Oxford Pharmascience Group PLC Company Update (3020U)
January 17 2017 - 1:00AM
UK Regulatory
TIDMOXP
RNS Number : 3020U
Oxford Pharmascience Group PLC
17 January 2017
Technical, Clinical and Regulatory Update
Oxford Pharmascience Group plc (AIM: OXP), the specialty
pharmaceutical company that redevelops medicines to make them
better, safer and easier to take, provides the following
update.
Highlights
-- Dosing commenced in the Phase I exploratory pharmacokinetic
(PK) study designed to confirm improved release properties of
OXPzero(TM) Ibuprofen
-- Confirmation that FDA responses on US regulatory pathway for
OXPzero(TM) Ibuprofen over-the-counter (OTC) and prescription (Rx)
categories are expected during Q1 2017
-- Successful manufacturing process validation of OXPzero(TM) Ibuprofen at intermediate scale
-- Further NSAID*, OXPzero(TM) Ketorolac, successfully synthesised at laboratory scale
-- Remains well funded to pursue strategy, with circa GBP21.9 million net cash at year end
As reported on 9 November 2016, the Company had completed
laboratory work to identify modifications to the OXPzero(TM)
technology platform that alter the release properties and enable
faster release of the NSAID. Evaluation of the modified OXPzero(TM)
Ibuprofen technology modifications in an in vitro gastric cell
model developed by the University of Newcastle has shown that the
modifications did not cause diminution in the viability of gastric
cells. Therefore it is considered likely that the beneficial
gastrointestinal effect of the OXPzero(TM) technology is preserved
in the modified version(s).
Accordingly, the Company is now pleased to announce that dosing
of healthy subjects in its Phase I exploratory PK study "OAT-01"
has begun. OAT-01 is a three-part, open label, active controlled,
crossover study designed to assess the PK profile of the lead
OXPzero(TM) Ibuprofen technology modifications against licensed
ibuprofen products to verify that the improvements in speed of
ibuprofen release seen in the lab studies translate into in vivo
improvements. Further details on the study can be found at
ClinicalTrials.gov NCT02974361. Dosing of all three study parts is
due to be completed by the end of Q2 2017, with first readouts
expected no later than Q2 2017.
The Company also announces that pre-IND** packages have been
submitted to the FDA for both OXPzero(TM) Ibuprofen OTC and Rx
programmes. The FDA has indicated that its formal feedback will be
provided during Q1 2017 in written format only. Clarity on the
regulatory pathway is expected to further facilitate partnering
discussions for the key US market.
The Company is also pleased to announce that it has successfully
synthesised a further NSAID molecule, ketorolac, at laboratory
scale. Ketorolac is an NSAID in the family of heterocyclic acetic
acid derivatives which is used for moderate-to-severe pain, often
prescribed in place of opioids. The use of ketorolac is heavily
restricted (to not more than five days) due to the potential of
increasing the frequency and severity of adverse reactions which
include gastro-intestinal bleeding. The Company believes that a
safer version of ketorolac would be an effective alternative or
complement to opioids in certain clinical settings.
In addition to the above developments, the Company has also
completed intermediate scale process validation of OXPzero(TM)
Ibuprofen. Three batches of 40 kilogrammes have been produced by
the Company's contract manufacturer Dipharma Francis S.r.l. This is
a significant achievement giving confidence that OXPzero(TM)
products can be manufactured effectively at commercial scale and
cost.
The Company continues in dialogue with prospective partners
regarding these developments with a view to commercializing its
OXPzero(TM) assets. Updates will be provided as required.
As at 31 December 2016, the Company had net cash of circa
GBP21.9 million and remains well funded to pursue its strategy.
Commenting on the progress, CEO Marcelo Bravo said:
"We have focused on clinical and regulatory activities
identified in our commercial interactions last year as being
important to partners and we are pleased with the progress achieved
in the past weeks. In parallel to these, our dialogue with
prospective licence partners for our NSAID technology and assets
continues, with a focus on prescription markets."
This announcement contains inside information.
*NSAID - non-steroidal anti-inflammatory drug
** IND - refers to the Initial New Drug application which is
required by the FDA before any US clinical trials can commence
For further information please contact:
Oxford Pharmascience Group Plc
Marcelo Bravo, Chief Executive +44 20 7554 5875
N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell/Lauren Kettle +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.
About OXPzero(TM) NSAIDs
Specifically, by comparison with generic NSAIDs, OXPzero(TM)
Ibuprofen and OXPzero(TM) Naproxen are milder in the GI tract,
delivering major reduction in severe GI mucosal damage,
significantly mask the bitter taste/burn associated with NSAIDs,
and deliver an attractive pharmacokinetic profile with adaptable
drug release properties.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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