Salute Press :: Archives :: April/May 2008 Issue


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April/May 2008 Issue

• Cancer Awareness Month:Side Effect Becomes Style Statement
• Novel Approach May Spell Safer Gene Therapy
• Give Early-Stage Research A Funding Chance
• Cancer Briefs: Chemo Damage & Preventing Cancer
• Pioneering Gene Therapy Restores Sight

Cancer Awareness Month:Side Effect Becomes Style Statement

Ilene Raymond Rush
Editor-in-Chief
April 15, 2008

When Rachel Levin Troxell, 36, developed lymphedema, a complication of chemotherapy and radiation that results in swelling of the lymph nodes, she was "devastated". She hated the flesh-colored compression garment designed to reduce the swelling, and how it instantly identified the vibrant graphic designer and documentarian as a cancer survivor.

In conversations about her condition with Drexel University design student Kristen Dudley, 22, whose grandmother had lymphedema, the two women decided to develop an alternative to the heavy, itchy and hot garments and LympheDIVAS (www.lymphedivas.com) was born. The company, which went online in October, 2006, produces Lycra arm sleeves and gauntlets in an array of colors that are - according to their website - "comfortable, breathable, and oh-so-divalicious."

Sadly, Levin Troxell succumbed to breast cancer earlier this year. However, her parents, Dr. Howard and Judy Levin, her husband, Jason Troxell, and Dudley, now the Senior Vice President/Creative Director of LympheDIVAS, remain committed Rachel's vision. To honor Cancer Awareness month, Dudley answered questions on lymphedema, the loss of Levin Troxell, and the impact of LympheDIVAS.

How many breast cancer patients develop this condition and is it limited to breast cancer survivors?

About 1 million women in America are at-risk to develop the condition. Although we don't know how many go on to develop lymphedema, we estimate it to be about 40%. All women at risk for lymphedema are advised to wear a compression sleeve for air travel, heavy lifting or exercise.

Anyone who has had lymph nodes removed risks lymphedema. Many people experience it in the lower extremity as well. Those who have upper extremity lymphedema have more then likely gone through breast cancer surgery since lymph nodes are often removed from under the arm. Some cases of melanoma surgeries lead to upper extremity lymphedema as well.

How is lymphedema traditionally treated?

Lymphedema is treated in a number of ways depending on the severity of an individual case. Wrapping the arm with bandages, utilizing a custom made garment (which can cost around $600 and is extremely tight) and draining fluid using MLD (Manual Lymph Drainage) are the usual therapies. Other than these procedures, medicinal beige garments are available over the counter to manage lymphedema.

How did the company get started and how did you get on board?

I met Rachel in March of 2006, when a mutual friend introduced us to discuss Rachel's dissatisfaction with her current compression arm sleeve. Rachel not only disliked the look of her garment, but how it felt, and she knew that other women must have felt the same way. We held a focus group at University of Penn and Rachel's prediction proved true - every woman agreed with her. So we decided to make it happen. We wrote a business plan, and because I was still at student at Drexel University, I submitted it into the annual business plan competition. I presented our plan once we became finalists, and we won 3rd place. It was fabulous!

Can you describe your product and how it is sold?

I tell women, "Replace your medical device with a fashion accessory." Women who wear them design our compression garments. We offer stylish color and print options, moisture-wicking capabilities and Lycra © © Body Care for added softness. We have 15 styles - 9 prints, 6 solids. Currently we sell online at www.lymphedivas.com, over the phone 1-866-411-DIVA, through breast care boutiques and DMEs as well as direct to customers at conferences such as the annual Young Survival Coalition conference.

How has this company and your work with breast cancer survivors affected your life?

Honestly, the first couple of conferences/shows were very overwhelming and emotional for me. However, when the presentation broke and we had the chance to meet the ladies, it was really wonderful to feel as if we could offer them something new and exciting. At this point it is an absolute joy. I am thrilled with what I do, and I adore my lovely DIVAs! I have many return customers and have created special bonds with them.

And, if you can, can you tell me how Rachel's passing has affected you and the operation of LympheDIVAS?

I miss my partner very much. She could never be replaced, but having Rachel's parents and husband involved in the business has been a true blessing.

After Rachel passed I experienced a real sense of clarity and focus that I had not had for quite some time. I consider her with every move I make - I do find myself missing her very much, especially when we are having a bit of success, because I miss sharing that with her.

