Inspire Completes Patient Enrollment

Inspire Completes Patient Enrollment In Three Late-Stage Clinical Trials In Cystic Fibrosis


Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today patient enrollment is complete in three of its late-stage clinical trials. "We are pleased to be executing on our strategic plan with the achievement of these patient enrollment milestones in the clinical development programs for denufosol, PROLACRIA™ and AZASITE®, as this places us in a position to have top-line results from all our late-stage clinical programs within 18 months. We would like to thank the dedicated clinical investigators, study coordinators and patients who participated in our trials as well as the Cystic Fibrosis Foundation and its affiliates for raising awareness of the importance of participating in clinical trials," stated Benjamin R. Yerxa, Ph.D., Executive Vice President and Chief, Research and Development. Denufosol Tetrasodium for Cystic Fibrosis Inspire announced today that TIGER-2, the Company's second Phase 3 pivotal clinical trial (Trial 08-110) with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis (CF), has completed patient enrollment. TIGER-2 is a 48-week trial comparing 60 mg of denufosol to placebo, administered three-times daily by jet nebulizer, in a targeted 450 CF patients. The Company expects to have top-line results from TIGER-2 in the first quarter of 2011. "We are excited that patient enrollment in TIGER-2 is complete. This is an important step toward bringing this potential new treatment to cystic fibrosis patients," said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation. "Denufosol's novel approach to treating the underlying ion channel defect in CF lung disease makes it a promising therapy, and we look forward to the results from this trial."

Recent Patient Assistance

A teenager was recently diagnosed with CF. Both parents had been out of work for several weeks. Mother's unemployment was about to end. Reaching Out helped by paying the family's power bill.

Is Your Showerhead Harboring Hidden Dangers?

WASHINGTON (AP) - In what may be the scariest shower news since Alfred Hitchcock's "Psycho," a study says showerheads can harbor tiny bacteria that come spraying into your face when you wash.

People with normal immune systems have little to fear, but these microbes could be a concern for folks with cystic fibrosis or AIDS, people who are undergoing cancer treatment or those who have had a recent organ transplant.

Researchers at the University of Colorado tested 45 showers in five states as part of a larger study of the microbiology of air and water in homes, schools and public buildings. They report their shower findings in Tuesday's edition of Proceedings of the National Academy of Sciences.In general, is it dangerous to take showers? "Probably not, if your immune system is not compromised in some way," lead author Norman R. Pace says. "But it's like anything else — there is a risk associated with it."The researchers offer suggestions for the wary, such as getting all-metal showerheads, which microbes have a harder time clinging to.Still, showerheads are full of nooks and crannies, making them hard to clean, the researchers note, and the microbes come back even after treatment with bleach.People who have filtered showerheads could replace the filter weekly, added co-author Laura K. Baumgartner. And, she said, baths don't splash microbes into the air as much as showers, which blast them into easily inhaled aerosol form.It doesn't seem as frightening as the famous murder-in-the-shower scene in Hitchcock's classic 1960 movie. But it's something to be reckoned with all the same.

The bugs in question are Mycobacterium avium, which have been linked to lung disease in some people. Indeed, studies by the National Jewish Hospital in Denver suggest increases in pulmonary infections in the United States in recent decades from species like M. avium may be linked to people taking more showers and fewer baths, according to Pace.Symptoms of infection can include tiredness, a persistent, dry cough, shortness of breath, weakness and "generally feeling bad," he said.

Showerheads were sampled at houses, apartment buildings and public places in New York, Illinois, Colorado, Tennessee and North Dakota.The researchers sampled water flowing from the showerheads, then removed them, swabbed the interiors of the devices and separately sampled water flowing from the pipes without the showerheads.By studying the DNA of the samples they were able to determine which bacteria were present.They found that the bacteria tended to build up in the showerhead, where they were much more common than in the incoming feed water.Most of the water samples came from municipal water systems in cities such as New York and Denver, but the team also looked at showerheads in four rural homes supplied by private wells. No M. avium were found in those showerheads, though some other bacteria were.In previous work, the same research team has found M. avium in soap scum on vinyl shower curtains and above the water surface of warm therapy pools.And stay tuned. Other studies under way by Pace's team include analyses of air in New York subways, hospital waiting rooms, office buildings and homeless shelters.

The research was funded by the Alfred P. Sloan Foundation and the National Institute of Occupational Safety and Health.Virginia Tech microbiologist Joseph O. Falkinham welcomed the findings, saying M. avium can be a danger because in a shower "the organism is aerosolized where you can inhale it."In addition to people with weakened immune systems, Falkinham also cited studies showing increased M. avium infections in slender, elderly people who have a single gene for cystic fibrosis, but not the disease itself.Two copies of the gene are needed to get cystic fibrosis, but having just one copy may result in increased vulnerability to M. avium infection as people age, said Falkinham, who was not part of Pace's research team.___

"Thank You" to Reaching Out

I am an adult CF patient on disability. My husband recently lost his job. Reaching Out helped me with a hospital bill payment. I am so thankful for the kindness and help that Reaching Out offers to CF patients and families. THANK YOU SO MUCH!

Dear Reaching Out:
I can't thank you enough for your help this month.As a CF Mom and single parent, I have really been strugglingto handle all of the bills I have to pay. Thank you so much for your help and thank you for the surprise GAS CARD! What a big help!

Thank you for your act of kindness toward our family. May God continue to Bless your Organization.

Lungs 4 Joseph

Joseph is waiting for his new lungs. Check out his blog spot and also help him raise the money he needs for the transplant.

New Resource added to www.reachingoutfoundation.org

1. The Power of Two: A Twin Triumph over Cystic Fibrosis (added: 19-Aug-2009)
http://www.stenzeltwins.com
Book Summary
The tragedy of cystic fibrosis has been touchingly recounted
before, but this is the first book to portray the symbiotic
relationship between twins who share this life-threatening
disease through adulthood. Isabel Stenzel Byrnes and Anabel
Stenzel tell of their struggle to pursue normal lives while
grappling with the realization that they might die young.
Their story reflects the physical and emotional challenges
of a particularly aggressive form of CF and tells how the
twins bicultural heritage Japanese and German influenced the
way they coped. The Power of Two is an honest and gripping
portrayal of day-to-day health care, the impact of chronic
illness on marriage and family, and the importance of a
support network to continuing survival. These two remarkable
sisters have much to teach about the power of perseverance
and about the ultimate power of hope.

New Resource added to www.reachingoutfoundation.org

1. Foundation Care (added: 19-Aug-2009)
http://www.FoundCare.com
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