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Biotech / Medical : Indications -- Asthma/Allergy -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (23)	3/4/2002 7:42:26 PM
From: keokalani'nui	Respond to of 86

[IL- Mab. Genaera and Medi.] Genaera Announces Two Presentations Demonstrating Promise of IL9 Blockade As New Therapeutic Strategy for Asthma - Includes Control of Downstream Mediator IL13 - PLYMOUTH MEETING, Pa., March 4 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR - news) today announced two presentations at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in New York City demonstrating the promise of IL9 (interleukin-9) blockade by antibody therapy as a new treatment strategy for asthma. The first presentation, ``Lung Delivery of an Interleukin-9 Antibody Inhibits BAL Interleukin-13 Levels in a Murine Model of Asthma,'' describes the beneficial effects of IL9 antibody therapy on lung inflammation in animal asthma, including a significant decrease in IL13 levels. IL13 is a downstream mediator of asthma symptoms controlled by IL9. The research was conducted by Genaera's scientists. The second presentation, ``IL9 Induces IL13 Expression In Vitro and In Vivo,'' describes that IL9 upregulates IL13 in mast cells, lymphocytes and transgenic mice. The research was conducted by Genaera's scientists, in cooperation with Dr. Jamila Louahed, Dr. Jacques Van Snick, and Dr. Jean-Christophe Renauld of the Ludwig Institute for Cancer Research, Brussels, Belgium. Dr. Roy Levitt, President and Chief Executive Officer of Genaera, commented, ``Research and publications from the laboratory of Dr. Richard Flavell, Professor of Immunobiology at the Howard Hughes Medical Institute, Yale University School of Medicine, are also consistent with IL9 having an important role in asthmatic inflammation. In a recent publication by Dr. Flavell, the overexpression of IL9 in the lungs of transgenic mice resulted in an asthma-like phenotype. Various cytokines, including IL4, IL5 and IL13 were expressed in the lung in response to IL9 overexpression. These findings suggested that pathologic changes in the lung require additional signals beyond IL9 to fully develop. Thus, in our opinion, the prophylaxis or treatment of asthma based on blockade of IL9 by an antibody is promising, and well worth development and testing in human clinical trials.'' Dr. Levitt commented further, ``Over the last six years, the success of our genomics program in identifying and validating multiple therapeutic targets for major respiratory diseases certainly rivals that reported by any other company. Moreover, as few others have done so far, we have successfully translated the promise of the well-publicized genomics era into two major products in development: our IL9 antibody, partnered with MedImmune, and our small molecule mucoregulator drug, LOMUCIN(TM), targeting the hCLCA1 chloride channel. We will continue our innovative work to translate genomics data on important therapeutic targets into innovative products to help people, while also advancing multiple products derived from our unique aminosterol compound library.'' Genaera has partnered with MedImmune, Inc. for the development of a proprietary IL9 antibody. Genaera believes there is substantial potential for development of an IL9 antibody, based on the extensive biological validation of IL9 as the unique genomic target for asthma and the Company's strong intellectual property position. Over fifty research reports support IL9 as a central mediator of asthma. These include publications from Yale University, Cambridge University, Ludwig Institute for Cancer Research, Meakins-Christie Laboratories of McGill University, Helsinki University, University of California San Francisco, Institut Pasteur and the Imperial College School of Medicine.

To: scaram(o)uche who wrote (23)	3/20/2002 1:06:57 PM
From: nigel bates	Read Replies (1) \| Respond to of 86

[CpG-rich DNA conjugates/ragweed/Dynavax] EMERYVILLE, Calif., March 20 /PRNewswire/ -- An anti-allergy therapy under development at Dynavax Technologies Corporation proved effective in reversing an established allergic response to ragweed pollen in mice, according to a paper published in the March issue of the Journal of Allergy and Clinical Immunology, Volume 109, #3. The paper provides positive evidence of the potential role that this therapy may play in the treatment of human allergic disorders, including asthma. According to lead author, Marsha Wills-Karp, Ph.D., of the Division of Immunobiology at the Cincinnati Children's Hospital Medical Center, ``The paper presents the first demonstration that the novel therapy may actually reverse airway responsiveness, a hypersensitivity of the lungs associated with asthma. Prior studies showed that Dynavax's ImmunoStimulatory DNA sequences (ISS) containing CpG motifs could prevent the development of allergic airway responses in murine models, but until now, no study had evaluated the ability of ISS to reverse the condition. This finding gives us greater confidence about the compound's potential as a potential asthma therapy.'' In the study reported in Journal of Allergy and Clinical Immunology, mice were sensitized and challenged with ragweed pollen extract, and then treated intradermally twice at one-week intervals with Dynavax's immunostimulatory oligodeoxynucleotide (ISS) chemically linked to Amb a 1 (Amb a 1-ISS). One week after treatment, the mice were rechallenged intratracheally with ragweed extract and airway responses were measured. The results showed that after sensitization, treatment with Dynavax's AIC (Amb a 1-ISS) significantly reduced asthma symptoms, including airway hyper-responsiveness and eosinophilia induced by subsequent pulmonary allergen challenge. AIC also significantly increased allergen-specific IgG antibody responses and interferon (IFN) gamma responses compared to those of untreated animals or animals treated with native allergen. IFN gamma is a key cytokine involved in Th1 responses. IgG is a class of antibody typically associated with non-allergic immune responses. The paper's author noted that, ``Interestingly, the inhibitory effect of Amb a 1-ISS on allergen-driven airway hyper-responsiveness was independent of suppression of Th2 cytokine production,'' indicating that the compound had in fact reprogrammed the immune system and down-regulated a potentially harmful response to ragweed allergen. ``We are excited by these new preclinical data confirming AIC's ability to reprogram immune responses and modify allergic conditions in animals,'' stated Gary Van Nest, PhD., Dynavax Vice President of Preclinical Research. ``Recently we have begun to see significant indications that this approach may provide a safe and effective therapy for other allergic disorders, including rhinitis, in humans.'' Dynavax's proprietary technology platform is based upon a unique short immunostimulatory sequence of single-stranded DNA, termed ISS. AIC is a new therapeutic drug combining the company's ISS technology with Amb a 1, the main allergen in ragweed pollen, in order to divert the immune system response away from harmful allergic reactions to ragweed -- thereby potentially relieving the inflammatory symptoms associated with allergic rhinitis. Other pre-clinical studies have suggested that AIC induces an enhanced Amb a 1-specific, Th1-type response, possibly reprogramming the immune system away from the strong Th2 response associated with allergic inflammation and histamine release -- both of which are implicated in asthma. AIC is Dynavax's lead product. It has been studied in eight clinical trials, three of which were Phase II studies completed in 2001 in Canada, France, and the U.S.