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April/May 2008 Issue

Novel Approach May Spell Safer Gene Therapy

Ilene Raymond Rush
Editor-in-Chief
April 15, 2008

A novel strategy for circumventing safety problems that have plagued gene therapy has been offered by a complex multicenter group of researchers, including Professor Claudio Napoli, a Full Professor at the II University of Naples and Adjunct Professor at the Sbarro Research Institute for Cancer Research and Molecular Medicine and the Center of Biotechnology at the College of Science and Technology of Temple University. The study appears online in the journal Cell (Cell 2008 Feb 8;132:397-409).

The researchers report that adenovirus type 5, a common vector for delivering gene therapy, transfects liver cells by a different mechanism than previously thought. That mechanism offers a new target for modifying the viral vector to make it safe for clinical use.

Prior studies indicated that it would be possible to use adenovirus as a vector to deliver genes into specific locations, such as a solid tumor. But when the virus is injected intravenously, it accumulates in the liver instead of circulating in the body, raising the risk of toxicity and transfection of other cells.

Basically, adenovirus consists of three major proteins - fiber, penton and hexon. In earlier work, most researchers held that the main mechanism of viral transduction was the fiber protein's interaction with a receptor on the target cell. But attempts to mutate the fiber protein did not block the virus's accumulation in the liver in vivo.

Professor Andrew Baker of the University of Glasgow, who led the current research, noted that all of these fiber-modified viruses still ended up transducing the liver. The Cell paper, therefore, focuses instead on the hexon protein. The researchers mutated the protein, disabling its ability to interact with a blood-clotting enzyme, Factor X. Those mutations, and pharmacological blockade of the interaction, did indeed block gene transfer, suggesting that the virus enters liver cells via the interaction of the hexon protein and Factor X.

The researchers note that fiber-mediated transduction works when the virus is injected in muscle or cell culture, but when injected into the bloodstream, this mechanism takes over.

"Now that we have learned the mechanism that an adenovirus uses we could modify that process by genetically engineering the virus, to improve uptake into several cell types, including stem cells," says Dr. Napoli.

"Our hope is that this new discovery will point to new avenues to develop important and safer delivery of gene therapies," adds Antonio Giordano, M.D., Ph.D., the Director of the Sbarro Institute for Cancer Research and Molecular Medicine. in Philadelphiai, PA.

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April/May 2008 Issue

Give Early-Stage Research A Funding Chance

Antonio Giordano, M.D., Ph.D.
Director, Sbarro Institute
April 15, 2008

In a recent article in the New England Journal of Medicine, Tadataka Yamada, M.D., the President of the Global Health Program for the Bill and Melinda Gates Foundation, announced Grand Challenges Explorations, a new $100 million initiative which will fund hundreds of innovative early-stage research projects over the course of 5 years, investing $100,000 in each one.

Ideas will be solicited from around the globe, in an effort to emphasize that new and exciting advances are not limited to researchers in the United States and Western Europe. The projects will require creative thinking but no preliminary data, and will be run by two groups of reviewers - one composed of internal scientists, and another of partners and advisers with a history of identifying creative solutions to difficult problems.

While noting that the foundation expects many of these projects to fail, Dr. Yamada says that they stand ready to put substantial funding behind those that succeed - no matter from where they arise.

As the Director of the Sbarro Institute for Cancer Research and Molecular Medicine in Philadelphia, as well as labs across Europe, it is impossible not to applaud this effort. Hard experience has taught many investigators that those innovative or bold solutions that divert from traditional thinking of the scientific or medical community face enormous difficulties in funding and acceptance. But Dr. Yamada notes that if "we are not willing to take risks and fail often, we will miss many opportunities to capture novel approaches that can transform a field. Above all, unfortunately, peer review can kill truly novel ideas because they are, by definition, peerless."

It's an initiative worth applauding, an essay worth reading and a sentiment worth remembering.

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April/May 2008 Issue

Cancer Briefs:Chemo Damage & Preventing Cancer

Ilene Raymond Rush
Editor-in-Chief
April 15, 2008

Shielding Healthy Cells From Chemo Damage

Fasting for two days protects healthy cells against chemotherapy, according to a study appearing online in PNAS Early Edition.

Mice given a high dose of chemotherapy after fasting continued to thrive. The same dose killed half the normally fed mice and caused lasting weight and energy loss in the survivors.

