FDA approves TOPIGEN's ASM8 Investigational New Drug Application
MONTREAL, Dec. 8 /PRNewswire/ - Dr. Paolo Renzi, TOPIGEN's Chief
Scientific Director, announced that after reviewing TOPIGEN's submission, the
Food and Drug Administration (FDA) has stated that a Phase 1 clinical trial
can be initiated for ASM8, a new inhalation drug that is designed to treat
asthma through a unique approach by attacking multiple mediators of the
inflammatory mechanism rather than the single mediator approach of current
therapies.
"As no human safety data are currently available for inhaled ASM8, the
present study is designed to investigate both the safety and tolerability of
this new inhaled drug for the treatment of asthma in a Phase 1 pilot trial in
humans", explained Dr. Renzi. "In this trial set to begin by the end of
January 2005, healthy human male and female volunteers will be randomized to
receive a single inhaled dose of nebulized ASM8. As such, standard and airway-
specific assessments of safety parameters will be included in the study."
Asthma is a complex disease of the airways involving multiple
inflammatory and structural cells. ASM8 consists of two modified
phosphorothioate antisense oligonucleotides (AS-ODNs). The antisense
oligonucleotides inhibit the expression and function of receptors that
function in two distinct, but overlapping, pathways for inflammation. Each of
the targeted inflammatory pathways has been shown to be important in allergic
inflammation and asthma. Pharmacology studies conducted in vitro have shown
that AS-ODNs inhibit these pathways in human cell lines and primary cell
cultures, including eosinophils purified from the blood of asthmatic subjects.
"ASM8 is the lead product in our development portfolio of drugs to treat
respiratory diseases and approval of our first clinical trial is an important
milestone for TOPIGEN", added Paul K. Wotton, President and CEO of TOPIGEN.
"Not only will data from this first-in-humans study provide essential
information for the design and conduct of subsequent clinical trials with
ASM8, but it will also put us a step further in establishing the safety and
effectiveness of this potentially breakthrough drug for patients with asthma
or other allergic diseases".
About Topigen
Privately-owned and incorporated in 2000, TOPIGEN is a biopharmaceutical
company focused on developing products for the treatment of inflammatory
respiratory diseases with primary emphasis on asthma, chronic obstructive
pulmonary disease (COPD) and allergic rhinitis. Together, these diseases
affect some 30% of the world's population, representing sales of over
$23 billion worldwide in 2003. TOPIGEN is developing a pipeline of novel drugs
fuelled by a patented, RNA-based, proprietary platform that targets multiple
pathways and mediators, delivered directly to the site of action, instead of a
single pathway used by new products on the market and drugs currently under
development. TOPIGEN operations are centered on the development of innovative
products to address the enduring and still unmet needs of the respiratory
disease market. http://www.topigen.com
SOURCE:
Joan Beauchamp Pascale Grand
Enigma Communications Enigma Communications
514.982.0308, ext. 209 514.982.0308, ext. 229
j.beauchamp@enigma.ca p.grand@enigma.ca
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