China Bans Leg-Lengthening Surgery

BEIJING - China has banned the controversial practice of leg-lengthening, a cosmetic surgery procedure popular among young professionals who believe height will help them climb the career ladder, after a rash of botched operations has left patients disfigured.

Leg extension surgery is a procedure that looks like something out of the Middle Ages.

A doctor breaks the patient's legs and inserts steel pins into the bones, just below the knees.

For complete story, please visit The New Zealand Herald

Living Virus Which Destroy's Cancer Enter's Phase 2 Clinical Trials

SAN ANTONIO, July 20 /PRNewswire/ -- The Cancer Therapy & Research Center Institute for Drug Development, in collaboration with Oncolytics Biotech Inc., a biotechnology company, has enrolled the first two patients in a new Phase II clinical study for patients with various types of sarcomas that have metastasized to the lung. CTRC is one of only three sites in the United States, and the only in Texas, enrolling patients. The novel anti-cancer therapy, REOLYSIN(R), is a living virus, not a chemotherapy drug, that is toxic to cancer cells but not harmful to normal cells. This novel therapy, using a living virus, is the first of its kind available at CTRC.

According to Monica Mita, MD, principal investigator at the CTRC Institute for Drug Development, REOLYSIN(R)'s name was derived from the human reovirus, a mild virus that occurs naturally in the environment.

"This novel therapy has shown success because the reovirus replicates in and destroys the cancer cells within the patient's body," said Mita. "Cancer cells have several molecular and genetic abnormalities. In normal, healthy cells, the reovirus is unable to reproduce because of an enzyme named PKR. The enzyme is suppressed in cancer cells, and therefore the reovirus can replicate in the cancer cell and kill it."

"REOLYSIN(R) typifies the true targeted therapy approach that seeks to use fundamental differences between cancer and normal cells as the basis for effective anti-cancer approaches and we are thus very excited about the this study," said Francis Giles, MD, director of the CTRC Institute for Drug Development.

Eligible patients are those who have a bone or soft tissue sarcoma that has spread to the lung and who are deemed by their physician to be unresponsive to or untreatable by standard therapies. These include patients with osteosarcoma, Ewing sarcoma family tumors, malignant fibrous histiocytoma, synovial sarcoma, fibrosarcoma and leiomyosarcoma.

The second patient to enroll in the study was diagnosed with breast cancer in April 2005 and 11 months later received an additional diagnosis for a rare form of sarcoma. A specialist at the Dana-Farber Cancer Institute in Boston referred her to CTRC, where Mita suggested the REOLYSIN(R) study. After discussing it with her family and doctor, she decided it was the best treatment option for her.

"This new therapy gives me another option in the fight against my cancer," said the 35-year-old mother of three who travels to San Antonio for treatment with her husband and children. "Before coming to CTRC, I had already been through one chemotherapy cycle for this disease, and I got the impression that no one really knew what to do with me or how to treat my cancer. REOLYSIN(R) was a less toxic option for me."

"We are delighted, but not surprised, with the rate of accrual at the CTRC Institute for Drug Development," said Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. "As an evolving oncology company, the placement of Oncolytics' very innovative and sophisticated studies is of critical importance and we are delighted to have the CTRC Institute for Drug Development as our collaborator. This study is expected to yield information that will guide the late stage clinical development program for REOLYSIN(R)."

REOLYSIN(R) demonstrated success against tumors during earlier phases of scientific testing. This study (REO 014) is a Phase II, open-label, single agent study with the primary objective of measuring tumor responses and the duration of those responses, and of describing any evidence of anti-tumor activity. REOLYSIN(R) will be given intravenously to patients for five consecutive days. Patients may receive additional five-day cycles of therapy every four weeks for a maximum of eight cycles. Up to 52 patients will be enrolled in the study.

Source: Cancer Therapy and Research Center

Gene Therapy for Type 2 Diabetes -Phase 2/3 Human Trials Begins

HAYWARD, Calif., July 19 /PRNewswire/ -- Metabolex, Inc., a biotechnology company dedicated to the discovery and development of novel therapeutics for diabetes and related metabolic disorders, announced that it has completed enrollment in the 400-patient Phase 2/3 study of its novel insulin sensitizer, MBX-102/JNJ 39659100, in patients with type 2 diabetes. Metabolex will receive a milestone payment from Ortho-McNeil, Inc., which holds an exclusive license for worldwide development and commercialization of MBX-102/JNJ 39659100.

