Navigation Links
Bronchitol Cystic Fibrosis Dose Trial Results Positive
Date:8/11/2008

itionally, no serious adverse events emerged during the 400 mg treatment period and the adverse event profile was similar across all doses.

People affected by cystic fibrosis typically experience a decline in lung function of 1-2% per year during their life, as measured by FEV1.

Pharmaxis has received Orphan Drug Designation and fast track status from the Food and Drug Administration (FDA) for Bronchitol in cystic fibrosis.

Bronchitol is designed to hydrate the airway surface, improve lung hygiene and promote normal lung clearance. Additional data from this trial will be presented at a forthcoming scientific congress. A European, Pharmaxis sponsored, regulatory Phase III clinical trial, designed to lead to a marketing application for Bronchitol in adults and children with cystic fibrosis is due to report preliminary data early in 2009.

Approximately 75,000 people in the major pharmaceutical markets are affected with cystic fibrosis and no products have been approved to improve lung hydration.

To find out more about Pharmaxis, go to http://www.pharmaxis.com.au .

About the Trial

The following information is provided in accord with the ASX and AusBiotech Code of Best Practice for Reporting by Biotechnology, Medical Device and other Life Sciences Companies.

Name of Trial DPM-CF-202 (a Phase II study with Bronchitol)

Blinding Status Open

Design Crossover, Dose response

Treatment Route Inhalation

Frequency Twice daily

Dose levels 400mg, 240 mg, 120 mg, 40 mg for 2 weeks,

1-2 weeks washout between doses

No of subjects PP population 38

Subject Selection diagnosis of cystic fibrosis (sweat test or

Criteria genotype), of either gender, aged 7 years or


'/>"/>

SOURCE Pharmaxis Ltd
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Pharmaxis Long-Term Safety Study of Bronchitol Completes
2. Pharmaxis Establishes Named Patient Program for Bronchitol
3. Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial
4. Promising Cystic Fibrosis Compound on Track for Development
5. Symbollon Pharmaceuticals, Inc. Evaluates the Clinical Effects of IoGen(TM) on Fibrocystic Breast Disease
6. Pediatric Pulmonary Expert Comments on Study of Lung Transplants for Cystic Fibrosis
7. Cystic Fibrosis Foundation Reports Upward Trend for Key Health Outcomes
8. Cystic Fibrosis Foundation Announces Positive Early Results for Phase 2 Clinical Trial of VX-770 - an Oral Compound to Treat CF
9. Lung Transplants in Cystic Fibrosis Patients With Life-Threatening Bacteria Sparks Debate at ISHLT Meeting
10. PTC Therapeutics Announces Data Supporting Cough Frequency as a New Outcome Measure in Evaluating Treatments for Cystic Fibrosis
11. PTC Therapeutics Announces Data from Additional Clinical Studies of PTC124 in Cystic Fibrosis Confirming Activity
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... Vernak, RPh, of Vernak Farms Pharmacy in ... George Roentsch Scholarship by the Professional Compounding Centers of ... Houston during PCCA,s International Seminar, held October ... independent pharmacist and PCCA member who embodies the innovative ... well-known pharmacist in the compounding community. ...
(Date:10/22/2014)... , Oct. 22, 2014 AVACEN Medical ... device received 510 (k) OTC clearance by the U.S. ... 100 to be marketed over the Internet for: ... muscle spasms; and minor strains and sprains . ... The AVACEN 100 (MSRP $2495) is a sophisticated medical ...
(Date:10/22/2014)... , October 22, 2014 ... ), a clinical-stage pharmaceutical company focused on the ... positive top-line clinical results from its Phase IIa ... insulin capsules, to treat type 1 diabetes. The trial ... under a U.S. Food and Drug ...
Breaking Medicine Technology:PCCA Awards Charlene Vernak, RPh, the George Roentsch Scholarship 2AVACEN Medical Announces FDA Clearance of First Medical Device with Internal Game Mode 2Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes 2Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes 3Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes 4
(Date:10/22/2014)... HealthDay Reporter , TUESDAY, Oct. 21, ... may lead to increased blood pressure, according to a new ... in blood pressure for young adult women or for teenagers, ... drank lightly or moderately, their risk of high blood pressure ... parallels studies in older adult men and women," said lead ...
