![](/cdn/assets/images/search/clock.png)
We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
SEB SA | AQEU:SKP | Aquis Europe | Ordinary Share |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.20 | 0.20% | 102.30 | 102.00 | 102.30 | 103.00 | 100.00 | 100.50 | 2,353 | 16:29:57 |
RNS Number:7395P Skyepharma PLC 15 September 2003 For Immediate Release 15 September, 2003 SkyePharma's partner Astralis initiates US phase I trial for novel psoriasis treatment LONDON, ENGLAND, September 15, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) welcomes the recent announcement by its partner Astralis Ltd (OTCBB: ASTR - News) that it has initiated a Phase I clinical trial in the USA for PsoraxineTM, a novel injectable treatment for moderate psoriasis, a common chronic skin condition. A first generation version of PsoraxineTM has already been studied extensively in Venezuela, where nearly 3,000 patients participated in open-label clinical studies, the vast majority showing a positive response with few side-effects. Through a service agreement, SkyePharma is providing development, manufacturing, pre-clinical and clinical development services to Astralis for a second generation version of PsoraxineTM, up to the completion of Phase II clinical studies. In the event that Phase II studies are successfully completed, Astralis will offer SkyePharma the option to acquire the worldwide licensing and distribution rights to PsoraxineTM. SkyePharma has a minority equity stake in Astralis. Michael Ashton, SkyePharma's Chief Executive, said "We are delighted that the US Food & Drug Administration has authorised the start of US clinical studies of PsoraxineTM. We look forward to working with our partner Astralis to validate the very promising results from the previous studies in Venezuela. Psoriasis remains a common and highly debilitating condition with well-recognised failings in standard treatments. Despite the recent introduction of some new approaches to psoriasis, there remains a substantial opportunity for a safe and effective new therapy." The double-blind, placebo-controlled US study is being conducted by Dr. William Abramovits, Professor of Dermatology at Baylor University Medical Center, Dallas, Texas. The trial will evaluate the safety of a single dose of PsoraxineTM in patients with moderate psoriasis that has lasted for more than three months and covers between 3% and 15% of the body surface. PsoraxineTM is administered by intramuscular injection and the trial will encompass three dose ranges of 50, 150, and 300 micrograms in addition to a placebo control arm. The study will also provide some preliminary information on efficacy using measures of psoriasis severity and Quality of Life improvement. Notes to Editors About SkyePharma SkyePharma PLC uses its world-leading drug delivery technology to develop easier-to-use and more effective formulations of drugs. The majority of challenges faced in the formulation and delivery of drugs can be addressed by one of the Company's proprietary technologies in the areas of oral, injectable, inhaled and topical delivery, supported by advanced solubilisation capabilities. For more information, visit http://www.skyepharma.com. About psoriasis Psoriasis is a chronic, genetically linked skin disorder that affects approximately 2-3% of the world's population. For example, there are 7 million patients in the USA, with around 250,000 new cases diagnosed every year. The prevalence in Europe is similar. About 25% of patients are classified as moderate to severe, with over 10% of their body area affected. Psoriasis symptoms result from the overproduction of skin by epidermal cells induced by cells from the immune system. These blood cells over-stimulate the epidermis and act as though the skin was damaged, manufacturing skin cells at a much faster rate than is required by undamaged skin. The overproduction of skin cells can cause symptoms ranging from itchy rash-like patches to painful plaques or pustules, accompanied by massive inflammation. Psoriasis is normally episodic, with patients experiencing flares of increasing severity followed by periods of remission. Disease severity in psoriasis is measured by the PASI (Psoriasis Area and Severity Index) score, based on subjective assessment by the patient and objective measurements by the clinician. The PASI score ranks from 0-72 with zero indicating symptom-free. The FDA hurdle for demonstrating the efficacy of psoriasis treatments is a 75% reduction in PASI score. About PsoraxineTM PsoraxineTM is a protein-based therapy that is believed to stimulate cells from the patient's immune system to reverse the inflammatory process responsible for psoriasis symptoms. Jose O'Daly MD, PhD, Chairman of the Board and Head of R&D for Astralis, is a Venezuelan parasitologist. While developing an improved vaccine for leishmaniasis, a parasitic infection transmitted by sandflies and endemic in much of South America, he noticed that vaccinated patients with psoriasis saw their symptoms resolve. The version of PsoraxineTM used in the clinical studies in Venezuela was based on a cellular extract from several species of the Leishmania parasite. Since 1992, nearly 3,000 patients have been treated with a course of injections in open-label studies. A clinically significant reduction in PASI score was reported for a great majority of the patients treated. The only significant side-effect in these studies was pain at the injection site. The second generation version of PsoraxineTM to be used in the US trials is a purified protein fraction. About Astralis Astralis Ltd, an emerging biotechnology company based in Fairfield, New Jersey, focuses on the research and development of novel treatments for immune system disorders and skin diseases. For further information visit www.astralisltd.com. Except for the historical information herein, the matters discussed in this news release include forward-looking statements that may involve a number of risks and uncertainties. Actual results may vary significantly based upon a number of factors, which are described in SkyePharma's 20-F and other documents on file with the SEC. These include without limitation risks in obtaining and maintaining regulatory approval for existing, new or expanded indications for its products, other regulatory risks, risks relating to SkyePharma's ability to manufacture pharmaceutical products on a large scale, risks that customer inventory will be greater than previously thought, risks concerning SkyePharma's ability to manage growth, market a pharmaceutical product on a large scale and integrate and manage an internal sales and marketing organization and maintain or expand sales and market share for its products, risks relating to the ability to ensure regulatory compliance, risks related to the research, development and regulatory approval of new pharmaceutical products, risks related to research and development costs and capabilities, market acceptance of and continuing demand for SkyePharma's products and the impact of increased competition, risks associated with anticipated top and bottom line growth and the possibility that upside potential will not be achieved, competitive products and pricing, and risks associated with the ownership and use of intellectual property rights. SkyePharma undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release. For further information please contact: SkyePharma PLC +44 207 491 1777 Michael Ashton, Chief Executive Officer Peter Laing, Director of Corporate Communications Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000 Tim Anderson / Rebecca Skye Dietrich Astralis Ltd Mike Ajnsztajn, Chief Executive Officer +1 973 227 7168 Gina Tedesco, Chief Financial Officer This information is provided by RNS The company news service from the London Stock Exchange END MSCLTMRTMMTBBBJ
1 Year SEB Chart |
1 Month SEB Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions