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Altus Completes Study on Lead Product for Malabsorption

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 14, 2003--Altus Biologics Inc., a

developer of novel orally delivered proteins, today announced results

obtained from a Phase 1 trial of TheraCLEC, an orally delivered enzyme

replacement therapy. TheraCLEC is currently being investigated for the

treatment of malabsorption as a result of pancreatic insufficiency. The

primary objectives of the study were to assess the safety and tolerability of

repeated escalating doses of TheraCLEC in healthy volunteers. Analysis of the

data showed a favorable safety and tolerability profile across a wide range

of doses.

" We are very encouraged by the results of this study, " said

s, M.D., Director, Medical Affairs and Clinical Research at Altus®.

Dr. s noted, " TheraCLEC in repeated doses was well tolerated and

demonstrated an overall favorable safety and tolerability profile. We believe

this orally delivered enzyme will provide a major breakthrough for the

treatment of pancreatic insufficiency and will make a real difference in the

lives of patients especially given the limitations of current treatments. "

Gallotto, Vice President of Commercial Development, Branded Products

for Altus stated, " Altus has reached a major milestone in the development of

orally-delivered protein therapies with the completion of a well-designed and

controlled safety study of its enzyme replacement therapy for pancreatic

insufficiency. " Mr. Gallotto added, " Based on these results, we are

aggressively advancing our clinical development program with the initiation

of a multi-center, dose ranging clinical trial to assess the safety and

clinical activity of TheraCLEC in patients with cystic fibrosis. "

About TheraCLEC

TheraCLEC is a novel therapy intended to treat malabsorption as a result of

pancreatic insufficiency, a condition that affects most cystic fibrosis (CF)

patients, as well as many patients with chronic pancreatitis, pancreatic

cancer, Shwachman-Diamond syndrome and other diseases. In each of these

diseases, a deficiency of pancreatic enzymes causes poor absorption of

essential nutrients, which often leads to malnutrition, impaired growth and

poor survival. TheraCLEC is intended to replace missing digestive enzymes to

promote and maintain proper digestion and growth in affected patients. A

clinical study for TheraCLEC is underway at CF care centers throughout the

United States.

TheraCLEC is the first in a portfolio of products under development applying

Altus' technology and expertise for orally delivered protein therapies.

Protein therapeutics delivered as oral lumenal therapies offer distinct

advantages over systemically delivered proteins because they are directly and

more readily delivered to the site of action. This may lead to a significant

therapeutic effect, and an improved safety profile. Altus' focus is to

develop and maximize the potential of orally delivered proteins to treat

gastrointestinal and metabolic diseases. TheraCLEC is being developed in

collaboration with the Cystic Fibrosis Foundation, Bethesda, MD and in Europe

with Dr. Falk Pharma, Freiburg, Germany. Dr. Falk Pharma has licensed the

commercial rights to TheraCLEC for Europe. Altus retains exclusive commercial

rights in all other territories.

About Cystic Fibrosis

One of the conditions in which enzyme replacement is used as a life-saving

treatment is cystic fibrosis. Cystic fibrosis is a life-threatening disease

affecting approximately 30,000 patients in the United States, 35,000 patients

in Europe and a significant number of additional patients globally. CF is an

inherited disorder in which mucus secretions become abnormally thick,

hampering the normal functioning of the respiratory, digestive, and

reproductive systems. As a result, malnutrition can occur and normal growth

may be hindered. Today in the US, nearly 90 percent of people with CF are

afflicted with pancreatic insufficiency and have an average life expectancy

in the early 30's, while CF patients without pancreatic insufficiency have a

life expectancy of about 50 years. One in 31 Americans-more than 10 million

people-is an unknowing carrier of the defective CF gene.

About Altus

Altus Biologics Inc. is a privately held life sciences company that has

developed a unique, powerful and proprietary protein crystallization

technology, known as Crystalomics, to enable the rapid commercialization

of high-value protein-based products. Altus focuses on the commercialization

and development of targeted therapies for the treatment of gastrointestinal

and metabolic diseases. Altus' technology allows its products to act chiefly

by creating a highly stable protein therapeutic that allows for oral delivery

of the protein to the gastrointestinal tract that provides a localized or

topical effect within the gastrointestinal (GI) lumen. Through its branded

products portfolio, the company's vision is to be the worldwide leader in the

rapid and efficient development of valuable orally delivered proteins. The

Company has a series of products in various stages of research and

development all leveraging the Crystalomics technology. Crystalomics is also

proving to be an innovative drug delivery technology that can transform

proteins into highly concentrated, stable, and pure crystalline products that

offer significant advantages in the overall route of administration, safety,

and storage of protein therapeutics, as well as in the manufacture of

small-molecule drugs. Altus has numerous development partners and is

constantly evaluating the opportunity to expand its product development

efforts through partnering opportunities. Altus® and Crystalomics are

trademarks of Altus Biologics Inc.

For more information on Altus, visit www.altus.com or for more information

about Altus' clinical trials, patients and physicians can contact the Altus

Medical Product Information Department at .

CONTACT:

Altus Biologics Inc.

Gallotto, 617/299-2952

rgallotto@...

SOURCE: Altus Biologics Inc.

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05/14/2003 08:10 EASTERN