Resistentia Reports Pioneering Results from Phase I Allergy Immunotherapy Trial.UPPSALA, Sweden -- The interim report from Resistentia's phase I trial with RP01, a novel universal allergy immunotherapy, shows positive results. The therapy was well tolerated and the healthy volunteers developed anti-IgE antibodies, supporting the novel mode of action of the immunotherapy. "There is a tremendous need for an efficient, long-acting and cost-effective asthma and allergy treatment. The strength of the interim report has encouraged us to step up our development efforts ahead of the upcoming phase II trials," says Marcus Bosson, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Resistentia Pharmaceuticals. He adds: "We can see that this immunotherapy produces the desired effect. This is an important milestone in the development process". RP01 induces the immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. to produce antibodies against Immunoglobulin E immunoglobulin E n. Abbr. IgE The class of antibodies produced in the lungs, skin, and mucous membranes and responsible for allergic reactions. (IgE), the key molecule triggering allergic reactions. The antibodies induced by the immunotherapy bind to IgE and block it from starting allergic reactions. The treatment thus has the potential to block allergenic Allergenic A substance capable of causing an allergic reaction. Mentioned in: Echinococcosis triggers such as grass, pollen or dust mite dust mite House dust mite, see there . The main purpose of the trial was to study the safety and tolerability of the immunotherapy. Interim data indicate no changes in the studied safety parameters. Those participating in the study have not displayed any general adverse effects that can be linked to the treatment. A secondary objective of the study was to establish the pharmacodynamic profile of the immunotherapy. Here as well, interim data displayed positive results with development of anti-IgE antibodies. The phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I , which was initiated in March 2006, includes several groups of healthy volunteers that have been given escalating doses of the immunotherapy. Professor Sven-Erik Dahlen, Chairman of Resistentia's Scientific Advisory Board, concludes: "The mechanism developed in discovery research has now been confirmed in man with no apparent safety concerns. It will be very interesting to follow the continued clinical development in subjects with allergy and asthma". Preparations for phase II clinical trials in allergic patients continue. About Resistentia Pharmaceuticals Resistentia Pharmaceuticals AB is a privately held biotech company developing innovative immunotherapies that target allergy and asthma as well as inflammatory disorders. Founded in 1998, the company has developed an industrial organization with experiences ranging from molecular immunology, pre-clinical and clinical drug development to industrial biopharmaceutical production. In addition to its lead anti-IgE immunotherapeutic, Resistentia has initiated pre-clinical development of an immunotherapeutic against complement factor C5a for the treatment of rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. and other autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . About RP01 RP01 is an immunotherapeutic that stimulates the immune system to produce antibodies against IgE (Immunoglobulin E), the key mediator of allergic reactions. The antibodies bind to IgE, thereby blocking it from causing allergic reactions. Such a mechanism of action is efficient regardless of what triggers the allergy, be it pollen, grass, dust mite, foodstuffs foodstuffs npl → comestibles mpl foodstuffs npl → denrées fpl alimentaires foodstuffs food npl → or pets. RP01 has been investigated in a series of pre-clinical studies and has displayed strong efficacy in combination with an excellent safety profile. RP01 will primarily target allergic asthma. Other potential indications include allergic rhinitis and peanut allergy. |
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