7th Feb 2014 07:00
Oxford Pharmascience Group plc
("Oxford Pharmascience" or "the Company")
Oxford PharmaScience Receives Regulatory Approval to Start Pilot Clinical Study of OXP001 400mg Ibuprofen
Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces that its Clinical Trial Application for OXP001 400mg Ibuprofen has received approval from the UK Medicines and Healthcare Products Regulatory Agency ('MHRA') and the Ethics Review Committee. OXP001 delivers 400mg of ibuprofen via the company's OXPzero™ technology and it aims to provide significantly reduced risks of gastrointestinal (GI) side effects for use in the treatment of conditions requiring the chronic use of NSAIDs.
NSAIDs are one of the most widely used classes of drugs, with more than 30 million users worldwide consuming NSAIDs each day. However, chronic use of NSAIDs causes well documented GI side effects including ulcers and bleeding and lead to significant morbidity and mortality in many patients.
Marcelo Bravo, Chief Technology Officer commented
"Securing regulatory approval for our initial in-human clinical trial has achieved another important milestone in the development of safer NSAIDs via our OXPZero technology.
We are extremely excited about reaching this milestone as this is the first product of its kind featuring the OXPzero™ technology which has a dual mode of action to significantly reduce gastrointestinal side effects and will offer a new treatment option for those patients taking NSAIDs long term."
The pilot clinical study will be a two arm study between OXP001 and reference Ibuprofen 400 mg tablets in a total of 44 healthy adults and will assess the incidence of upper gastrointestinal irritation via endoscopy. Patient recruitment will start shortly aiming to dose the first patient early in March. Further details about the clinical trial are available via www.clinicaltrials.gov.
For further information:
Oxford Pharmascience Group Plc
Nigel Theobald, Chief Executive +44 207 554 5875
N+1 Singer
Shaun Dobson +44 20 7496 3000
About Oxford Pharmascience Group Plc
Oxford Pharmascience Group Plc uses a range of proprietary technology platforms to re-develop existing medicines to make them better, safer or easier to take. The Company does not manufacture or sell its own pharmaceutical products direct to consumers but instead seeks to license its technologies and dossiers to a network of partners, mainly leading pharmaceutical companies with Rx (prescription) and OTC (Over the Counter) branded portfolios.
Oxford Pharmascience Group Plc focuses on existing medicines that are proven to be safe and effective but nevertheless still have associated issues and side effects often affecting compliance. By working with such medicines the Company is able to develop new innovative products for a fraction of the cost, in much quicker timescales and without the high risk of failure associated with developing new drugs.
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