TIDMMTPH
RNS Number : 7105Q
Midatech Pharma PLC
08 June 2018
8 June 2018
Midatech Pharma PLC
("Midatech", "Company" or "Group")
Midatech Pharma US enrols first patient in Gelclair(R) trial in
stem cell transplant
- Patients now being enrolled at the Dana-Farber/Brigham and
Women's Cancer Center and Massachusetts General Hospital
Midatech Pharma (AIM: MTPH, Nasdaq: MTP), the international
specialty pharmaceutical company focussed on developing and
commercialising products in oncology and immunotherapy, today
announces that, further to the Group's announcement dated 20
December 2017, patient enrolment is now underway in its Gelclair(R)
Phase IV trial in the US.
The Phase IV trial, which is being conducted at both
Dana-Farber/Brigham and Women's Cancer Centre and Massachusetts
General Hospital by the Group's US subsidiary, Midatech Pharma US,
has enrolled its first patient. The trial has been designed to
study the effects of Gelclair(R) (bioadherent oral gel) on various
aspects of oral mucositis ("OM") in patients undergoing stem cell
transplant therapy ("SCT"). Results from the study will provide
valuable data on the treatment of OM in SCT patients and could
significantly increase the use of Gelclair in the in-hospital
setting.
Up to 20,000 patients annually suffering from illnesses such as
leukemia, lymphoma, or other life-threatening diseases might be
treated with, and benefit from, stem cell transplant therapy. The
most common side effect of SCT is severe OM, an intensely painful
and debilitating inflammation and ulceration of the surface of the
mouth, that can lead to complications such as inability to eat and
increased risk of infection due to open sores in the mucosa. SCT
patients experiencing OM often require supplemental prescription
analgesia products (such as opioids) for pain, and/or parenteral
nutritional therapy to address their eating difficulties; patients
experiencing OM may also require extended time in highly
specialized specialised SCT units until their condition resolves,
leading to significantly higher overall treatment costs.
The primary objective of this blinded, randomised, controlled
study is to confirm the efficacy and tolerability of Gelclair for
the management of OM, and determine the ideal timing for initiation
of therapy in allogeneic stem cell transplant recipients
conditioned with high-dose chemotherapy. Establishing how best to
use Gelclair for the treatment of OM pain as well as its possible
impact on the incidence and severity of OM as compared to the use
of standard of care practices, will enable health care providers to
optimise support for their patients as they manage this common and
traumatising side effect of stem cell transplantation regimens.
Gelclair is the leading gel barrier prescription product
prescribed for OM in the retail sector. Gelclair has been used
effectively on thousands of ambulatory patients who suffer from OM
due to various cancer therapies such as radiation and chemotherapy.
"Oral mucositis is a debilitating side effect often suffered by
patients undergoing stem cell transplantation therapy, resulting in
significant morbidity, pain, and discomfort. The expert treatment
centres at Dana Farber and MGH are renowned for their work in SCT
therapy, and in this regard are already enrolling appropriate
patients for trial participation," said David R. Benharris,
Midatech Pharma US President. "The trial aims to establish how
Gelclair can assist health care professionals and SCT units to
better manage patient care, as well as improve upon the health care
economics, relative to the treatment of oral mucositis, which is
commonly seen in this patient population."
Midatech expects to complete patient enrolment in mid-2019.
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
+44 (0)1235 888300
www.midatechpharma.com
Panmure Gordon (UK) Limited (Nominated Adviser and Broker)
Freddy Crossley / Emma Earl / Ryan McCarthy
+44 (0)20 7886 2500
Consilium Strategic Communications (Financial PR)
Mary Jane Elliott / Ivar Milligan / Nicholas Brown
+44 (0)20 3709 5700
midatech@consilium-comms.com
Westwicke Partners (US Investor Relations)
Chris Brinzey
+1 339 970 2843
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
Midatech has licensed the exclusive rights to promote and sell
Gelclair(R) in the United States from Helsinn Healthcare S.A.
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,
sustained release drug delivery or Nano Inclusion 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
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END
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