Midatech Pharma PLC Midatech submits MTD201 CTA filing (6633P)
04 September 2017 - 4:00PM
UK Regulatory
TIDMMTPH
RNS Number : 6633P
Midatech Pharma PLC
04 September 2017
4 September 2017
Midatech Pharma PLC
("Midatech", "Company" or "Group")
Midatech submits MTD201 CTA filing for first in human study in
carcinoid cancer and acromegaly
Midatech on track to start clinical development with MTD201 in
Q4 2017
Midatech Pharma (AIM: MTPH, Nasdaq: MTP), the international
specialty pharmaceutical company focused on developing and
commercialising products in oncology, today announces submission of
a clinical trial application (CTA) for a first in human study of
its MTD201 programme in carcinoid cancer and acromegaly. The
Company expects to enter the clinic in Q4 2017, pending the
regulatory approval to conduct the clinical trial which is expected
shortly.
These indolent and rare hormone tumour diseases cause
debilitating morbidity and mortality for patients, and it is
anticipated that MTD201 will provide a much-needed addition to the
choice of therapies available to patients, physicians, and payors.
MTD201 uses Midatech's innovative sustained release platform to
produce a long-acting dose of octreotide, a somatostatin analogue
treatment for these tumours being developed as an alternative
version of the commercially available product, Sandostatin(R) LAR
(SLAR). The market for octreotide is estimated to be $2bn
globally(1) .
MTD201 is manufactured using Midatech's proprietary Q-Sphera
microsphere platform which uses micro-fluidic technology to produce
a precision sustained release particle formulation. The study aims
to establish that MTD201 is interchangeable with SLAR
pharmacokinetically and/or pharmacodynamically and, by
extrapolation, that it will achieve equivalent therapeutic control
of growth hormone whilst providing an alternative to SLAR in
patients with active acromegaly. The study is expected to complete
in the first half of 2018. The potential benefits of MTD201 versus
SLAR include interchangeability, faster and simpler reconstitution
with fewer errors and less wastage, reduced pain on injection due
to a smaller syringe needle and volume injected, and improved
economics.
Dr Jim Phillips, Chief Executive Officer of Midatech Pharma,
said: "MTD201 will provide a much-needed addition to currently
available therapies for the treatment of carcinoid cancer and
acromegaly. This clinical trial is the culmination of more than
five years of development and is a key value inflection point for
our proprietary sustained release technology platform as it moves
into the clinic for the first time on track for Q4 2017. We have
seen compelling data for MTD201 in pre-clinical models, and we are
excited by the potential for this to be evidenced in patients as
well."
(1) Novartis.com; Ipsen.com
- Ends -
For more information, please contact:
Midatech Pharma PLC
Jim Phillips, CEO
Tel: +44 (0)1235 841575
www.midatechpharma.com
Panmure Gordon (UK) Limited (Nominated Adviser and Broker)
Corporate Finance
Freddy Crossley / Duncan Monteith
Broking
Tom Salvesen
Tel: +44 (0)20 7886 2500
Consilium Strategic Communications (Financial PR)
Mary Jane Elliott / Ivar Milligan / Philippa Gardner
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 US
commercial operation marketing four cancer care supportive
products, and co-promoting two others. Midatech's strategy is to
internally develop oncology products and collaborate with partners
in other therapy areas, and to drive growth both organically and
through strategic acquisitions. The Company's R&D activities
are supported by two breakthrough drug delivery technologies:
Q-Sphera for sustained release and our proprietary gold
nanoparticles. The Group, listed on AIM: MTPH and Nasdaq: MTP,
employs c.110 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 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 company news service from the London Stock Exchange
END
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