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Pfizer plans new use for stem-cells

Big drug companies have largely stayed away from testing exotic stem-cell treatments. But now Pfizer is betting that a radical new adult stem-cell treatment may be able to stave off diabetes-induced retina damage, a leading cause of blindness.

In an unusual deal, the big drug maker is funding the creation of a biotech company in San Diego called EyeCyte, which will develop stem-cell treatments for eye diseases. The company is based on work by Scripps Research Institute ophthalmologist Martin Friedlander, who has pinpointed bone- and blood-marrow stems cells that, in animal experiments, have a remarkable ability to target and repair damaged blood vessels in the eye. Abnormal blood vessels are a key problem in both diabetic eye disease and macular degeneration.

In the future, patients with early signs of blood-vessel damage in the eye might go to the doctor in the morning and leave a blood sample. Adult stem cells would be isolated in the lab over the next few hours, and then the patient would come back in the afternoon and get an injection of his own purified stem cells into the eye. That single injection could stave off further blood-vessel damage for years, preserving eyesight that would otherwise be lost.

"It is unbelievable. These cells know where to go and they target the site of injury," said Friedlander. In his lab, he has cured mice "10 times over" in work funded by the National Eye Institute. The big question, he said, is whether the treatment will help people.

Developing a complicated procedure to purify stem cells for human trials was difficult at Scripps, because academic settings and government grants support basic research, not the applied-process development required for such targeted research, and Friedlander didn't want to go the typical venture-capital route. So instead, he approached Pfizer (nyse: PFE - news - people ) about funding a company to commercialize the therapy. His timing was good, as Pfizer this April started a new regenerative-medicine unit devoted to therapies involving stem cells.

"Pfizer has put its flag in the ground that there is future in regenerative medicine," said Corey Goodman, president of the company's biotech unit. "The eye is a very good place to be starting--it is an isolated organ, and there is a huge need."

The drug maker is putting in a modest $3 million to get the new company of the ground. But if the therapy looks promising in a couple of years, Pfizer has the right of first refusal to buy it outright. The concept is to combine "the entrepreneurial spirit of the start-up, but with the muscle and clout and access to resources of a pharmaceutical company," said Goodman. It's far from being a passive investment; Goodman says Pfizer's top scientists will work with Friedlander and his team.

Goodman also says Pfizer would consider more deals like this in the future. The company has little to lose by trying new things. Its stock is in the dumps, and its main drug, Lipitor, will face patent expiration in 2011.

Few good treatments exist for diabetic retinopathy, in which blood vessels that bring oxygen to the retina grow abnormally, leading to leakage of fluid or blood cells. To solve the problem, doctors sometimes resort to the radical step of using lasers to kill retina cells responsible for peripheral vision in order to preserve enough oxygen for those engaged in central vision.

Far better would be a treatment that repaired the vessel damage and restored proper blood flow. The first focus for EyeCyte will devise an efficient procedure for isolating and purifying the stem cells, called "CD44 high." Purified stem cells would be injected into a patient's eyes, where they would mature into support cells that could jump-start healing.

The object is to have a stem-cell treatment ready for human trials within three years, said Mohammad A. El-Kalay, EyeCyte chief executive and a veteran of several cell-therapy companies. When he heard about the technology four years ago, he "got very excited" because it looked like there might be enough cells in one patient's blood to treat the eyes without having to laboriously grow more cells in the lab.

"The goal is to intervene with these progenitor cells, stabilize the eye and prevent things from getting worse," said Friedlander. If it works as well as he hopes, one stem-cell injection might prevent further damage for as long as a decade.

Friedlander's stem-cell therapy could one day compete with drugs like Lucentis from Genentech. This drug is approved for macular degeneration and is in testing for diabetic eye disease. Novartis (nyse: NVS - news - people ) also sells treatments for various eye diseases.

Besides Pfizer, one of the few big drug companies involved in cell therapy is Johnson & Johnson. It is an investor in the San Diego biotech company Novocell, which is developing stem-cell therapy to cure diabetes.

