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Appointment of CRO for Safestat pilot study

30th Apr 2014 07:01

RNS Number : 8433F
Oxford Pharmascience Group PLC
30 April 2014
 



Oxford Pharmascience Group plc("Oxford Pharmascience" or "the Company")Appointment of contract research organisation for Safestat™ pilot study

Oxford Pharmascience progresses towards clinical proof of concept study with its OXP003 Safestat™ atorvastatin product and appoints Quotient Clinical to undertake its early clinical development program

Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces that it has reviewed its proposed initial clinical development programme for its Safestat™ atorvastatin product with the Medicines and Healthcare Products Regulatory Agency ("MHRA") using the Scientific Advice Scheme* and has appointed Quotient Clinical to conduct the proof of concept study with this novel drug delivery technology.

The Company has completed initial formulation development of Safestat™, its colon targeted drug delivery formulation of atorvastatin and is proceeding towards clinical proof of concept testing. A critical milestone for the Company was to seek feedback on the proposed clinical programme via a Scientific Advice meeting with the MHRA. Following successful completion of this milestone, the Company has appointed Quotient Clinical as its clinical partner. The initial proof of concept study aims to demonstrate the colon delivery of atorvastatin will reduce Cytochrome P450 ("CYPP450") metabolism and hence increase efficacy and improve safety of atorvastatin through reduced inter and intra-patient variability and lower risk of drug-drug interactions with medications that are CYP450 inhibitors.

Statins are the first line treatment for the reduction of cholesterol in the fight against cardiovascular disease. Atorvastatin is a commonly prescribed statin, however it also has numerous side effects resulting in poor patient compliance such as myopathy (muscle dysfunction). Although the global statins market, valued at $20.5 billion in 2011, is declining due to the introduction of generics it is forecast to be one of the largest drug categories with global sales of over $12 billion by 2018 (source: Evaluate Pharma- Statins market to 2018, April 2014). The company is applying advanced targeted delivery to the colon technology to develop a safer, less variable drug delivery solution for atorvastatin.

Dr.Liz King, Director of Research & Development at Oxford Pharmascience commented, "Participating in the Scientific Advice programme of the MHRA and appointing Quotient Clinical are key milestones that enable us to proceed with confidence to the next stage of development for our statins programme. We plan to initiate subject screening for our proof of concept study with atorvastatin by the end of 2014, with results due in spring 2015".

Mark Egerton, Chief Executive Officer, Quotient Clinical commented "Quotient is delighted to be working with Oxford Pharmascience to investigate the potential for Safestat™ to deliver superior statin products with better safety profiles, which will represent a significant step forward for patients."

*Companies seeking scientific advice should note that any scientific advice given is not legally binding with regard to any future application of the product concerned, neither on the part of MHRA/CHM nor on the company. Furthermore, advice cannot be taken as indicative of any future agreed position

 

For further information:

 

Oxford Pharmascience Group Plc

Marcelo Bravo, Chief Executive +44 20 7554 5875

 

N+1 Singer (Nominated Adviser & Broker)

Aubrey Powell/Jen Boorer +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.

 

 

 

This information is provided by RNS
The company news service from the London Stock Exchange
 
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