"We have had great success in recruiting patients into the trial, which is a testament to the promise of our approach and the efforts of our investigators," said Harold Van Wart, Ph.D., Metabolex's president and chief executive officer. "Our clinical team is now working to ensure the patients in the trial are well monitored, and we expect to share the results early next year, when all patients have completed the 16-week trial and we have examined the data."

The randomized, double-blind, placebo- and active comparator-controlled, multicenter Phase 2/3 trial is evaluating MBX-102/JNJ 39659100 at daily doses of 200, 400 and 600 mg versus Actos(R) (pioglitazone, a thiazolidinedione -- TZD -- drug) 30 mg in patients with type 2 diabetes taking concomitant insulin. The primary endpoint is change in hemoglobin A1c (HbA1c) levels -- the gold-standard measure of a patient's blood glucose control over time -- with weight gain and edema as key secondary endpoints. Fasting blood glucose, triglycerides, cholesterol, uric acid and adiponectin levels are being evaluated. The trial is being conducted at 67 clinical sites in four countries.

MBX-102/JNJ 39659100 is being studied for its potential to lower blood glucose by treating insulin resistance, an underlying cause of type 2 diabetes, and a potential contributor to cardiac disease. The drug modulates genes that are linked to insulin sensitization without appearing to affect those genes associated with weight gain and edema, unlike the currently marketed insulin sensitizers from the thiazolidinedione (TZD) class. Clinical research to date suggests the difference in gene expression may offer the efficacy advantages of TZDs with an improved safety profile.

In addition, preclinical work has shown that MBX-102/JNJ 39659100 may have potent anti-inflammatory activity. Inflammation has been linked to the development of insulin resistance and type 2 diabetes, suggesting an additional mechanism by which MBX-102/JNJ 39659100 may control the disease process in diabetes.

In June 2006, Metabolex entered into a strategic alliance with Ortho-McNeil, Inc., giving Ortho-McNeil an exclusive license for worldwide development and commercialization of MBX-102/JNJ 39659100. Metabolex is conducting the Phase 2/3 trial of MBX-102/JNJ 39659100; Johnson & Johnson Pharmaceutical Research & Development, L.L.C. will be responsible for all additional testing of the compound.

About Metabolex

Metabolex is a privately held biotechnology company dedicated to the discovery and development of novel therapeutics to transform the treatment of diabetes and related metabolic disorders. Metabolex has drawn on its deep understanding of diabetes to create the largest database of genes involved in diabetes and to build a rich pipeline of product candidates and drug discovery targets. The company has three clinical-stage compounds: MBX-102/JNJ 39659100, in Phase 2/3 testing; MBX-2044, in Phase 2a; and MBX-8025, being studied in dyslipidemia, which has completed Phase 1 studies. Ortho-McNeil, Inc. has the exclusive right to develop and commercialize MBX-102/JNJ 39659100 and MBX-2044. For additional information about Metabolex and its development pipeline, visit http://www.metabolex.com/.

Source: Metabolex, Inc.

Human Trials of Alzheimer's Vaccine Begines

VIENNA, July 19/PRNewswire/ -- The Alzheimer's vaccine known as Affitope AD01 from Affiris has now entered the clinical phase of its development and is now being tested on humans for the first time. This development means that the 8.5 million-Euro venture capital finance agreement the company concluded with Munich-based MIG-Fonds in April 2006 has reached a key milestone on schedule. Up to 24 Alzheimer's patients are to be vaccinated, with the aim of this initial phase I trial being to demonstrate the vaccine's safety and its suitability for human use.

Affiris GmbH, based in Vienna, Austria, today announced the start of a phase I clinical trial for its Alzheimer's vaccine, Affitope AD01. The vaccine is being administered at the Vienna General Hospital (AKH) to up to 24 patients who have reached the disease stage "mild to moderate". The patients will be vaccinated four times over a period of three months, and the safety and suitability of the vaccine will be analysed over six months.

