TIDMMTPH
RNS Number : 5339Y
Midatech Pharma PLC
18 May 2016
Midatech Pharma PLC
("Midatech" or the "Company")
Midatech Pharma announces clinical pipeline update
Midatech Pharma (AIM: MTPH; Nasdaq: MTP), the international
specialty pharmaceutical company focused on commercialising and
developing products in oncology and other therapeutic areas, today
announces an update on its clinical pipeline developments.
Midatech is working on eight internal research and development
projects, including using its proprietary gold nanoparticle (GNP)
and Q Chip technologies, in three distinct markets; oncology,
immunology and CNS/ocular. It also has multiple partnerships across
a further five development programmes, and is growing revenues from
its marketed product portfolio in the United States.
Low bioavailability results from MTD101 Phase IIa trial
MTD101 (Midaform) failed to demonstrate the release profile seen
in prior studies
MTD101 is a self-dissolving, oral, postage stamp-sized strip
containing GNP conjugated insulin for transbuccal delivery. The
oral delivery system used for this trial was a novel and unique
application of Midatech's GNP technology and is not used in the
Company's other GNP programs; all other GNP programs delivered via
injection.
A recently completed Phase IIa study with 12 patients assessed
the pharmacokinetics and pharmacodynamics of insulin delivered
using a non-injected, oral, self-dissolving, transbuccal strip
platform of Midatech's GNP against sub-cutaneous insulin. The low
bioavailability results vs sub-cutaneous insulin that were seen in
the study will lead Midatech and its joint venture partner, MonoSol
Rx, to begin the process of evaluating strategic options for this
programme.
Midatech's MTX110 oncology candidate for DIPG expands treatment
on a compassionate basis
Increasing potential for fast tracked project to market for
Midatech
Diffuse Intrinsic Pontine Glioma (DIPG) is an ultra-rare
childhood tumour with between 300 to 1,000 recorded global cases
per year with a current survival rate of almost zero. Midatech has
used its expertise in drug development and nanotechnology to
rapidly advance this programme approximately one year ahead of
schedule.
Midatech today announces that a second patient has been dosed
with the Company's MTX110 treatment for DIPG and that the programme
continues to show promising potential. A regulatory meeting has
been held to explore a potential route to market in Europe and
Midatech is on course to submit a Clinical Trial Application in
2016. Until then, Midatech is supplying the treatment on a named
patient basis in the UK and is preparing for additional patient
treatments.
Within the United States, interest in using the treatment at
other centres is under evaluation with the FDA.
Preparation for commencement of dosing in Phase I immunotherapy
trial
First immunotherapy study to be initiated by Midatech with
applicability in oncology
Preparations are being made and the Company is on track to
commence dosing in a first-in-human clinical trial for its
collaborative innovative vaccine against type 1 diabetes, MTX102.
With support from an EU Consortium grant, the study, running in the
UK and Sweden, will commence in June as previously planned. Data
updates from this trial are expected in the second half of
2016.
MTX102 makes use of Midatech's primary platform technology,
using GNPs, which are known to be both safe and inert in vivo. In
this vaccine, which has applicability in oncology, GNPs are
chemically bound to small antigens which generate a tolerogenic
response when injected into the skin, turning down the immune
response against the insulin producing cells, which causes type 1
diabetes. This is the first product of its type that mimics the
natural process of insulin regulation. Discovery, pre-clinical and
toxicology work has already been successfully conducted. Results
from this study are expected in 2017.
Glioblastoma (MTR103) and Hepatocellular (MTR104) carcinoma
candidate selection
IND enabling programs are scheduled to commence
Candidate selection is ongoing with a number of compounds for
the treatment of glioblastoma (brain) and liver cancers and
investigational new drug application (IND) enabling programs are
scheduled to commence at the end of 2016. Midatech has a
collaboration with Dana-Farber Cancer Institute, the principal
teaching Institute of Harvard Medical School in Boston, MA and one
of the premier cancer institutes in the US. Through these
collaborations, the Company has gained access to a robust global
network of clinical expertise which will help determine the best
possible pathways for the application of Midatech's leading GNP
technology.
Q-Octreotide programme (MTD201) for the treatment of acromegaly
and carcinoid syndrome
Pilot preclinical study confirmed the systemic release profile
of Midatech's Q-Octreotide compared favourably with the current
market leader, Sandostatin(R) LAR Depot (Novartis).
