arGentis Pharmaceuticals, LLC has selected Target Health, Inc. as its Clinical Research Organization (CRO) partner for their upcoming clinical trials. With clinical trial costs increasing dramatically, it has been demonstrated that the selection of a quality CRO provides cost saving opportunities for their drug sponsors. Utilizing Target Health’s global expertise across multiple therapeutic categories will allow arGentis to expand development capacity without requiring an increase in staff or facilities.
“This alliance delivers us immediate speed and efficiency to our drug development efforts resulting in quality clinical trial data at high levels of regulatory compliance,” stated Tom Davis, arGentis’ Chief Executive Officer. “Target Health’s proven track record of NDA and PMA approvals verifies that we will be able to accrue valuable clinical study performance through enhanced planning and achieve favorable end points to our trials.”
According to Dr. Jules T. Mitchel, President of Target Health Inc., “We are pleased to have been chosen by arGentis as their CRO partner to facilitate their forthcoming clinical trials. Their product therapies fit well with our expertise and are in areas of unmet medical needs. We look forward to working with the arGentis management team along with their scientific advisors toward advancing their platforms for FDA review.”
arGentis licensed two transdermal therapies for the treatment of dry eye syndrome (DES) from the Southern College of Optometry in 2006. The company plans to submit an Investigational New Drug application to the FDA on both products in the fourth quarter of 2007. Target Health will assist in this filing and provide all regulatory and quality deliverables throughout the clinical trial process.
arGentis Pharmaceuticals, LLC is a specialty pharmaceutical company located in Memphis, TN. The company seeks to in-license therapies for chronic diseases with demonstrated proof of concept for further development and commercialization.
The Human Heart
Anterior (frontal) view of the opened heart. White arrows indicate normal blood flow.
They have already been dubbed “master” heart cells, and hold the promise of treating patients with serious cardiovascular disease: Three US research groups claim that they can produce stem cells that give rise to different tissues found in the mammalian heart.
Each team has identified cardiovascular “precursor” cells from cultures of mouse embryonic stem cells (ESCs). It is very likely that these versatile cells will also be found in the embryonic human heart, the researchers say, raising hopes of one day repairing and “rejuvenating” damaged hearts by growing these embryonic stem cell lines in a lab.
Two of the groups, one led by Kenneth Chien of the Massachusetts General Hospital in Boston, the other by Gordon Keller of Mount Sinai School of Medicine in New York, say their precursors give rise to three types of cells in the heart. Cardiac muscle cells can be grown, as can the smooth muscle that makes up the blood vessels that supply the heart, and crucial endothelial cells that line the coronary blood vessels, they say.
The third team, led by Stuart Orkin of the Children’s Hospital in Boston, has identified precursors for cardiac and smooth muscle.
Being able to rebuild both cardiac muscle and blood vessels may be important for repairing hearts ravaged by cardiovascular disease. “Where there’s damage, there’s damage to more than one cell type,” notes Orkin.
Cell therapies for failing hearts have been hampered by the lack of a suitable stem cell. Some cardiologists have tried injecting bone marrow stem cells into patients’ coronary blood vessels or heart muscle. But there is no good evidence that injected marrow cells can differentiate into new heart tissue.
Trials with muscle cells taken from the legs have been even less successful, with some patients developing dangerous arrhythmias – where the heart does not beat to a correct rhythm.
These newly found precursor cells, discovered in culture, seem to correspond to cells present in the mouse embryo, which give rise to heart tissue during normal development, the three teams say. Mimicking natural developmental processes in culture boosts the prospects of successful cardiac repair, they argue.
“This is the beginning of science-based cardiovascular regenerative medicine,” claims Chien.
The researchers are now trying to work out if they are each studying cells on the same developmental pathway. “It’s hard to be absolutely dogmatic about that,” says Orkin, because each group identified their cells using different cell-surface marker molecules.
And each team wants to repeat the experiments with human ESCs, so that they can begin moving towards clinical trials. “We are following up very quickly with human cells,” says Keller.
