Levitt Letter Extra News

By Judy Siegel-Itzkovich www.JPost.com

The volunteer organization Ezer Mizion is holding a drive on Wednesday for blood samples to find a compatible donor for a six-year-old Kfar Saba girl named Amit, who has leukemia.

Six year old Amit awaits a bone marrow transplant

People between 18 and 50 years old and in good health who have never donated a sample to any bone marrow registry are invited to give a small sample to see whether they have a compatible type for stem cell transplants.

In addition to Amit, other cancer sufferers in Israel and around the world could benefit, especially Jews who have related tissue types. Thousands of new potential stem cell donors are expected to join Ezer Mizion’s registry.

The organization is also raising money to process the blood samples, each of which costs $46. Donations can be made and more information is available on the Web site at www.ezermizion.org.

The union of Jewish Agency staffers announced Tuesday that it was donating $4,600 to process 100 samples. Union head Yona Bezaleli and Jewish Agency chairman Ze’ev Bielski asked all staffers to join the project and find a compatible donor for Amit.

By Alex West
www.TheSun.co.uk

At least 40 al-Qaeda fanatics died horribly after being struck down with the disease that devastated Europe in the Middle Ages.

The killer bug, also known as the plague, swept through insurgents training at a forest camp in Algeria, North Africa. It came to light when security forces found a body by a roadside.

The victim was a terrorist in AQLIM (al-Qaeda in the Land of the Islamic Maghreb), the largest and most powerful al-Qaeda group outside the Middle East. It trains Muslim fighters to kill British and US troops.

Now al-Qaeda chiefs fear the plague has been passed to other terror cells — or Taliban fighters in Afghanistan. One security source said: “This is the deadliest weapon yet in the war against terror. Most of the terrorists do not have the basic medical supplies needed to treat the disease. It spreads quickly and kills within hours. This will be really worrying al-Qaeda.”

Black Death comes in various forms.

Bubonic Plague is spread by bites from infected rat fleas. Symptoms include boils in the groin, neck and armpits.

In Pneumonic Plague, airborn bacteria spread like flu. It can be in the body for more than a week — highly contagious but not revealing tell-tale symptoms.

The al-Qaeda epidemic began in the cave hideouts of AQLIM in Tizi Ouzou province, 150km east of the capital Algiers. The group, led by wanted terror boss Abdelmalek Droudkal, was forced to turn its shelters in the Yakouren forest into mass graves and flee. The extremists supporting madman Osama bin Laden went to Bejaia and Jijel provinces — hoping the plague did not go with them.

A source said: “The emirs (leaders) fear surviving terrorists will surrender to escape a horrible death.”

AQLIM boss Droudkal claims to command around 1,000 insurgents. Training camps are also based in Morocco, Tunisia and Nigeria. AQLIM bombed the UN headquarters in Algiers in 2007, killing 41. Attacks across Algeria last year killed at least 70 people.

In an interview last July, Droudkal boasted his cell was in constant contact with other al-Qaeda “brothers”.

By Judy Siegel-Itzkovich The Jerusalem Post

The war in Gaza has not slowed down the work of Save a Child’s Heart (SACH), the voluntary organization based at Holon’s Wolfson Medical Center that has provided free cardiac surgery to over 600 Palestinians and nearly 2,000 others from around the world.

A three-week-old baby named Jafar from Gaza underwent surgery on the last Sunday in December, two days after Israel’s air strikes on Gaza were launched.

Dr. Lior Sasson, SACH’s chief surgeon, has done so many operations in recent weeks that he can hardly keep track. Jafar, he said, would almost surely have died quickly after birth because he was born with a severe congenital heart defect, the transposition of the great arteries.

“Tomorrow we hope to take out the drainage tube. He is a very sweet baby. We don’t care if he comes from a Hamas family or what. He is a baby,” he said.

In December alone, the SACH staff of 70 – including five physicians – performed lifesaving surgery on 10 children from Gaza. “It is not difficult to get them here. We have a well-oiled operation, and the security forces know us well. There are no problems, even during a war,” Sasson said.

Jafar was accompanied by his grandmother; Sasson conversed with her with the small amount of Arabic he knows.

SACH (www.saveachildsheart.org) was founded by the late Dr. Amram (Ami) Cohen, a pediatric heart surgeon who came on aliya from the U.S. in 1992 and quickly established the organization, which he turned into an important contributor to children’s health worldwide. He joined Wolfson’s staff and served as the deputy chief of cardiovascular surgery and head of pediatric cardiac surgery.

In 1988, while serving in the U.S. armed forces in Korea, the head of the international organization Save the Hearts approached him. The organization was sending orphaned and indigent Korean children to Western countries for medical care not available locally. Cohen was so impressed with the idea that he requested and received permission from his superiors to participate in the program, and during the rest of his time in Korea, performed 35 pediatric cardiac surgeries. Cohen died in a tragic accident while climbing the Kilimanjaro Mountain in 2001.

“Ami would be very proud of us that we are continuing what he started by operating on young children from Gaza,” Sasson concluded. Despite the world financial crisis, SACH is still able to attract donations with which the organization is able to continue.

By Willem Dercksen, The Jerusalem Post

Five-year-old Philipp, who has Down’s syndrome, is floating in the water next to a female dolphin and her newborn calf. Gone is his usual impatience. He gently caresses the mother’s back. The mother takes care that her calf is out of his reach.

It is Philipp’s second week at the reef. “He is growing day by day,” his mother Marlit, explains. His first day was hard. “Everything Philipp doesn’t know, he doesn’t want. He didn’t want a wet suit, he didn’t want to go into the water and he didn’t want to be with [trainer] Sophie. We wondered what we started here.”

