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European Pharmaceutical Contractor
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The immune system involves a balance between T helper cell Th1- and Th2-generated proteins called cytokines. Broadly speaking, in allergic individuals there is an over-stimulation of the Th2 response. A number of novel attempts aimed at restoring the Th1/Th2 balance are currently being investigated as possible cures for diseases such as allergic rhinitis and asthma. One such approach, Chiron's needle-free injection, Cat-PAD (peptide antigen desensitisation), is currently in Phase I. It consists of overlapping peptides containing T-cell specific allergen epitopes and MHC (major histocompatability complex)-binding sequences. Cat-PAD appears to offer significant advantages over traditional specific immune therapy. This is the only treatment known to halt the progression of allergic rhinitis, but because it involves the administration of specified quantities of allergen extracts over a three to five year period and because of serious safety concerns, immune therapy currently accounts for only two to four per cent of the US$9 billion allergy market.
The use of immune therapy is restricted to allergy specialists and is most frequently prescribed in Spain, Italy, France, Germany and the US. In contrast, despite possessing one of the highest prevalence rates of allergy in the world - with one in three people reporting allergy symptoms at some stage - immune therapy is rarely used in the UK. This is largely due to a dire lack of allergists and the severe prescribing restrictions imposed by the regulatory authorities following a 1986 British Medical Journal article citing 26 immune therapy induced fatalities over 30 years.
Cat-PAD has been erroneously labelled as an asthma vaccine and touted by the media as a potential means of removing the need for asthma inhalers in the future. In fact, it is more correctly labelled an allergy vaccine and a number of major obstacles must be overcome if it is to succeed, as illustrated in Figure 1.
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By Lisa Frawley, Respiratory Analyst at Datamonitor Healthcare
Lisa Frawley, PhD, is the Respiratory Analyst in the Immune Disorders and Inflammation group at Datamonitor Healthcare. She joined the company in September 2002 and has published a number of comprehensive reports in this area, involving analysis of pipeline therapies, physician treatment practices, inhaler devices and market dynamics. Prior to joining Datamonitor, Lisa studied Pharmacy at Trinity College Dublin, Ireland, where she practised as a Pharmacist in both retail and hospital settings, before commencing a PhD in Pharmacology at the University of Cambridge.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
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drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
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News and Press Releases |
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Azopharma Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
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