Midatech Pharma Plc: Midatech submits MTD201 CTA filing for first in human study in carcinoid cancer and acromegaly
September 04 2017 - 7:01AM
4 September 2017Midatech 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® LAR
(SLAR). The market for octreotide is estimated to be $2bn
globally1.
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 PLCJim Phillips, CEOTel:
+44 (0)1235 841575www.midatechpharma.com
Panmure Gordon (UK) Limited (Nominated
Adviser and Broker)Corporate FinanceFreddy Crossley /
Duncan MonteithBrokingTom SalvesenTel: +44 (0)20 7886
2500
Consilium Strategic Communications (Financial
PR)Mary Jane Elliott / Ivar Milligan / Philippa GardnerTel: +44
(0)20 3709 5700Email: midatech@consilium-comms.com
Westwicke Partners (US Investor
Relations)Chris BrinzeyTel: +1 339 970 2843Email:
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 StatementCertain
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.
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