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Pluristem reports strong results of stroke drug test

04.12.08

Pluristem Therapeutics stock soared 113% Monday on Nasdaq, after the Haifa-based biotherapeutics firm, which specializes in stem-cell therapy products, announced it had successfully completed a preclinical study on its treatment of stroke patients. The study conducted under the supervision of Prof. Frank Emmrich, head of the Fraunhofer Institute in Leipzig, Germany, demonstrated statistically significant improvement in functional and neurological condition in rats, after injection of the treatment.

This is Pluristem’s second preclinical study of the therapy, which involves injection of placental stem cells. The first study, which was conducted in France, showed improvement in mice that received the cells even 10 hours after occurrence of the stroke, compared to existing therapies on the market, which require the patient to receive treatment no later than three hours after the occurrence.

But at Pluristem there is even more excitement over the upcoming human clinical trial for its therapy for lower extremities arteriosclerosis this summer. “This will be the first clinical study in the world, in which placental stem cells are injected into humans, so everyone is on tenterhooks, as we are. But once we are able to prove it [viable], the sky is the limit,” Pluristem CEO Zami Aberman said at the firm’s offices in Haifa.

Aberman is a great believer in the potential inherent in placental stem cells. Up until a few years ago, the prevailing attitude was that the placenta was useless after birth. But Pluristem began examining the placenta as an interesting source of stem cells for biological therapies, based on the assumption that the source of stem cells for production of blood cells is the placenta rather than the umbilical cord.

Arteriosclerosis is a disease in which clots are formed in blood vessels, mainly in the legs. Diabetics, heavy smokers and overweight people for the bulk of those suffering from arteriosclerosis. According to Aberman’s data, the number of patients worldwide reflects a $4 billion market for the therapy, and this is just for the lower limbs. In the U.S. alone there are about 12 million patients, and Pluristem believes that the blood circulation in their legs can be improved, and amputations prevented.

The first stage of clinical tests will begin between July and October, and continue over 6-12 months. The test, which will include 20 patients, involves a single injection, followed by monitoring of the healing process.

Aberman is expecting initial results by mid 2009. The next two stages will be far broader, and include 200 patients each. The paperwork for the first stage has already been submitted in Germany and the U.S., and Pluristem expects U.S. Federal Drug Administration approval of the Haifa plant by mid-June.

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Candidates May Post Drug Test Results

04.12.08

A bill that would let political candidates post the results of voluntary drug tests on a state Web site could get a final vote in the Senate today.

Sen. Harvey Peeler wanted to require drug testing for candidates after the state’s former treasurer, Thomas Ravenel, was indicted on a drug charge.

In mid-March 2008, Ravenel was sentenced to 10 months in prison after pleading guilty to a cocaine charge last September.
There are questions about whether the drug testing measure could survive legal challenges.

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Drug test or trust a teen: There’s a lot at stake

04.12.08

Here’s some chilling reading: Nearly one-third of all eighth-graders have taken an illicit drug; half of all teenagers say they’ve had a drink in the last 30 days; every day, almost 6,000 youths under 18 start smoking cigarettes.

What’s a parent to do?

Kim Hildreth, a mother living in Texas, doesn’t hesitate: Test your kids at home for tobacco, alcohol and drugs. “From a parent’s standpoint, we need all the tricks in the trick bag that we can get,” she says.

Hildreth is so passionate about this subject that several years ago she began selling mail-order drug-testing kits (DrugTestYourTeen.com).

Her advice: Take your child into the bathroom, hand them a cup and tell them, “This is how I’m going to sleep better at night.”

I asked her about ethics issues, like trust and respect.

“Don’t be a chump,” she answers in the straight-talking way that is oh-so-Texas. She likens it to not checking your child’s report card or not calling the other parents before letting your child go on a sleepover.

“If you blindly believe everything a teenager says to you, first of all you don’t recall being a teenager,” she says. “That’s just ignorant. It’s careless parenting.”

Hildreth is convinced these home tests are a deterrent. “It’s also an effective out for the other kids. They can say, ‘My mom’s such a crazy witch, she’ll drug test me.’ ”

Case closed? Not exactly.

Mary Devereaux also is a mother and she would never drug test her kids unless she had good reasons. Even then, she’d go to a professional.

For Devereaux, trust and respect are paramount. If you are drug testing your kids against their will, “you’ve already lost half the battle,” she says.

If the results are negative, “you’ve really damaged the trust,” she adds. If they’re positive? “You’re still going to have to go to a professional to find out exactly what you’re dealing with.”

Devereaux directs the biomedical ethics seminars for the University of California San Diego’s Research Ethics Program. She cites literature warning that home tests are not always reliable and there are tricks that can taint the results. She also argues that research is inconclusive over whether the threat of random drug testing is an effective deterrent.

Her advice: Talk to your kids about drugs and alcohol and tobacco. If you see signs that your child’s behavior is changing, ask your child what’s going on. Contact other parents, if necessary, and school officials.

“My impulse is to have conversations, and if drug testing needs to be done, then it needs to be done by a professional,” Devereaux says.

“I think parenting is all about trust and communication,” she adds.

As an ethicist and a mother, she does not dismiss the drug problem. It’s serious and it’s scary. She also is sympathetic to the other side of the debate. “I can see why people resort to this because it seems like an easy solution,” Devereaux says.

But someday, those kids are going to be on their own and away from your home drug tests. “The real goal here is to get your child or your teenager to decide for themselves not to do drugs,” she says.

But ethics issues aren’t always black and white. Hildreth remains unswayed on the other side. “I hear all the arguments, and it just makes me scratch my head,” she says. “I’m blind about why it should be an issue. It’s just part of our job.”

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