Source: Affiris GmbH

Dr. Walter Schmidt, CEO of Affiris GmbH, comments: "This, the most important chapter in our company history so far, is a fantastic development for both Alzheimer's sufferers and our investors. The need for such a treatment is particularly pressing given the enormous number of sufferers worldwide - over 12 million. Our investors, MIG-Fonds, are naturally also delighted that we have reached this important milestone on schedule."

Affiris has developed the Alzheimer's vaccine from patented Affitope technology, which is based on mimotopes and allows customized vaccines to be manufactured cost-effectively. Dr. Schmidt explains the special features of Affiris' approach to the Alzheimer's vaccine: "Alzheimer's is caused by beta-amyloid, an unintentionally formed fragment of one of the body's own proteins that occurs on the surface of brain cells and has the scientific abbreviation APP. In principle, it is extremely difficult to develop a vaccine as it is vital to ensure that the immune system only reacts after the beta-amyloid has separated into the brain fluid and not before, when it is present as a healthy component of the APP protein of brain cells. Nobody wants to provoke an immune response against the patient's brain cells. Our approach protects the brain cells and only combats the disease-causing beta-amyloid."

The second major disease that Affiris has chosen to tackle is hardening of the arteries, or atherosclerosis. A customized vaccine is also being developed to treat this disease and is currently still at the pre-clinical stage of development.

Vitamin D Deficiency Leaves Millions of Children and Adults at Risk For Numerous Diseases and Disorders

MCLEAN, Va., July 18 /PRNewswire/ -- In a review article published in The New England Journal of Medicine today, Dr. Michael F. Holick, Ph.D., M.D., one of the nation's leading experts on vitamin D, explores the nature of vitamin D deficiency and concludes it to be one of the most commonly unrecognized medical conditions, a condition that leaves millions at risk of developing not only osteoporosis and fractures but also numerous serious and often fatal diseases, including several common cancers, autoimmune diseases, infectious diseases and heart disease.

In his review, Dr. Holick estimates that there are over one billion people worldwide at risk for vitamin D deficiency, with 30-50% of children and adults in the United States at high risk for this potentially life threatening condition.

According to Holick, the effects of this condition can be both immediate and far-reaching for women and children. For example, pregnant women, even when taking a prenatal vitamin, are still at high risk for preeclampsia, a condition characterized by hypertension, fluid retention and protein loss in the urine. Low levels of calcium and vitamin D in utero and in childhood may prevent the maximum deposition of calcium in the skeleton. Vitamin D deficiency in early life may increase the risk of developing serious chronic diseases such as type 1 diabetes, multiple sclerosis and rheumatoid arthritis.

In adults, recent evidence has shown that vitamin D deficiency can put an individual at risk for developing a variety of deadly cancers. Holick points to prospective and retrospective studies indicating that vitamin D deficiency is associated with a 30-50% increased risk of colon, prostate and breast cancer along with higher mortality among those diagnosed with these cancers, especially darker skin individuals who have the highest incidence of vitamin D deficiency in the US. Vitamin D deficiency has also been linked to an increased risk of infectious diseases including tuberculosis and influenza as well as hypertension and cardiovascular disease.

"Vitamin D deficiency is an epidemic in this country," stated Dr. Holick. "Sensible sun exposure and the use of supplements are the best ways to address this easily preventable condition," he added.

Dr. Michael F. Holick is a Professor of Medicine, Physiology and Biophysics at Boston University. He is internationally recognized for his expertise and contributions to the fields of vitamin D, calcium, bone and the biologic effects of light in dermatology, endocrinology, and medicine. To see this article as it appears in the New England Journal of Medicine, please visit Dr. Holick's website at www.uvadvantage.org.

About the Ultraviolet Light Research and Educational Foundation -- Founded in 2004, the UV Foundation is dedicated to funding research to explore the effects of ultraviolet light on the human body. For more information about the UV Foundation, call 703.677.6885 or visit info@uvfoundation.org.

Source: Ultraviolet Light Research and Educational Foundation

Alfred Mann Institute For Biomedical Development at the Technion - Israel Institute of Technology (AMIT) Opens Doors of the $100 Million Institute

AMIT Advancing Israel's Leading Scientific-Technological University

VALENCIA, Calif., July 18 /PRNewswire/ -- The Mann Foundation for Biomedical Engineering announced the opening of the most recent Alfred Mann Institute, this one at the Technion -- Israel Institute of Technology (AMIT) in Haifa, Israel. The AMIT is a university-based institute designed to enable commercialization of innovative biomedical technologies that improve human health.

The acronym AMIT stands for the Alfred Mann Institute at the Technion, which has a double meaning in Hebrew of "friend, colleague or partner." This partnership between the Mann Institute and the Technion will focus on advances in the biomedical, medical device and life sciences industries.

Alfred Mann, a world renowned entrepreneur and philanthropist, created the first AMI at the University of Southern California, which became operational in 2001 as a test-bed for the development for future AMIs. In 2004 he announced his Foundation's plans to establish a group of AMIs at a number of select universities over the coming years. Mann's vision has been to establish AMIs in an effort to make further advances in the biomedical field and bring new biomedical products to the public. AMIT is the second Institute to open its doors and the only Institute established internationally. A gift of $100M for the creation of the third AMI on the campus of Purdue University was announced earlier this year.

"We are delighted to partner with the Technion due to the university's technological innovation and tremendous contribution to Israel's economy," Al Mann stated in a conversation with Technion President, Professor Yitzhak Apeloig. "The Technion has already achieved impressive results and we believe it will continue to thrive in the areas of medicine, science, engineering and technology."

The motivation behind opening an institute within Israel came from Mann's wife, Claude Mann. Claude, who is not Jewish, has had a strong connection to the Jewish faith. Her father was active in the French Resistance during World War II and was sent to a concentration camp for hiding Jews from Nazi soldiers. Claude was born in a concentration camp and she will always hold a strong connection with the Jewish people.

During the opening ceremony of the institute, President Yitzhak Apeloig publicly applauded Claude's support of the university and honored her by dedicating a floor of the Institute in her name.

"We would like to express both our sincere gratitude and admiration to both Dr. Mann and his wife, Claude, for their generous donation to our university," stated President Apeloig. "We know that through the collaboration of our joint efforts, the Technion will continue to implement life changing research in a number of biomedical fields. We foresee that the Institute will create a platform for successful technologies and companies for years to come."

About the Mann Foundation for Biomedical Engineering

The Mann Foundation for Biomedical Engineering is a philanthropic organization that establishes university-based institutes (AMIs) to enable and support biomedical product development for the benefit of mankind. Alfred Mann's philanthropic mission is to create and expedite the delivery of life- improving biomedical products to patients.

Mann is chairman of the boards of directors for the Alfred Mann Institutes for biomedical development at USC, Purdue, and the Technion. Mann also is chairman and chief executive officer of MannKind Corp. and of Advanced Bionics Corp.; chairman of Second Sight LLC, Bioness Inc., AlleCure Corp., Quallion LLC and Inplantable Acoustics; and chairman emeritus of Pacesetter System Inc. and MiniMed. All of these highly successful companies were founded by Mann.

About the Technion

As Israel's oldest and premier institute of science and technology, the Technion -- Israel Institute of Technology has been an active and leading participant in Israel's establishment and development.

The university offers degrees in science and engineering, and related fields such as architecture, medicine, industrial management and education in an intellectually invigorating environment. Great emphasis is also placed on its humanities and social science programs, the incorporation of which take on ever-increasing importance in today's multi-faceted workplace. But Technion's goals go beyond providing a well-rounded technical education. At the institute, scientific instruction is interwoven with professional ethics, producing leaders sensitive to social and environmental issues.

As a whole, the Technion is committed to its role as one of Israel's top facilities for science and technology, a role that is necessary for the future of Israel and to all of humanity.

Source: Mann Foundation for Biomedical Engineering

NATURE'S SECRETS YIELD NEW ADHESIVE MATERIAL

Scientists report they have merged two of nature's most elegant strategies for wet and dry adhesion to produce a synthetic material that one day could lead to more durable and longer-lasting bandages, patches, and surgical materials. As published in this week's issue of the journal "Nature", the scientists, supported by the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health, have designed a synthetic material that starts with the dry adhesive properties of the gecko lizard and supplements it with the underwater adhesive properties of a mussel. The hybrid material, which they call a geckel nanoadhesive, proved in initial testing to be adherent under dry and wet conditions. It also adhered much longer under both extremes than previous gecko-based synthetic adhesives, a major issue in this area of research.

