TOPIGEN Pharmaceuticals Completes Enrollment of Phase II Clinical Study of TPI ASM8 in Asthma

Clinical Study On-Track for Completion

MONTREAL, CANADA | July 23, 2008 | TOPIGEN Pharmaceuticals Inc., a clinical-stage biopharmaceutical company specialized in developing products for respiratory disorders, today announced the completion of patient enrollment in a Phase II safety and efficacy study in asthma with one of its lead product candidates, TPI ASM8. The current clinical study builds on prior efficacy and safety data in a three-day study of TPI ASM8 in an allergen challenge model. TPI ASM8 is a novel, inhaled, anti-inflammatory drug in development for the management of moderate or severe asthma.

Mark Parry-Billings, Ph.D., Chief Development Officer at TOPIGEN, commented, "The completion of patient recruitment in this Phase II trial is on schedule, and represents a significant clinical achievement for TOPIGEN. We look forward to completing the study and reporting on data at the end of this year. TPI ASM8 is being developed initially for patients with moderate or severe asthma. There is a significant clinical need for improved medications to treat this patient group, particularly those patients who do not respond adequately to conventional medication. TPI ASM8 has the potential to provide an effective and well-tolerated approach to improve asthma control in these patients, and has the added advantage over other pipeline products of being delivered simply by inhalation."

This study is a Phase II, multi-center, double-blind, randomized, placebo controlled crossover study in subjects with asthma. It will evaluate TPI ASM8 given once daily by inhalation in a breath-actuated inhaler over a 14-day period. The Chief Investigator is Prof. Brian O'Connor, (Kings College Hospital, London, UK). Other study Investigators include Dr. Dave Singh (Medicines Evaluation Unit, Manchester, UK), Prof. Pierluigi Paggiaro (Ospedale Cisanello, Pisa, Italy), and Prof. Piero Maestrelli (University of Padova, Padova, Italy).

About Inhaled TPI ASM8

TPI ASM8 is based on TOPIGEN's proprietary RNA-silencing technology and consists of two modified RNA-silencing 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. TOPIGEN's oligonucleotides are distinct from other oligonucleotide approaches in that they are designed specifically to be non-immunostimulatory. TPI ASM8 targets two distinct cellular pathways involved in allergic airway inflammation by inhibiting the recruitment of allergic inflammatory cells, via an effect on the CCR3 receptor, and reducing the persistence of allergic inflammatory cells via interference with a common beta sub-unit for the receptors of interleukin IL-3, IL-5 and GM-CSF.

This pioneering multi-targeted approach of blocking the synthesis of specific receptors with RNA-silencing technology is expected to have advantages over current medications by providing broader, but specific, pharmacological activity with limited systemic availability, in a convenient, inhaled formulation. In an earlier Phase II allergen challenge study, TPI ASM8, at low lung doses, was shown to reduce eosinophil influx into the lungs after only three days' dosing and it provided protection against both the early and late asthmatic responses in patients with mild-to-moderate asthma. Eosinophils are cells that are recognized as key contributors to the inflammation and airway destruction in all grades of asthma and other allergic diseases. The drug was shown to be safe and well-tolerated, and systemic exposure was minimal following once daily inhalation. Data from the study was recently published in the American Journal of Respiratory and Critical Care Medicine in May 2008.

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. Asthma affects more than 60 million patients in the US, Europe and Japan. About 20 million of these patients have chronic persistent moderate or severe asthma (DataMonitor, 2008) and a high proportion of these patients are uncontrolled with conventional medications (Peters et al JACI, 2007; 119:1454-61).


TOPIGEN is a privately held, clinical-stage company focused on developing new classes of inhaled drugs for respiratory diseases such as chronic obstructive pulmonary disease (COPD) and asthma. TOPIGEN is actively progressing two drug candidates in Phase II trials for COPD and asthma, including TPI 1020, a novel anti-inflammatory, licensed from NicOx S.A. and TPI ASM8, which utilizes its proprietary mRNA-silencing technology. These drug candidates target multiple pathways and pro-inflammatory mediators involved in chronic pulmonary diseases.

Current venture investors include NovaQuest, MMV Financial, Inc., BDC Venture Capital, Fonds de solidarite FTQ, Desjardins Venture Capital, Caisse de Dépot et Placement du Québec (Caisse), T2C2/BIO 2000 and Lothian Partners 27 (sarl) SICAR. For more detailed information on TOPIGEN visit

SOURCE: Topigen Pharmaceuticals, Inc.

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