Anti-Interleukin-9 Data Presented at the American Thoracic Society Meeting
PLYMOUTH MEETING, Penn., May 24, 2007 /PRNewswire-FirstCall/ -- Genaera Corporation today reported that MedImmune, Inc. presented data related to the Interleukin-9 (IL-9) program at the American Thoracic Society (ATS) 2007 Annual Conference held May 18-23 in San Francisco, California. Genaera and MedImmune entered into a collaborative licensing agreement for this program in 2001. MedImmune is conducting research to evaluate the potential to use its fully humanized, developmental stage monoclonal antibody (MAb) targeting IL-9 to treat or prevent symptomatic, moderate-to-severe, persistent asthma. The ATS presentations summarize several preclinical and clinical studies on IL-9 biology and include results from two phase 1 clinical trials to evaluate the safety and pharmacokinetics of the antibody, known as MEDI-528, in healthy adults.
IL-9 is associated with features of asthma including increased airway inflammation, obstruction and hyperresponsiveness, mucin production and mast cell generation. Earlier preclinical study results have demonstrated that inhibition of IL-9 leads to decreased airway inflammation and hyperresponsiveness in animal models. The clinical results presented at ATS indicate that the anti-IL-9 MAb, currently being evaluated in a phase 2 trial in patients with asthma, was well tolerated.
"This first look at human anti-IL-9 data clearly supports the clinical plan MedImmune has undertaken to advance this novel potential treatment for patients with moderate to severe asthma," said Jack Armstrong, President and Chief Executive Officer of Genaera. "These data clearly support further study of MEDI-528 in asthma patients. We look forward to our continued relationship with MedImmune and are pleased that the anti-IL-9 antibody is progressing within their respiratory inflammation pipeline."
In addition to the clinical results described at ATS, results from preclinical studies focused on the role of IL-9 in the pathology of asthma were also presented. These data provide new insight into IL-9's role in mast cell regulation and allergen-induced airway remodeling.
About Anti-IL-9 MAb
IL-9 has been associated with symptoms of asthma including mucous production, lung infiltration of inflammatory cells, and IgE (an immune globulin associated with allergic disease) production. It is one of at least 29 naturally occurring interleukins in the human body.
Genaera Corporation is focused on advancing the science and treatment of metabolic diseases. We have significant market opportunities with a first-in- class molecule that has the potential to redefine the treatment paradigm for obesity and type 2 diabetes. In addition, we have a value-driven, fully out- licensed partnership with MedImmune for a second core program. Genaera is committed to directing resources to its core program and the aggressive clinical development of its key assets to build stockholder value.
This announcement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties, known and unknown. Forward-looking statements reflect management's current views and are based on certain expectations and assumptions. Such statements include, among others, statements regarding these preliminary results, clinical development plans and prospects for Genaera's programs including trodusquemine (MSI-1436), the IL-9 antibody program, LOMUCIN(TM), or squalamine. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "believe," "continue," "develop," "expect," "plan" and "potential" 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 risk factors, including, but not limited to: Genaera's history of operating losses since inception and its need for additional funds to operate its business; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; the risk that clinical trials for Genaera's product candidates, including trodusquemine (MSI-1436), the IL-9 antibody program, LOMUCIN(TM), or squalamine may be delayed or may not be successful; the risk that Genaera may not obtain regulatory approval for its products, whether due to adequacy of the development program, the conduct of the clinical trials, changing regulatory requirements, different methods of evaluating and interpreting data, regulatory interpretations of clinical risk and benefit, or otherwise; Genaera's reliance on its collaborators, in connection with the development and commercialization of Genaera's product candidates; market acceptance of Genaera's products, if regulatory approval is achieved; competition; general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industry; and the other risks and uncertainties discussed in this announcement and in Genaera's filings with the U.S. Securities and Exchange Commission, all of which are available from the Commission in its EDGAR database at www.sec.gov as well as other sources. You are encouraged to read these reports. Given the uncertainties affecting development stage pharmaceutical companies, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Genaera does not intend (and it is not obligated) to publicly update, revise or correct these forward-looking statements or the risk factors that may relate thereto.
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Posted: May 2007