TIDMMTPH
RNS Number : 6516O
Midatech Pharma PLC
21 May 2018
21 May 2018
Midatech Pharma PLC
("Midatech", "Company" or "Group")
Midatech commences equivalence study in exploratory phase of
Q-Octreotide (MTD201) for carcinoid cancer and acromegaly
- Initial dosing administered in potentially pivotal phase for
core near-to-market oncology asset
Midatech (AIM: MTPH, Nasdaq: MTP), the international specialty
pharmaceutical company focused on developing and commercialising
products in oncology and immunotherapy, today announces that it has
commenced initial dosing in the first in-human study of the
Company's sustained release product Q-Octreotide (MTD201) for the
treatment of carcinoid cancer and acromegaly, two rare and
debilitating hormone-based tumours with high mortality and
morbidity rates.
The clinical equivalence study is being conducted in 24 healthy
subjects in a double-blind, randomised, parallel group protocol to
evaluate the interchangeability between Q-Octreotide and the
reference product, Sandostatin(R) LAR(R) ("SLAR"), following single
dose administration. The aim is to establish equivalence of
Q-Octreotide with SLAR, and to show that it can achieve safe and
effective growth hormone levels in patients. The Company expects
data for this study to be available in the second half of 2018 and
intends to expand the study into a pivotal registration study, of
similar design in up to 100 subjects, to complete in the first half
of 2019.
The Company is seeking the same marketing product label
indications as SLAR. Moreover, the Company plans to highlight the
potential advantages of Q-Octreotide with prescribers and
regulators. These advantages, made possible by Midatech's novel
sustained release microsphere (Q-Sphera) technology, include:
improved speed and simplicity of reconstitution along with fewer
errors, a less painful injection with fewer blockages, minimal
wastage with fewer repeat injections and errors, and improved
economics.
Pending positive clinical data showing equivalence and
completion of commercial scale manufacture requirements, the
Company expects to file for marketing authorisation with the U.S.
Food and Drug Administration (FDA) in 2020. The Company believes
Q-Octreotide could capture up to 5% of the $2 billion annual market
for SLAR(1) .
Midatech's CEO-designate, Dr Craig Cook, commented: "We are
pleased to initiate this key study for one of our core programmes
in oncology, MTD201, which also represents an important milestone
for our sustained release Q-Sphera technology and its potential use
in future products. Having resolved important manufacturing
challenges and requirements, and incorporated invaluable regulatory
authority feedback into the program design, we are confident that
we have a robust study which will provide meaningful data on MTD201
in the second half of this year. Our pre-clinical data so far
illustrates the interchangeability as well as numerous benefits of
Q-Octreotide as a therapy for the debilitating and lethal diseases
of carcinoid cancer and acromegaly versus the standard of care. We
are working hard to bring this product to market to offer patients,
physicians and payors an alternative choice for treating these
diseases."
(1) www.novartis.com; www.ipsen.com
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR).
- Ends -
For more information, please contact:
Midatech Pharma PLC
Craig Cook, CEO-designate
Nick Robbins-Cherry, CFO
Tel: +44 (0)1235 888 300
www.midatechpharma.com
Panmure Gordon (UK) Limited (Nominated Adviser and Broker)
Freddy Crossley / Emma Earl / Ryan McCarthy
Tel: +44 (0)20 7886 2500
Consilium Strategic Communications (Financial PR)
Mary Jane Elliott / Ivar Milligan / Nicholas Brown
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 the research and development of a pipeline of medicines
for oncology and immunotherapy. Midatech's strategy is to
internally develop oncology products, and to drive growth both
organically and through strategic acquisitions. The Company's
R&D activities are focused on three innovative platform
technologies to deliver drugs at the "right time, right place":
gold nanoparticles ("GNPs") to enable targeted delivery; Q-Sphera
polymer microspheres to enable sustained release ("SR") delivery;
and Nano Inclusion ("NI") to provide local delivery of
therapeutics, initially to the brain. Midatech Pharma US is the
Group's US commercial operation, with four cancer supportive care
products and two further co-promoted products. The Group, listed on
AIM: MTPH and Nasdaq: MTP, employs c.100 staff in four countries.
For further company information see: www.midatechpharma.com
About carcinoid cancer and acromegaly
Carcinoid cancer is a cancer of the neuroendocrine system in
which tumours can grow in various regions of the body. Around
15,000 people are diagnosed with carcinoid tumours every year in
the UK and the US.(2 3) Acromegaly is an endocrine system disorder
which develops when the pituitary gland produces excessive amounts
of growth hormone. Around 4 people per million are diagnosed with
acromegaly annually.(4) Both conditions are rare and have high
mortality and morbidity rates.
(2) www.cancerresearchuk.org
(3) www.cancer.net
(4) www.pmj.bmj.com
Forward-Looking Statements
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 conditions using the nanoparticle and
sustained release drug delivery platforms, 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 news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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