Business Editors/Health/Medical Writers BIOWIRE2K
CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 20, 2005--Altus(R) Pharmaceuticals Inc. a annoncé aujourd'hui avoir achevé avec succès la phase II des essais cliniques du TheraCLEC sur les patients atteints de mucoviscidose (CF) avec une mauvaise assimilation due à une insuffisance pancréatique. La phase II de l'étude d'Altus représente l'essai de cohorte le plus important, aléatoire et à double insu jamais mené pour étudier l'innocuité et l'efficacité de l'enzymothérapie de remplacement dans le traitement des patients atteints d'insuffisance pancréatique.
( BW)(MA-ALTUS) Altus Pharmaceuticals Announces Positive Results of Phase II Trial of TheraCLEC; Largest Prospective Study for Pancreatic Insufficiency in Cystic Fibrosis
Business Editors/Health/Medical Writers BIOWIRE2K
CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 20, 2005--Altus(R) Pharmaceuticals Inc. announced today that it has successfully completed a Phase II clinical trial of TheraCLEC(TM) in cystic fibrosis (CF) patients with malabsorption due to pancreatic insufficiency. Altus' Phase II study is the largest prospective, randomized, double blind trial ever conducted to evaluate the safety and efficacy of enzyme replacement therapy in the treatment of patients with pancreatic insufficiency.
TheraCLEC was well tolerated by patients and the trial achieved its primary efficacy endpoint, a statistically significant improvement in fat absorption. Altus, a leader in the development of novel protein therapies to treat chronic gastrointestinal and metabolic diseases, plans to release the full Phase II results in October 2005 at the North American Cystic Fibrosis Conference in Baltimore, MD. This trial was made possible in part with a commitment since 2001 of $25 million from Cystic Fibrosis Foundation Therapeutics, Inc (CFFT), its largest therapeutics development award to date. CFFT is the nonprofit drug development affiliate of the Cystic Fibrosis Foundation, which is dedicated to finding a cure or control for people living with this devastating disease. Sheldon Berkle, President and Chief Executive Officer at Altus commented, "This is a significant milestone as we believe these are compelling data that hold great promise for an important new therapy for patients with a life-threatening disease.
TheraCLEC is a highly purified, sdiv product containing non-animal derived enzymes.
We believe it can provide improved compliance, stability and simplified dosing.
This could, in turn, offer both clinical and quality-of-life benefits for patients with malabsorption." This Phase II study enrolled 125 patients from 26 CF care centers across the United States. Patients with cystic fibrosis and pancreatic insufficiency were randomized to receive one of three fixed doses of TheraCLEC for one month. This study is the only trial of its kind to concurrently evaluate the impact of an enzyme replacement therapy on the absorption of fats, proteins and carbohydrates
CF is a genetic disease affecting approximately 30,000 people in the United States.
A defective gene causes the body to produce abnormally thick, sticky mucus that results in severe lung infections and causes pancreatic insufficiency, which impairs digestion. When the CF Foundation was created in 1955, few children with CF lived to attend elementary school. Fifty years later, because of research and care supported by the CF Foundation, the median age of survival for people with CF is now 35 years. More than 10 million Americans are unknowing, symptomless carriers of one copy of the defective CF gene; it takes two copies of the gene for a child to have CF
"TheraCLEC could represent a major advance in the treatment of pancreatic insufficiency associated with cystic fibrosis," said Robert J
. Beall, Ph.D., president and chief executive officer of the Cystic Fibrosis Foundation and CFFT.
"This is a significant accomplishment for the development of an important new treatment for cystic fibrosis patients. Through our collaboration with Altus, we are working to help individuals with pancreatic insufficiency as a result of CF, 90 percent of whom require enzyme therapy."
TheraCLEC is the first in a new class of orally-delivered recombinant enzyme replacement therapies from Altus and is intended to treat malabsorption resulting from pancreatic insufficiency. Pancreatic insufficiency is a condition where the pancreas is not producing sufficient amounts of endogenous enzymes to aid in the digestion of fats, proteins and carbohydrates.
TheraCLEC is intended to replace these essential digestive enzymes to promote and maintain proper digestion, nutrition and growth in affected patients. This condition is most often found in patients suffering from cystic fibrosis, chronic pancreatitis, pancreatic cancer and a number of other diseases.
TheraCLEC has been granted Orphan Drug status in the United States and Europe.
It was granted fast track status by the U.S Food and Drug Administration (FDA) in December 2003, and was accepted into the FDA's Continuous Marketing Application Pilot 2 Program in August 2004, which allows for frequent scientific feedback and interactions with the agency.
About the Cystic Fibrosis Foundation and CFFT
The mission of the Cystic Fibrosis Foundation is to assure the means to cure and control CF and to improve the quality of life for those with the disease. With money raised through donations from individuals, corporations and foundations since its establishment in 1955, the CF Foundation supports research and care to continue adding tomorrows everyday for people with CF
Established in 2000, Cystic Fibrosis Foundation Therapeutics, Inc (CFFT) is the nonprofit drug development affiliate of the CF Foundation that operates drug discovery, development and evaluation efforts. The CF Foundation provides total support for CFFT.
For more information about cystic fibrosis, the CF Foundation or CFFT, call 1 (800) FIGHT CF or visit www.cff.org.
About Altus Pharmaceuticals
Altus Pharmaceuticals is focused on developing and commercializing novel protein therapeutics for patients with chronic gastrointestinal and metabolic diseases.
Altus' in-depth knowledge of protein crystallization has resulted in a proprietary pipeline of orally delivered and injecdiv protein replacement products.
As a company, Altus is committed to improving the quality of life of patients.
More information about Altus and its clinical development programs can be found at www.altus.com.
Altus Pharmaceuticals Inc
Robert Gallotto, 617-299-2900 Vice President of Commercial Development
Cystic Fibrosis Foundation
Carolyn Habbersett, 301-907-2542 Director of Public Affairs www.cff.org