Premature Aging Drug, Rapamycin, Shows Promise For Progeria Patients As Well As Extending Human Life

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Main Category: Pediatrics / Children's Health
Also Included In: Genetics;  Seniors / Aging;  Cardiovascular / Cardiology
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Nicknamed the "forever young drug", Rapamycin, which was created from a substance found in the soil of Easter Island, has been found to have potential for reversing the effects of premature aging, and could even help extend our lifespans by ten years, researchers reported in Science Translational Medicine.

Rapamycin, also known as Sirolimus, is an immunosuppressant medication used to prevent rejection after organ transplantations. It is commonly used after kidney transplants. It is a macrolide antibiotic and was first discovered in Rapa Nui, Easter Island, hence its name. It is a product of the bacterium Streptomyces hygroscopicus. It was originally developed as an antifungal agent. However, as soon as its immunosuppressive and cell growth inhibiting (antiproliferative) properties were discovered, scientists focused on those two areas instead. In laboratory experiments, it has been shown to extend the lifespans of mice. Experts believe it may also be useful for treating certain cancers.

In this latest study, Rapamycin was used on children with HGPS (Hutchinson-Gilford Progeria Syndrome), a devastating genetic condition in which the child ages quickly and reaches old-age by the time they are 12 years old. The accelerated aging is caused by an accumulation in every cell in the body of a protein called Progerin.

The scientists explained that Rapamycin got rid of the progerin in the cells, leaving them healthy.

HGPS is a very rare disease. According to the NIH (National Institutes of Health), approximately 100 cases have been documented over the last 100 years.

Co-author and NIH Director Dr. Francis Collins, said:

"We found it pretty exciting that this drug has such a profoundly positive effect on cell cultures. The ability to understand the molecular basis [of diseases] and develop targeted therapies makes this a very exciting time to be a physician."

The researchers concluded in an Abstract in the journal:

"Our findings suggest an additional mechanism for the beneficial effects of rapamycin on longevity and encourage the hypothesis that rapamycin treatment could provide clinical benefit for children with HGPS."

Progeria affects children, who age much faster than they should. There are different forms of Progeria; Hutchinson-Gilford Progeria Syndrome (HGPS) is the most common. The condition was first described in an academic journal in 1886 by Dr. Jonathan Hutchinson (England), and then in 1897 by Dr. Hastings Gilford (England).

It is estimated that between 1 newborn in every 4 to 8 million has Progeria. Both sexes have the same risk. Progeria rates appear to be the same all over the world, regardless of race, geographical location, or ethnic group.

Babies with Progeria are born looking healthy. At the age of about 10 to 24 months they start showing signs of accelerated aging, which may include: Aging skinFailure to growGeneralized atherosclerosisHair lossJoint stiffnessLoss of body fatHip dislocationStrokePatients with Progeria die between 8 and 21 years of age (average 13 years). Virtually all patients die from heart disease. Patients commonly have cardiovascular problems, such as angina, stroke, hypertension (high blood pressure), enlarged heart, and heart failure - all of them are conditions associated with aging.

Experts have always said that any breakthrough in Progeria treatment would probably have results which would also benefit adults with diseases associated with aging.

Specialists say that it is unlikely that Progeria is an inherited disease. It is probably due to a rare genetic change which happens randomly. Non-twin siblings of a child with Progeria have the same risk of developing the condition as any other child outside the family. However, in approximately 1 in every 100 cases of HGPS, the syndrome may be passed down to the next generation.

"Rapamycin Reverses Cellular Phenotypes and Enhances Mutant Protein Clearance in Hutchinson-Gilford Progeria Syndrome Cells"
K. Cao, J. J. Graziotto, C. D. Blair, J. R. Mazzulli, M. R. Erdos, D. Krainc, F. S. Collins
Sci. Transl. Med. 3, 89ra58 (2011).

Written by Christian Nordqvist
Copyright: Medical News Today
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Nile Therapeutics Phase 2 Study Of CD-NP In Patients With Acute Decompensated Heart Failure Meets Primary Endpoint, Has Good Trends On Renal Function

Main Category: Heart Disease
Also Included In: Urology / Nephrology;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
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Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, announced results of its Phase 2 study evaluating its lead compound CD-NP in patients with acute decompensated heart failure (ADHF) and mild to moderate renal insufficiency. Study results demonstrated that multiple doses were characterized as well tolerated with favorable drug activity in this acute patient population.

The open-label, single-blind, placebo-controlled Phase 2 study included 77 patients who were randomized into six cohorts at one of four doses of CD-NP (1.25, 2.5, 3.75 and 5 ng/kg/min) or placebo. Two cohorts were enrolled at each of the 1.25 and 2.5 ng/kg/min dose levels. Patients received study drug for up to 72 hours and were followed for 30 days. The primary objective of the study was to assess the safety and tolerability of CD-NP in a renally compromised ADHF population, the intended population of the therapy. Secondary endpoints included several assessments of drug activity.

CD-NP infusion at 1.25, 2.5 and 3.75 ng/kg/min appeared to be well tolerated. A dose-dependent effect on blood pressure was observed, with minimal or mild blood pressure reduction at 1.25 and 2.5 ng/kg/min, and moderate blood pressure reduction at 3.75 ng/kg/min. Dose escalation was limited by significant blood pressure reduction at 5 ng/kg/min.

Secondary and exploratory analyses demonstrated favorable effects of CD-NP on renal function, particularly at the 1.25 and 2.5 ng/kg/min doses. At these doses, CD-NP appeared to preserve or enhance renal function compared to placebo, as evidenced by favorable trends in several biomarkers correlated with kidney function, including creatinine and cystatin-c. Data will be presented at an upcoming cardiology conference.

"The data from this trial appear to indicate that we have identified active doses of CD-NP suitable for evaluation in a larger double-blind, placebo controlled study in acute heart failure patients," said James Young, MD, Professor and Dean of Medicine of the Cleveland Clinic and member of Nile Therapeutics Scientific Advisory Board. "Particularly interesting is CD-NP's apparent effect on kidney function, which would be a unique and clinically important benefit over the current standard of care."

"We are excited and encouraged by this data, particularly by the demonstration of activity in the intended patient population, supporting our belief that CD-NP has the potential to be a valuable new therapy for patients with cardiovascular and renal disease," said Joshua Kazam, Chief Executive Officer of Nile Therapeutics. "We look forward to the continued advancement of the CD-NP program."

About Heart Failure

Heart failure is the fastest-growing clinical cardiac disease in the U.S. according to the American Heart Association, affecting over 5 million Americans. Over 1 million patients in the U.S. each year are hospitalized with ADHF, an acute exacerbation of heart failure. This hospitalization rate is almost double the rate seen 15 years ago, and is the most frequent cause of hospital admission in the U.S. for patients older than 65 years, generating annual inpatient costs of more than $33 billion.

Safe Harbor Paragraph for Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding the timing, progress and anticipated results of the clinical development, regulatory processes, clinical trial and data analysis timelines, anticipated benefits of CD-NP, Nile's strategy, future operations, outlook, milestones, the timing and success of Nile's product development, future financial position, future financial results, plans and objectives of management are forward-looking statements. Nile may not actually achieve these plans, intentions or expectations and Nile cautions investors not to place undue reliance on Nile's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Nile makes. Various important factors that could cause actual results or events to differ materially from the forward-looking statements that Nile makes include Nile's need to raise additional capital to fund its product development programs to completion, Nile's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in greater detail in the reports Nile files with Securities and Exchange Commission, including those described under the caption "Risk Factors" in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2009 filed with the Securities and Exchange Commission on March 3, 2010. Nile is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

Source: Nile Therapeutics, Inc

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Diabetes Drug Metformin Helps Lung Cancer Patients

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Main Category: Lung Cancer
Also Included In: Diabetes;  Cancer / Oncology;  Respiratory / Asthma
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Metformin and/or TZDs (thiazolidinediones) may undermine the progression of lung cancer, as well as improve survival rates and reduce the risk of advanced lung cancer for patients with both diabetes and lung cancer, researchers from The Cleveland Clinic explained at the 76th annual meeting of the American College of Chest Physicians - Chest 2010.

