FDA approves Topigen's investigational New Drug Application for new inhalation drug to treat asthma

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".

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