Philipp’s father Uwe, and his big brother, Pierre, also came to Eilat, in Israel. The care and the security of the family are important for the results of the therapy.

The second day was better. “Philipp was curious, he watched and he accepted Sophie, although he was gesturing all the time that he wanted his father,” Marlit says. Philipp cannot talk yet. His parents taught him a sign language to facilitate the step to talking.

The dolphins are stimulating Philipp. “This second week we see him making efforts to utter words all the time.”

Sophie Donio is one of the pioneers of the Dolphin Reef. She started as a diving master. “I noticed how deeply the dolphins affected our visitors,” she says. After a year, she proposed starting dolphin therapy for disabled children. Her proposal was accepted and she developed the program herself. “Step by step it improved. Still, every day I learn more.”

Now, Donio refers to it as “a supportive experience with the aid of dolphins. We are not trying to cure or heal people. We are giving moral support.”

Kids and Dolphins

The Dolphin Reef pays homage to a distinctive philosophy. The dolphins, a group of bottlenoses, are not forced to interact with humans. They are free to choose between human company and the continuation of their daily routine of hunting, courting, playing and socializing. The reef, a corner in the Gulf of Eilat closed by nets, provides the dolphins with a natural environment. The water is deep and full of fish, allowing them to hunt for most of their food themselves. Their social life is rich. The first time I visited the reef, a baby dolphin had been born. To celebrate, the whole group of dolphins escorted the mother and her calf for an hour and a half as they cavorted along the contours of the reef.

In addition to Donio, the reef has four other trainers. They know the dolphins, they can anticipate their behavior and they know their likes and dislikes. The trainers also have the ability to understand the needs and possibilities of their impaired pupils.

Each therapy session has two parts: in the sea and on a platform. In the water, the trainers mediate contact between the dolphins and their pupil. On the platform, the trainers play games with the children, very often closely watched or supported by one or more curious dolphins. All activities are dependent on the mental and physical abilities of the children.

PHILIPP WAS not planned. Nevertheless, Marlit was flying high when she noticed her pregnancy. After giving birth, she was completely shattered. “On the ultrasound the embryo seemed to be completely in order. I didn’t do an amniocentesis so as not to endanger his life. Now I am glad I didn’t, because during the pregnancy, I would have requested an abortion.”

Uwe and Pierre were a big support after Philipp’s birth. From the first minute they fell in love with him. For Marlit, it took a long time. “After two days I stopped crying for myself and started crying for the baby. But I continued crying for months for the baby I didn’t get.” Later, she understood that her pain was necessary to accept the child she had gotten and to be able to love him and to care for him. “Now, Philipp is my heart and my soul. He changed us all. Material things, like a new car or fashionable clothes, are not that important anymore. We experience that love, and our family is so much more important.”

It is not easy to have a child with Down’s syndrome. “You never know what Philipp will do. You can’t lose sight of him for a second.” Before Philipp was born, Marlit worked as a surgical assistant. She doesn’t have the time anymore. At home, Philipp gets therapy too, speech therapy, music therapy (”He is crazy about music”) and riding therapy (”He loves horseback riding the best”).

Because Philipp was not developing as Marlit and Uwe wanted him to, they began dolphin therapy. Marlit had read about it, and also saw a program on TV in her home in Lindenscheid, Germany. The finances were the main obstacle. The family has only one income, and the trip to Eilat, as well as their two-week stay in a hotel, are expensive. “We organized a flea-market in our home town to collect money. The Dolphin Kids [a German organization informing the public about dolphin therapy] showed a documentary movie, a supermarket sponsored drinks and snacks and a friend contacted the local press. We never thought that so many people were willing to help.”

The more therapy sessions I observe, the more impressive Donio becomes. Although she doesn’t speak German, she is able to communicate with Philipp effortlessly. Everything shows that they understand each other. In the water as well on the platform, Donio keeps eye contact all the time. Thus she knows how far she can go and how long Philipp is keeping his concentration.

She has a very special bond with the dolphins: They like to approach her, and they seem to understand Philipp’s possibilities. During a ball game on the platform, Donio engages one of the dolphins to throw the ball to Philipp a few times, by using his nose. Later, one of the dolphins lends a bottlenose when Philipp drops a plastic basket in the water.

“Today was a very good session,” Donio says close to the end of Philipp’s second week. “In the water he is more and more controlled in his interactions with the dolphins. Today he was really caressing them tenderly. And did you see us playing games on the platform? It was the first time Philipp laughed aloud. Everything shows that he is getting more and more confident and brave. Maybe I will let him swim with a mask tomorrow.”

Marlit and Uwe are equally enthusiastic. “Here in Eilat, Philipp became more loose and relaxed, more independent too,” Marlit says. “At home, he asks for help for everything. Yesterday we saw him take a bottle and pour himself a glass of water on his own.”

During this conversation, Philipp is sitting on one of the many cushions on a floating platform, listening to music on his headphones. “Also in the water you could notice that he gained courage,” Uwe adds. “He is not sticking to Sophie all the time. It is important for his future development that he learns to fight his fears.”

CHAN IS crying on this, his first day. He is in the sea with Donio. When putting his wet suit on, his little finger got stuck and it did hurt. “Maybe it was still painful, or maybe it was just the fright” Donio comments when they climb out of the water. She is satisfied with the start. “Cindy (the paterfamilias of the dolphin family) was with us all the time. Other dolphins came to touch Chan’s feet.”

