First-in-Class Anti-IL-12/23 Biologic Targets Proteins Believed to Play a Role in Psoriasis

Horsham, PA (September 25, 2009) – Centocor Ortho Biotech Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved STELARA™ (ustekinumab) for the treatment of adult patients 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.  The efficacy and safety of STELARA were evaluated in one of the largest clinical development programs for a biologic medication in the treatment of psoriasis.

STELARA is a first-in-class human monoclonal antibody that selectively targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are believed to play a role in the development of psoriasis.

“Findings from clinical studies showed that approximately seven out of 10 patients receiving STELARA achieved 75 percent skin clearance after just two doses, and maintained response for one year with continued treatment,” said Mark Lebwohl, MD, professor and chairman of the Department of Dermatology, The Mount Sinai School of Medicine, and study investigator.  “STELARA is a meaningful new option for patients with psoriasis that offers maintenance dosing every 12 weeks following two starter doses.”

Read the entire article here.

Cancer Expert Lee B. Riley, MD, PhD Served as Co-Investigator and Co-Author in the Phase III Melanoma Vaccine Trial for Patients with Advanced Disease

Suzanne Lapierre-Roman of Allentown was diagnosed with metastatic melanoma at age 29 in July of 2005. The news came as a complete surprise. While pregnant with her fourth child, Suzanne was experiencing pain thought to be caused by her gallbladder, and soon after delivery, had it removed. Test results that came back showed she had cancer – advanced melanoma. “It was a shock,” she says. “At the time, I didn’t even know what melanoma was.”

Suzanne was first seen at a number of university hospitals in Philadelphia and then a local hospital. “I wasn’t given much hope,” she says. “I was told to go on chemotherapy. Then, I heard about Dr. Lee Riley at St. Luke’s. He tested me to see if I would qualify for a melanoma clinical trial. I went on in October 2005.”

The treatment, formulated by National Cancer Institute (NCI) investigators, involves the use of a potent designer peptide vaccine gp100:209-217 (210M) which mimics the antigen that sits on the surface of a patient’s own tumor cells. On its own, the peptide shows little activity. However, in this trial, the vaccine was given in combination with the FDA-approved inpatient therapy for melanoma, High-Dose IL-2, made from a natural protein produced by the body.Dr. Riley, Medical Director of St. Luke’s Cancer Center, served as a co-author and a clinical investigator for the randomized study. St. Luke’s Cancer Center in Bethlehem was the only site in Pennsylvania to participate in the trial and was a major contributor of study participants, including Suzanne. Dr. Riley joined on as an investigator in the study in 2002. The promising results of the trial were presented at the June 2009 meeting of the American Society of Clinical Oncology in Orlando, Florida.

It’s been nearly four years since Suzanne went on the trial and today she is totally disease-free. “Dr. Riley was the only one who gave me hope,” she says. “He told me, ‘When this treatment works, it’s a home run.’ Well, I got my home run. Today, I don’t have any signs of the disease. Dr. Riley is just awesome; I owe him my life.”

“Suzanne’s great results are typical for someone who responds to IL-2, and there is a very good chance she will not have a recurrence. This study suggests that, in the future, more than twice as many people should respond the way Suzanne has,” says Dr. Riley.

Dr. Riley stresses the significance of this study. “The trial has demonstrated for the first time that, a vaccine can improve the outcome of patients with the most advanced stage of melanoma (stage IV). This is a major advance for cancer vaccine research and should stimulate additional cancer vaccine studies.”

More about the study

One hundred and eighty-five patients were enrolled in the study in 21 states from 2000 to 2007. The majority of patients in this study were between the ages of 31 and 60 and had advanced disease. All of the patients were heavily pretreated with surgery and, in some cases, patients had also undergone prior chemotherapy, radiation therapy, or immunotherapy including IL-2.

Study participants received two to four vaccine injections every three weeks. The study showed that those who received the vaccine with high-dose IL-2 had a significant response rate, 22.1 percent compared to 9.7 percent who just received the high-dose IL-2. The overall survival for those receiving the vaccine with IL-2 was 17.6 months compared to 12.8 months (p=0.084).

“The vaccine induces anti-tumor T-cells and the IL-2 stimulates the T-cells to grow and divide,” says Dr. Riley. “T-cells belong to a group of white blood cells known as lymphocytes and play a central role in cell-mediated immunity.”

Now that the study is over, the trial’s investigators are evaluating ways to move it forward so that others with advanced melanoma may also benefit.