SOURCE: Forbes

23 Jun, 2008

Overactive Bladder at a Young Age? - Ask the Expert

Dear Dr. Motola,
I have had an overactive bladder for several years but for the most part it's been manageable. I am 42. Normally, I feel the urge to void about every 90 minutes. But it has started to interfere with important activities, like taking an intense admissions test for graduate school, when I need one or two extra restroom breaks. The other time I feel the urge to go more often is after ejaculating. Then, I feel the urge to go about every 30 minutes for the remainder of the day. I have finally sought treatment and my doctor gave me Vesicare which is supposed to be similar to Detrol LA but I can't see much improvement and I'm not sure if this is even what I need. I seems like it's a prostate problem, but it doesn't exactly fit any of the common problems that I've researched on the internet, like BPH. The ejaculation factor seems to be puzzling to my doctor and other experts I've consulted.

Urinary frequency occurs for many different reasons, one which may be an overactive bladder. Prior to being labeled as having an overactive bladder certain testing should occur in order to exclude other underlying conditions.

Drugs such as Detrol LA and Vesicare are used for the treatment of overactive bladder. Other drugs also exist within this category which may also be effective.

It is important for you to undergo testing to eliminate other disease processes that may be causing the urinary frequency which you are experiencing. Prostatic conditions can also occur in the early 40s, and should also be considered as a potential source of your problem.

SOURCE: www.healthcentral.com

26 Dec, 2007

Aspirin, Hormone Therapy Combo Can Shorten Lives of Prostate Cancer Patients

By Amanda Gardner

WEDNESDAY, Dec. 26 (HealthDay News) -- Men undergoing hormone therapy for prostate cancer who take baby aspirin to protect their heart run a significantly higher risk of dying, new research suggests.

Apparently, baby aspirin interacts with the hormone therapy to elevate liver-function test levels. The end result is the man must stop potentially lifesaving hormone therapy.

The findings are contained in a letter published in the Dec. 27 issue of the New England Journal of Medicine.

Hormonal therapy, which involves reducing levels of male hormones called androgens, is a common treatment for prostate cancer, but it can raise the risk of a heart attack. So men who are older or have known coronary risk factors such as diabetes or smoking usually take baby aspirin while undergoing hormone therapy because aspirin helps prevent blood clots.

"Aspirin is being prescribed more widely for these men so we looked to see if there was any effect of aspirin on prostate cancer outcomes," said lead researcher Dr. Anthony V. D'Amico, chief of the division of genitourinary radiation oncology at Brigham & Women's Hospital and the Dana-Farber Cancer Institute, both in Boston.

The authors analyzed data on 206 men with localized prostate cancers who were already enrolled in a trial to compare radiation therapy alone with radiation therapy plus hormone therapy. The hormone therapy included six months of the anti-androgen flutamide.

Flutamide had a tendency to elevate results of liver-function tests. Although these elevations were benign, they meant hormonal therapy had to be stopped, at least temporarily, D'Amico explained.

Men who didn't complete six months of hormone therapy were 3.5 times more likely to die compared to men who got the full course of hormone therapy.

"It was sort of a paradoxical finding," D'Amico said. "Men who were taking aspirin were more likely to die of prostate cancer than those who were not, which didn't make sense at first."

But when the researchers delved deeper, they realized that the men who were taking aspirin were more likely to have to stop hormone therapy.

"Liver function is something you monitor" when undergoing hormone therapy, D'Amico explained. "When the tests elevate, you take the patient off of hormone therapy till the tests normalize, then you restart the therapy."

An explanation for this interaction comes from previous animal studies, D'Amico said. For rabbits that take aspirin while undergoing hormone therapy, that aspirin is magnified 100-fold in terms of how much gets into the blood. "That makes it a toxic dose of aspirin," he explained.

Although such a study can't establish a cause-and-effect association, it does appear likely, D'Amico said.

"If a man is taking baby aspirin just to prevent heart disease, we would ask the oncologist to ask the primary-care physician if he could come off the baby aspirin for the months while he's getting cancer therapy. If the aspirin is just for prevention, this is probably the simplest thing to do," he said. "But if the patient is on aspirin because he absolutely needs it, then they'd have to treat the prostate cancer without hormone therapy. It really comes down to a trade-off: How much do they need the aspirin versus how much do they need hormonal therapy, and there are alternative treatments for prostate cancer."

SOURCE: www.healthcentral.com

27 Dec, 2007

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