I had noticed too that dolphins were swimming next to Donio and Chan all the time. It seemed as if the dolphins felt that Chan needed them. “Chan did not react so much to the dolphins,” Donio continues, “but he was watching them. It is amazing to start the session with a crying kid and to get such a happy ending.” She is crazy about Chan. “What a sweet boy.” When I ask her if she has these feelings towards all of her pupils, she just smiles.

Chan, six, lacks control over his muscles. Doctors diagnosed cerebral palsy (or more specifically, spastic quadriplegia) two weeks after his birth. It was caused by an infection his mother, Dunja Franke had caught during the pregnancy.

The bad news hit Franke hard. “I cried and cried and cried. My own parents died when I was six and I wanted to give this child everything I missed. In the first period after his birth, I was not able to feed him, to change his clothes, nothing. Family and friends helped me to get through.”

While still in the hospital in Cologne, Chan received Vojta therapy, stimulation of the sensorimotor system’s reflex points. When Franke started crying during the first session, the therapist told her to leave. “Your child will not gain anything from a crying mother,” she said. “She was right” Franke realizes now. “Looking back, I feel grateful for her remarks.” When Chan smiled for the first time, Franke returned to her old self.

Following the advice of the Vojta therapist, Franke treats Chan as a normal child as far as possible. “His father cannot do that. He doesn’t dare to leave Chan alone for a second. He wanted Chan to sleep in our bed. He didn’t join the therapy sessions and he was crying on a daily basis, also in Chan’s presence.” Franke felt like she had to take care of two babies. “Chan’s father loves him very much, but he cannot accept that his son is impaired.” The parents separated after two years. Now Chan visits his father every other weekend.

Chan had dolphin therapy before they came to Eilat. “When Chan was nearly two years old, the two of us went to Florida. There, in the water, he spoke his first word: mama.” A year later they went to Sharm e-Sheikh. “Unfortunately, in that period no dolphins showed up.” Later, Franke and Chan went to Spain twice. “Chan also learned a lot there.” Suddenly, he used words like “you” and “me.” One evening in Spain he said: “You also eat.” (Franke always feeds Chan first.) The dolphin therapy does not help Chan in physically; there is no cure for his disease. It only works mentally.

Franke had to be creative, too, to be able to afford the therapy in Eilat. This time a cousin was the guardian angel by donating the revenues from a benefit concert by his punk band. In Eilat she is receiving practical help from her brother and sister. Together they are renting an apartment and both assist on the platform and in transporting Chan. He cannot sit nor move on his own.

Even an outsider can notice that Chan benefits from the therapy. He is shining – in the water, on the platform and after the sessions in a shady spot on the reef’s secluded beach. I get an enthusiastic response when I ask him if he enjoys the therapy. But he doesn’t want me to carry him into the water. “Too tired.”

A BIT SKEPTICAL by nature, I wonder whether the effects of the dolphin therapy will last. Isn’t it just that being on a holiday, in a powerful environment of desert and sea, relaxes a child and his parents, evoking different behavior than at home?

When I express these thoughts to Donio, she walks into her office to get me a book. The doctoral thesis of Nicole Kohn, a German scientist. “Try your best, I cannot read that language myself.”

The thesis reports on the effects of dolphin therapy among 193 multiply disabled children. About half of them received dolphin therapy in Eilat, the others in Key Largo, Florida. It was the first time that a survey on this scale had been done. Kohn bases her findings on interviews with parents, teachers and therapists.

Her research does not leave much doubt that the dolphin therapy has significant positive effects on cognitive, motor and/or emotional development. It also shows that these effects last – she repeated her interviews six weeks after the end of therapy.

Another significant finding is that when the development of a child improves, the parents benefit too. Many parents reported that the quality of their own lives had improved due to the therapy.

Back home, I wait three months before calling Philipp’s parents to ask if they still notice the effects of the therapy. Philipp, Marlit proudly tells me, spoke his first full sentence: “Papa come.” Moreover, his fine motor skills improved, he does not need a diaper anymore at night and he makes an effort to dress and undress himself. “In a way, we also got therapy as a family,” Marlit concludes. “We learned that Philipp is able to do much more than we thought he could and we also learned how to challenge him.”

From Chan’s mother I wanted to know if this time too something beautiful happened to her son. “Chan looks up now if he hears something,” Franke says. “He is using more words, and if I turn a video about dolphins on, he starts laughing and telling me: ‘There, we were also there.’”

The Dolphin Reef in Eilat has a Web site, www.dolphinreef.co.il, that provides information on the therapy program.

By Stuart Winer, www.Israel21c.com

A new development that will one day enable the removal of breast lumps and tumors with a device that is no more invasive than a needle prick is very cool. Literally.

Israel’s Arbel Medical hopes that its IceSense technology will pave the way for simple cryotherapy, a method of surgery that uses extreme cold to kill diseased tissue.

There are 15 million women in the United States suffering from benign breast lumps. Every year one million women are sliced open on the operating table in expensive surgery to remove breast lumps.

“Half the medical world is dealing with removing these [lumps],” says Didier Toubia, CEO of the Yokneam-based company. “At present there are no non-invasive treatments for benign breast lumps.”

According to Dr Rafi Klein, a senior surgeon specializing in breast surgery at the Ramban Medical Center in Haifa and an advisor for Arbel, the threat of cancer prompts doctors to recommend removing all breast lumps even from young women.

“There is a lot of demand for finding a solution to surgery without causing scars,” he told ISRAEL21c.