The stem cell company, Geron of Menlo Park, California, also plans to treat heart disease using cells derived from human ESCs. It is concentrating on generating precursors for cardiac muscle, rather than “master” heart cells.
Geron’s CEO, Tom Okarma, says the company already has promising results from experiments in rodents with damage following a simulated heart attack. Okarma also hopes to avoid problems with immunological rejection by generating “tolerance” using immune cells derived from the same ESC lines.
Stem cells may help repair damaged 1) ___ after a heart attack. A study, done on mice, shows that stem cells play a limited, but significant role in 2) ___ damaged hearts. However, it remains unclear whether it is heart cells that are doing the repair, or cells from elsewhere in the 3) ___. Richard Lee and colleagues of the Harvard Medical School genetically engineered mice so their heart muscle cells could be stained with a fluorescent 4) ___. Around 80% of the heart 5) ___ cells in young mice picked up the stain. As the mice 6) ___, this level remained the same, which demonstrates that heart muscle cells are not normally replaced in life. However, when heart attacks were induced in the mice, the number of stained cells dropped to 70%, suggesting that new muscle cells are formed in response to injury. The study showed that the adult mouse 7) ___ has a limited ability to repair itself. The mechanism to activate cardiac 8) ___ is present, but it’s inadequate. This could be, because mammals don’t have enough [heart] stem cells? There are other theories as well. We need to understand what is holding the system back, so that we can devise a strategy to turn that brake off. Heart stem cells were first discovered last year. It’s not clear if this team has identified heart stem cells in the mice. Are they pre-existing immature cardiac muscle cells? Or are they [stem cells] from the heart or elsewhere in the body? Source: Nature Medicine (DOI: 10.1038/nm1618).
ANSWERS: 1) tissue; 2) repairing; 3) body; 4) protein; 5) muscle; 6) aged; 7) heart; 8) regeneration
by Mike Adams
July 26, 2007
A compound found in blueberries shows promise of preventing colon cancer, according to a new study. Scientists at Rutgers University and the U.S. Department of Agriculture conducted a joint study on animals, and found that the compound — called pterostilbene — lessened pre-cancerous lesions and inhibited genes involved in inflammation. Researchers presented the study at the American Chemical Society’s annual meeting in March.
“This study underscores the need to include more berries in the diet, especially blueberries,” said study leader Bandaru Reddy, Ph.D., a professor in the chemical biology department at Rutgers. Although the blueberry compound won’t cure colon cancer, it represents a strategy for preventing the disease naturally, said Reddy, who specializes in studying the relationship between nutrition and colon cancer.
The researchers studied 18 rats in which colon cancer had been induced in a manner similar to human colon cancer development. All of the animals were placed on a balanced diet, with half of the animals’ diets supplemented with pterostilbene. After eight weeks, the rats fed pterostilbene had 57 percent fewer pre-cancerous colon lesions compared to the control group. The researchers also noted that pterostilbene inhibited certain genes involved in inflammation, considered a colon cancer risk factor.
Colon cancer is the second leading cause of cancer death in the U.S. It has been linked to a high intake of saturated fats and calories common in Western diets. Pterostilbene may be able to reverse this process, possibly by lowering lipids, Reddy said.
Reddy cited a recent study by co-author Agnes Rimando of the Department of Agriculture. Rimando demonstrated that blueberries, particularly their skins, can lower cholesterol when fed to animals.
Some thirty different species of blueberries are native to North America. The berries are rich in anthocyanins, widely recognized for their antioxidant qualities. Blueberries are also a good source of ellagic acid, which blocks metabolic pathways that can lead to cancer.
Eating blueberries reduces your risk of colon cancer. At the same time, blueberries also contain natural medicine that lowers cholesterol
When buying blueberries, fresh is always best. Buy organic wherever possible, but if you must buy conventional blueberries, be sure to wash them with a natural, plant-based veggie wash liquid to remove the pesticide residue. Also, be careful about buying dried blueberries. Most are made with added sugar or chemical preservatives.
