PipelineReview.com - Biotech News & Online Store - Topigen Presents New Data on Its Phase II Asthma Product, TPI ASM8, at the American Thoracic Society Annual Meeting

Topigen Presents New Data on Its Phase II Asthma Product, TPI ASM8, at the American Thoracic Society Annual Meeting

23 May 2007

Clinical Data Highlights First Demonstration of Efficacy With an RNA-Therapeutic in Respiratory Disease

MONTREAL, Canada and SAN FRANCISCO, CA , USA | May 22, 2007 | TOPIGEN Pharmaceuticals, Inc., a clinical stage

biopharmaceutical company specializing in respiratory disorders, today announced that it presented new clinical data concerning its lead product, TPI ASM8 for asthma, during the American Thoracic Society (ATS) Annual Meeting, held in San Francisco at the Moscone Convention Center (May 18 - 23, 2007). With more than 13,000 members, the ATS is a leading medical association dedicated to advancing lung, critical care and sleep medicine.

TPI ASM8 is based on TOPIGEN's proprietary RNA-targeting chemistry and consists of two modified RNA-targeting oligonucleotides designed specifically to reduce the recruitment and persistence of chronic inflammatory cells and their associated release of cytokines -- all key components underlying the cause of the disease.

During Poster Session #408, Louis-Philippe Boulet, M.D., FRCPC, FCCP, one of the principal investigators of the study, reported on the Phase II TPI ASM8 clinical investigation that was designed to evaluate the safety, tolerability and efficacy of inhaled TPI ASM8. Top line Phase II results were announced in July of 2006. The study demonstrated significant inhibitory effects on allergen-induced responses in 17 stable, mildly allergic asthmatic subjects when treated with TPI ASM8. Dr. Boulet is a Pneumologist at the Institute of Cardiology and Pneumology at Laval Hospital, Sainte-Foy, Quebec and a Professor of Medicine (Tenure), University of Laval.

Once daily treatment with TPI ASM8 for three days inhibited the influx of eosinophil cells by nearly half (49%), compared to placebo and halted the increase in total cells and neutrophils after an allergen challenge. Eosinophil and neutrophil cells are key to the inflammatory response in asthma. TPI ASM8 reduced the early allergic response and the late allergic response. The study also verified that the efficacy was through the suppression of the target genes and validated them as important in the potential treatment of asthma.

Dr. Boulet commented on the results of the study: "Inhaled TPI ASM8 demonstrated protection in early and late stage allergic responses in patients with asthma and was shown to be safe and well tolerated. The substantial reduction of eosinophil cell levels of 49 percent and target-gene suppression is a breakthrough. For heterogeneous diseases like asthma, it is important to target multiple mediators simultaneously. TOPIGEN is now studying the drug in an expanded Phase II study to exploit the full potential of this novel drug."

Paul O'Byrne, M.D., Chairman of Medicine, McMaster University, Canada and a principal investigator, added: "These data support the potential utility of RNA-antagonists as a new therapeutic option for millions of sufferers with respiratory diseases. I look forward to working with TOPIGEN to move this drug candidate to its next stage of clinical development."

Dr. Paolo Renzi, Chief Scientific Officer and Founder of TOPIGEN, concluded: "This is very much a breakthrough study in many respects. We believe the success of this study is a result of our multi-targeted approach of blocking the expression of specific genes with RNA-antagonists, such as TPI ASM8."

Details of the Poster Sessions involving TOPIGEN research and development follow:

Poster - #408 - Effects of inhaled TPI ASM8 on allergen-induced responses in humans. (Source: TOPIGEN Pharmaceuticals Inc., Laval University; McMaster University, Hamilton, ON; University of Saskatchewan, Saskatoon, SK; and University of Montreal) Sunday, May 20, 2007.

Poster - #L61 - Comparative effects of inhaled TPI 1020, a NO-donating derivative of budesonide, and budesonide on neutrophil migration and activation in in vitro and in vivo models of COPD. (Source: TOPIGEN Pharmaceuticals Inc.; University of Montreal; and CHUM Research Center) Tuesday, May 22, 2007.

Poster - #J69 - FANA-containing siRNA demonstrate enhanced efficacy over unmodified siRNA to inhibit RSV replication. (Source: TOPIGEN Pharmaceuticals Inc.; CHUM Research Center; and McGill University) Monday, May 21, 2007.

About Inhaled TPI ASM8

TPI ASM8 is a first-in-class, inhaled RNA-targeting drug candidate currently in Phase II clinical development for the treatment of asthma. TPI ASM8 targets two distinct cellular pathways involved in allergic airway inflammation by inhibiting the recruitment of allergic inflammatory cells, called eosinophils, via an effect on the CCR3 receptor, and also reducing the persistence of allergic inflammatory cells via interference with 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 RNA-antagonists is expected to have advantages over current medications by providing broader pharmacological activity with limited systemic availability.

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 hyper responsiveness 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 TOPIGEN

TOPIGEN is a privately held, clinical-stage biopharmaceutical company focused on developing new classes of inhaled drugs for respiratory diseases such as asthma, COPD and allergic rhinitis. TOPIGEN's pipeline includes small molecule and RNA-targeting therapeutics. The Company has two lead product candidates, inhaled TPI ASM8 for the treatment of asthma and inhaled TPI 1020 for the treatment of Chronic Obstructive Pulmonary Disease (COPD). Both are currently undergoing Phase II trials. By topically targeting multiple affected airway receptors, the Company expects to improve outcomes for many patients with respiratory diseases. This specific approach has shown promising preclinical and clinical results in inhibiting the underlying inflammation associated with many pulmonary conditions.

Current venture investors include CDP Capital - Technology Ventures, Desjardins Venture Capital, T2C2 / BIO, Fonds de solidarité FTQ, BDC Venture Capital and Multiple Capital Inc. For more detailed information on TOPIGEN visit www.topigen.com.

SOURCE: TOPIGEN Pharmaceuticals, Inc.

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