IceSense provides that solution by offering the hope of efficient treatment in local clinics without the need for hospitalization, recuperation, or scarring. The IceSense mechanism enables the local application of super-cold temperatures and a fine control of the temperature itself. Liquid nitrogen is pumped to the end of a thin needle probe cooling the tip to the extreme cold required for cryotherapy. Utilizing ultrasound, surgeons can then guide the needle to the exact location of the lump and then freeze the unwanted tissue inside the body.

About the same size as a washing machine, the IceSense apparatus can be operated even in local clinics and medical centers. Providing treatment for breast lumps in local medical centers would be a big step towards the current trend in the US to conduct as much surgery as possible in local clinics by using non-invasive methods. This keeps expensive and over-worked operating rooms and teams free for more serious surgical procedures that require a hospital environment.

An hour-long surgery to remove a breast lump requires a full operating room team, costs about $2,000 and takes up several hours of the patient’s time with pre and post operation procedures. And the scars left behind will last a lifetime. An IceSense treatment will cost less than half that amount, take less than an hour at the clinic, and patients will be able to walk out right after the procedure.

While the theory of cryotreatment has been around for over 30 years, practical restraints have prevented its use for internal medicine. Although widely used today to treat external skin problems such as warts, moles, and cysts, using the same method for internal disorders is problematic. Effective treatment demands temperatures well below freezing point and generating such low temperatures in a way that is also convenient for the tightly controlled environment of invasive surgery is fraught with difficulties.

The most popular method of achieving cryotemperatures, that is temperatures well below freezing point, is by using liquid nitrogen. Nitrogen, the gas that makes up nearly 80% of the air that we breathe, is still viscous at 170 degrees centigrade below zero. This super-cold liquid is used in a variety of applications to provide extreme cooling. However, applying liquid nitrogen to internal tissue without using invasive surgery to cut a clear path to the target is impractical. The storage and handling of liquid nitrogen is awkward, requiring cumbersome vacuum-insulated storage vats and expensive piping to deliver the liquid before it boils into a gas. In addition, most liquid nitrogen systems are designed to supply the liquid at high pressure that is at odds with the delicacy of surgery.

Arbel engineer Alexander Levin explains that building a system to work with surgically small and precise amounts of liquid nitrogen was a challenge. Just keeping the nitrogen as a liquid while it is transferred to the probe required a newly designed siphon, but the real problem was concentrating the nitrogen in the end of the probe without freezing the entire length of the shaft. If the temperature of the shaft became super-cold it would freeze healthy tissue along its length.

“We needed to overcome all of these problems,” Levin recalls.

Levin resolved the difficulties by pulsing the nitrogen instead of using a steady flow. The pulses of just 0.2 grams of nitrogen do not cool the shaft of the probe but when collected in the tip the liquid boils into gas drawing heat from the end of the probe and the surrounding body tissue. The gaseous nitrogen is then drawn off back down the probe. As the temperature at the end of the probe plummets, an ice-ball forms around the tip freezing the surrounding body tissue.

The pulse mechanism enables precise and subtle temperature control at the tip of the probe ensuring the resulting ice-ball freezes only the target tissue. The IceSense pulse system gives surgeons precise control over the size and application of the ice-ball to minimize any collateral damage and target only the intended tissue.

The freezing procedure has several advantages over invasive knife surgery. It is easier to perform and does not require an operating room and team. In addition, the extreme cold acts as a form of anesthetic numbing the patient’s sensations in the area around the probe and reducing the need for chemical anesthetics.

Recuperation from cryosurgery is also healthier for the patient. The sudden surgical plundering of diseased tissue is traumatic for the body, but with cryotherapy the frozen tissue remains in place and is then dissolved out of the body by the immune system.

This natural method of disposal has an added bonus; regular knife surgery to remove cancerous tissue is always likely to leave behind some cancerous cells that escape the surgeon’s efforts. The remaining cells can spawn a return of the cancer in the same location. However, the dead tissue left behind after cryosurgery triggers a vigorous immune reaction. This heightened immune response has proved effective in killing off lingering cancerous tissue and may safe-guard against a resurgence of the disease.

According to Klein the procedure is similar to a needle biopsy. Although at first only a qualified general surgeon will be authorized to use IceSense, Klein predicts the procedure may follow the course of needle biopsies that were at first performed only by surgeons, but today are conducted by x-ray technicians as well. Once a surgeon has approved the procedure, an x-ray technician would be authorized to remove the lump.

Klein says that the benefits to the patient of non-invasive surgery outweigh the disadvantages to surgeons who tend to prefer a more tactile approach to surgery.

“Surgeons are like children – they like to feel things in their hands,” he says. “At first if feels like you are missing something but we are doctors and if you can do something that the patient feels better with and leaves no scars you feel better about it because it is better for the patient.”

At present Arbel intends to focus on benign breast lumps before expanding the technology for use to treat breast cancer as well. Benign lumps are easier to treat and the paperwork required to perform the procedures is easier. Toubia will begin trials on patients at the end of the year in Israel and intends to apply for FDA clearance to start clinical trials in the US by spring next year.

“It is an attractive business venture,” says Toubia who hopes to capture some 40% of the $500 million breast-lump market after IceSense becomes available to the public in 2009.

Toubia envisions breast cancer clinics using IceSense to treat women in a simple and quick procedure that only requires a local anesthetic. If successful IceSense will increase the number of women that can be treated on a daily basis as well as alleviate the difficult dilemma that many young women face when diagnosed with a breast lump.

“The whole decision as to whether or not to take out a lump will be made much easier,” Klein says. “Today women have to consider if they want to have surgery whereas like this it is much easier to do and more young women will choose to do it.”

