Genaera Corporation (Nasdaq: GENR) today announced a publication describing the relationship of its mucoregulator target to mucus overproduction in asthma. Genaera's second genomics-based target in development, hCLCA1, regulates abnormal mucus production and has the potential to be an important new therapeutic target for asthma and other respiratory and sinus diseases.
The paper, "A Calcium-Activated Chloride Channel (hCLCA1) is Strongly Related to IL-9 Expression and Mucus Production in Bronchial Epithelium of Patients with Asthma," is published in the February 2002 issue of the Journal of Allergy and Clinical Immunology, the official publication of the American Academy of Allergy, Asthma and Immunology. The publication describes that hCLCA1 mRNA was increased in the lung epithelial and mucus producing cells of asthmatic patients, and was strongly and selectively co-localized with mucus production.
Professor Qutayba Hamid, MD, PhD, of the Meakins-Christie Laboratories, McGill University, Montreal, Canada, and lead author of the study, commented, "These findings suggest the inhibition of hCLCA1 may be an important new therapeutic strategy to control mucus overproduction in chronic airway disorders. The potential applications are conditions in which mucus overproduction and inflammation are significant medical problems, including asthma, cystic fibrosis, COPD and chronic sinus disorders."
Based on the identification of this gene, hCLCA1, by Genaera scientists, the Company has developed LOMUCIN(TM), its second-genomics based therapeutic. LOMUCIN(TM) is intended to block the hCLCA1-dependent mucus overproduction present in respiratory and sinus disorders, and thereby provide a new strategy for opening the airways and easing breathing in patients with these diseases. The first clinical trial for LOMUCIN(TM) was initiated in asthma in August 2001, and other clinical trials are in preparation. Clinical development in cystic fibrosis is supported by an initial grant of up to $1.7 million from the Cystic Fibrosis Foundation.
Roy C. Levitt, M.D., President and Chief Executive Officer, commented, "We have moved from cloning the hCLCA1 gene, to discovering its function and relationship to abnormal mucus production, and now we are testing LOMUCIN(TM) in humans to inhibit mucin due to this novel pharmaceutical target.
LOMUCIN(TM) may provide a unique advantage over conventional treatments because it appears to specifically inhibit the overproduction of abnormal gel-forming mucins that clog the small airways in chronic lung diseases like asthma, COPD and cystic fibrosis. In contrast, current therapies generally attempt to deal with mucus clearance once it is present in the airways, instead of preventing excess mucus production."
There is extensive unmet medical need for a therapy that can prevent abnormal mucus production. Chronic sinusitis is one of the most common reasons for physician visits in the United States, with 35 million cases per year. It is thought that many of the symptoms of chronic sinusitis result from excess mucus production. Among other respiratory diseases, there are up to 50 million patients with conditions exacerbated by excess mucus production where mucoregulator therapy may be of benefit. Mucus overproduction and small airway plugging is one of the hallmarks of asthma. Excess mucus production is also associated with COPD and chronic bronchitis. The orphan disease state of cystic fibrosis is characterized by a dramatic increase in mucus production, and mucoregulator therapy may be beneficial in this condition as well.
Genaera Corporation is a biopharmaceutical company committed to developing medicines for serious diseases from genomics and natural products. Research and development efforts are focused on anti-angiogenesis, obesity, infectious diseases and respiratory diseases. Genaera has four products in development addressing substantial unmet medical needs in major pharmaceutical markets. These include squalamine, an anti-angiogenesis treatment for cancer and eye disease; trodulamine, an appetite suppressant for medically significant obesity; interleukin-9 antibody, a respiratory treatment based on the discovery of a genetic cause of asthma currently in development at MedImmune, Inc.; and LOMUCIN(TM), a mucoregulator to treat the overproduction of mucus and secretions involved in many forms of chronic lung disease.
This announcement contains forward-looking statements that are subject to risks and uncertainties. Forward-looking statements reflect management's current views and are based on certain expectations and assumptions. Such statements include, among others, statements regarding the preliminary results and future clinical development plans and prospects for the small molecule mucoregulator program, including LOMUCIN(TM). You may identify some of these forward looking-statements by the use of words in the statements such as "anticipate," "develop," "continuing," and "progress," or other words of similar meaning. Genaera's actual results and performance could differ materially from those currently anticipated and expressed in these and other forward-looking statements as a result of a number of factors, including, but not limited to, the additional data to be collected from the clinical trials, results of additional clinical development plans, results of ongoing preclinical and clinical studies in our drug development candidates, general financial, economic, regulatory and political conditions affecting the biotechnology industry and the other risks and uncertainties discussed in this announcement and in Genaera's filings with the U.S. Securities and Exchange Commission. Genaera does not intend (and it is not obligated) to publicly update, revise or correct these forward-looking statements. This discussion is permitted by the Private Securities Litigation Reform Act of 1995.
