SOPHIA ANTIPOLIS, France, January 21 /PRNewswire-FirstCall/ -- NicOx S.A. (Nouveau Marche: NICOX) reports that its partner, Biolipox AB, issued a press release today announcing the start of phase II clinical trials in allergic rhinitis with a NicOx compound, NCX 1510. This is the first compound to be selected from the ongoing research and co-development agreement between the two companies for the discovery and development of novel compounds in the respiratory field (29 January 2003 and 25 June 2001 press releases).
Following the successful completion of a Phase I programme, this is the first new product from a series of compounds under evaluation to move from healthy volunteers into patients. The phase IIa study is an out-of-season allergen provocation study which will be carried out at Lund University Hospital involving 36 patients. It aims to determine the first efficacy parameters in patients suffering from allergic rhinitis as well as assessing tolerability and overall safety. Results are expected for mid 2004.
Michele Garufi, Chairman and CEO of NicOx, commented: "The move into phase II clinical development is a significant step in our collaboration with Biolipox and is noteworthy as it comes only one year after the start of our research and co-development agreement. The rapid entry into phase II validates NicOx's strategy of close cooperation with companies focused in specialist areas to accelerate the clinical development and reduce time to market for our technology."
Biolipox, a pharmaceutical research and development company in respiratory and inflammation has decided to continue the clinical development of a nasal spray for the treatment of both allergic and non-allergic rhinitis. The decision was taken following the successful completion of clinical Phase I, showing good tolerability of the drug in healthy volunteers. The results from the ongoing Phase IIa study will be available in mid 2004. The world wide rhinitis market is valued at more than US$ 8 billion.
Thirty-six patients suffering from allergic rhinitis are taking part in the Phase IIa study, which aims to evaluate the efficacy of the new nasal spray. The study which is an out-of-season allergen provocation study is carried out at Lund University Hospital, a center with consolidated experience in clinical studies of inflammation and allergies.
"Biolipox is running a number of innovative projects with the potential to become very important for the future treatment of allergies and asthma. The clinical development of this nasal spray is part of a more extensive collaboration between our clinic and Biolipox," explains Associate Professor Lennart Greiff at the ENT Clinic at Lund University Hospital. "We hope that this new allergy drug will be a good addition in the treatment of allergic inflammation," he continues.
Allergic rhinitis is a common clinical condition that affects approximately 30% of adults and up to 40% of children in industrialized societies, but the impact of the condition is often underestimated. The symptoms, such as nasal congestion, itching and fatigue, can have a major effect on patients' quality of life. The economic toll of allergic rhinitis is evident from studies investigating both direct cost of medication (for example, in 2002 US$ 6 billion spent on prescription medications), as well as indirect costs (such as the 3,5 million lost workdays and 2 million missed school days annually in the United States). There is a large unmet need for new and improved treatments to complement the currently used symptomatic therapies.
"We are very pleased with the first results, showing good tolerability in humans, says Associate Professor Lars Larsson, Medical Director at Biolipox "The advantage of using a nasal spray to treat hay fever is that symptoms are relieved very quickly as the medicine is administered directly to target tissues in the patient's nose. This also leads to fewer side-effects, because the drug is less widely distributed to other tissues and organs of the body," explains Larsson.
"The new product is the first to successfully move from research into patients from a series of compounds identified in the research collaboration between Biolipox and NicOx S.A, says Chief Executive Officer Torbjorn Bjerke at Biolipox. Its continuation in clinical development is a significant step forward in Biolipox strategy to focus on new innovative treatments within the respiratory field, Bjerke continues".
Biolipox AB is a pharmaceutical R&D company, focused on creating novel, efficacious and cost effective therapeutic opportunities for respiratory conditions and other inflammatory disorders. Biolipox' scientific platform is based on world-class arachidonic acid cascade research, performed at the Karolinska Institutet. The company has a portfolio of potential blockbusters in the respiratory therapy area and unique targets for novel anti-inflammatory and analgesic drugs.
NicOx S.A. (Bloomberg: NICXF, Reuters: NCOX.LN), headquartered in Sophia-Antipolis, France, is a Public company listed on the Nouveau Marche of Euronext Paris (segment: Next Economy). NicOx is targeting several major pharmaceutical markets including pain and inflammation, cardiovascular diseases, respiratory disorders, inflammatory bowel diseases, urinary incontinence, osteoporosis, certain dermatological disorders, certain liver diseases, Alzheimer's disease and colon cancer.