By Nicky Blackburn, www.Israel21c.com

For Prof. Beka Solomon it was obvious. If it isn’t possible to send drugs to the brain to treat Alzheimer’s disease the normal way because of the blood-brain barrier that prevents drugs from moving from the blood stream into the brain, then send them through the nose instead.

Solomon, of the Molecular Microbiology and Biotechnology Department at Tel Aviv University, has been working in this field for the last 13 years after years of research in immunotherapy, and found in mouse trials that filamentous phages, a harmless bacterial virus found almost everywhere from the depths of the ocean to the lining of the stomach, can be an effective treatment against Alzheimer’s disease when carried to the brain through the nose.

Alzheimer’s is a debilitating disease that leads to progressive loss of memory and cognitive functions, and a great deal of suffering for both the person afflicted and their loved ones. In the U.S. alone, there are now more than five million people living with Alzheimer’s, but there is currently no drug on the market that can cure or effectively stop the progression of this disease.

The cause of this disease and other neurological diseases like amyotrophic lateral sclerosis (ALS) is widely concluded to be plaque formation, which causes inflammation in the brain. Up to now, scientists working on a cure for the disease have focused on dissolving and preventing plaque formation, but most have come up against two problems: firstly, the difficulty in developing drugs that pass through the highly selective blood-brain barrier; and secondly, unwanted side-effects of inflammation and hemorrhaging.

In her research, Solomon shows that by administering non-lytic filamentous phages in small doses through the nasal passages, the phages have a direct and rapid route to the brain. There they lock onto the extracellular plaques associated with Alzheimer’s and dissolve them, reducing inflammation in the brain without any side effects. The body then gets rid of the waste naturally.

“The filamentous phages have a nanotubular appearance which is very similar in shape to amyloid fibrils, the main component of amyloid plaque, which is the plaque linked to Alzheimer’s,” explains Solomon, who recently presented her findings at a meeting of the American Society for Microbiology in Canada.

Solomon first began thinking about sending phages through the nasal passages because the plaque that causes Alzheimer’s first appears in the olfactory bulb. As a result, one of the early symptoms of this devastating disease is loss of smell.

To test her hypothesis, Solomon and her colleagues treated 150 mice with the phage intranasally for 12 months. They found the mice that had exhibited the symptoms of Alzheimer’s regained their sense of smell and also showed memory and cognitive improvement. After one year of treatment, they had 80 percent fewer plaques than untreated mice.

The phages were eliminated from the brain and secreted from the body in urine and feces. The researchers saw no adverse effects in the peripheral organs — the kidneys, liver, lungs, and spleen biology were all normal.

“The mice showed very nice recovery of their cognitive function,” says Solomon, who emigrated with her family from Romania to Israel about 40 years ago. “We saw a reduction in the amyloid plaque and a reduction in brain inflammation. Afterward the phages were eliminated naturally from the body through the kidneys without any adverse side-effects.”

“This is a potential breakthrough, but it needs to be proved further,” Solomon told ISRAEL21c. “Bateriophages are one of the most numerous life forms on earth and mammalian organisms are very frequently exposed to interactions with them. We know for instance that they are a very important part of the natural flora of the gut and research groups all over the world have developed classic phage therapy as an alternative to antibiotics. We are used to living with them, it’s not unusual, but to take them to the brain in unusual. This is the first attempt to use phages as a treatment for Alzheimer’s.”

Ramot, the commercial arm of Tel Aviv University is now planning to commercialize Solomon’s research and has licensed the technology to a startup company.

“Beka is a real pioneer in developing an immunotherapeutic approach for the treatment of Alzheimer’s disease,” says Irit Ben-Chlouch, director of business development, life sciences at Ramot. “She was the first to show the disease can be treated using antibodies and, as the main focus of her lab, has developed several different breakthrough approaches.”

In the meantime, Solomon plans to continue with her research, which she regards as a platform technology. She and fellow researchers at the university are now exploring whether this intranasal administration of filamentous phages can also be used to help patients suffering from Parkinson’s disease and Huntingdon’s disease.

She is also exploring the possibility of adding medicines, such as anti-inflammation agents to the phages, to bring the brain additional therapeutic medicines.

By Tim Johnson, McClatchy Newspapers

BEIJING � The medicine cabinet in the average U.S. home is filling with drugs made in China , and some experts say that could be a prescription for trouble.

China’s booming pharmaceutical industry has doubled exports to the United States in the past five years, undercutting competitors and making American consumers reliant on the safety of Chinese factories and captive to any disruptions in Sino-U.S. commerce.

It might seem like merely a trade issue. But industry experts in Europe and the United States say national-security concerns are edging into the debate.

Consider this scenario:
If a major anthrax attack were to occur in the United States � larger than the one in 2001, when five people died� pharmaceutical companies that make the two antibiotics most suitable for treatment, Cipro and doxycycline, would have no choice but to rely on China or India for key ingredients once American stockpiles were exhausted. Those ingredients no longer are made in the West.

A Portuguese company that ramped up doxycycline production in 2001 at Washington’s request said China now controls the flow of its crucial drug component.

“If we were asked to do this again, we would be dependent on China providing us with key starting materials that are unavailable in the rest of the world,” said Guy Villax, the chief executive of Hovione, a Lisbon -based fine chemicals company.

The spectacular growth of China’s pharmaceutical industry coincides with some equally huge problems. A kickback scandal ensnared China’s State Food and Drug Administration and its chief in charges that they gave approval for bogus drugs, including a counterfeit antibiotic that left 13 people dead. Wary of rising public anger, the state issued a Draconian sanction: It executed the agency chief in July.

