Biotech Values

[DewDiligence]

More on ISPH’s drug for cystic fibrosis:

[GENR’s Lomucin would seem to be falling further into oblivion with each passing day.]

http://biz.yahoo.com/rc/040427/health_inspire_stocks_1.html

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Inspire soars after positive cystic fibrosis trial

Tuesday April 27, 1:11 pm ET
By Ransdell Pierson

NEW YORK, April 27 (Reuters) - The shares of Inspire Pharmaceuticals Inc. (NasdaqNM:ISPH) jumped 21 percent on Tuesday after the company said its experimental drug for cystic fibrosis, a serious hereditary disease, significantly improved lung function in a mid-stage trial.

The Durham, North Carolina-based company said the results from the Phase II trial for the drug, known as INS37217 Respiratory, surpassed its expectations. It hopes the drug, if approved, could some day slow progression of the condition.

The trial involved 90 patients with cystic fibrosis, which typically kills sufferers by their 30s, often due to thick mucous build-up in the lungs, where bacteria multiply. The average age of participants was 16.

Inspire said 93 percent of patients remained in the trial because the drug was so well tolerated. Almost half of all patients taking the medicine and placebos reported coughs.

After four weeks of treatment, patients taking the drug had "significantly better" lung function than those taking placebos, the company said, although the main purpose of the study was to gauge the safety of the various doses of the medicine.

Lung function was assessed by the volume of air the lungs could expel.

"The results of this study exceeded our expectations and have provided important scientific support for the concept of INS37217 Respiratory as early intervention therapy," said company Chief Executive Christy Shaffer.

About 30,000 people in the United States have the genetic condition, which is typically diagnosed by age 3 and progressively worsens over time.

"We are hoping our drug will slow the progress of symptoms by restoring a more normal lung function early in life," said Inspire spokeswoman Mary Bennett.

Current treatments include Chiron Corp.'s (NasdaqNM:CHIR) Tobi, an inhaled form of antibiotic tobramycin used to fight lung infections, and Genentech Inc.'s (NYSE:DNA) Pulmozyme, which breaks up mucous. But those drugs have not extended life expectancy, Bennett said.

The nonprofit Cystic Fibrosis Foundation, which helped finance the study, said the results "far surpassed the success criteria" it had anticipated. [They definitely did *not* say this about GENR’s Lomucin.]

In the trial, one group of patients received a placebo, while other patients received one of three different doses of the Inspire drug three times daily by nebulizer for 28 days.

Mucous builds up in the lungs and other organs of patients with cystic fibrosis because of a defect in a protein that controls the transport of salt ions across cell membranes. Such "ion channels" are necessary to keep water moving to the surface of the airways and thereby push mucous out of the lungs.

Inspire said its drug works by activating a separate ion channel that otherwise lies dormant in most people.

Inspire shares rose $2.96 to $16.95 in heavy afternoon trading on the Nasdaq.
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