(Date:10/22/2014)... News) -- Measures taken by Firestone officials at the ... have limited the spread of the disease there and ... Natural Rubber Co. provides health services to about 80,000 ... populated communities. Between Aug. 1 and Sept. 23, ... those 80,000 people. That incidence rate of 0.09 percent ...
(Date:10/22/2014)... Dennis Thompson HealthDay Reporter ... cameraman who was diagnosed with Ebola while working for NBC ... and can leave the special isolation unit at Nebraska Medical Center ... weeks, the hospital said Tuesday. A blood test confirmed by ... Mukpo, 33, can head home to Providence, R.I., NBC News ...
(Date:10/20/2014)... With a mere 19 days to November ... brief fundraising stop at the  Law Offices of ... a debate last night with his opponent Gov. Rick ... first seven minutes because Crist had an electric fan ... in one word: "weird." , Before touching on his ...
(Date:10/20/2014)... The Advocator Group, LLC is ... Foundation for Suicide Prevention’s (AFSP) Out of the Darkness ... organization that hosts hundreds of community walks throughout the ... used to help understand and prevent suicide through not ... well. , The Advocator Group shares this passion ...
Breaking Medicine News(10 mins):Health News:Binge Drinking May Boost Blood Pressure in Young Men 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 3Health News:Binge Drinking May Boost Blood Pressure in Young Men 4Health News:Tire Company Sets Standard for Ebola Care in Liberia: CDC 2Health News:U.S. Cameraman Treated for Ebola 'Free' of the Virus 2Health News:U.S. Cameraman Treated for Ebola 'Free' of the Virus 3Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 2Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 3Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 2Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 3
... care at community health clinics especially women ... cardiologist than those who receive primary care at hospitals, ... the American Heart Association . , Researchers from the ... Medical School reviewed the electronic medical records of 9,761 ...
... April 27 Robert J. Gould, a behavioral ... nation,s most successful social marketing campaigns, has been ... by Partnership,s board of directors was announced today ... board."Rob,s unique combination of behavioral science expertise, proven ...
... a worrisome rise in childhood obesity, Florida school districts ... but there is little research available to determine if ... a $2.2 million grant from the National Institutes of ... a Florida State University College of Medicine researcher will ...
... today that, working with the UN Refugee Agency (UNHCR), it will send ... African countries. , ... Washington, D.C. (Vocus) April 27, 2009 -- The ... Refugee Agency (UNHCR), it will send over 346,000 life-saving bed nets to ...
... April 27 50,000 hand addressed letters were sent to ... Notre Dame officials, urging ND Grads to fight ... sent 50,000 letters to Alumni from ,88 and back. (Older ... post cards are designed to be sent to Vatican and ...
... Company (Nasdaq: STAA ) today announced that it will release financial ... May 5, 2009 after ... host a conference call and webcast on Tuesday, ... 1:30 p.m. Pacific to discuss the Company,s first quarter results ...
Cached Medicine News:Health News:Patients at community health clinics less likely to be referred to cardiologist 2Health News:Patients at community health clinics less likely to be referred to cardiologist 3Health News:Robert J. Gould Named President at Partnership for Prevention 2Health News:FSU researcher wins $2.2 million grant to study childhood obesity 2Health News:FSU researcher wins $2.2 million grant to study childhood obesity 3Health News:UN Foundation to Help Protect More than a Million Refugees from Malaria in Africa 2Health News:50,000 Letters Sent to Notre Dame Alumni Re: Obama; In Letter, Bishop Gracida Urged Former U.S. Ambassador to the Vatican Mary Ann Glendon to Refuse Award 2Health News:STAAR Surgical Announces First Quarter 2009 Earnings Release Date and Conference Call 2
... Shandon Cryotome FE and FSE are a ... Electron. The microtome is outside of the ... as well as faster temperature adjustment. Simple, ... Complete temperature controls on the main touch-screen ...
A standard, durable and reliable indirect....
Designed to retain the desired curve during oral intubation....
Facilitates intubation of tracheal tubes....
Medicine Products: