Arriva-ProMetic Recombinant Alpha 1-Antitrypsin (rAAT) Moves into the Clinic for Dermatology Applications
MONTREAL, Canada & ALAMEDA, California, USA, Nov. 7 /CNW/ - ProMetic Life
Sciences (TSX:PLI) and Arriva Pharmaceuticals, Inc. announced today that their
joint venture (JV), Arriva-ProMetic Inc, has received approval from the United
States Food and Drug Administration and Health Canada to initiate a Phase Ib
clinical trial for it's proprietary recombinant alpha 1-antitrypsin (rAAT)
topical gel in patients with atopic dermatitis.
Arriva-ProMetic has developed a topical gel containing rAAT
(Dermolastin(TM)). The rAAT contained in this proprietary gel formulation is
produced from yeast, which unlike commercially available forms of plasma-
derived AAT, eliminates the risk associated with blood-borne infectious
agents. Production of rAAT in yeast cells allows for the manufacture of large
quantities of the protein therapeutic, an essential component of a clinical
study program, thus enabling Arriva-ProMetic to commence clinical studies.
Data from previous clinical studies using a topical application of
commercially available plasma-derived AAT demonstrated positive results when
evaluated in patients with chronic atopic dermatitis and psoriasis. In these
studies, topical application decreased pain and itching and in at least one
study, promoted growth of healthy, scar-free tissue.
Plasma-derived AAT has been on the market since 1989 and is marketed by
Bayer under the trade name Prolastin(R). Currently, Prolastin(R) is
administered by intravenous infusion and is approved only for the treatment of
patients with congenital deficiency of AAT with clinically demonstrable
emphysema. The limited availability of plasma-derived AAT has precluded the
development of this potential anti-inflammatory agent for evaluation in other
disease states.
Our preclinical program confirmed that the rAAT gel was well tolerated.
"No clinically relevant toxicity was noted during the studies conducted to
date," said Dr Martin Preuveneers, CEO of Arriva Pharmaceuticals, Inc. "The
successful completion of our preclincial program was crucial in securing
approval of our investigational drug application and thus allowing us to move
Dermolastin(TM) into clinical trials".
Throughout 2001 and 2002, the Arriva-ProMetic Inc. JV has invested
considerably in proprietary topical formulations of rAAT, which are to be
studied as treatment for dermatological conditions including atopic dermatitis
and psoriasis. "We are thrilled with the FDA and CTA's decision to not only
approve entry of Dermolastin(TM) into the clinic, but to accelerate it into
clinical trials in patient populations" said ProMetic CEO, Pierre Laurin. "As
per the mandate of the Arriva-ProMetic JV, this collaborative work will
continue and other formulations for gastroenterological and urological
indications will also be developed."
ABOUT ALPHA-1-ANTITRYPSIN
Alpha-1-antitrypsin is a glycoprotein primarily produced by hepatocytes,
and to a lesser extent, immune system cells. AAT belongs to a family of
structurally-related proteins classified as serine protease inhibitors or
SERPINS, which are known to inhibit several proteases including trypsin,
cathepsin G, thrombin, tissue kallikrein, as well as neutrophil elastase. The
proteinase/antiproteinase balance is believed to be important for maintaining
healthy skin. Alterations in local tissue proteinase/antiproteinase balance,
resulting from genetic or environmental factors, may lead to an increased
susceptibility to inflammatory diseases of the skin such as atopic dermatitis
and psoriasis.
ABOUT ATOPIC DERMATITIS
Atopic dermatitis is a common form of inflammation of the skin. Atopic
dermatitis is a chronic skin disorder characterized by pruritus, dry skin, and
excoriation, which may be localized to a few patches or involve large portions
of the body. It is a common disease affecting approximately 6% of the general
population and in the United States alone, it is estimated that more than 15
million individuals are afflicted with this disorder. Since 1970, the
incidence of atopic dermatitis has increased by 30%.
ABOUT PROMETIC LIFE SCIENCES
ProMetic Life Sciences Inc., is an international bio-pharmaceutical
company with headquarters in Montreal, Quebec with additional facilities in
the UK. ProMetic is engaged in research, development, manufacture and
marketing of a variety of commercial applications from its proprietary
platform technologies, which are used in therapeutics, large-scale drug
purification, chemical genomics and proteomics, drug delivery and drug
development. Additional information is available on the company's website:
www.prometic.com .
ABOUT ARRIVA PHARMACEUTICALS, INC.
Arriva Pharmaceuticals, Inc., is a privately held biopharmaceutical
company. The company's goals are to develop, manufacture and market clinical
grade recombinant protease inhibitors. Arriva has developed technology for
large-scale production of stable non-animal sources of recombinant proteins in
Saccharomyces cerevisiae (baker's yeast). The areas of therapeutic focus are:
- Respiratory diseases: hereditary emphysema, asthma, and other
respiratory indications.
- Dermatological diseases: atopic dermatitis, psoriasis.
For more information, visit www.arrivapharm.com .
ABOUT ARRIVA-PROMETIC
Arriva and ProMetic formed a joint venture in 1999 to develop and
commercialize recombinant alpha-1-antitrypsin (AAT) and other serine protease
inhibitors for the treatment of various inflammatory conditions, including
dermatological diseases such as atopic dermatitis and psoriasis. The FDA & CTA
decision also allowed broad coverage for the use of additional protease
inhibitors, such as the secretory leukocyte protease inhibitor (SLPI), for the
treatment of inflammatory skin diseases.
ABOUT PROMETIC LIFE SCIENCES
ProMetic Life Sciences Inc., is an international bio-pharmaceutical
company with headquarters in Montreal, Quebec with additional facilities in
the UK. ProMetic is engaged in research, development, manufacture and
marketing of a variety of commercial applications from its proprietary
platform technologies, which are used in therapeutics, large-scale drug
purification, chemical genomics and proteomics, drug delivery and drug
development. Additional information is available on the company's website:
www.prometic.com .
This press release contains forward-looking statements that involve risks
and uncertainties, including, but not limited to the Company's ability to
develop, manufacture, and successfully commercialize value-added
pharmaceutical products and to obtain contracts for its products and services
and commercial acceptance of advanced affinity separation technology.
Shareholders are cautioned that these statements are predictions and these
actual events or results may differ materially from those anticipated in these
forward-looking statements.
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For further information: Noonan Russo Presence Euro RSCG, Medias: Lynn
Blenkhorn: (212) 845-4276, Investors: Sharon Weinstein: (212) 845-4271,
www.nrp-euro.com; Arriva Pharmaceuticals, Inc., Martin J. Preuveneers, PhD,
Chairman and CEO, (510) 337-2846, www.arrivapharm.com; ProMetic Life Sciences
Inc., Pierre Laurin, President and CEO, (514) 341-2115; Patrick Hofman(514)
673-1116; Sofie St. Laurent(514) 673-1116; www.prometic.com |