Never Burn Again

Protect Your Skin Against the Sun’s Fury

By Tina Cantelmi and Randy Lieberman

Skin cancer is the most common form of cancer in the U.S., with more than one million Americans diagnosed each year, according to the American Academy of Dermatologists.

And while most people are well aware that sunbathing has an adverse effect on the health and appearance of their skin, many are unaware of the accumulation of incidental exposure received during the day. This exposure happens every day, whether walking the dog, driving a car or sitting in an office with lots of windows.

The American Academy of Dermatology (AAD) suggests daily use of a sunscreen with a Sun Protection Factor (SPF) of 15. Many doctors, including Dr. David Vasily, a board certified dermatologist, prefer to err on the side of caution, suggesting an SPF of 30 for patients. Dr. Vasily suggests sunscreen to be part of the morning regime, applied to the face, neck and upper chest, if exposed. The hands, may also age a great deal due to the sun, and, the sun’s harmful rays are a noted cause of many skin cancers.

There is no golden standard among sun-screen brands out there, but thankfully, sunscreens overall have improved greatly in the last decade by adding more protection against UVA radiation from the sun. From easy-to-apply powdered sunscreens to flawless spray-on-tans that allow five to seven days of wear, ongoing research and development means a cache of new and safer options for that healthy glow, minus the risk of skin cancer and premature aging from the sun.

New research has brought an over-the-counter sunscreen to store shelves that has an active ingredient never used before in the United States. The FDA recently approved Anthelios, made by L’Oreal, to prevent sunburn and protect against ultraviolet B (UVB) and ultraviolet A (UVA) rays. The new product has an SPF of 15.

According to WebMD Health News contributor Miranda Hitti, Anthelios SX contains a mix of three active ingredients, one of which is ecamsule. Ecamsule has not been marketed in the U.S., but it’s been marketed in Europe and Canada as Mexoryl SX since 1993.

Mexoryl SX is “particularly effective against short UVA waves” and doesn’t degrade when exposed to the sun for long periods of time, unlike other UVA filters, said a L’Oreal news release.

Currently, most sunscreens, according to dermatologist Dr. Vasily, need to be reapplied every two to four hours for highest maximum protection against UVA and UVB radiation. Longer-lasting formulas that wear and remain stable throughout the day, say in the future, look for new mixtures of botanicals, including colloidal oatmeal, turmeric and antioxidants soon on drug store shelves.

Cancer risk jumps 75 percent if ultraviolet radiation device used before 30. International cancer experts have moved tanning beds and other sources of ultraviolet radiation into the top cancer risk category, deeming them as deadly as arsenic and mustard gas. For years, scientists have described tanning beds and ultraviolet radiation as “probable carcinogens.”

A new analysis of about 20 studies concludes the risk of skin cancer jumps by 75 percent when people start using tanning beds before age 30. Experts also found that all types of ultraviolet radiation caused worrying mutations in mice, proof the radiation is carcinogenic. Previously, only one type of ultraviolet radiation was thought to be lethal. The new classification means tanning beds and other sources of ultraviolet radiation are definite causes of cancer, alongside tobacco, the hepatitis B virus and chimney sweeping, among others. The research was published online in the medical journal Lancet Oncology on Wednesday, by experts at the International Agency for Research on Cancer in Lyon, the cancer arm of the World Health Organization. “People need to be reminded of the risks of sunbeds,” said Vincent Cogliano, one of the cancer researchers. “We hope the prevailing culture will change so teens don’t think they need to use sunbeds to get a tan.”

Most lights used in tanning beds give off mainly ultraviolet radiation, which cause skin and eye cancer, according to the International Agency for Cancer Research. The classification of tanning beds as carcinogenic was disputed by Kathy Banks, chief executive of The Sunbed Association, a European trade association of tanning bed makers and operators. “The fact that is continuously ignored is that there is no proven link between the responsible use of sunbeds and skin cancer,” Banks said in a statement. She said most users of tanning beds use them less than 20 times a year.

But as use of tanning beds has increased among people under 30, doctors have seen a parallel rise in the numbers of young people with skin cancer. In Britain, melanoma, the deadliest kind of skin cancer, is now the leading cancer diagnosed in women in their 20s. Normally, skin cancer rates are highest in people over 75. Previous studies found younger people who regularly use tanning beds are eight times more likely to get melanoma than people who have never used them. In the past, WHO warned people younger than 18 to stay away from tanning beds.

Cogliano cautioned that ultravoilet radiation is not healthy, whether it comes from a tanning bed or from the sun. The American Cancer Society advises people to try bronzing or self-tanning creams instead of tanning beds.

Continue reading the entire story at The Today Show – Health: Skin Cancer.