RFID Helps Grow and Track Potted Plants. In the Netherlands,
plant growers are using an RFID-based solution from WPS Horti Systems to improve plant health and production.
By Mary Catherine O’Connor
Copyright RFID Journal LLC 2008, Used With Permission
July 20, 2007
RFID Journal—A Dutch company called WPS Horti Systems is providing growers a high-tech, RFID-based means of improving plant health and production, from seed to sale. Nearly five years ago, WPS worked with European auto-ID technology systems integrator Zetes to develop the Plant Order System, using RFID hardware from Tagsys. The company has been selling the system ever since, and a dozen of its customers have deployed it.
In the greenhouse, potted plants are placed in clear plastic pots, RFID-tagged at the bottom.
WPS’ Plant Order System is designed for use at greenhouses where plants are grown from seedlings to mature plants, as well as at large plant warehouses where the mature plants are stored and readied for shipment. At the greenhouses, growers place each potted plant into a larger plastic container with a Tagsys 10-TL passive 13.56 MHz transponder permanently attached to its base, encoded with a number to uniquely identify the plant inside.
Tagsys interrogators, mounted under the conveyor systems moving the plants from one growing area to the next, read the tag of each passing pot. At various stages of growth, the conveyors bring each plant to a mounted digital camera to be photographed. The Zetes software correlates each image with the container’s RFID tag number, then sends this data to a program that analyzes characteristics of the plant’s image—such as size, shape or color—and determines whether the plant is adequately healthy. Once the plant is grown and ready to ship, says Olivier Burah, Tagsys’ vice president for Europe, the Middle East and Asia (EMEA), it is removed from the container, which can then be reused for another potted plant.
The pot is placed on a small tray designed to keep it stable as it moves on a conveyor system into a storage area, and later to a shipping area.
Aside from monitoring each plant’s health, the Plant Order System also enables growers to perform automated inventory counts and updates on each type of plant. On a daily basis, workers at the greenhouse tend to any ailing plants, applying fertilizer or taking whatever other measures they deem appropriate. Prior to implementing the Plant Order System, growers had to manually inspect all seedlings and plants in the greenhouse to find those requiring special care.
The mature plants are shipped to warehouses for storage and order preparation. There, each plant is transferred to the pot in which it will be sold. This pot is then placed on a small tray designed to keep it stable as it moves on a conveyor system into a storage area, and later to a shipping area. If the warehouse has deployed the Plant Order System, a Tagsys 10-TL tag is permanently attached to the base of each tray. As in the grow houses, readers are fixed beneath the conveyor system. In the warehouse, however, the data collected as the tagged trays move through the facility is used to route each plant to an appropriate storage area, or to the shipping area, based on directions the Zetes software receives from the warehouse’s ordering system.
Tagsys interrogators, mounted under the conveyor systems moving the plants from one growing area to the next, read the tag of each passing pot.
Some WPS customers have deployed the Plant Order System in facilities as large as 700,000 square meters, Tagsys claims, requiring the installation of up to 50 readers. Plant production, according to Tagsys, is a huge industry in Holland, with more than 1,500 growers of potted plants employing 1,000 hectares of greenhouse space. The plants are then sold to retailers at an average of €5 ($6.9) apiece, says Burah.
In addition to automating the inventorying and monitoring of plants, Burah adds, the platform provides WPS customers added visibility into their operations, enabling them to further increase productivity and reduce losses.
Andy Greenberg, 07.24.07
When a single data center sneezes, the Internet gets a cold.
That’s what several major Web sites learned Tuesday afternoon when a power outage in downtown San Francisco disabled 365 Main, a Web server company that hosts sites including Craigslist, Technorati, SixApart, Yelp, GameSpot, the homepage of Sun Microsystems and Red Envelope. The outage, which began at about 1:45 p.m. Pacific time, disabled the sites for more than an hour.
In a statement issued at 4 p.m. Pacific time, 365 Main said that it was 100% operational again and running on back-up generators until it could confirm that utility power was stable.