According to the authors, their findings mark the first time that two polar opposite adhesion strategies in nature have been merged into a man-made reversible adhesive. "Our work represents a proof of principle that it can be done," said Phillip Messersmith, D. D.S., Ph.D., a scientist at Northwestern University in Evanston, Ill. and the senior author on the paper. "A great deal of research still must be done to refine the fabrication process and greatly reduce its cost. There's no reason to believe that these improvements can't be achieved, but it's going to take time."

Dr. Messersmith said the inspiration for the geckel nanoadhesive came about two years ago when he noticed an article about the adhesive force of a single hair from the foot of gecko. As lizard fans have long marveled, geckos climb walls and other dry, steep surfaces not by producing a glue-like substance but through a natural adaptation of the hairs of that cover the soles of their feet.

Roughly one-tenth the thickness of a human hair, each gecko hair splits multiple times at the end. These split ends contain cup-like structures called spatulae that vastly increase the hair's surface area. Whereas a human hair touches a surface just once, the gecko makes multiple contacts with the suction-like spatulae. With roughly a half million hairs on each foot, scientists estimate a gecko has a billion spatulae at work as it scampers up a wall.

Messersmith knew that researchers have attempted for several years to produce synthetic adhesives based on the adherence strategy of the gecko. What caught his eye in this article is gecko adhesion doesn't work well in water. Messersmith, who studies the underwater adhesion of mussels, had an idea. What if each synthetic gecko-inspired polymer, called a pillar, was coated with a man-made adhesive protein inspired by the mussel? As Messersmith mused, nobody had ever tried it and, if successful, this hybrid approach might spawn a new and potentially superior direction in designing temporary adhesive materials.

As reported in "Nature", Messersmith's idea turned out to be correct. He and his colleagues designed a small nanopolymer array that mimicked the natural spatial patterns of the hair on the foot of a gecko. They then coated their creation with a thin layer of a synthetic compound. This unusual compound mimics the reversible bonding action of a mussel adhesive protein that Messersmith's group has studied for the past several years.

In their initial experiments, which were led by graduate student Haeshin Lee, they found that the wet adhesive force of each pillar increased nearly 15 times when coated with the mussel mimetic and applied to titanium oxide, gold, and other surfaces. The dry adhesive force of the pillars also improved when coated with the compound.

"That actually wasn't so surprising to us," said Lee, the lead author on the study. "The mussel-inspired adhesive is extremely versatile in that it can bond reversibly to inorganic surfaces under wet and dry conditions."

As Lee noted, the next research hurdle was whether their hybrid geckel nanoadhesive would continue to stick to surfaces after multiple contacts. This has been a major challenge with other gecko-based adhesives. They typically stick well at first but lose their ability to adhere after a few cycles of contact with a tipless cantilever.

Using the cantilever and repeatedly touching it down, Lee developed a camera to visualize the process down to individual pillars. He found that the geckel hybrid maintained 85 percent of its adherence under wet conditions after 1,100 contacts with the tip. Under dry conditions, the level of adherence was 98 percent.

"This isn't quite a home run, but it's somewhere in between a double and a triple," said Lee, who devised on his own a special imaging devise to visualize individual pillars during the experiments.

Messersmith said that while the results are extremely promising, his group still must tackle several practical problems before it can scale up its research. "Any time that you fabricate an array of nano pillars of this type over large areas, you must have a very effective way of doing it without losing the efficacy of the approach," said Messersmith. "We'll also need to reduce the fabrication costs to make geckel commercially viable."

But Messersmith said he envisions great possibilities for geckel. "Band aids already adhere well, except if you go swimming, take a shower, or somehow expose it to a lot of water," said Messersmith. "So I think the most important thing with this adhesive is the added value of resisting immersion in water."

"I should add that the essential component of the wet adhesive polymer on the pillars contains a chemical that we have discovered last year adheres well to mucosal surfaces, such as those inside our mouth," he noted. "It may be possible to develop patches in the future that can be applied on the inside of the cheek to cover damaged tissue."

The National Institute of Dental and Craniofacial Research is the Nation's leading funder of research on oral, dental, and craniofacial health.

The National Institutes of Health (NIH) -- "The Nation's Medical Research Agency" -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.