Intelligent First Aid Kit Talks Through Range of Injuries

By Randy Lieberman

In a world where smart phones and smart boards make it easier for people to do business and learn, why can’t the same idea be applied to emergency situations?

The Intelligent First Aid Kit was created by medical and teaching professionals and has made first aid care, smarter. The idea seems simple enough: Combine all the necessary supplies with an easy-to-follow audio instruction system. The result is a comprehensive and accessible unit that anyone can use.

The Intelligent First Aid Kits range in price from the $30′s for home use and the $130′s for commercial and institutional use. They are the RX for the typically confusing mystery box of tubes and ointments found in most home, school or work first aid kits. With Intelligent First Aid people with little or no first-aid training can become the temporary E.M.T., until 911 responders arrive.

Bold-lettering and large icons help people quickly diagnose which talking pack is the correct to use in the situation. The kit eliminates the mad scrambling and searching that can occur during an emergency, ideally leaving more time for the caretaker to tend to the victim.

The talking first aid kit also features easy-to-understand, illustrated instructions and color-coded packaging to help differentiate each pack of medical supplies. It also provides step-by-step audio instructions on a range of injuries, ranging from frostbite, to asthma and choking, among others common emergencies.

The kit also comes with a flashlight and book light in case of an injury at night.

For more information, contact www.IntelligentFirstAid.com.

Experts say a spectrum of natural sleeping and waking rhythms exists, ranging from extreme morning people to extreme “night owls.”

A new study examines how morning people compare with night owls on a strength test and looks at what other physiological processes may contribute to their performance.

Researchers tested participants’ leg muscle strength at various points in the day. They looked at nine “early birds” and nine “night owls,” who were classified as such based on a questionnaire.

Surprisingly, morning people’s strength tends to remain constant throughout the day, but night owls have peak performance in the evening, said researchers from the University of Alberta in Canada.

“We thought that morning people would be better at this in the morning, but they never changed,” said study co-author Olle Lagerquist, a Ph.D. candidate in neurophysiology at the University of Alberta.

That may be because evening people show increased motor cortex and spinal cord excitability in the evening, about 9 p.m., meaning they had maximal central nervous system drive at that time, Lagerquist said.

Morning people, on the other hand, never achieve this level of central nervous system drive because the excitability of the motor cortex does not coincide with the excitability of the spinal cord. In other words, these two measures never peak at the same time, he said. Early birds’ brains were most excitable at 9 a.m. and slowly decreased throughout the day.

Researchers don’t know whether this means evening people who are athletes are necessarily better off.

Although night owls may maximize their strength in the evening, they are at a serious disadvantage if they have to compete in the morning. Morning people, on the other hand, would have the same average performance regardless of the time of the competition, Lagerquist said.

Based on the findings, Lagerquist recommends that people who struggle athletically in the morning try going to the gym at night, as they may feel more awake and perform better then, he said.

Continue reading the rest of the story here at CNN.com – Health.

There’s nothing better than that feeling of waking up completely and utterly refreshed.

Of course it’s a shame that the last time you woke feeling that way was on summer break in your college days, but hey – that’s the way it goes, isn’t it?

These days, sleep is little more than something that cuts into your every-day hectic schedule. Sure, you love going to sleep, and you definitely acknowledge that you need to sleep at least a few hours, but the reality is that you simply cannot prioritize it above everything else in your life. I mean, you’re already behind on Twitter messages as it is.

Besides, you function extremely well on just 5 or 6 hours thank-you very much. In fact, you’re quite proud of it.

Well sorry to burst your bubble, but what if I were to tell you that lack of sleep is one of the Western world’s foremost reasons for increased obesity, heart disease, and diabetes? That it’s physiologically impossible for you to ‘get away with’ a lack of sleep? The truth is that what you in fact have is a very massive and very demanding sleep debt. And the interest is mounting.

Continue reading the rest of the story here at the “Dumb Little Man” Blog. Kat Eden’s bio is here.

Melanoma is the most aggressive form of skin cancer.  Staging, which involves determining the size of the tumor and its extent of spread, is the best predictor of whether a patient will succumb to disease or survive.

However, its predictive ability is relatively inaccurate, particularly for patients with melanomas that have invaded deeply into the skin.

A simple blood test that can be used alongside staging to improve the accuracy of outcome prediction would therefore be an extremely important development.

The project, led by histopathologist Dr Gerald Saldanha and Dr Howard Pringle, both in the University of Leicester Department of Cancer Studies and Molecular Medicine, aims to assess whether the measurement of a certain class of molecule called microRNA can identify patients who are more likely to have aggressive melanoma.

