickly as possible. From 2008 to 2010, JDRF provided significant financial support - a total of over $1.5 million in funding - to the early-stage development of SmartInsulin™.

"A measure of JDRF's success is identifying and advancing promising research that may benefit people with type 1 diabetes," says Dr. Karin Hehenberger, Senior Vice President of Strategic Alliances at JDRF. "Merck's acquisition of SmartCells is an example of exactly this. A potentially transformational innovation has now been taken up by a large pharmaceutical company thanks in part to our support. This acquisition adds important financial and drug development capabilities to this promising glucose-responsive insulin."

Biotechnology companies often face challenges in advancing novel therapies beyond the initial stages of research. Through its Industry Discovery and Development Program (IDDP), JDRF identifies unique technologies that would not be advanced otherwise and partners with companies to test concepts and bring better treatments and therapeutics leading to a cure to patients faster. To date, JDRF has funded type 1 diabetes projects at 30 companies, committing approximately $72 million in research funding.

"Our funding to SmartCells was an important step in what has become the JDRF Insulin Initiative," noted Dr Sanjoy Dutta, Director of Glucose Control research at JDRF. "We are focused on supporting an effort towards the development of faster-acting insulins, other glucose-responsive insulins and novel therapies that will help people with diabetes maintain glucose control with less effort."

Diabetes is a large and growing challenge with as many as 3 million people in the United States living with type 1 diabetes and another 30,000 are newly-diagnosed each year. A recent CDC modeling report indicated that as many as one in three individuals could have diabetes, either type 1 or 2, by the year 2050. Better treatments are desperately needed to help people live better with the disease today as research continues toward an eventual cure.

Source:
Joana Casas
Juvenile Diabetes Research Foundation International

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Alcohol consumption decreases with the development of disease

ScienceDaily (Nov. 23, 2010) ? In a cross-sectional study from the 2004 and 2007 Australian National Drug Strategy Household (NDSH) surveys, respondents were questioned about their current and past drinking, the presence of formal diagnosis for specific diseases (heart disease, type 2 diabetes, hypertension, cancer, anxiety, depression) and self-perceived general health status. The sample sizes for the 2004 and 2007 NDSH surveys were 24,109 and 23,356, respectively.

The authors report that respondents with a diagnosis of diabetes, hypertension, or anxiety were more likely to have reduced or stopped alcohol consumption in the past 12 months. The likelihood of having reduced or ceased alcohol consumption in the past 12 months increased as perceived general health status declined from excellent to poor (although the authors do not point out that lifetime abstainers were more likely than moderate drinkers to report less than excellent health status).

The authors conclude that the experience of ill health is associated with subsequent reduction or cessation of alcohol consumption ("sick quitters"), which is consistent with most prospective epidemiologic studies. The authors also conclude that this may at least partly underlie the observed 'J-shaped' function relating alcohol consumption to premature mortality. On the other hand, most modern epidemiologic studies are careful not to include "sick quitters" within the non-drinking category, and relate health effects of drinkers with those of lifetime abstainers. Further, prospective studies in which alcohol intake is assessed at different times (rather than having "changes" based only on recall at one point in time, as was done in this study) usually indicate that subjects who decrease their intake are more likely to subsequently develop adverse health outcomes, especially related to cardiovascular disease, than those who continue moderate drinking.

Editor's Note: This article is not intended to provide medical advice, diagnosis or treatment.

Story Source:

The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Boston University Medical Center, via EurekAlert!, a service of AAAS.

Journal Reference:

Wenbin Liang, Tanya Chikritzhs. Reduction in alcohol consumption and health status. Addiction, 2010; DOI: 10.1111/j.1360-0443.2010.03164.x

Note: If no author is given, the source is cited instead.

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Study Opens New Avenue For Obesity And Diabetes Drug Development

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Diabetes;??Bio-terrorism / Terrorism;??Sleep / Sleep Disorders / Insomnia
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UC Irvine researchers have discovered that circadian rhythms - the internal body clock - regulate fat metabolism. This helps explain why people burn fat more efficiently at certain times of day and could lead to new pharmaceuticals for obesity, diabetes and energy-related illnesses.

The study was headed by Paolo Sassone-Corsi, Donald Bren Professor and chair of pharmacology. A leading expert on circadian rhythms, he discovered many of the key molecular switches governing these biological processes. He and his colleagues found that one of these, a protein called PER2, directly controls PPAR-gamma, a protein essential for lipid metabolism. Since circadian proteins are activated by 24-hour, light-dark patterns, PER2 turns on and off PPAR-gamma's metabolic capabilities at regular intervals.

"What surprised us most, though, is that PER2 targets one specific amino acid on the surface of the PPAR-gamma molecule," Sassone-Corsi said. "This kind of specificity is very rare in cell biology, which makes it exciting, because it presents us with a singular target for drug development."

Daniele Piomelli, Louise Turner Arnold Chair in Neurosciences at UCI, and Todd Leff, associate professor of pathology at Wayne State University in Detroit, collaborated on the study, which appears this month in Cell Metabolism.

Twenty-four-hour circadian rhythms regulate fundamental biological and physiological processes in almost all organisms. They anticipate environmental changes and adapt certain bodily functions to the appropriate time of day. Disruption of these cycles can profoundly influence human health and has been linked to obesity, diabetes, insomnia, depression, heart disease and cancer.

Last year, Sassone-Corsi helped discover that proteins involved with circadian rhythms and metabolism are intrinsically linked and dependent upon each other to ensure that cells operate properly and remain healthy.

Rajesh H. Amin and James G. Granneman of Wayne State University and UCI's Benedetto Grimaldi, Marina Maria Bellet, Sayako Katada, Giuseppe Astarita and Jun Hirayama contributed to the current study, supported by the National Institutes of Health.

Source:
Tom Vasich
University of California - Irvine

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Biodel To Present Data From Product Development Programs At 2010 Diabetes Technology Meeting

Main Category: Diabetes
Also Included In: Conferences;??Pharma Industry / Biotech Industry
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Biodel Inc. (Nasdaq: BIOD) announced today that the following abstracts describing recent findings from the company's product development programs have been accepted for poster presentation at the Tenth Annual Diabetes Technology Meeting in Bethesda, MD, November 11 and 12, 2010:

"Characterization of Pharmacokinetics and Toleration of Three Variant Formulations of Linjeta"; presented by Dr. Frank Flacke, November 12

"A Stabilized Liquid Glucagon Formulation For Bi-hormonal Pump Use"; presented by Dr. Solomon Steiner, November 12

"A New Formulation of Insulin Glargine with an Extended Release Profile"; presented by Dr. Roderike Pohl, November 12

"'Smart' Basal Insulin Formulation That Releases Insulin in Response to Changing Blood Glucose Concentrations"; presented by Nandini Kashyap, November 11

The Diabetes Technology Meeting focuses on the latest technological advances for people with diabetes. Its purpose is to bring together technology developers and users to facilitate the creation of new and cost-effective tools including an artificial pancreas to help people with diabetes. This year's meeting will include sessions on technologies for metabolic monitoring, biomarkers for early diagnosis of diabetes, the performance of closed-loop artificial pancreas systems and alternative delivery routes for insulin.

Safe-Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements about future activities related to the complete response letter regarding the company's new drug application for Linjeta™; the company's response to the complete response letter; the importance of the complete response letter; and the company's focus, goals, strategy, research and development programs, and ability to develop and commercialize product candidates. Forward-looking statements represent our management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, our ability to respond to the complete response letter regarding our new drug application for Linjeta™ in a timely manner and the possibility that information we provide in response to the letter may not be accepted by the FDA; our ability to secure FDA approval for Linjeta(TM) and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel(TM) technology; the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the FDA's findings regarding data anomalies observed in India in our Phase 3 clinical trial of Linjeta(TM) for patients with Type 1 diabetes; the possibility that patients taking Linjeta(TM) may experience more injection site discomfort than they experience with competing products; unexpected data that may result from our clinical trials and our research and development activities; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent quarterly report on Form 10-Q for the quarter ended June 30, 2010. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.

Source: Biodel Inc

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