An initial report from the blog Valleywag blamed the event on a drunken employee, however 365 spokesperson Cynthia Harris said the rumor was unfounded.
In a sense, falling victim to an ordinary power blackout is more embarrassing — most server companies have backup power systems designed to handle just such a mishap.
The outage was particularly troubling for SixApart, whose online Web applications depend on continuous uptime to compete with offline tools like Microsoft Word. SixApart said its homepage was down till 3:45 p.m. Pacific time.
“We spend a lot of money making sure that we have reliable service and that we have redundant server systems in place,” says SixApart spokesperson Jane Anderson. “So it’s very unfortunate that it was a power outage that brought the site down.”
A spokesman for blog search engine Technorati, whose home page was down until 3:05 p.m., was equally displeased. “These are peak hours, U.S. daytime hours while people are still in front of their computers looking at publications and media outlets,” says Aaron Krane. “The whole point of a co-location site is keeping servers safe from power fluctuations.”
Seth Grodin, who uses SixApart’s Typepad blogging application to produce a widely read marketing blog, says he was “annoyed and upset” by the downtime.
“I depend on them, and this is horrible,” says Grodin, whose blog is the 12th most popular on the Web according to Technorati’s rankings. “On the other hand, I’m sure they’ll fix this. If the blogging world has to take a day off, that’s not the end of the world.”
Ironically, 365 Main had issued a press release earlier in the day touting the site’s two years of continuous uptime.
That kind of continuous service is only to be expected, says Margie Backaus, Chief Business Officer at 365 Main competitor Equinix.
“It’s literally happened maybe two or maybe three times in the eight years I’ve been here,” Backaus says.
Equinix invests in redundant batteries and diesel generators to keep its data centers online. As much as 70% of the $100 million or so that goes into building a data center is spent on power systems, Backaus says.
“As a data center provider right now, I feel their pain because I know they’re just running around to try to figure out what happened,” she added.
Click to play
Checkers or Draughts, as it is known in Great Britain, has ancient roots. It is thought that the earliest form of checkers was a game discovered in an archeological dig at Ur in Iraq. Carbon dating makes it appear that this game was played around 3000 B.C. However, the game used a slightly different board, a different number of pieces and no one is quite certain of the exact rules.
In Ancient Egypt a game called Alquerque, which had a 5X5 board was a common and much played game. Historians have traced it as far back as 1400 B.C. It was a game of such popularity that it was played all over the western world for thousands of years.
A nifty gadget promises to restore a healthy new smile, from an imperfect or damaged one. It’s an ultrasound 1) ___ that fits neatly inside a person’s mouth like a brace and could help to regrow damaged teeth. Two research engineers at the University of Alberta in Canada, developed the miniature device after ultrasound stimulation encouraged damaged teeth and 2) ___ tissue to regrow in animals. A scientist in Alberta’s medical faculty, was able to regrow teeth in rabbits with a larger device, but only when some tooth 3) ___ remained in place. The ultrasound device could help those who have had their teeth broken while playing high impact 4) ___ such as ice hockey and rugby. The tooth brace sends low-power ultrasound 5) ___ to the damaged tooth over many months. A piezoelectric crystal generates the ultrasound by vibrating at 6) ___ above 20 kilohertz when fed an alternating voltage from an oscillator charged by a battery. Physiotherapists often use ultrasound to help broken bones knit back together, although the healing 7) ___ is not precisely understood. One theory is that pressure waves mimic the effect of strenuous exercise, loading a bone and tricking it into generating more bone cells – a process called 8) ___. El-Bialy’s work on rabbits in 2003 (American Journal of Orthodontics and Dentofacial Orthopedics, vol 124, p 427) first showed that low-power ultrasound also encourages growth of dental tissue.
ANSWERS: 1) transmitter; 2) jawbone; 3) root; 4) sports; 5) pulses; 6) frequencies; 7) mechanism; 8) osteogenesis