Cases of tainted toothpaste, toys, and pet food that have made global consumers wary of the “Made in China ” label added urgency to a high-profile drug agency purge.

Even so, China’s $65 billion pharmaceutical industry is galloping at an annual growth rate of 24 percent in the first eight months of this year. Competitors say China’s drug companies not only have low-cost advantages, but also get a nearly free pass from U.S. drug regulators, who hold the screws to American companies� raising their costs significantly� but rarely inspect in China .

China says it’s a reliable source of safe medicine for its own citizens and export markets. At a news conference in early December, the deputy drug agency chief, Wu Zhen, called on countries to work together to ensure a safe global supply chain of medicines.

“To solve the drug safety problems, we need international cooperation,” Wu said. “We hope to have . . . more cooperation, and less finger-pointing.”

China dominates more than just antibiotics. U.S. regulators license 714 plants in China to produce ingredients for over-the-counter, generic, and prescription drugs for Americans. China has snagged a major share of the global sales of many vitamins, antibiotics, enzymes, and painkillers. It makes a third of the world’s acetaminophen, an over-the-counter pain medication. Acetaminophen is sold under many brand names, the best known of which is Tylenol, though Tylenol itself isn’t made in China .

This brings up another possible scenario:
“Just suppose you are taking some cholesterol drug, and its intermediates or active ingredients are made in China . Then there’s some conflict with Taiwan. Will your drug still be available?” asked Joe Acker , the president of the Synthetic Organic Chemical Manufacturers’ Association , a trade group in Washington. “The whole drug supply could be in jeopardy in these kinds of situations.”

Acker noted that he thinks that the United States could rebound from disruptions in the increasingly globalized supply chain for drug components, in which materials are bought from a number of low-cost countries.

“I’m not a Chicken Little type of person,” Acker said. “However, if there were to be a major problem, and we could not source material from China, we would have to gear up production very quickly.”

The anthrax scare jolted the United States just a week after the terrorist attacks of Sept. 11, 2001. Letters containing anthrax spores were mailed to news organizations in Florida and New York and to the offices of two U.S. senators. Authorities don’t know the source of the letters, and no arrests have been made.

Because of the attacks, the Health and Human Services Department increased stockpiles of antibiotics and vaccines against anthrax.

“We have enough antibiotics . . . to treat 40 million Americans,” Bill Hall, a spokesman for the department, said in an e-mail, adding that the government also has 28.75 million doses of anthrax vaccine.

Bayer, the German health-care giant, held patent protection until 2004 over the antibiotic known as ciprofloxacin, which it marketed as Cipro. That antibiotic now is mass-produced by generic firms, which get a key ingredient, dichloro fluorobenzene, from one of four Chinese companies or two Indian firms.

The Chinese and Indian companies are all but exempt from oversight by the U.S. Food and Drug Administration.

“Only 13 inspections were conducted in China in 2007,” Rep. John Dingell, a Michigan Democrat who chairs the House Committee on Energy and Commerce, said at a hearing Nov. 1. “At this rate, it would take the FDA 55 years just to clear this backlog.”

By giving China a virtual pass on FDA inspections, Acker said, Chinese firms get a cost savings of about 25 percent above American companies, which face unannounced on-site inspections at any time.

Since European pharmaceutical companies also face tougher standards, they too have stopped producing some basic drug ingredients, ceding production to Chinese and Indian companies that face less scrutiny and have lower costs.

On both sides of the Atlantic, manufacturers say they fret over the national-security implications of the massive off-shoring of production to Asia.

“If there is a peak in demand triggered by a pandemic or a terrorist event, there will be little domestic production capacity to meet public health needs,” said an August 2006 white paper by the U.S. chemicals trade group in conjunction with the European Fine Chemicals Group, its counterpart.

Chinese chemical companies that sell ingredients used by foreign pharmaceutical firms also shield themselves from the news media.

Sun Dongliang, the deputy chief of the chemical industry chamber under the powerful China Council for the Promotion of International Trade, refused a request for an interview.

“He thinks that your interview has nothing to do with the chemical industry. It’s about pharmaceutical things,” said an assistant who gave only her surname as Guo.

All four Chinese companies that manufacture the key ingredient for ciprofloxacin declined requests for interviews.

China offered foreign journalists a tour of two model pharmaceutical plants in Hangzhou on Nov. 23. The plants were spotless. Workers in facemasks toiled in jumpsuits on assembly lines. Polished machinery gleamed. One factory made Chinese medicines to treat prostate ailments. The other made herbal remedies.

Outsiders say Chinese drug plants run the gamut from First to Third World.

“You will see some companies where you can eat off the floor. They are state-of-the-art,” said Acker, the U.S. trade group chief. “I hear other stories of places where people are making chemicals while wearing flip-flops.”

Despite multiple requests over a two-week period, McClatchy was unable to gain access to any drug ingredient-manufacturing facilities other than the model firms presented by the Chinese government.

Although Chinese authorities warn against foreign finger-pointing, the government’s own reaction to the scandal over bogus and substandard drugs earlier this year was extremely harsh.

After drug chief Zheng Xiaoyu’s execution, the state began a vast housecleaning. This week, it said it had shut down 300 drug and medical-device makers, convicted 279 people of irregularities and prompted drug companies to withdraw 7,300 applications for drug approval, indicating more rigor in the approval process.

Such actions left doubt whether consumers ought to be reassured by the factories shut down or alarmed at the state of the industry. Wu, the deputy drug chief, said he hoped to restore faith in Chinese drugs after the kickback scandal.

“The corruption case . . . has tarnished our image,” he said. “One of the targets of this campaign is to clean up the legacy caused by this corruption case.”

Still unclear is whether increased self-policing is sufficient given the magnitude of China’s production and its rising share of global medicine chests.

Villax, the Portuguese executive who’s a board member of the European Fine Chemicals Group, said some Chinese pharmaceutical manufacturers were cutting corners and that unless enforcement tightened “people will die.”

“It’s not low-cost labor that concerns us,” Villax said. “What we’re saying is there are a lot of people not playing by the rules, and not getting caught.”

A sign of the troubles that can occur in the pharmaceutical industry came at a plant that was manufacturing a key ingredient used in ciprofloxacin.

A deafening blast ripped through the Fuyuan Chemical Co. plant in Jiangsu province on July 28, 2006. Once the smoke cleared, 22 people lay dead and another 29 were injured. China’s State Administration of Work Safety later issued a report charging the plant with ignoring safety rules, adopting low construction standards and operating without permits.

By Karin Kloosterman, www.Israel21c.com

For most of his professional life, Tel Aviv University professor Michael Ovadia focused on snakes and the medicinal properties of their venom. But seven years ago, after meditating on a biblical passage, Ovadia’s career focus began to take a twist… a cinnamon twist to be exact.

Today the spiritual scientist from TAU’s Department of Zoology is commercializing a unique cinnamon extract that is touted to quell viral infections from HIV to the Avian flu.

A research and license deal on his patent-pending cinnamon extract was signed last week between TAU’s technology transfer company Ramot and Frutarom, a multinational nutraceutical company based in Israel. Frutarom is expected to use the extract in a whole host of applications from disinfecting the air as a spray against Avian flu in airports; to a daily supplement that protects people against the common flu.

Those researching in the field of natural medicine know that snake venom, especially the notorious poisonous kind, has unique anti-viral and analgesic properties that can help fight human illness and disease. For the past 40 years, Ovadia had been working with natural antidotes and found that certain kinds of venom can deactivate Parainfluenza (Sendai) virus — a virus similar to the human flu.

Work was going well. Papers were published, patents had been developed, and his reputation in the field was established. But Ovadia was still waiting for the breakthrough that every scientist dreams about.

That breakthrough would come to him one morning in the synagogue while listening to a reading from the Old Testament.

“There is a passage that explains how the High Priests — the Kohens — would prepare a holy oil used on their bodies before they made a ritual animal sacrifice,” recalls Ovadia. “I had a hunch that this oil, which was prepared with cinnamon and other spices, played a role in preventing the spread of infectious agents to people.”

Taking his hunch to the laboratory bench, Ovadia’s initial experiments proved to be true — his savory cinnamon extract was able to quickly and effectively immunize chicken embryos from the Newcastle disease virus — one which costs the poultry industry in the US millions of dollars a year.

Further studies on Avian Flu H9, Sendai virus, the HIV virus, and Herpes Simplex 1 also achieved positive results. Not only was the extract able to neutralize the viruses, it also showed for selected viruses that it has the potential to immunize against them as well.

Michael Ovadia mulls the effects of a cinnamon stick: I had a hunch that this oil [described in the Bible], which was prepared with cinnamon and other spices, played a role in preventing the spread of infectious agents to people.

Now before people start dropping cinnamon sticks in their hot chocolate and sprinkling it all over their lattes — take note that the cinnamon extract developed by Ovadia has special properties that won’t be found at coffee shops or in the kitchen cupboard. First of all, it comes from a special variety of cinnamon; coumarin and cinnamon aldehyde, which are by-products of cinnamon ‘juice’. These are actually damaging to the liver in high quantities, and must be removed.

“You cannot take high doses from the natural form of cinnamon,” Ovadia told ISRAEL21c. “If you used it several times a day to protect you from the flu, it would be toxic.”

During seasonal epidemics, around 10-20% of the world is infected with the influenza virus and the elderly and young are particularly at risk. In America alone, the U.S. Centers for Disease Control and Prevention estimates that 35-50 million Americans are infected with the flu every season. Despite the use of vaccines, the influenza virus is still associated with significant mortality worldwide — especially now that people travel regularly and work together in offices and closed spaces.

Moreover, the global circulation of the deadly Bird Flu H5 (with more than 50% mortality in infected humans) may cause a sudden worldwide pandemic within two to three months. Until a vaccine is invented, antivirals will be the only medical intervention for use in such a pandemic, says Ovadia.

“What we know is that this technology is capable of neutralizing viruses very fast and that it is applicable to various applications,” said Dr. Nissim Chen, the business development manager of Ramot who managed the commercialization process which ending up with the licensing to Frutarom. “For example, it can be used in air conditioning systems in hospitals and prevent infections spreading from one person to the other in closed spaces.”

There is a growing tendency for researchers and clinicians to explore natural compounds against disease, agrees Chen, adding that Ovadia is well-known for his work in natural inhibitors of snake venom.

“This work with cinnamon is really an extension of his research. And at Tel Aviv University in general, there are several groups working on biological and chemicals structure of natural inhibitors,” he said.

Besides the human application, Ovadia sees that cinnamon fills an important niche in the agriculture industry where chicks need to be immunized by hand against the deadly Newcastle disease virus.

“If someone needs to immunize 1,000 chicks through drops in the chick’s eye, then we know they are not doing this accurately — it is also an issue of animal welfare,” says Ovadia.

