March 29, 2004
Astralis Initiates U.S. Phase II Clinical Trial for Psoraxine® for the Treatment of Psoriasis
Fairfield, New Jersey, March 29, 2004 -- Astralis Ltd (OTCBB: ASTR) announced today that the Company has begun its Phase II clinical trial for Psoraxine®. The trial, a randomized, double blind, placebo controlled study, will evaluate the safety and efficacy of repeated administrations of Psoraxine®, for patients with moderate to severe plaque psoriasis.
The Company anticipates that a total of 120 patients at 10 clinical sites in the U.S. will participate in the study. Each patient will receive a series of 6 intramuscular injections, once every two weeks, and subsequently will be evaluated for an additional 8 weeks without treatment. The primary objective is to evaluate the safety and efficacy of multiple administrations of Psoraxine® at three alternative dose-levels, compared to a placebo. The Company will also seek, through the study, to detect and evaluate specific immunological changes, which may be induced by the repeated exposure to Psoraxine® and to generate information necessary for a better understanding of the drug’s mechanism of action.
Psoraxine® is a protein-based therapy that is believed to act as an immunostimulator, rather than an immunosuppressor. The Company has completed a Phase I clinical trial in patients with moderate psoriasis and no adverse events related to Psoraxine® were reported.<snip>
Astralis Ltd
75 Passaic Ave
Fairfield, New Jersey, 07004
Phone: 1 (973) 227- 7168
Fax: 1 (973) 227- 7169
Email: info@astralisltd.com
===============================================================
SkyePharma's Partner Astralis Initiates US Phase II Trial for Novel Psoriasis Treatment
Skyepharma PLC
30 March 2004
For Immediate Release 30 March, 2004
SkyePharma's Partner Astralis Initiates
US Phase II Trial for Novel Psoriasis Treatment
LONDON, UK, 30 March 2004 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) welcomes the recent announcement by its partner Astralis Ltd (OTC Bulletin Board: ASTR) that it has initiated a Phase II clinical trial in the USA for PsoraxineTM, a novel injectable treatment for moderate psoriasis, a common chronic skin condition. This follows the successful completion of a US Phase I trial, which commenced in September 2003. A first generation version of PsoraxineTM was 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.
Michael Ashton, SkyePharma's Chief Executive, said 'The US Food & Drug Administration's decision to authorize the Phase II trial for PsoraxineTM is an encouraging step forward. We are optimistic that this trial will replicate the very promising results seen in the previous studies in Venezuela. There is still significant unmet medical need in psoriasis and we are convinced that there is a substantial opportunity for a safe and effective new treatment.'
The randomised double-blind, placebo-controlled US study will evaluate the safety and efficacy of repeated doses of PsoraxineTM in 120 patients with moderate to severe plaque psoriasis. Patients at 10 US sites will receive a course of six intramuscular injections, administered every two weeks, with an 8-week follow-up period and the trial will involve three dose levels in addition to a placebo control arm. The study will also examine specific immunological changes in order to further elucidate the mode of action of PsoraxineTM.
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 is a substantial investor in Astralis.
For further information please contact:
SkyePharma PLC +44 207 491 1777
Michael Ashton, Chief Executive Officer
Peter Laing, Director of Corporate Communications +44 207 491 5124 Sandra Haughton,
US Investor Relations +1 212 753 5780
Buchanan Communications +44 207 466 5000
Tim Anderson / Mark Court
Notes for editors
About SkyePharma
SkyePharma PLC develops pharmaceutical products benefiting from world-leading drug delivery technologies that provide easier-to-use and more effective drug formulations. There are now nine approved products incorporating three of SkyePharma's five technologies in the areas of oral, injectable, inhaled and topical delivery, supported by advanced solubilisation capabilities. For more information, visit
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 affected by 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 being 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
astralisltd.com <snip> |