Please continue to read the entire story here at Science Daily.

Prevent sun-damaged skin

The UV Index scale used in the United States conforms with international guidelines for UVI reporting established by the World Health Organization.

Whether a UV Index reading of 2 or less (low danger from the sun’s UV rays for the average person) to a reading of 8 to 10 (very high risk of harm from unprotected sun exposure), the helpful tool provides guidelines and precautionary measures to keep you and your skin safe. Covering up exposed skin areas and seeking shade might not be enough to protect your skin from dangerous UV Rays.

Preparation and planning can mean the difference between sun-damaged skin and an enjoyable day at the beach.

Emergency rooms report 18 percent more traffic in May through August, when children are outside running, kicking, riding, and swimming. So America’s top ER and pediatric doctors want to give you advice about what lands kids in the hospital — and how you can help them avoid the trip.

Tune up old bikes
A dusty old bike may up your kid’s accident risk.

Young cyclists — along with inline skaters and skateboarders — should always wear helmets, period. “But it’s not just head injuries that send kids to our doorstep,” says Barbara Gaines, MD, surgical director of the pediatric ICU at Children’s Hospital of Pittsburgh. “We see a lot of abdominal injuries that occur when bikers stop short and fly into the handlebars. And if the protective foam covering has worn off the handles, exposed metal edges can cut into skin.” At the beginning of each summer, give family bikes a good once-over. Make sure the brakes work, and look for worn parts.

Know the signs of concussion
Between 1.8 and 3.8 million sports-related concussions go undiagnosed every year in the United States, reports the CDC.

Although treatment usually involves only a few days of rest, more serious damage can result if a child suffers a concussion and then reinjures his head before it heals — and this can lead to permanent problems with coordination, speech, and even memory.

If your child receives a blow to the head, watch for concussion symptoms: confusion, memory loss, headache, dizziness, ringing in the ears, slurred speech, nausea, or vomiting. Some can be subtle, so if there’s any doubt, play it safe: Take him out of the game, and call his doctor. “Contrary to what people think, you don’t always lose consciousness, and often there’s no bump or visible sign,” explains Shannon. Finally, don’t be fooled if your child insists that he feels fine — pain isn’t a good guide in this case, since his motivation to get back in the game may make him downplay his symptoms.

Make your kids drink
They should guzzle water at least every half hour to prevent dehydration.

“Kids will play outside until they drop, so you need to be sure they stay hydrated in order to prevent heatstroke and exhaustion,” says Gaines. Even thirsty children need nudging: They tend to relax and socialize during game breaks rather than refuel with water, found University of Connecticut researchers who studied the habits of kids at sports camp.

If you’re supervising an activity, call a time-out every 20 to 30 minutes, and encourage players to drink up at least 4 to 5 ounces each time. “If you’re not there to enforce the rule, pack water bottles and remind kids to sip and refill frequently,” says Gaines.

Always designate a lifeguard
Even if your kid’s the next Michael Phelps, don’t assume he’s safe alone in the pool.

“One misconception I’ve seen is parents’ belief that once their child is 6 to 8 years old, they can reduce their vigilance at the pool,” says Michael Shannon, MD, emergency medicine chief at Children’s Hospital Boston. “But even if they’ve been swimming for years, young children can tire suddenly — to the point where they can’t make it to the pool’s edge.” And don’t think it’s okay to simply keep an ear tuned in to pool activity, warns Gaines: “People think that a child who falls into the water will splash and make a lot of noise, but the truth is that drowning tends to be silent.”

Choose the right shoes
Your little soccer star may experience leg pain if she doesn’t take the proper exercise precautions.

If your child wears her cleats during team workouts or for extended runs, the stiff soles and poor support may cause kneecap pain or shin splits, says Rebecca Demorest, MD, an assistant attending physician at the Hospital for Special Surgery and assistant professor of pediatrics at Weill Cornell Medical College in New York City. Make sure kids do warm-up or cool-down laps in running shoes, which are much gentler on the body. And tell them to test the ground before a game; in late summer (depending on where you live), it’s often hard and dry enough that cleats aren’t necessary.

Have young athletes cross-train
Even with proper footwear, child athletes who pound the same pavement every day can quickly develop repetitive-motion injuries.

Watch for signs of soreness or inflammation lasting more than a day. “If kids want to exercise daily, make sure they mix things up,” says Ted Ganley, MD, orthopaedic director of the Sports Medicine and Performance Center at Children’s Hospital of Philadelphia. “If basketball is their preferred sport, reserve 2 days a week for activities like swimming or biking, which don’t put all their weight on their legs.”