Instead, he believes, “we will be able to administer this cinnamon extract through a tiny pin prick in the shell before the chick hatches.” Such an immunization gives the chickens protection against the Newcastle virus, Ovadia assures.

Applying this research to the global scale could only be done with the help of a large company — which is where Frutarom comes in. The Israeli-based flavor and food additive company has grown in the last 10-15 years from $10 million a year to a projected $350 million by the end of 2007.

“We’re going to take this know how from a food supplement to protect people from illness to neutraceuticals in drugs; it can also be used in agriculture against Bird flu — certainly it represents a very diversified product line,” said Frutarom’s CEO Ori Yehudai.

According to the company, Ovadia will continue to lead research into the development of the extract, and Frutarom estimates that the new cinnamon product will be launched in about a year. Hopefully just before flu season.

By Nicky Blackburn, www.Israel21c.com

The best thing to do if you suffer peripheral arterial disease (PAD), a chronic condition that happens when a plaque blockage occurs in a peripheral artery in the legs or pelvis, is to walk. Walk, and walk, and walk. The act of walking enlarges and expands the small blood vessels around the artery, ensuring that you receive a steady flow of blood to the lower extremities despite the plaque blockage.

For some patients with PAD, however, walking just isn’t possible. Perhaps they have an injury or swelling, perhaps they are elderly or diabetic. The upshot is that oxygen-rich blood does not reach the lower limbs. This causes pain, changes in skin color, ulcers and difficulty in walking. But if the plaque blockage — made of fats and cholesterol — grows large enough to completely block the artery or ruptures to form a blood clot, the result is a total loss of circulation to the legs and feet, which can cause gangrene and amputation.

Nearly 12 million Americans now suffer from PAD, and experts predict this number will rise to 19 million. While there are existing treatments including angioplasty, atherectomy, or bypass for some of these people, for the 750,000 patients whose condition has deteriorated into critical limb ischemia (CLI), there is no existing therapy. These ‘no-option’ patients are not candidates for conventional treatments, have an alarming mortality rate, and face imminent amputation. Every year in America some 187,000 no-option patients undergo amputation of a lower limb.

Now Israeli start-up PerAssist has developed a new treatment that may give these no-option patients a chance to save their limbs. The company’s innovative peri-arterial booster device called PeriBoost improves blood flow to the lower limbs of PAD patients in much the same way that walking does.

A PeriBoost sleeve is fitted around a major, intact, healthy blood vessel — usually the femoral or iliac arteries — near the diseased peripheral region using a minimally invasive laparoscopic procedure. A balloon is then inserted between the artery and the sleeve, and is held in place by the sleeve. The balloon is inflated and deflated in synchronization with the patient’s heart beat. An external control device includes an ECG.

The PeriBoost enlarges and expands the small blood vessels around the artery, ensuring that you receive a steady flow of blood to the lower extremities despite the plaque blockage.

This pumping action squeezes the blood downstream, ensuring that blood flow in the artery is maximized. By doing this it enlarges the small arteries around the blockage, bringing more blood down to the lower limbs.

“We aren’t treating the block,” says Roni Bibi, the CEO of PerAssist, “We are bringing more blood downstream, enlarging the velocity and flow to the small arteries by about 90 percent, to recover the leg and avoid amputation.”

The treatment, which has not yet undergone clinical trials and is designed for the legs only, is designed to be carried out daily for three hours over three months. It is not painful, according to Bibi, and the patient can function normally throughout the procedure.

“The blood vessel is not like a muscle, it has no sensors or nerves. All we are doing is pushing it and this does not cause any pain,” Bibi tells ISRAEL21c. “The patient can eat, sleep, read – whatever they want. They won’t feel a thing.”

PeriBoost compares well to existing treatments. For example, it does not require arteries to be incised or perforated, and therefore does not damage artery walls. In one treatment, a doctor will drill inside the artery, remove the blockage and clean the artery from the inside. This is major invasive surgery, can only be carried out in the upper leg, and often ends up as nothing more than temporary relief as the same area becomes quickly blocked again. Stents and bypass surgery are also significant surgical events, and very problematic for the elderly or diabetic.

PeriBoost is likely to be much cheaper than any of these existing treatments, and it can be left in place for future use if peripheral vessels become re-occluded. The only main drawback to PeriBoost is that treatment is slow — three months, rather than a few days of recovery after one surgery.

The idea for PeriBoost came from Dr. Aaron Hoffman, the company’s chief medical officer and director of the department of vascular surgery and transplantation at Rambam Medical Center in Haifa, and a friend of his, water engineer, Gaby Weizman. Hoffman, who is also an associate professor at the faculty of medicine at the Technion-Israel Institute of Technology and has been involved in cutting-edge vascular medicine for over 20 years, recognized the problems in this field for no-option patients and turned to his friend to see if they could come up with a joint solution. In 2005 PerAssist was set up at the Misgav Venture Accelerator. Bibi joined the company as its CEO.

In the last two years the company has taken its device through successful animal trials. “It was the first medical device proven to increase the Ankle Brachial Index [ABI the golden standard for PAD diagnosis] on a large animal model,” says Bibi.

The company now plans to raise an additional investment of $1.5 million to fund it through clinical trials, which are expected to be held in Switzerland, Germany and Italy. The company aims to receive CE approval in the first stage, and afterwards look for FDA approval. If all goes according to plan, the product could be out in the European market by the end of next year, and in the US in 2009.

“This is a good project and it can help a lot of people,” says Bibi. “For so many patients there is no solution today except amputation. We are holding out the promise of an alternative.”