N4 Pharma PLC Update on Toxicity Testing of Nuvec® Particles (6506J)
June 30 2017 - 1:00AM
UK Regulatory
TIDMN4P
RNS Number : 6506J
N4 Pharma PLC
30 June 2017
30 June 2017
N4 Pharma Plc
("N4 Pharma" or the "Company")
Update on toxicity testing of nuvec(R) particles
N4 Pharma Plc (AIM: N4P), a specialist pharmaceutical company
which reformulates existing drugs and vaccines to improve their
performance, is pleased to announce the latest research results for
its nuvec(R) nanoparticles which it is developing as a delivery
system for DNA and mRNA vaccines and therapeutics.
Toxicity Study Results
The objective of this study (funded via a biomedical Catalyst
grant) was to assess the systemic tolerability of the nuvec(R)
Silica nanoparticles when administered as a single dose via
subcutaneous injection to rats, a standard non-clinical species for
such studies.
Animals were dosed once with 50, 150, 400 or 900 mg/kg
nanoparticles, and then observed for 14 days. Clinical
observations, body weights and food consumption were recorded,
blood plasma samples were analysed for clinical pathology and
selected common target organs were examined microscopically.
The nanoparticles did not cause any systemic toxicity and all
organs examined microscopically were normal, including at the
highest dose, which is likely to be many times in excess of the
concentrations that might be administered to humans. While there
was some mild to moderate inflammation observed at the injection
sites at all doses, these were non-specific and generally
indicative of local inflammation.
According to the board certified pathologist used in the study,
these were similar to that which would be expected following
implantation of a medical device or as a result of injecting a
vaccine and would almost certainly resolve over time.
In conclusion, a single subcutaneous administration of the
nuvec(R) nanoparticles to rats did not cause any toxicological
effects considered likely to be of long term concern.
ApconiX Limited, the Company's partners in these studies, have
approved this as an accurate reflection of the results
observed.
Following these results, further in vivo studies to demonstrate
the transfection capability of the Company's nuvec(R) particles
will be performed.
Nigel Theobald, CEO of N4 Pharma, commented:
"We continue to make good progress demonstrating the capability
of our nuvec(R) vaccine delivery system.
We have already demonstrated its transfection capability
compared to standard industry in vitro techniques (lipofectamine)
and it is important we undertake studies to further show we can
achieve transfection in an in vivo environment. Whilst there remain
several important steps before we can demonstrate the suitability
of our nuvec(R) system to our potential commercial partners, the
fact that we can show there is no systemic toxicity is a very
important hurdle to overcome.
We will provide further updates as each step of the program
develops."
Enquiries:
N4 Pharma Via Alma PR
CEO, Nigel Theobald
Stockdale Securities Tel: +44(0)207 601
Tom Griffiths 6100
Beaufort Securities Tel: +44(0)207 382
Elliot Hance 8300
Alma PR Tel: +44(0)778 090
Josh Royston 1979
Robyn Fisher Tel: +44(0)754 070
6191
About N4 Pharma
N4 Pharma was formed in 2014 by Nigel Theobald, the former Chief
Executive of AIM quoted Oxford Pharmascience Group plc. It is a
specialist pharmaceutical company which reformulates existing drugs
and vaccines to improve their performance.
N4 Pharma's reformulation work falls under two divisions:
-- generic, already commercialised, drugs; and
-- delivery of novel and existing vaccines.
N4 Pharma has identified a number of established drugs that
could be improved upon through its reformulation techniques. N4
Pharma's most advanced reformulation is for sildenafil, widely
marketed as Viagra, where N4 Pharma is seeking to improve the speed
at which the drug takes effect whilst also extending its duration
of action.
N4 Pharma's reformulation approach should take approximately
three years to obtain regulatory approval as opposed to the
traditional process for new drugs of on average ten years. The cost
and risk profile of this model is also significantly less than the
traditional process. N4 Pharma's business model is to take
reformulated drugs from its portfolio through to the stage where it
will license its newly reformulated drugs to pharmaceutical
companies to commercialise them. N4 Pharma's revenues should be
derived from up front milestone and royalty payments associated
with the licence.
About ApconiX
ApconiX is a specialist pre-clinical toxicology consultancy
based in Biohub at Alderley Park
This information is provided by RNS
The company news service from the London Stock Exchange
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