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TOPIGEN Reports Positive Therapeutic Results from Initial Phase II Trial Studying Inhaled TPI-ASM8 in Patients with Mild-to-Moderate Asthma

19 Jul 2006

Phase II Data Validates TPI-ASM8 Clinical Targets and Efficacy of Multi-targeted Antisense in the Respiratory Tract

MONTREAL, Canada and PARSIPPANY, NJ, USA | July 18, 2006 | TOPIGEN Pharmaceuticals Inc., an emerging

biopharmaceutical company specializing in developing treatments for respiratory diseases, today announced preliminary data from its first Phase II clinical trial of inhaled TPI-ASM8 as a single agent in patients with allergic asthma. The results indicate that inhaled TPI-ASM8 demonstrated protection in early and late stage allergic responses in patients with asthma.

Paul O'Byrne, M.D., Chairman of Medicine, McMaster University, Canada and the principal investigator of the study commented on the results, "These are impressive and encouraging data for a potential new class of therapeutics for treating respiratory diseases. This is the first demonstration of efficacy with a RNA-targeting drug in respiratory patients. In this 'proof-of-principle' trial, inhaled TPI-ASM8 was shown to be safe and well tolerated and it demonstrated significant biological and physiological activity in study subjects, including substantial reductions of eosinophil cell levels and suppression of target gene expression. I am looking forward to working on expanded Phase II studies with TOPIGEN to exploit the full potential of this novel drug."

The 17-patient, randomized, placebo-controlled, multicenter, crossover, allergen challenge Phase II trial was designed to assess overall safety and tolerability and to demonstrate proof-of-principle that inhaled TPI-ASM8 would show biological activity in the respiratory tract of patients with mild-to-moderate asthma. The study evaluated repeated administration of once daily doses of inhaled TPI-ASM8, given for four days at delivered doses similar to currently marketed steroids.

Paolo Renzi, M.D., TOPIGEN's Chief Scientific Officer and Founder commented, "TOPIGEN is the first company to show a biological effect in an established model of asthma with lung-specific antisense oligonucleotide therapy. This was our very first attempt to examine the activity of inhaled TPI-ASM8 in patients and these results confirmed earlier findings seen in our pre-clinical studies. Assuming that these data are confirmed in subsequent and larger clinical studies, we are confident that we can develop a meaningful therapeutic alternative to inhaled corticosteroids for patients with asthma. There is a pressing need to develop new drugs with highly specific mechanisms of action that can alter the course of the disease while minimizing systemic side effects."

Paul K. Wotton, Ph.D., President and Chief Executive Officer of TOPIGEN added, "This study provides strong validation of TOPIGEN's novel approach on multiple levels. First and foremost, TOPIGEN's proprietary antisense therapy approach works effectively in the respiratory tract. Second, our specific and multi-targeted approach is safe and effective in this patient population. And third, it provides validation of our receptor targets in patients with asthma. This is a significant milestone towards building TOPIGEN as a leading biopharmaceutical company focused on developing innovative treatments for respiratory diseases."

About Inhaled TPI-ASM8

TPI-ASM8 is a new inhalation drug currently in Phase II clinical development for the treatment of asthma. The drug consists of two modified antisense oligonucleotides designed specifically to reduce the recruitment and persistence of chronic inflammatory cells, two key components underlying the cause of the disease. Using TOPIGEN's proprietary antisense chemistry designed for the lungs, the drug targets two distinct cellular pathways involved in allergic airway inflammation by inhibiting the recruitment of allergic inflammatory cells, called eosinophils, via the CCR3 receptor and reducing the persistence of allergic inflammatory cells via inhibition of a common beta sub-unit for the receptors of interleukin (IL) 3, 5 and GM-CSF. This pioneering multi-targeted approach of blocking the expression of specific genes with antisense oligonucleotides is expected to have advantages over current medications.

About Asthma

Asthma is a chronic inflammatory disease of the airways in which many cells and cellular elements play a role--in particular, mast cells, eosinophils and T-lymphocytes. In susceptible individuals, this inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness and coughing, particularly at night and/or in the early morning. The inflammation also causes an associated increase in the airway hyperresponsiveness to a variety of stimuli. Symptoms are usually associated with widespread, but variable airflow obstruction, that is at least partly reversible with treatment. Allergic asthma accounts for most cases of the disease and afflicts people who are predisposed to developing hypersensitivity to environmental allergens.

About Antisense Oligonucleotides

Antisense oligonucleotides are chemically-modified molecules (nucleotides) that are designed to bind to a specific sequence of a messenger RNA's (mRNA) target through base-pairing interactions, thereby interfering with expression of the protein encoded by the mRNA. Scientists are using antisense oligonucleotides to design new, more effective drugs to inhibit gene expression and production of abnormal levels of cell proteins involved in diseases.

About TOPIGEN

TOPIGEN Pharmaceuticals, Inc. is a clinical stage privately-held biopharmaceutical company focused on developing new classes of inhaled drugs for respiratory diseases. TOPIGEN's pipeline includes proprietary RNA-targeting technology and small molecule approaches to treating disease. The Company has two drugs presently in Phase II clinical development and multiple discovery programs for the treatment of asthma, Chronic Obstructive Pulmonary Disease (COPD) and allergic rhinitis. In addition to inhaled TPI-ASM8, TOPIGEN has commenced Phase II trials on inhaled TPI-1020, a novel corticosteroid for COPD. TPI-1020 is a unique inhaled corticosteroid belonging to a new class of nitric oxide-donating therapeutics targeted at inflammation (notably neutrophils) in the lung. For more detailed information on TOPIGEN visit www.topigen.com.

Contact:

Corporate Contact:
TOPIGEN Pharmaceuticals, Inc.
Paul K. Wotton, Ph.D., 514-868-0404
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or
IR/PR Contact:
LaVoie Group
Donna LaVoie, 978-745-4200 X103
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SOURCE: TOPIGEN Pharmaceuticals, Inc.

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