Study leader, Peter Mazzone, MPH, MD, FCCP, said:

Our study, as well as other research, suggests an association between metformin and/or TZDs use and the risk of developing lung cancer. However, unique to this study, we have been able to report less advanced cancer in those who do develop cancer, a decreased frequency of squamous cell and small cell carcinomas, and improved survival, when controlled for stage, in people taking metformin and/or TZDs.

Dr. Mazzone and team set out to find out what impact metformin and TZDs might have on lung cancer presentation and its progression. They examined the medical records of 157 patients - they all had diabetes as well as a history of lung cancer. They gathered information on where they lived, age, sex, marital status, family size, education, occupation - collectively known as "demographics - as well as their smoking history, what diabetes drugs they used, and lung cancer data (cancer stage, histologic findings and survival).

They compared lung cancer characteristics between those who had taken metformin/TZDs before lung cancer diagnosis (metformin/TZD group) and those who hadn't (the other group).

The researchers found that: Those in the metformin/TZD group had a 20% risk of developing metastasis or a small cell or squamous cell carcinoma.Those in the other group had a 42.4% risk of developing metastasis or a small cell or squamous cell carcinoma.Patients in the metformin/TZD group had a better survival rate versus those in the other groupPatients who had used either TZDs or metformin before a lung cancer diagnosis had similar ages, smoking histories and gender ratios.Dr. Mazzone said:

The initial trend we have seen is toward metformin being more protective than TZDs. The findings from our completed study may lead to chemoprevention studies in at-risk groups, and, possibly, trials that add one or both of these medications to standard treatment.

The researchers explain that diabetes medications, such as metformin may have a significant role to play in lung cancer therapy. Diabetes Type 2 affects tens of millions of Americans, many of whom don't know they have the disease. In 2008 over 41 million metformin prescriptions were written in the USA; it is one of the most common diabetes type 2 medications.

President of the American College of Chest Physicians, David Gutterman, MD, FCCP, said:

This new information adds to the growing body of evidence that metformin may help prevent and inhibit the progression of lung cancer. However, more studies are needed before any changes in the standard treatment for lung cancer can be proposed.

Source: Chest 2010 76th annual meeting of the American College of Chest Physicians

Written by Christian Nordqvist
Copyright: Medical News Today
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AAN Launches New Medical Journal To Help Doctors Best Treat Patients

Continuing its mission to help neurologists best treat their patients, the American Academy of Neurology has launched Neurology: Clinical Practice, a new medical journal aimed at providing doctors with the latest information on how to improve outcomes for the one in six people affected by a neurologic disorder. The new journal will be sent as a supplement to the November 2, 2010, print issue of Neurology®, the world's most widely read and highly cited peer-reviewed neurology medical journal.

Neurology: Clinical Practice features best practices, evidence-based research and articles on topics that directly affect practicing neurologists.

"The first issue features 10 engaging article on topics such as the latest treatment advances in multiple sclerosis, Parkinson's disease and stroke," said John Corboy, MD, a professor of neurology at the University of Colorado-Denver and co-director of the Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus in Denver. "In addition, articles on Medicare, health care reform and electronic health records are included to help neurologists run their practices." Corboy is also a Fellow of the American Academy of Neurology.

The first of two trial issues for Neurology: Clinical Practice debuts November 2, 2010, with the second issue planned for February 2011.

To view the new issue of Neurology: Clinical Practice, visit here.

The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.

Source:
American Academy of Neurology

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