The chemotherapy worked as intended on cancer, extending the lifespan of mice injected with aggressive human tumors, reports a group led by Valter Longo of the University of Southern California.

Test tube experiments with human cells confirm the differential resistance of normal and cancer cells to chemotherapy after a short period of starvation.

Making chemotherapy more selective has been a top cancer research goal for decades. Oncologists could control cancers much better, and even cure some, if chemotherapy were not so toxic to the rest of the body. Human trials are planned.

See Newswise>>

Preventing Cancer: Steps You Can Take

* Don't smoke. Quit now if you do.

* Eat well. A healthy diet includes whole-grain breads and cereals and 5 to 9 servings of fruits and vegetables every day.

* Be active and maintain a healthy weight. Be physically active for at least 30 minutes on 5 or more days each week.

* Avoid UV radiation from the sun, sunlamps and tanning booths.

* Avoid chemicals and other substances that raise your risk of getting cancer. Follow instructions and safety tips on the products you use.

* Avoid and treat infections that can cause cancer. Talk to your doctor about avoiding viruses that cause cancer, and about any stomach problems.

See: Wise Choices>>

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April/May 2008 Issue

Pioneering Gene Therapy Restores Sight

Univerity of Pennsylvania
Press Release
May 1, 2008

Researchers from the University of Pennsylvania have used gene therapy to safely restore vision in three young adults with a rare form of congenital blindness. Although the patients did not achieve normal eyesight, the preliminary results set the stage for further studies of an innovative treatment for this and possibly other retinal diseases. Results from the clinical trial done at The Children's Hospital of Philadelphia appear online in The New England Journal of Medicine.

"This is the first gene therapy trial for a nonlethal pediatric condition," said Albert M. Maguire, M.D., Associate Professor, Department of Ophthalmology, University of Pennsylvania School of Medicine and a physician at The Children's Hospital of Philadelphia. Maguire, together with his wife, Jean Bennett, M.D., Ph.D., Professor of Ophthalmology at Penn and Senior Investigator at the F.M. Kirby Center for Molecular Ophthalmology at Penn's Scheie Eye Institute, have been researching inherited retinal degenerations such as Leber congenital amaurosis (LCA), for 18 years. LCA is a group of inherited blinding diseases that damages light receptors in the retina. It usually begins stealing sight in early childhood and causes total blindness during a patient's twenties or thirties. Currently, there is no treatment for LCA.

"Patients' vision improved from detecting hand movements to reading lines on an eye chart," Maguire added. In 2001, Bennett and Maguire were part of a team which reported successfully reversing blindness using gene therapy on dogs affected by the same naturally occurring form of congenital blindness.

The current study is sponsored by the Center for Cellular and Molecular Therapeutics at The Children's Hospital of Philadelphia, directed by Katherine A. High, M.D. High, a study leader and an Investigator of the Howard Hughes Medical Institute, has been a pioneer in translational and clinical studies of gene therapy for genetic disease, and in 2005 initiated a collaboration with Bennett and her group to translate their exciting animal findings into a clinical study.

The scientists used a vector, a genetically engineered adeno-associated virus, to carry a normal version of the gene, called RPE65, that is mutated in one form of LCA. Three patients received the gene therapy via a surgical procedure performed by Maguire between October 2007 and January 2008 at The Children's Hospital of Philadelphia, where the gene vector was manufactured at the hospital's Center for Cellular and Molecular Therapeutics (CCMT).

Starting two weeks after the injections, all three patients reported improved vision in the injected eye. The researchers also reported that each injected eye became approximately three times more sensitive to light, and each was improved compared to the uninjected, previously better functioning eye.

Testing continued over a period of six months following the gene therapy vector administration. One patient was better able to navigate an obstacle course compared to before the injection. The patients also had less nystagmus, an involuntary movement of the eyes that is common in LCA. In the patient who experienced better vision even in the uninjected eye, the researchers suggest that the reduced nystagmus benefited both eyes.

"The current clinical trial will continue with more patients and with ongoing follow-up to monitor results," said Bennett. "We expect improvements to be more pronounced if treatment occurs in childhood, before the disease progresses."

In addition to the team at The University of Pennsylvania and The Children's Hospital of Philadelphia, the Second University of Naples and the Telethon Institute of Genetics and Medicine (both in Italy), and several other American institutions took part in the research.

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