MTD201, a sustained release version of Octreotide, is used to
treat the incapacitating symptoms of metastatic carcinoid tumours,
where it suppresses or inhibits the severe diarrhoea and flushing
episodes associated with the disease, and to normalise the
over-production of growth hormone in people suffering acromegaly
who have had inadequate response to other therapies. Recent
preclinical data has showed positive release profile data compared
to Sandostatin LAR. Midatech plans to submit its IND to the FDA and
begin bio-equivalence studies in late 2016.
Commenting on the clinical pipeline developments, Dr. Jim
Phillips, Chief Executive Officer of Midatech Pharma, said: "I am
pleased with the progress we have made across our pipeline in
oncology. We are obviously disappointed by the results in the
insulin MidaSol legacy program, however in the recent Q-Octreotide
and OpsiSporin data we have made significant progress in 2016
validating the clinical platform and we look forward to now
increasing our focus towards oncology, where our technology is
better suited and where we have revenue generating products and
have shown we can reach niche markets."
- ENDS -
For more information, please contact:
Midatech Pharma PLC
Jim Phillips, CEO
Tel: +44 (0)1235 888300
www.midatechpharma.com
Panmure Gordon (UK) Limited (Nominated Adviser and Broker)
Corporate Finance
Freddy Crossley / Atholl Tweedie / Duncan Monteith
Corporate Broking
Tom Salvesen
Tel: +44 (0)20 7886 2500
RBC Europe Limited (Joint Broker)
Paul Tomasic / Rupert Walford / Thomas Stockman / Laura
White
Tel: +44 (0)207 653 4000
Consilium Strategic Communications (Financial PR)
Mary Jane Elliott / Ivar Milligan / Matthew Neal / Hendrik
Thys
Tel: +44 (0)20 3709 5700
Email: midatech@consilium-comms.com
Westwicke Partners (US Investor Relations)
Chris Brinzey
Tel: +1 339 970 2843
Email: chris.brinzey@westwicke.com
Notes for Editors
About Midatech Pharma PLC
Midatech is an international specialty pharmaceutical company
focused on oncology and other therapeutic areas with a commercial
platform and four marketed products in the US. Midatech's strategy
is to develop products in-house in oncology and with partners in
other indications, and to accelerate growth organically and through
strategic acquisitions. The Company's R&D activities are
supported by two breakthrough drug delivery technologies. The
Group, listed on AIM: MTPH and Nasdaq: MTP, employs c.100 staff in
four countries. For further company information see:
www.midatechpharma.com
Forward-Looking Statement
Certain statements in this press release may constitute
"forward-looking statements" within the meaning of legislation in
the United Kingdom and/or United States. Such forward-looking
statements include, but are not limited to, statements regarding
the ability of Midatech to successfully test, manufacture, produce
or commercialize products for DIPG or other conditions using the
nanoparticle drug delivery platform, and the ability for products
in development to achieve positive clinical results, and the
ability to meet or achieve timelines associated with pre-clinical
studies, clinical trials or regulatory submissions. Any
forward-looking statements are based on currently available
competitive, financial and economic data together with management's
views and assumptions regarding future events and business
performance as of the time the statements are made and are subject
to risks and uncertainties. We wish to caution you that there are
some known and unknown factors that could cause actual results to
differ materially from any future results, performance or
achievements expressed or implied by such forward-looking
statements.
Reference should be made to those documents that Midatech shall
file from time to time or announcements that may be made by
Midatech in accordance with the London Stock Exchange AIM Rules for
Companies ("AIM Rules"), the Disclosure and Transparency Rules
("DTRs") and the rules and regulations promulgated by the US
Securities and Exchange Commission, which contains and identifies
other important factors that could cause actual results to differ
materially from those contained in any projections or
forward-looking statements. These forward-looking statements speak
only as of the date of this announcement. All subsequent written
and oral forward-looking statements by or concerning Midatech are
expressly qualified in their entirety by the cautionary statements
above. Except as may be required under the AIM Rules or the DTRs or
by relevant law in the United Kingdom or the United States,
Midatech does not undertake any obligation to publicly update or
revise any forward-looking statements because of new information,
future events or otherwise arising.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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